National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (July Update) Instrument 2023 (Cth)

Case

PB 58 of 2023

National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (July Update) Instrument 2023

National Health Act 1953

I, SOUMYA SUDARSHAN, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated               29 June 2023

SOUMYA SUDARSHAN

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Highly Specialised Drugs Program) Special Arrangement 2021
(PB 27 of 2021)   2

  1. Name

(1)This instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (July Update) Instrument 2023.

(2)This instrument may also be cited as PB 58 of 2023.

  1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1.  The whole of this instrument 1 July 2023 1 July 2023

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

  1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

  1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021)

  1. Part 1, Division 1, Section 6, definition for “CAR drug”

substitute:

CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:

(a)        abatacept;

(b)        adalimumab;

(c)        ambrisentan;

(d)        avatrombopag;

(e)        azacitidine;

(f)        benralizumab;

(g)        bosentan;

(h)        burosumab;

(i)         dupilumab;

(j)         eculizumab;

(k)        elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;

(l)         eltrombopag;

(m)       epoprostenol;

(n)        etanercept;

(o)        iloprost;

(p)        infliximab;

(q)        ivacaftor;

(r)         lenalidomide;

(s)        lumacaftor with ivacaftor;

(t)         macitentan;

(u)        mepolizumab;

(v)        midostaurin;

(w)       nusinersen;

(x)        omalizumab;

(y)        onasemnogene abeparvovec;

(z)        pasireotide;

(aa)      pegcetacoplan;

(bb)      pegvisomant;

(cc)      pomalidomide;

(dd)      ravulizumab;

(ee)      riociguat;

(ff)       risdiplam;

(gg)      romiplostim;

(hh)      selexipag;

(ii)        sildenafil;

(jj)        tadalafil;

(kk)      teduglutide;

(ll)        tezacaftor with ivacaftor and ivacaftor;

(mm)    tocilizumab;

(nn)      ustekinumab;

(oo)      vedolizumab.

  1. Schedule 1, entry for Abatacept

(a)omit from the column headed “Circumstances”: C8748

(b)insert in numerical order in the column headed “Circumstances”: C14076

  1. Schedule 1, entry for Adalimumab

substitute:

Adalimumab Injection 20 mg in 0.2 mL pre‑filled syringe Injection Humira C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Injection 20 mg in 0.4 mL pre‑filled syringe Injection Amgevita C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Injection 40 mg in 0.4 mL pre‑filled pen Injection Humira C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Yuflyma C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Injection 40 mg in 0.4 mL pre‑filled syringe Injection Humira C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Yuflyma C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Injection 40 mg in 0.8 mL pre‑filled pen Injection Amgevita C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Hadlima C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Hyrimoz C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Idacio C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Injection 40 mg in 0.8 mL pre‑filled syringe Injection Amgevita C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Hadlima C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Hyrimoz C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2
Idacio C12120 C14061 C14063 C14064 C14107 C14136 See Schedule 2 See Schedule 2

  1. Schedule 1, after entry for Atazanavir with cobicistat

insert:

Avatrombopag Tablet 20 mg Oral Doptelet C14054 C14101 C14130 C14131 C14132 See Schedule 2 See Schedule 2

  1. Schedule 1, entry for Azacitidine

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Azacitidine Sandoz C12439 C12983 C12986 C13010 C13011 C13012 C13015 C13029 See Schedule 2 See Schedule 2

  1. Schedule 1, after entry for Bosentan in the form Tablet 125 mg (as monohydrate)

insert:

Buprenorphine Injection (modified release) 8 mg in 0.16 mL pre-filled syringe Injection Buvidal Weekly C14075 4 2
Injection (modified release) 16 mg in 0.32 mL pre-filled syringe Injection Buvidal Weekly C14075 4 2
Injection (modified release) 24 mg in 0.48 mL pre-filled syringe Injection Buvidal Weekly C14075 4 2
Injection (modified release) 32 mg in 0.64 mL pre-filled syringe Injection Buvidal Weekly C14075 4 2
Injection (modified release) 64 mg in 0.18 mL pre-filled syringe Injection Buvidal Monthly C14139 1 2
Injection (modified release) 96 mg in 0.27 mL pre-filled syringe Injection Buvidal Monthly C14139 1 2
Injection (modified release) 100 mg in 0.5 mL pre-filled syringe Injection Sublocade C14138 1 2
Injection (modified release) 128 mg in 0.36 mL pre-filled syringe Injection Buvidal Monthly C14139 1 2
Injection (modified release) 160 mg in 0.45 mL pre-filled syringe Injection Buvidal Monthly C14139 1 2
Injection (modified release) 300 mg in 1.5 mL pre-filled syringe Injection Sublocade C14138 1 2
Tablet (sublingual) 400 micrograms (as hydrochloride) Sublingual Subutex C14157 28 2
Tablet (sublingual) 2 mg (as hydrochloride) Sublingual Subutex C14157 84 2
Tablet (sublingual) 8 mg (as hydrochloride) Sublingual Subutex C14157 112 2

  1. Schedule 1, after entry for Buprenorphine in the form Tablet (sublingual) 8 mg (as hydrochloride)

insert:

Buprenorphine with naloxone Film (soluble) 2 mg (as hydrochloride)-0.5 mg (as hydrochloride) Sublingual Suboxone Film 2/0.5 C14074 84 2
Film (soluble) 8 mg (as hydrochloride)-2 mg (as hydrochloride) Sublingual Suboxone Film 8/2 C14074 112 2

  1. Schedule 1, entry for Eltrombopag in each of the forms: Tablet 25 mg (as olamine); and Tablet 50 mg (as olamine)

(a)omit from the column headed “Circumstances”: C13325 C13326

(b)omit from the column headed “Circumstances”: C13395

(c)insert in numerical order in the column headed “Circumstances”: C14126 C14127 C14129

  1. Schedule 1, entry for Etanercept

substitute:

Etanercept Injection 50 mg in 1 mL single use auto‑injector, 4 Injection Enbrel C9417 C14068 C14070 C14071 C14154 C14155 See Schedule 2 See Schedule 2
Injections 50 mg in 1 mL single use pre‑filled syringes, 4 Injection Enbrel C9417 C14068 C14070 C14071 C14154 C14155 See Schedule 2 See Schedule 2
Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent 1 mL Injection Enbrel C9417 C14068 C14070 C14071 C14154 C14155 See Schedule 2 See Schedule 2

  1. Schedule 1, entry for Infliximab

(a)omit from the column headed “Circumstances” (all instances): C12039

(b)insert in numerical order in the column headed “Circumstances” (all instances): C14141

  1. Schedule 1, entry for Lamivudine with Zidovudine

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Lamivudine/Zidovudine Viatris 150/300 C4454 C4512 120 5

  1. Schedule 1, after entry for Mepolizumab in the form Powder for injection 100 mg

insert:

Methadone Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL Oral Aspen Methadone Syrup C14178 840 2
Biodone Forte C14178 840 2
Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL Oral Aspen Methadone Syrup C14178 840 2
Biodone Forte C14178 840 2

  1. Schedule 1, entry for Romiplostim in each of the forms: Powder for injection 375 micrograms; and Powder for injection 625 micrograms

(a)omit from the column headed “Circumstances”: C13329 C13376

(b)omit from the column headed “Circumstances”: C13399

(c)insert in numerical order in the column headed “Circumstances”: C14098 C14099 C14149

  1. Schedule 1, entry for Tocilizumab in each of the forms: Concentrate for injection 80 mg in 4 mL; and Concentrate for injection 200 mg in 10 mL; and Concentrate for injection 400 mg in 20 mL

(a)omit from the column headed “Circumstances”: C8635

(b)omit from the column headed “Circumstances”: C9384

(c)omit from the column headed “Circumstances”: C10532 C10535 C10536 C10541 C10542 C10545 C10567

(d)omit from the column headed “Circumstances”: C10571 C10616

(e)insert in numerical order in the column headed “Circumstances”: C14082 C14083 C14085 C14091 C14093 C14144 C14145 C14148 C14162 C14164 C14179

  1. Schedule 2, entry for Abatacept [Maximum quantity: 1 dose; Maximum repeats: 4]

(a)omit from the column headed “Circumstances”: C8748

(b)insert in numerical order in the column headed “Circumstances”: C14076

  1. Schedule 2, entry for Adalimumab

substitute:

Adalimumab C12120 C14061 C14063 C14064 2 doses 3
C14107 C14136 2 doses 5

  1. Schedule 2, after entry for Ambrisentan

insert:

Avatrombopag C14054 C14101 C14130 C14131 C14132 30 5

  1. Schedule 2, entry for Eltrombopag

(a)omit from the column headed “Circumstances”: C13325 C13326

(b)omit from the column headed “Circumstances”: C13395

(c)insert in numerical order in the column headed “Circumstances”: C14126 C14127 C14129

  1. Schedule 2, entry for Etanercept

substitute:

Etanercept C9417 C14068 C14070 C14071 Sufficient for treatment for 4 weeks 3
C14154 C14155 Sufficient for treatment for 4 weeks 5

  1. Schedule 2, entry for Infliximab [Maximum quantity: 1 dose of 3 mg per kg of patient weight; Maximum repeats: 3]

(a)omit from the column headed “Circumstances”: C12039

(b)insert in numerical order in the column headed “Circumstances”: C14141

  1. Schedule 2, entry for Romiplostim

substitute:

Romiplostim C14098 1 vial 5
C13396 C14099 Sufficient for treatment for 4 weeks 5
C14149 1 vial Sufficient for treatment for 24 weeks

  1. Schedule 2, entry for Tocilizumab

substitute:

Tocilizumab C8638 C9386 C9407 C9417 C9494 C11752 C11782 C12163 C12436 C12450 C12451 C14083 C14144 C14145 C14162 1 infusion 3
C10570 C14085 C14091 C14148 2 infusions 3
C8627 C8637 C9380 C9495 C14082 C14164 1 infusion 5
C14093 C14179 2 infusions 5

  1. Schedule 3, entry for Abatacept

(a)omit:

C8748 Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or re‑commencement of treatment after a break in biological medicine of less than 24 months).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient’s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
Up to a maximum of 4 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C14076 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
Up to a maximum of 4 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. 		Compliance with Written Authority Required procedures

  1. Schedule 3, entry for Adalimumab

substitute:

Adalimumab C12120 Severe active juvenile idiopathic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. 		Compliance with Authority Required procedures
C14061 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures
C14063 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Authority Required procedures
C14064 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(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:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Authority Required procedures
C14107 Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated 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.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures - Streamlined Authority Code 14107
C14136

Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated 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.

An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

 Compliance with Authority Required procedures - Streamlined Authority Code 14136

  1. Schedule 3, after entry for Atazanavir with cobicistat

insert:

Avatrombopag C14054 Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C14101 Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment or Grandfather treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have changed treatment from either romiplostim or eltrombopag to this drug under the Balance of Supply/Change of Therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C14130 Severe thrombocytopenia
Initial treatment - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion. 		Compliance with Written Authority Required procedures
C14131 Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Grandfather treatment restriction; OR
Patient must be changing therapy from romiplostim or eltrombopag to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with romiplostim or eltrombopag may change to avatrombopag under this restriction. 		Compliance with Authority Required procedures
C14132 Severe thrombocytopenia
Grandfather treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 July 2023; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a sustained platelet response to the non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The platelet count must have been no more than 4 weeks old at the time that non-PBS-subsidised treatment with this drug was initiated and must be documented in the patient's medical records.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the First Continuing treatment or Re-initiation of interrupted continuing treatment criteria. 		Compliance with Written Authority Required procedures

  1. Schedule 3, after entry for Bosentan

insert:

Buprenorphine C14075 Opioid dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment. 		Compliance with Authority Required procedures - Streamlined Authority Code 14075
C14138 Opioid dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment; AND
Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 14138
C14139 Opioid dependence
Must be treated by a health care professional.
The treatment must be within a framework of medical, social and psychological treatment; AND
Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone. 		Compliance with Authority Required procedures - Streamlined Authority Code 14139
C14157 Opioid dependence
The treatment must be within a framework of medical, social and psychological treatment.
A medical practitioner must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 2 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. 		Compliance with Authority Required procedures - Streamlined Authority Code 14157

  1. Schedule 3, after entry for Buprenorphine

insert:

Buprenorphine with naloxone C14074 Opioid dependence
The treatment must be within a framework of medical, social and psychological treatment.
A medical practitioner must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 2 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. 		Compliance with Authority Required procedures - Streamlined Authority Code 14074

  1. Schedule 3, entry for Eltrombopag

substitute:

Eltrombopag C13327 Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under first continuing or re‑initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS‑subsidised treatment with this drug; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C14126 Severe thrombocytopenia
Initial treatment - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures
C14127 Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must be changing therapy from romiplostim or avatrombopag to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with romiplostim or avatrombopag may change to eltrombopag under this restriction. 		Compliance with Authority Required procedures
C14129 Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have changed treatment from either romiplostim or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Etanercept

substitute:

Etanercept C9417 Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. 		Compliance with Authority Required procedures
C14068 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures
C14070 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(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:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Authority Required procedures
C14071 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Authority Required procedures
C14154 Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated 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.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures - Streamlined Authority Code 14154
C14155 Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated 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.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures - Streamlined Authority Code 14155

  1. Schedule 3, entry for Infliximab

(a)omit:

C12039 Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. 		Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C14141 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be aged 18 years or older.
Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. 		Compliance with Written Authority Required procedures

  1. Schedule 3, after entry for Mepolizumab

insert:

Methadone C14178 Opioid dependence
The treatment must be within a framework of medical, social and psychological treatment.
A medical practitioner must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 2 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. 		Compliance with Authority Required procedures - Streamlined Authority Code 14178

  1. Schedule 3, entry for Romiplostim

substitute:

Romiplostim C13396 Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under first continuing or re‑initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS‑subsidised treatment with this drug; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week 		Compliance with Authority Required procedures
C14098 Severe thrombocytopenia
Initial treatment - New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.
Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. 		Compliance with Written Authority Required procedures
C14099 Severe thrombocytopenia
First Continuing treatment or Re-initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have changed treatment from either eltrombopag or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records. 		Compliance with Authority Required procedures
C14149 Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction. 		Compliance with Authority Required procedures

  1. Schedule 3, entry for Tocilizumab

(a)omit:

C8635 Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or re‑commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient’s response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. 		Compliance with Written Authority Required procedures

(d)omit:

C10571 Systemic juvenile idiopathic arthritis
Balance of supply ‑ Continuing treatment
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. 		Compliance with Authority Required procedures
C10616 Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; or (ii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(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:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Written Authority Required procedures

(e)insert in numerical order after existing text:

C14082 Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated 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.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures - Streamlined Authority Code 14082
C14083 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Authority Required procedures
C14085 Systemic juvenile idiopathic arthritis
Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months)
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND
Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (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); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); OR
Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must be under 18 years of age.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. 		Compliance with Authority Required procedures
C14091 Systemic juvenile idiopathic arthritis
Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)
Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(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 active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Authority Required procedures
C14093 Systemic juvenile idiopathic arthritis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(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 active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 14093
C14144 Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
Patient must not have already failed , or ceased to respond to, PBS-subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. 		Compliance with Written Authority Required procedures
C14145 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures
C14148 Systemic juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(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, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The assessment of response to prior treatment must be documented in the patient's medical records.
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and
(b) the details of prior treatment including dose and duration of treatment.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C-reactive protein (CRP) level and platelet count.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. 		Compliance with Authority Required procedures
C14162 Severe active juvenile idiopathic arthritis
Initial treatment - Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(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:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C14164 Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated 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.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. 		Compliance with Authority Required procedures - Streamlined Authority Code 14164
C14179 Systemic juvenile idiopathic arthritis
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(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 active joints, from at least 4, by at least 50%:
- elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
- shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 14179
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