PB 93 of 2014
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.
Dated 27 November 2014
KIM BESSELL
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health
___________________________________________________________________________
1 Name of Instrument
(1) This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No.9).
(2) This Instrument may also be cited as PB 93 of 2014.
2 Commencement
This Instrument commences on 1 December 2014.
3 Amendments to PB 116 of 2010
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
[1] Part 1, Division 1, Section 4, definition for CAR drug
substitute:
CAR drug (Complex Authority Required drug) means any of the following highly specialised drugs:
(a) abatacept;
(b) adalimumab;
(c) ambrisentan;
(d) azacitidine;
(e) bosentan;
(f) eculizumab;
(g) eltrombopag;
(h) epoprostenol;
(i) etanercept;
(j) iloprost;
(k) infliximab;
(l) ivacaftor;
(m) lenalidomide;
(n) macitentan;
(o) omalizumab;
(p) rituximab;
(q) romiplostim;
(r) sildenafil;
(s) tadalafil;
(t) tocilizumab
[2] Part 1, Division 1, Section 4, definition for eligible patient
substitute:
eligible patient means a person who
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) if receiving treatment at or from a public hospital, is receiving medical treatment by a medical practitioner as:
(i) a non-admitted patient; or
(ii) a day admitted patient; or
(iii) a patient on discharge; or
(iv) an admitted patient who has been prescribed a HSD pharmaceutical benefit referred to in section 9A.
[3] Part 1, Division 2, Section 9
insert after existing text:
9A HSD pharmaceutical benefits which may be supplied to public hospital admitted patients
The HSD pharmaceutical benefits which may be supplied to public hospital admitted patients under this Special Arrangement are referred to in the table below:
(a) if a drug is referred to in the table below and paragraphs (b), (c) and (d) do not apply – all HSD pharmaceutical benefits containing that drug;
(b) if a form of the drug is referred to in the table below and paragraphs (c) and (d) do not apply – all HSD pharmaceutical benefits containing that drug in that form;
(c) if a manner of administration of that form of the drug is referred to in the table below and paragraph (d) does not apply – all HSD pharmaceutical benefits containing that drug in that form with that manner of administration;
(d) if a brand of a drug in that form with that manner of administration is referred to in the table below – that brand of HSD pharmaceutical benefit containing that drug in that form with that manner of administration;
(e) if one or more circumstances and/or purposes code is identified in the table below – the HSD pharmaceutical benefit must be prescribed for one of those circumstances and/or purposes.
Drug
Form
Manner of Administration
Brand
Circumstances
Code
Purposes
Code
eculizumab
Note: A circumstances and/or purposes code mentioned in the above table is the same circumstances and/or purposes code referred to in section 9 (circumstances code) or section 14 or section 15 (purposes code).
[4] Part 2, Division 1, Section 17
insert after existing text:
17A Modified application of paragraph 92A(1)(f) conditions of approval
(1) Section 8 of the conditions of approval for approved pharmacists under paragraph 92A(1)(f) of the Act does not apply to the supply of a HSD pharmaceutical benefit, once prepared as a final product ready for infusion to a person, when the HSD pharmaceutical benefit has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less.
(2) For the purposes of this section, shelf life means the period of time that a medicine can be stored and still be considered safe and effective for use.
[5] Part 2, Division 3, Section 22
insert after existing text:
22A Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have non-CAR drugs
(1) If an eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit has a non-CAR drug, then either the:
(a) eligible medical practitioner; or
(b) approved hospital authority treating the eligible patient;
must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes.
(2) These records must be kept for 2 years after the date the prescription to which the records relate is written.
[6] Part 2, Division 4, Section 23
insert after existing text:
23A Information to be kept for prescription of HSD pharmaceutical benefits referred to in section 9A that have CAR drugs
(1) If an eligible medical practitioner prescribes a HSD pharmaceutical benefit referred to in section 9A for supply under Part VII of the Act, and that HSD pharmaceutical benefit has a CAR drug, then either the:
(a) eligible medical practitioner; or
(b) approved hospital authority treating the eligible patient;
must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes.
(2) These records must be kept for 2 years after the date the prescription to which the records relate is written.
[7] Schedule 1, entry for Abatacept
omit from the column headed “Circumstances”: C3712 C3796 C3797 substitute: C4694 C4695 C4734 C4742 C4768
[8] Schedule 1, entry for Adefovir in the form Tablet containing adefovir dipivoxil 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
APO-Adefovir
TX
EMP
C3971 C3972 C3973 C3974
60
5
D
[9] Schedule 1, entry for Deferiprone in each of the forms: Tablet 500 mg; and Oral solution 100 mg per mL, 250 mL
omit from the column headed “Responsible Person”: OA substitute: TX
[10] Schedule 1, after entry for Doxorubicin Pegylated Liposomal
insert:
Eculizumab
Solution concentrate for I.V. infusion 300 mg in 30 mL
Injection
Soliris
XI
EMP
C4667 C4668 C4691 C4692 C4708 C4712 C4713 C4725 C4732 C4733 C4750 C4760 C4761 C4767
P4733 P4760
1
0
D
C4667 C4668 C4691 C4692 C4708 C4712 C4713 C4725 C4732 C4733 C4750 C4760 C4761 C4767
P4732 P4761
1
4
D
C4667 C4668 C4691 C4692 C4708 C4712 C4713 C4725 C4732 C4733 C4750 C4760 C4761 C4767
P4667 P4668 P4691 P4692 P4708 P4712 P4713 P4725 P4750 P4767
1
5
D
[11] Schedule 1, entry for Etanercept in the forms: Injections 50 mg in 1 mL single use pre-filled syringes, 4; and Injection 50 mg in 1 mL single use auto injector, 4
omit from the column headed “Circumstances”: C4484 substitute: C4461 C4486 C4487 C4540
[12] Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg [Maximum Quantity: 1; Number of Repeats: 0]
(a) omit from the column headed “Circumstances”: C3710
(b) omit from the column headed “Circumstances”: C3813 C3814
(c) insert in numerical order in the column headed “Circumstances”: C4698 C4705 C4714 C4715 C4716 C4717 C4718 C4738 C4762
(d) omit from the column headed “Purposes”: P3710
(e) omit from the column headed “Purposes”: P3813 P3814
(f) insert in numerical order in the column headed “Purposes”: P4698 P4705 P4714 P4715 P4716 P4717 P4718 P4738 P4762
[13] Schedule 1, entry for Infiximab in the form Powder for I.V. infusion 100 mg [Maximum Quantity: 1; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C3710
(b) omit from the column headed “Circumstances”: C3813 C3814
(c) insert in numerical order in the column headed “Circumstances”: C4698 C4705 C4714 C4715 C4716 C4717 C4718 C4738 C4762
[14] Schedule 1, entry for Infiximab in the form Powder for I.V. infusion 100 mg [Maximum Quantity: 5; Number of Repeats: 1]
(a) omit from the column headed “Circumstances”: C3710
(b) omit from the column headed “Circumstances”: C3813 C3814
(c) insert in numerical order in the column headed “Circumstances”: C4698 C4705 C4714 C4715 C4716 C4717 C4718 C4738 C4762
[15] Schedule 1, after entry for Interferon Gamma 1b
insert:
Ivacaftor
Tablet 150 mg
Oral
Kalydeco
VR
EMP
C4735 C4743 C4769
56
5
D
[16] Schedule 1, entry for Omalizumab
omit:
Powder for Injection 150 mg with Diluent
Injection
Xolair
NV
EMP
C3740 C3742 C3822
See Note 1
See Note 2
D
[17] Schedule 1, entry for Rituximab
omit from the column headed “Circumstances”: C3720 C3823 C3824 substitute: C4740 C4741 C4753
[18] Schedule 1, after entry for Sildenafil
insert:
Simeprevir
Capsule 150 mg (as sodium)
Oral
Olysio
JC
EMP
C4669 C4684 C4758 C4759
42
0
D
[19] Schedule 1, entry for Tocilizumab in each of the forms: Concentrate for injection 80 mg in 4 mL; Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL
(a) omit from the column headed “Circumstances”(in all instances): C3716 C3825 C3826
(b) insert in numerical order in the column headed “Circumstances”: C4672 C4673 C4688 C4729 C4730
[20] Schedule 2, after details relevant to Responsible Person code VI
insert:
VR
Vertex Pharmaceuticals (Australia) Pty Ltd
34 160 157 157
[21] Schedule 2, after details relevant to Responsible Person code XA
insert:
XI
Alexion Pharmaceuticals Australasia Pty Ltd
59 132 343 036
[22] Schedule 3, entry for Abatacept
substitute:
Abatacept
C4694
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months).
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion. Up to a maximum of 4 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to a treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures
C4695
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply.
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures
C4734
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply.
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures
C4742
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with this drug for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
If methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion. Up to a maximum of 4 repeats will be authorised.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Applications for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.
Compliance with modified Authority Required procedures
C4768
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with this drug must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
Compliance with modified Authority Required procedures
[23] Schedule 3, after entry for Doxorubicin Pegylated Liposomal
insert:
Eculizumab
C4667
P4667
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment – beyond initial 48 weeks of treatment
Patient must have received 48 weeks of treatment under Initial treatment-New patient, Initial treatment-Balance of supply and Continuing treatment-New patient with PBS-subsidised eculizumab for this condition; AND
Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND
Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40%; OR
Patient must have severe TMA-related neurological impairment; OR
Patient must have severe TMA-related gastrointestinal impairment; OR
Patient must have severe TMA-related pulmonary impairment; OR
Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 ml/min); AND
Patient must not receive more than 24 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment; and
(6) Evidence that the patient has had a treatment response including haematological results of no more than 1 month old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 month old at the time of application; and
(7) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(8) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4668
P4668
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial 3 - Grandfather eculizumab patients
Patient must have had documented history of active and progressing thrombotic microangiopathy (TMA); AND
Patient must have had documented an ADAMTS-13 activity level consistent with a diagnosis of aHUS; AND
Patient must have received treatment with eculizumab for this condition prior to 1 December 2014; AND
Patient must have received treatment with eculizumab within the last 6 months at the time of application; AND
Patient must have demonstrated on-going treatment response as specified in the Continuing treatment New Patient criteria for PBS-subsidised treatment with eculizumab for this condition, if the patient has received adequate therapy in order to demonstrate response; AND
Patient must not have experienced treatment failure with eculizumab for this condition as specified in the Continuing treatment New Patient criteria for PBS-subsidised treatment with eculizumab for this condition; AND
Patient must have clinical features of active organ damage or impairment at the time of a diagnosis of aHUS episode that required treatment with eculizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L ; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(2) tissue biopsy confirming TMA in patients who don t have evidence of platelet consumption and haemolysis; AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients ; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for initial PBS-subsidised eculizumab treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application; and
(6) The result of ADAMTS-13 activity on a blood sample at the time this condition was diagnosed; and
(7) Evidence that the patient has previously received treatment with eculizumab for this condition within the last 6 months at the time of application; and
(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; or clinical reasons to justify the commencing of treatment with PBS-subsidised eculizumab; and
(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(10) A confirmed negative STEC (Shiga toxin-producing E.Coli) result if available at the time of diagnosis; or evidence that the diagnosis was not associated with an infection; and
(11) Where available in the week prior to commencing eculizumab results demonstrating:
(a) a platelet count of less than 150 x10^9/L ; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(b) tissue biopsy confirming TMA in patients who don t have evidence of platelet consumption and haemolysis; AND
(c) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients ; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment ; and
(12) Where available within one month prior to commencement of eculizumab, evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
Compliance with modified Authority Required procedures
C4691
P4691
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment – beyond initial 48 weeks of treatment
Patient must have received 48 weeks of treatment under Initial treatment-New patient, Initial treatment-Balance of supply and Continuing treatment-New patient with PBS-subsidised eculizumab for this condition; AND
Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND
Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40%; OR
Patient must have severe TMA-related neurological impairment; OR
Patient must have severe TMA-related gastrointestinal impairment; OR
Patient must have severe TMA-related pulmonary impairment; OR
Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 ml/min); AND
Patient must not receive more than 24 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment; and
(6) Evidence that the patient has had a treatment response including haematological results of no more than 1 month old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 month old at the time of application; and
(7) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(8) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4692
P4692
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment 2 – Recommencement of treatment after an initial 48-week period
Patient must have demonstrated treatment response to previous 48 weeks of treatment with PBS-subsidised eculizumab for this condition; AND
Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
The authority application must be in writing and must include:
(1) A completed authority prescription form(s); and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Initial treatment 2- Recommencement of treatment after an initial 48-week period; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application, and
(6) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;
(7) Evidence that the patient has had a treatment response to their previous treatment with eculizumab ; and
(8) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(9) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4708
P4708
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment – following recommencement of treatment after an initial 48-week period
Patient must have received Initial treatment 2-recommencement of treatment after an initial 48-week period with PBS-subsidised eculizumab for this condition; AND
Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS-subsidised eculizumab for this condition; AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and
(6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4712
P4712
Where the patient is receiving treatment at/from a private or public hospital
Continuing treatment – New patient
Patient must have received 24 weeks therapy under the initial restriction with PBS subsidised eculizumab for this condition; AND
Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition; AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure
A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and
(6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4713
P4713
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial 3 - Grandfather eculizumab patients
Patient must have had documented history of active and progressing thrombotic microangiopathy (TMA); AND
Patient must have had documented an ADAMTS-13 activity level consistent with a diagnosis of aHUS; AND
Patient must have received treatment with eculizumab for this condition prior to 1 December 2014; AND
Patient must have received treatment with eculizumab within the last 6 months at the time of application; AND
Patient must have demonstrated on-going treatment response as specified in the Continuing treatment New Patient criteria for PBS-subsidised treatment with eculizumab for this condition, if the patient has received adequate therapy in order to demonstrate response; AND
Patient must not have experienced treatment failure with eculizumab for this condition as specified in the Continuing treatment New Patient criteria for PBS-subsidised treatment with eculizumab for this condition; AND
Patient must have clinical features of active organ damage or impairment at the time of a diagnosis of aHUS episode that required treatment with eculizumab; AND
Patient must not receive more than 24 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L ; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(2) tissue biopsy confirming TMA in patients who don t have evidence of platelet consumption and haemolysis; AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients ; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for initial PBS-subsidised eculizumab treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application; and
(6) The result of ADAMTS-13 activity on a blood sample at the time this condition was diagnosed; and
(7) Evidence that the patient has previously received treatment with eculizumab for this condition within the last 6 months at the time of application; and
(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; or clinical reasons to justify the commencing of treatment with PBS-subsidised eculizumab; and
(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(10) A confirmed negative STEC (Shiga toxin-producing E.Coli) result if available at the time of diagnosis; or evidence that the diagnosis was not associated with an infection; and
(11) Where available in the week prior to commencing eculizumab results demonstrating:
(a) a platelet count of less than 150 x10^9/L ; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(b) tissue biopsy confirming TMA in patients who don t have evidence of platelet consumption and haemolysis; AND
(c) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients ; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment ; and
(12) Where available within one month prior to commencement of eculizumab, evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
Compliance with modified Authority Required procedures
C4725
P4725
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment 2 – Recommencement of treatment after an initial 48-week period
Patient must have demonstrated treatment response to previous 48 weeks of treatment with PBS-subsidised eculizumab for this condition; AND
Patient must not have ever experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must have the following clinical conditions:(i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal;AND(ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
The authority application must be in writing and must include:
(1) A completed authority prescription form(s); and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Initial treatment 2- Recommencement of treatment after an initial 48-week period; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application, and
(6) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;
(7) Evidence that the patient has had a treatment response to their previous treatment with eculizumab ; and
(8) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(9) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4732
P4732
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment 1 – New patient – Balance of Supply
Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
Patient must not receive more than 20 weeks supply under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
ADAMTS-13 activity result must have been submitted to the Department of Human Services. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial Treatment 1 New Patient, ADAMTS-13 activity must have been measured 1-2 weeks following the last plasma exchange or infusion, and must have been submitted to the Department of Human Services within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the two weeks prior to collection of the ADAMTS-13 assay must also have been provided to Department of Human Services
Compliance with modified Authority Required procedures
C4733
P4733
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment 1 – New patient
Patient must have active and progressing thrombotic microangiopathy (TMA); AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND
Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND
Patient must have clinical features of active organ damage or impairment; AND
Patient must not receive more than 4 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L ; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(2) tissue biopsy confirming TMA in patients who don t have evidence of platelet consumption and haemolysis; AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients ; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form- Initial PBS-subsidised eculizumab treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application; and
(6) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay; and
(7) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 1-2 weeks following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to the Department of Human Services within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, under Initial treatment 1-balance of supply; and
(8) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days; and
(9) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within one month of application; and
(10) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application
Compliance with modified Authority Required procedures
C4750
P4750
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment – New patient
Patient must have received 24 weeks therapy under the initial restriction with PBS subsidised eculizumab for this condition; AND
Patient must have demonstrated on-going treatment response of PBS-subsidised eculizumab treatment for this condition; AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure
A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and
(6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
C4760
P4760
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment 1 – New patient
Patient must have active and progressing thrombotic microangiopathy (TMA); AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND
Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND
Patient must have clinical features of active organ damage or impairment; AND
Patient must not receive more than 4 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L ; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; OR
(2) tissue biopsy confirming TMA in patients who don t have evidence of platelet consumption and haemolysis; AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients ; or
(iv) a renal biopsy
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form- Initial PBS-subsidised eculizumab treatment; and
(3) A signed patient acknowledgement or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) A copy of a current Certificate of vaccination; and
(5) A measurement of body weight at the time of application; and
(6) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay; and
(7) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 1-2 weeks following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to the Department of Human Services within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, under Initial treatment 1-balance of supply; and
(8) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days; and
(9) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within one month of application; and
(10) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application
Compliance with modified Authority Required procedures
C4761
P4761
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment 1 – New patient – Balance of Supply
Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
Patient must not receive more than 20 weeks supply under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
ADAMTS-13 activity result must have been submitted to the Department of Human Services. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial Treatment 1 New Patient, ADAMTS-13 activity must have been measured 1-2 weeks following the last plasma exchange or infusion, and must have been submitted to the Department of Human Services within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the two weeks prior to collection of the ADAMTS-13 assay must also have been provided to Department of Human Services
Compliance with modified Authority Required procedures
C4767
P4767
Where the patient is receiving treatment at/from a private or public hospital
Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment – following recommencement of treatment after an initial 48-week period
Patient must have received Initial treatment 2-recommencement of treatment after an initial 48-week period with PBS-subsidised eculizumab for this condition; AND
Patient must have demonstrated ongoing treatment response to the previous 24 weeks of PBS-subsidised eculizumab for this condition; AND
Patient must not have experienced treatment failure with eculizumab including PBS-subsidised eculizumab for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction
Must be treated by a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist, or, must be in consultation with a paediatric nephrologist, a nephrologist, a paediatric haematologist or a haematologist
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: platelet count, haptoglobin, and LDH; AND
(2) One of the following:
a) An increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with eculizumab or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure . A treatment failure is defined as a patient who is:
(1) dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) on dialysis and has been on dialysis for 4 months of the previous 6 months while receiving PBS-subsidised eculizumab and has failed to demonstrate significant resolution of extra-renal complications if originally presented
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment
The authority application must be in writing and must include:
(1) A completed authority prescription form; and
(2) A completed aHUS eculizumab Authority Application Supporting Information Form for Continuing treatment; and
(3) A copy of a current Certificate of vaccination; and
(4) A measurement of body weight at the time of application; and
(5) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application ; and
(6) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved; and
(7) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required
Compliance with modified Authority Required procedures
[24] Schedule 3, entry for Infiximab
(a) omit:
C3710
C3710
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS‑subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
Compliance with modified Authority Required procedures
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with infliximab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 22 weeks of treatment;
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone
(b) omit:
C3813
P3813
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with infliximab; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with infliximab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with infliximab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of infliximab therapy is a 22‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures
C3814
P3814
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS‑subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with infliximab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with infliximab are not eligible to commence treatment with infliximab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with infliximab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised infliximab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised infliximab treatment is a 22‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 22 weeks of treatment;
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures
(c) insert in numerical order following existing text:
C4698
P4698
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing treatment.
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with infliximab; AND
Patient must have received infliximab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction;
AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for single infusion at a dose of 3 mg per kg. Up to a maximum of 2 repeats will be authorised.
All applications for continuing treatment with infliximab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with infliximab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab.
If a patient fails to demonstrate a response to treatment with infliximab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
Compliance with modified Authority Required procedures
C4705
P4705
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply.
Patient must have received insufficient infliximab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient infliximab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 22 weeks treatment; AND
The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures
C4714
P4714
Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Initial treatment (new patient)
Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or specialist paediatric gastroenterologist if aged between 6 to 17 years.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the signed patient acknowledgement.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment. The most recent Mayo clinic, partial Mayo clinic or PUCAI score must be no more than 1 month old at the time of application.
Patients who fail to achieve a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 within the first 12 weeks of receiving this drug for ulcerative colitis, or have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
A partial Mayo clinic or PUCAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
The patient or guardian (required if patient aged 6 to 17 years) must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.
Patients may qualify for PBS-subsidised treatment under this restriction once only.
Compliance with modified Authority Required procedures
C4715
P4715
Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Initial PBS-subsidised treatment of moderate to severe ulcerative colitis in a patient who has previously received non-PBS-subsidised therapy with this drug (grandfather)
Patient must have been receiving treatment with this drug prior to 1 December 2014; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing treatment with this drug; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing treatment with this drug; OR
Patient must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 prior to commencing treatment with this drug; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced treatment with this drug where a Mayo clinic, partial Mayo clinic or PUCAI baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or specialist paediatric gastroenterologist if aged between 6 to 17 years.
Applications for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and baseline Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition and
(ii) the date of commencement of this drug and
(iii) the signed patient acknowledgement.
The current Mayo clinic or partial Mayo clinic or PUCAI assessment must be no more than 1 month old at the time of application. The baseline assessment must be from immediately prior to commencing treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to be sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 2 repeats will be authorised. No applications for increased repeats will be authorised.
The patient or guardian (required if patient aged 6 to 17 years) must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
Compliance with modified Authority Required procedures
C4716
P4716
Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years.
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or specialist paediatric gastroenterologist if aged between 6 to 17 years.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a PUCAI score less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg. Up to a maximum of 2 repeats will be authorised. No applications for increased repeats will be authorised.
Compliance with modified Authority Required procedures
C4717
P4717
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months).
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with infliximab and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised infliximab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised infliximab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised infliximab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab.
If a patient fails to demonstrate a response to a treatment with infliximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures
C4718
P4718
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply.
Patient must have received insufficient infliximab therapy under the Continuing Treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures
C4738
P4738
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must have not failed previous PBS-subsidised treatment with infliximab for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application including severity.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg. Up to a maximum of 3 repeats will be authorised.
Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with infliximab.
Applications for a patient who has received PBS-subsidised treatment with infliximab and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised infliximab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised infliximab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised infliximab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
If a patient fails to demonstrate a response to treatment with infliximab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.
Compliance with modified Authority Required procedures
C4762
P4762
Where the patient is receiving treatment at/from a private or public hospital
Moderate to severe ulcerative colitis
Balance of supply
Patient must have received insufficient therapy with this drug under the Initial treatment (new patient) restriction to complete the 3 doses (i.e. the initial infusion regimen at weeks 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; OR
Patient must have received insufficient therapy with this drug to complete 24 weeks of treatment under the Initial PBS-subsidised treatment restriction for patients who had previously received non-PBS subsidised treatment ( Grandfathered patient); AND
The treatment must provide no more than the balance of up to 3 doses (new patients) or 2 repeats (Continuing patients or Grandfathered patients).
Patient must be 6 years of age or older.
Must be treated by a gastroenterologist (code 87) or a consultant physician [internal medicine specialising in gastroenterology (code 81)] or a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician or specialist paediatric gastroenterologist if aged between 6 to 17 years.
Compliance with modified Authority Required procedures
[25] Schedule 3, after entry for Interferon Gamma 1b
insert:
Ivacaftor
C4735
Where the patient is receiving treatment at/from a private or public hospital
Cystic fibrosis
Continuing treatment
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition
Patient must be 6 years of age or older
Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug
Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation
Dosage of ivacaftor must not exceed the dose of 150 mg twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 28 weeks
Dosage of ivacaftor must not exceed the dose of 150 mg daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib verapamil
Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 8 weeks
Ivacaftor is not PBS-subsidised for this condition as a sole therapy
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, prednisone, rufinamide
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Authority Continuing Application Supporting Information Form; and
(3) the result of a FEV1 measurement performed within one month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and
(4) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(5) a recent sweat chloride result; and
(6) height and weight measurements at the time of application; and
(7) a measurement of number of days of hospitalisation (including hospital in the home) in the previous 6 months
Compliance with modified Authority Required procedures
C4743
Where the patient is receiving treatment at/from a private or public hospital
Cystic fibrosis
Initial treatment - Grandfather patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND
Patient must have received treatment with ivacaftor for this condition prior to 1 December 2014; AND
Patient must have received treatment with ivacaftor within the last 6 months at the time of application; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition
Patient must be 6 years of age or older
Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug
Dosage of ivacaftor must not exceed the dose of 150 mg twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 28 weeks.
Dosage of ivacaftor must not exceed the dose of 150 mg daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib verapamil
Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 8 weeks
Ivacaftor is not PBS-subsidised for this condition as a sole therapy
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, prednisone, rufinamide
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Application Supporting Information Form; and
(3) a signed patient acknowledgement; or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene performed prior to commencing treatment with ivacaftor; and
(5) the result of a FEV1 measurement performed prior to commencing treatment with ivacaftor for this condition; and
(6) the result of a FEV1 measurement performed within a month prior to date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and
(7) evidence that the patient had either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities prior to commencing treatment with ivacaftor for this condition; and
(8) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(9) a copy of sweat chloride result performed prior to commencing treatment with ivacaftor for this condition; and
(10) a recent sweat chloride result prior to commencing PBS-subsidised ivacaftor; and
(11) height and weight measurements at the time of application; and
(12) height and weight measurements performed immediately prior to commencement of ivacaftor; and
(13) a baseline measurement of number of days of hospitalisation (including hospital-in-the home) in the 12 months prior to commencement of ivacaftor; and
(14) a measurement of the number of days of hospitalisation (including hospital-in the home) in the 6 months prior to the date of application; and
(15) dates of prior ivacaftor therapy
Compliance with modified Authority Required procedures
C4769
Where the patient is receiving treatment at/from a private or public hospital
Cystic fibrosis
Initial treatment – New patients
Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND
Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR
Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with standard therapy for this condition
Patient must be 6 years of age or older
Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry
Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug
Dosage of ivacaftor must not exceed the dose of 150 mg twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole
Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 28 weeks
Dosage of ivacaftor must not exceed the dose of 150 mg daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib verapamil
Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets of ivacaftor will last for 8 weeks
Ivacaftor is not PBS-subsidised for this condition as a sole therapy
Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, prednisone, rufinamide
The authority application must be in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Cystic Fibrosis Ivacaftor Authority Application Supporting Information Form; and
(3) a signed patient acknowledgement; or an acknowledgement signed by a parent or authorised guardian, if applicable; and
(4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene; and
(5) the result of a FEV1 measurement performed within a month prior to the date of application. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and
(6) evidence that the patient has either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; and
(7) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and
(8) a copy of a sweat chloride result; and
(9) height and weight measurements at the time of application; and
(10) a baseline measurement of the number of days of hospitalisation (including hospital-in-the home) in the previous 12 months
Compliance with modified Authority Required procedures
[26] Schedule 3, entry for Macitentan [Circumstances Code C4620]
omit text from the column headed “Authority Requirements - Part of Circumstances” and substitute:
Compliance with modified Authority Required procedures
[27] Schedule 3, entry for Macitentan [Circumstances Code C4631]
omit text from the column headed “Authority Requirements - Part of Circumstances” and substitute:
Compliance with modified Authority Required procedures
[28] Schedule 3, entry for Macitentan [Circumstances Code C4634]
omit text from the column headed “Authority Requirements - Part of Circumstances” and substitute:
Compliance with modified Authority Required procedures
[29] Schedule 3, entry for Macitentan [Circumstances Code C4635]
omit text from the column headed “Authority Requirements - Part of Circumstances” and substitute:
Compliance with modified Authority Required procedures
[30] Schedule 3, entry for Macitentan [Circumstances Code C4639]
omit text from the column headed “Authority Requirements - Part of Circumstances” and substitute:
Compliance with modified Authority Required procedures
[31] Schedule 3, entry for Ribavirin and Peginterferon Alfa-2a
substitute:
C4184
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4184
C4185
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4187
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24.
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4187
C4188
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4193
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4197
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4197
C4206
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4206
C4207
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[32] Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b
substitute:
C4184
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4184
C4185
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4187
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4187
C4188
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with simeprevir; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4189
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4189
C4192
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4192
C4193
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4197
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and in whom plasma HCV RNA is undetectable by an HCV RNA quantitative assay at week 4; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with simeprevir and for whom the results of an HCV RNA qualitative assay at week 4 show that the plasma HCV RNA is detectable but less than 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than or equal to 25 IU/mL; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12; AND
The treatment must cease in patients using peginterferon and ribavirin in combination with simeprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4197
C4198
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop.
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4198
C4199
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4199
C4200
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12.
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4203
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures
C4206
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4206
C4207
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant
Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre.
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
C4208
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated); AND
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be limited to a maximum duration of 48 weeks; AND
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age.
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4209
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
The treatment must be the sole PBS-subsidised treatment for hepatitis C; AND
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C; AND
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis; AND
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24
Patient must weigh at least 27 kg; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures
[33] Schedule 3, entry for Rituximab
substitute:
Rituximab
C4740
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF) alfa antagonist; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with rituximab for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 2 infusions of rituximab under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction 'TNF' alfa antagonist means adalimumab, certolizumab pegol, etanercept, golimumab and infliximab.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
Assessment of a patient's response to an initial course of treatment must be made at least 12 weeks after the first infusion so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services within 4 weeks of the date it was conducted. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with rituximab.
A patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, may apply for a further course of rituximab under the Continuing treatment restriction.
If a patient who fails to demonstrate a response to treatment with rituximab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who fails to demonstrate a response to rituximab treatment and who qualifies to trial an alternate bDMARD according to the interchangeability arrangements for bDMARDs for the treatment of severe rheumatoid arthritis, may do so without having to have a 22 week treatment-free period.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response
Compliance with modified Authority Required procedures
C4741
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing treatment
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must have received this drug as the most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition; AND
Patient must not receive more than 2 infusions of rituximab under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
The authority application must be made in writing and must include:
(a) completed authority prescription form(s); and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
A patient may qualify to receive a further course of treatment (every 24 weeks) with this agent provided they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab. The demonstration of response must be submitted within 4 weeks of assessment.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with rituximab.
A patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, may apply for a further course of rituximab under the Continuing treatment restriction.
If a patient fails to demonstrate a response to treatment with rituximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures
C4753
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months).
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF) alfa antagonist; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 2 infusions of rituximab under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction 'TNF' alfa antagonist means adalimumab, certolizumab pegol, etanercept, golimumab and infliximab.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab
The authority application must be made in writing and must include:
(a) completed authority prescription form(s); and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Applications for a patient who has received PBS-subsidised treatment with rituximab and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised rituximab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised rituximab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response at least 12 weeks after the first infusion. This assessment must be submitted no later than 4 weeks from the date of the assessment.
A patient may qualify to receive a further course of treatment (every 24 weeks) with this agent provided they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab. The demonstration of response must be submitted within 4 weeks of assessment.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with rituximab.
A patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, may apply for a further course of rituximab under the Continuing treatment restriction.
If a patient fails to demonstrate a response to treatment with rituximab under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
If a patient fails to demonstrate a response to a treatment with rituximab and who qualify to trial an alternate bDMARD according to the interchangeability arrangements for bDMARDs for the treatment of severe rheumatoid arthritis, may do so without having to have a 22 week treatment-free period.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures
[34] Schedule 3, after entry for Sildenafil
insert:
Simeprevir
C4669
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4684
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures
C4758
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4758
C4759
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater
Patient must be 18 years or older; AND
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Must be treated in an accredited treatment centre
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised simeprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4759
[35] Schedule 3, entry for Tocilizumab
(a) omit:
C3716
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS‑subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances;
the requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs;
if the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the joint count and ESR and/or CRP are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are no more than one month old at the time of initial application;
if the above requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with tocilizumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures
C3825
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — continuing treatment
Continuing PBS‑subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with tocilizumab; and
(c) whose most recent course of PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment was with tocilizumab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with tocilizumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of tocilizumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures
C3826
Where the patient is receiving treatment at/from a private or public hospital
Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS‑subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with tocilizumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with tocilizumab are not eligible to commence treatment with tocilizumab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with tocilizumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised tocilizumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised tocilizumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone
Compliance with modified Authority Required procedures
(b) insert in numerical order following existing text:
C4672
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months) or Initial 2 (change or recommencement of treatment after break of less than 24 months) – balance of supply.
Patient must have received insufficient tocilizumab therapy under the Initial 1 (new patient or patient recommencing treatment after break of more than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient tocilizumab therapy under the Initial 2 (change or recommencement of treatment after break of less than 24 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures
C4673
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing Treatment – balance of supply.
Patient must have received insufficient tocilizumab therapy under the Continuing Treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Compliance with modified Authority Required procedures
C4688
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after break of less than 24 months).
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition and are eligible to receive further bDMARD therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
The authority application must be made in writing and must include:
(a) completed authority prescription form(s); and
(b) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
Applications for a patient who has received PBS-subsidised treatment with tocilizumab and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment, within the timeframes specified below.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under either of the initial 1 or 2 treatment restrictions, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to demonstrate a response to a treatment with tocilizumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
If a patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Compliance with modified Authority Required procedures
C4729
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of more than 24 months)
Patient must have severe active rheumatoid arthritis; AND
Patient must have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; AND
Patient must not have failed previous PBS-subsidised treatment with tocilizumab for this condition, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose,the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
If a patient fails to demonstrate a response to treatment with tocilizumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP is provided with the initial application, the same marker will be used to determine response.
Compliance with modified Authority Required procedures
C4730
Where the patient is receiving treatment at/from a private or public hospital
Severe active rheumatoid arthritis
Continuing treatment.
Patient must have a documented history of severe active rheumatoid arthritis; AND
Patient must have demonstrated an adequate response to treatment with tocilizumab; AND
Patient must have received tocilizumab as their most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
For the purposes of this restriction bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
At the time of authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
All applications for continuing treatment with tocilizumab must include a measurement of response to the prior course of therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with tocilizumab, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with an initial treatment course.
Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
If a patient fails to demonstrate a response to treatment with tocilizumab under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
Compliance with modified Authority Required procedures
