PB 83 of 2015
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 9)
National Health Act 1953
___________________________________________________________________________
I, STEVE DUNLOP, 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 28 August 2015
STEVE DUNLOP
A/g 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) Special Arrangement Amendment Instrument 2015 (No. 9).
(2) This Instrument may also be cited as PB 83 of 2015.
2 Commencement
This Instrument commences on 1 September 2015.
3 Amendment
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
[1] Schedule 1, entry for Apomorphine
omit
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
[2] Schedule 1, entry for Fosamprenavir
omit
Oral liquid 50 mg (as calcium) per mL, 225 mL
Oral
Telzir
VI
EMP
C4454 C4512
8
5
D
[3] Schedule 1, entry for Ibandronic acid in the form Concentrated injection for I.V. infusion 6 mg (as ibandronate sodium monohydrate) in
6 mL
omit from the column headed “Circumstances” C1035 C3343 insert C5257 C5291
[4] Schedule 1, entry for Infliximab in the form Powder for I.V. infusion 100 mg Maximum Quantity 1 Repeats 0
a) omit from the column headed “Circumstances” C3259 C3262 C3815 C3816 C3817 C3818 C4865
b) insert in numerical order after existing items C5149 C5197 C5233 C5234 C5303 C5304 C5311 C5376 C5377
[5] Schedule 1, entry for Pamidronic Acid
omit
Injection set containing 2 vials powder for I.V. infusion containing disodium pamidronate 30 mg and 2 ampoules solvent 10 mL
Injection
Aredia 30 mg
NV
EMP
C4424 C4425
1
2
C
Injection set containing 1 vial powder for I.V. infusion containing disodium pamidronate 90 mg and 1 ampoule solvent 10 mL
Injection
Aredia 90 mg
NV
EMP
C4421 C4426 C4428 C4429 C4431 C4432
1
11
PB
[6] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL
omit from the column headed “Circumstances” C4424 C4425 insert C4430 C4433
[7] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL
a) omit from the column headed “Circumstances” C4421 C4426 C4428 C4429 C4431 C4432
b) insert C4430 C4433 C5218 C5291 C5256 C5257
[8] Schedule 1, omit entry for Telaprevir
[9] Schedule 1, entry for Zoledronic Acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
a) omit from the column headed “Circumstances” C1035 C1233 C1500 C3341 C3342 C3343 C4051 C4052
b) insert C5175 C5176 C5258 C5292 C5329 C5330 C5403 C5404
[10] Schedule 3, entry for Ibandronic acid
substitute
Ibandronic acid
C5257
P5257
Where the patient is receiving treatment at/from a private hospital
Bone metastases
The condition must be due to breast cancer.
Compliance with Written and Telephone Authority Required procedures
C5291
P5291
Where the patient is receiving treatment at/from a public hospital
Bone metastases
The condition must be due to breast cancer.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5291
[11] Schedule 3, entry for Infliximab
a) omit
C3259
P3259
Where the patient is receiving treatment at/from a private or public hospital
Chronic plaque psoriasis (whole body) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has received prior 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
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the whole body; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS‑subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 chronic plaque psoriasis 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 is indicated by a current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) 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 application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
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
C3262
P3262
Where the patient is receiving treatment at/from a private or public hospital
Chronic plaque psoriasis (face, hand, foot) — initial treatment 1
Initial treatment as systemic monotherapy (other than methotrexate), commencing a Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot, where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; and
(b) have not received any prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has received prior 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
(c) have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that PBS‑subsidised treatment with a biological agent will cease if they do not meet the predetermined response criterion for ongoing PBS‑subsidised treatment, as outlined in the restriction for continuing treatment of psoriasis affecting the face, hand or foot; and
(d) have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or
(ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or
(iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or
(iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks;
unless the patient has had a break in PBS‑subsidised biological agent treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to at least 1 of the 4 treatments, for a minimum of 6 weeks; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 chronic plaque psoriasis 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 is demonstrated in the patient at the time of the authority application and is indicated by chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot, where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment;
a PASI assessment is completed for each prior treatment course, preferably whilst still on treatment but no longer than 1 month following cessation of each course of treatment;
the most recent PASI assessment is no more than 1 month old at the time of application;
if treatment with any of the drugs mentioned at (d) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, or phototherapy is contraindicated, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (d) 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 application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy (dosage where applicable, date of commencement and duration of therapy); and
(iii) the signed patient and prescriber acknowledgements;
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
b) omit
C3815
C3815
Where the patient is receiving treatment at/from a private or public hospital
Chronic plaque psoriasis (whole body) — initial treatment 2
Initial treatment, or recommencement of treatment, with infliximab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis; and
(b) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS‑subsidised therapy with infliximab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 chronic plaque psoriasis 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 who have previously demonstrated a response to PBS‑subsidised treatment with infliximab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS‑subsidised infliximab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
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
C3816
P3816
Where the patient is receiving treatment at/from a private or public hospital
Chronic plaque psoriasis (whole body) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis; and
(b) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle was with infliximab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with infliximab; and
where biological agent means adalimimab, etanercept, infliximab or ustekinumab; 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 chronic plaque psoriasis 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 infliximab treatment is defined as a Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the pre‑biological treatment baseline value for this Treatment Cycle;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 22‑week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24‑week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS‑subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with infliximab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet along with the date of the assessment of the patient's condition;
the most recent PASI assessment is no more than 1 month old at the time of application;
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
C3817
P3817
Where the patient is receiving treatment at/from a private or public hospital
Chronic plaque psoriasis (face, hand, foot) — initial treatment 2
Initial treatment, or recommencement of treatment, with infliximab as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over who:
(a) have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle; and
(c) have not failed PBS‑subsidised therapy with infliximab for the treatment of this condition in the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 chronic plaque psoriasis 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 who have previously demonstrated a response to PBS‑subsidised treatment with infliximab within this Treatment Cycle are only eligible to recommence therapy with this drug within this same cycle, following a break in therapy, where evidence of a response to their most recent course of PBS‑subsidised infliximab treatment was submitted to the Chief Executive Medicare within 1 month of cessation of that treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological agent treatment, including dosage, date and duration of treatment;
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
C3818
P3818
Where the patient is receiving treatment at/from a private or public hospital
Chronic plaque psoriasis (face, hand, foot) — continuing treatment
Continuing treatment as systemic monotherapy (other than methotrexate), within an ongoing Biological Treatment Cycle, by a dermatologist for adults 18 years and over:
(a) who have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; and
(b) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle was with infliximab; and
(c) who have demonstrated an adequate response to their most recent course of treatment with infliximab; and
where biological agent means adalimumab, etanercept, infliximab or ustekinumab; 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 chronic plaque psoriasis 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 infliximab treatment is defined as the plaque or plaques assessed prior to biological agent treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre‑biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre‑biological treatment baseline value;
the PASI assessment submitted to demonstrate response is performed on the same affected body area assessed to establish the baseline value;
the PASI assessment of response is made after at least 12 weeks of treatment, in the case of a 22‑week initial treatment course, or is conducted within 4 weeks prior to completion of the course, in the case of a 24‑week treatment course, and is submitted to the Chief Executive Medicare no later than 1 month from the date of completion of the course of treatment;
where an assessment of the patient's response to a course of PBS‑subsidised treatment is not undertaken and submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed to respond to treatment with infliximab;
the application for authorisation is made in writing and includes a completed copy of the appropriate Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams along with the date of the assessment of the patient's condition;
the most recent PASI assessment is not more than 1 month old at the time of application;
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
c) omit
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
d) insert in numerical order after C5120
C5149
P5149
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1, Whole body (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, Whole body (change or recommencement of treatment) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 1, Face, hand, foot (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, Face, hand, foot (change or recommencement of treatment) restriction to complete 22 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); 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 dermatologist.
Compliance with modified Authority Required procedures
C5197
P5197
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Initial treatment – Initial 1, Whole body (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received 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 and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that 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 (whole body); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin 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 criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements.
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
C5233
P5233
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Initial treatment – Initial 1, Face, hand, foot (new patient (no prior biological agent) or patient recommencing treatment after a break of 5 years or more)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received any prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must not have received 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 and wish to commence a new Treatment Cycle; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 3 of the following 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must have signed a patient and prescriber acknowledgement indicating they understand and acknowledge that 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 (face, hand, foot); AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
Where treatment with methotrexate, cyclosporin or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, cyclosporin or acitretin 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 criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]; and
(iii) the signed patient and prescriber acknowledgements.
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
C5234
P5234
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Continuing treatment, Face, hand, foot
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
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; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); 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 dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.
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:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
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
C5303
P5303
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Initial treatment – Initial 2, Whole body (change or recommencement of treatment)
Patient must have a documented history of severe chronic plaque psoriasis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
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 patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle.
Compliance with modified Authority Required procedures
C5304
P5304
Severe chronic plaque psoriasis
Continuing treatment, Whole body
Patient must have a documented history of severe chronic plaque psoriasis; AND
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; AND
Patient must have demonstrated an adequate response to their most recent course of treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); 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 dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the prebiological treatment baseline value for this Treatment Cycle.
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:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
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
C5311
P5311
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; AND
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; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be an adult.
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
C5376
P5376
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Initial treatment – Initial 2, Face, hand, foot (change or recommencement of treatment)
Patient must have a documented history of severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents for this condition within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised therapy with this drug for the treatment of this condition in the current Treatment Cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
For the purposes of this restriction 'biological agent' means adalimumab, etanercept, infliximab, secukinumab or ustekinumab.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
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 patients who have demonstrated a response to PBS-subsidised treatment with this drug within this Treatment Cycle and who wish to recommence treatment with this drug within the same Cycle following a break in therapy, will only be approved where evidence of the patient's response to their most recent course of PBS-subsidised treatment with this drug has been submitted within 1 month of cessation of treatment.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.
Compliance with modified Authority Required procedures
C5377
P5377
Where the patient is receiving treatment at/from a private or public hospital
Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment, Face, hand, foot 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 restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist.
Compliance with modified Authority Required procedures
[12] Schedule 3, entry for Pamidronic Acid
substitute
C4430
Where the patient is receiving treatment at/from a private hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy
Compliance with Written and Telephone Authority Required procedures
C4433
Where the patient is receiving treatment at/from a public hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy
Compliance with Written and Telephone Authority Required procedures – Streamlined Authority Code 4433
C5218
Where the patient is receiving treatment at/from a public hospital
Multiple Myeloma
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5218
C5256
Where the patient is receiving treatment at/from a private hospital
Multiple Myeloma
Compliance with Written and Telephone Authority Required procedures
C5257
Where the patient is receiving treatment at/from a private hospital
Bone metastases
The condition must be due to breast cancer.
Compliance with Written and Telephone Authority Required procedures
C5291
Where the patient is receiving treatment at/from a public hospital
Bone metastases
The condition must be due to breast cancer.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5291
[13] Schedule 3, omit entry for Telaprevir
[14] Schedule 3, entry for Zoledronic Acid
substitute
Zoledronic acid
C5175
P5175
Where the patient is receiving treatment at/from a private hospital
Bone metastases
The condition must be due to breast cancer.
Compliance with Written and Telephone Authority Required procedures
C5176
P5176
Where the patient is receiving treatment at/from a public hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5176
C5258
P5258
Where the patient is receiving treatment at/from a private hospital
Bone metastases
The condition must be due to castration-resistant prostate cancer.
Compliance with Written and Telephone Authority Required procedures
C5292
P5292
Where the patient is receiving treatment at/from a private hospital
Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti-neoplastic therapy.
Compliance with Written and Telephone Authority Required procedures
C5329
P5329
Where the patient is receiving treatment at/from a private hospital
Multiple myeloma
Compliance with Written and Telephone Authority Required procedures
C5330
P5330
Where the patient is receiving treatment at/from a public hospital
Multiple myeloma
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5330
C5403
P5403
Where the patient is receiving treatment at/from a public hospital
Bone metastases
The condition must be due to breast cancer.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5403
C5404
P5404
Where the patient is receiving treatment at/from a public hospital
Bone metastases
The condition must be due to castration-resistant prostate cancer.
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5404
