National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2015 (PB 30 of 2015)

Link to law: https://www.comlaw.gov.au/Details/F2015L00457

PB 30 of 2015
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 20151
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 instrument under subsections 100(1) and (2) of the National Health Act 1953.
Dated  27 March 2015
 
 
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 2015.
(2)     This instrument may also be cited as PB 30 of 2015.
2              Commencement
                This instrument commences on 1 April 2015.
3              Amendment
                Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1—Amendments
[1]   Division 1, Section 4
Insert:
medication chart prescription has the meaning given in the Regulations, but does not include a medication chart prescription for a person receiving treatment in a residential care service.
[2]   Section 4 (definition of paperless claim for payment)
Repeal the definition.
[3]   Section 4
Insert:
residential care service has the meaning given by the Regulations.
[4]   Section 4 (definition of supply certification form)
Repeal the definition.
[5]   Section 4 (note under definition of under co-payment data)
Repeal the first note.
[6]   Division 3 - heading and note
Repeal the heading and note, substitute:
                            Division 3 – HSD Authority Required procedures
[7]   Section 10
Repeal the heading, substitute:
                            HSD Authority Required procedures
[8]    Subsection 10(2)
Repeal the subsection, substitute:
             (2)  The Authority Required procedures as provided for in sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 are to be followed.
             (3)  In addition to the requirements of subsection (2), where ‘Compliance with modified Authority Required procedures’ appears in the circumstances mentioned in Schedule 3 for the code, in addition to ‘Compliance with Written or Telephone Authority Required procedures’, any other requirement included in the circumstances is to be followed as part of the Authority Required procedures. 
[9]   Section 11
Repeal the section.
[10]  Section 12
Repeal the section.
[11]  Section 13
Repeal the section.
[12]  Paragraph 18(1)(b)
            Repeal the paragraph.
[13]  Paragraph 19(b)
Omit ‘more than 4.’ and substitute “more than 4; and
(c)          applies to the supply of a HSD pharmaceutical benefit on a medication chart prescription as indicated in the Regulations.”
[14]  Section 19 - Note
Repeal the note.
[15]  Subsection 21(b)
Repeal the paragraph, substitute:
(b)          preparing a medication chart prescription for the HSD pharmaceutical benefit in accordance with regulation 19AA of the Regulations.
[16]  Section 22
Repeal the section.
[17]  Section 23
Omit “preparing and signing a prescription for the drug.” substitute “writing a prescription for the HSD pharmaceutical benefit in accordance with regulation 19 of the Regulations.”
[18]  Section 26
Repeal the section, substitute:
             26  Application of regulation 13 in relation to CAR drugs
                   Regulation 13 of the Regulations does not apply in relation to a prescription for an HSD pharmaceutical benefit that has a CAR drug supplied under this Special Arrangement.
[19]  Part 3
Repeal the Part.
[20]  Part 4, Division 1
Repeal the Division.
[21]  Section 30
Repeal Note 2.
[22]  Part 4, Division 2, subdivision 2
Repeal the subdivision.
[23]  Section 45
Repeal the section.
[24]  Subsection 46(1)
Repeal the subsection, substitute:
             (1)  This section applies to an approved hospital authority for a public hospital or a private hospital that supplies an HSD pharmaceutical benefit.
[25]  Subsection 46(3)
Omit “ paragraph 45(2)(b)”, substitute “Schedule 4”.
[26]  Subsection 47(3)
Omit “ paragraph 45(2)(b)”, substitute “Schedule 4”.
[27]  Section 48
Omit “ paragraph 45(2)(b) and ”. 
[28]  Subsection 50(1)
Repeal the subsection.
[29]  Paragraphs 51(c), (d) and (e)
Repeal the paragraphs, substitute:
(c)          a medication chart prescription may be written for an eligible patient receiving treatment from a hospital; and
[30]  Section 54
Repeal the section.
[31]  Section 55
Repeal the section.
[32]  After section 53
            Insert:
54        Transitional arrangements for existing public hospital medication chart prescribing and paperless claiming
                   (1) An eligible medical practitioner at a public hospital may prescribe a HSD pharmaceutical benefit that has a non-CAR drug under this Special Arrangement, before 1 April 2017, by following the requirements for prescribing from a medication chart in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015.
                   (2) An approved hospital authority for a public hospital can supply a HSD pharmaceutical benefit prescribed under subsection (1).
                   (3) The requirements for prescribing, supplying and claiming from a medication chart set out in the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015, continue to apply in relation to a medication chart prepared under subsection (1).
                   (4) However, this section does not apply if the public hospital referred to in subsections (1) and (2) is a listed approved hospital under regulation 59 of the Regulations.
                   (5) However, if this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules. 
55        Transitional arrangements for existing non-medication chart public hospital paperless claiming
                   (1) An approved hospital authority for a public hospital may supply a HSD pharmaceutical benefit that has a non-CAR drug before 1 April 2017, from a prescription other than a medication chart, in accordance with Part 4, Division 2, Subdivision 2 of the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 as in force immediately before 1 April 2015.
                   (2) However, if this section applies, the supply certification referred to in subrule 5(1A) of the rules made under subsections 98AC(4) and 99AAA(8) of the Act is allowed, and then required, as indicated in transitional rule 12 of those rules.
 
[33]  Schedule 1, after entry for Adefovir
        insert:
Alemtuzumab
Solution concentrate for I.V. infusion 12 mg in 1.2 mL
Injection
Lemtrada
GZ
EMP
C4829 C4834
C4838 C4850
P4829 P4850
3
0
D

 
 
 
Lemtrada
GZ
EMP
C4829 C4834
C4838 C4850
P4834 P4838
5
0
D

 
[34]  Schedule 1, entry for Apomorphine
  omit and substitute:
Apomorphine
Injection containing apomorphine hydrochloride 10 mg in 1 mL
Injection
Apomine
HH
EMP
C4833 C4860
 
360
5
D

 
Injection containing apomorphine hydrochloride 20 mg in 2 mL
Injection
Apomine
HH
EMP
C4833 C4860
 
360
5
D

 
Injection containing apomorphine hydrochloride 50 mg in 5 mL
Injection
Apomine
HH
EMP
C4833 C4860
 
180
5
D

 
Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre-filled syringe
Injection
Apomine PFS
HH
EMP
C4833 C4860
 
180
5
D

 
[35]  Schedule 1, after entry for Dolutegravir
        insert:
Dolutegravir with abacavir and lamivudine
Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg
Oral
Triumeq
VI
EMP
C4472 C4480
C4495 C4523
 
60
5
D
[36]  Schedule 1, entry for Infiximab in the form Powder for I.V. infusion 100 mg [Maximum Quantity: 1; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”: C3492 C3811  C3812
(b)      insert in numerical order in the column headed “Circumstances”: C4823  C4836  C4846  C4854  C4865 
(c)      omit from the column headed “Purposes”: P3492  P3811  P3812
(d)      insert in numerical order in the column headed “Purposes”: P4823  P4836  P4846  P4854  P4865
 
 
[37]  Schedule 1, entry for Lanthanum in each of the forms Tablet, chewable, 500 mg (as carbonate hydrate), Tablet, chewable, 750 mg (as carbonate hydrate), Tablet, chewable, 1000 mg (as carbonate hydrate):
(a)     omit from the column headed “Circumstances”: C3103  C3104 C3390  C3391 
(b)     insert in numerical order in the column headed “Circumstances”: C4832  C4847 
[38]  Schedule 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg:
(a)     omit from the column headed “Circumstances”: C3103  C3104 C3390  C3391 
(b)     insert in numerical order in the column headed “Circumstances”: C4832  C4847 
[39]   Schedule 1, entry for Sildenafil in the form Tablet 20 mg (as citrate)
   insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
Sildenafil AN PHT 20
EA
EMP

C4608 C4615 C4621 C4636 C4641
 
See Note 1
See Note 2
D
[40]   Schedule 1, after entry Stavudine
  insert:
Sucroferric oxyhydroxide
Tablet, chewable, 2.5 g  (equivalent to 500 mg iron)
Oral
Velphoro
FN
EMP
C4832 C4847
 
180
5
D
[41]  Schedule 1, entry for Tacrolimus in each of the forms: Capsule 0.5 mg; Capsule 1 mg; Capsule 5 mg; Capsule 0.5 mg (once daily prolonged release); Capsule 1 mg (once daily prolonged release)and Capsule 5 mg (once daily prolonged release)
       omit from the column headed “Responsible Person”: JC                                                substitute:  LL
[42]  Schedule 2, after details relevant to Responsible Person code CR
insert:
EA
Amnel Pharma Australia Pty Ltd
21 447 854 484

FN
Fresenius Medical Care Australia Pty Ltd
80 067 557 877

[43]  Schedule 2, after details relevant to Responsible Person code  JC
insert:
LL
Astellas Pharma Australia Pty Ltd
81 147 915 482
 
[44]  Schedule 3, after entry for Adefovir
 insert:
Alemtuzumab
C4829
P4829
Where the patient is receiving treatment at/from a public hospital
Multiple sclerosis – Continuing treatment
Patient must have previously been issued with an authority prescription for this drug,
Patient must not show continuing progression of disability while on treatment with this drug, and
Patient must not receive more than one PBS-subsidised treatment per year.
Treatment must be as monotherapy, and Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4829

 
C4834
P4834
Where the patient is receiving treatment at/from a public hospital
Multiple sclerosis – Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient,
The treatment must be as monotherapy,
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years,
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4834


 
C4838
P4838
Where the patient is receiving treatment at/from a private hospital
Multiple sclerosis - Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient,
The treatment must be as monotherapy,
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years,
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application.
Compliance with Written and Telephone Authority Required procedures


 
C4850
P4850
Where the patient is receiving treatment at/from a private hospital
Multiple sclerosis – Continuing treatment
Patient must have previously been issued with an authority prescription for this drug,
Patient must not show continuing progression of disability while on treatment with this drug,
Patient must not receive more than one PBS-subsidised treatment per year,
The treatment must be as monotherapy,
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist.
Compliance with Written and Telephone Authority Required procedures


[45]  Schedule 3, entry for Apomorphine
substitute:
Apomorphine
C4833
P4833
Where the patient is receiving treatment at/from a public hospital
Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4833

 
C4860
P4860
Where the patient is receiving treatment at/from a private hospital
Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy.
Compliance with Written and Telephone Authority Required procedures


[46]  Schedule 3, after entry for Dolutegravir
insert:
Dolutegravir with abacavir and lamivudine
C4472
P4472
Where the patient is receiving treatment at/from a private hospital
HIV infection – Initial treatment
Patient must be antiretroviral treatment naive.
Patient must be aged 12 years or older, and
Patient must weigh 40 kg or more.
Compliance with Written and Telephone Authority Required procedures

 
C4480
P4480
Where the patient is receiving treatment at/from a public hospital
HIV infection – Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection.
Patient must be aged 12 years or older, and must weigh 40 kg or more.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4480

 
C4495
P4495
Where the patient is receiving treatment at/from a public hospital
HIV infection – Initial treatment
Patient must be antiretroviral treatment naive.
Patient must be aged 12 years or older, and Patient must weigh 40 kg or more.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4495

 
C4523
P4523
Where the patient is receiving treatment at/from a private hospital
HIV infection – Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection.
Patient must be aged 12 years or older, and must weigh 40 kg or more.
Compliance with Written and Telephone Authority Required procedures


[47]   Schedule 3, entry for Infliximab
omit:
 
C3492
P3492
Where the patient is receiving treatment at/from a private or public hospital
Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS‑subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) 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) an 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, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle 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

 
C3811
P3811
Where the patient is receiving treatment at/from a private or public hospital
Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with infliximab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with infliximab during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with infliximab within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, 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 within an ongoing Treatment Cycle 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

 
C3812
P3812
Where the patient is receiving treatment at/from a private or public hospital
Psoriatic arthritis — continuing treatment
Continuing treatment with infliximab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with infliximab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with infliximab; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with infliximab 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 Psoriatic 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 within an ongoing Treatment Cycle 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

 
insert in numerical order following existing text:      
 
C4823
P4823
Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic arthritis - Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis,
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle,
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle,
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle,
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be an adult.
Treatment criteria: Must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
At the time of the authority application, medical practitioners should request the appropriate quantity 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 3 repeats may be authorised.
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug.
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been 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 submitted no later than 4 weeks from the date that course was ceased.
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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


 
C4836
P4836
Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic arthritis - Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis,
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; or
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition,
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months,
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months,
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be an adult.
Treatment criteria: Must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation 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) an 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).
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic 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 quantity 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 3 repeats may be authorised.
Compliance with modified Authority Required procedures


 
C4846
P4846
Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic 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,
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Treatment criteria: Must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Compliance with modified Authority Required procedures


 
C4854
P4854
Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic arthritis - Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 22 weeks treatment; or
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 22 weeks treatment.
The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.
Treatment criteria:must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Compliance with modified Authority Required procedures


 
C4865
P4865
Where the patient is receiving treatment at/from a private or public hospital
Severe psoriatic arthritis - Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis,
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle,
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug,
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be an adult.
Treatment criteria:Must be treated by a rheumatologist; or must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (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 major 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).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications.
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised 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 the initial treatment course.
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form.
At the time of the authority application, medical practitioners should request the appropriate quantity 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 may be authorised.
Compliance with modified Authority Required procedures


 
[48]  Schedule 3, entry for Lanthanum
substitute:
Lanthanum
C4832
P4832
Where a patient is receiving treatment at/from a public hospital
Hyperphosphataemia - Initiation and stabilisation
The condition must not be adequately controlled by calcium,
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy.
The treatment must not be used in combination with any other phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832


 
C4847
P4847
Where a patient is receiving treatment at/from a private hospital
Hyperphosphataemia - Initiation and stabilisation
The condition must not be adequately controlled by calcium,
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy.
The treatment must not be used in combination with any other phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.
Compliance with Written and Telephone Authority Required procedures


[49]  Schedule 3, entry for Sevelamer
substitute:
Sevelamer
C4832
P4832
Where a patient is receiving treatment at/from a public hospital
Hyperphosphataemia - Initiation and stabilisation
The condition must not be adequately controlled by calcium,
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy.
The treatment must not be used in combination with any other phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832


 
C4847
P4847
Where a patient is receiving treatment at/from a private hospital
Hyperphosphataemia - Initiation and stabilisation
The condition must not be adequately controlled by calcium,
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy.
The treatment must not be used in combination with any other phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.
Compliance with Written and Telephone Authority Required procedures


[50]  Schedule 3, after entry for Stavudine
insert:
Sucroferric oxyhydroxide
C4832
P4832
Where a patient is receiving treatment at/from a public hospital
Hyperphosphataemia - Initiation and stabilisation
The condition must not be adequately controlled by calcium,
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy.
The treatment must not be used in combination with any other phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832


 
C4847
P4847
Where a patient is receiving treatment at/from a private hospital
Hyperphosphataemia - Initiation and stabilisation
The condition must not be adequately controlled by calcium,
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; or
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy.
The treatment must not be used in combination with any other phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease.
Compliance with Written and Telephone Authority Required procedures


 
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