National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 3) (No. PB 31 of 2012) (Cth)

PB 31 of 2012

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 3)

National Health Act 1953

___________________________________________________________________________

I, KIM BESSELL, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated 24 April 2012

KIM BESSELL

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________________

1 Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.3).

(2)This Instrument may also be cited as PB 31 of 2012.

2 Commencement

This Instrument commences on 1 May 2012.

3 Amendments to PB 116 of 2010

Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1 Amendments

Section 4, Definition of CAR drug, entry for tadalafil

omit:

(o)

substitute:

(p)

Section 4, Definition of CAR drug, entry for tocilizumab

omit:

(p)

substitute:

(q)

Section 4, Definition of CAR drug

omit:

(a) abatacept;

(b) adalimumab;

(c) ambrisentan;

(d) azacitidine;

(e) bosentan;

(f) epoprostenol;

(g) etanercept;

(h) iloprost;

(i) infliximab;

(j) lenalidomide;

(k) omalizumab;

(l) rituximab;

(m) Romiplostim;

(n) sildenafil; and

substitute:

(a) abatacept;

(b) adalimumab;

(c) ambrisentan;

(d) azacitidine;

(e) bosentan;

(f) eltrombopag;

(g) epoprostenol;

(h) etanercept;

(i) iloprost;

(j) infliximab;

(k) lenalidomide;

(l) omalizumab;

(m) rituximab;

(n) romiplostim;

(o) sildenafil;

paragraph 24(2)(g)

substitute:

(g)for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of adult patients with severe active rheumatoid arthritis — a quantity of units that are sufficient, based on the weight of the patient and taking into account whether any other strength injections will contribute part of the dose, to provide for the whole or part of a single dose of 8 mg per kg;

paragraph 24(2)(k)

substitute:

(k) for HSD pharmaceutical benefits that have the drug romiplostim, for initial treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

(i) at the time of the initial written authority application — a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;

(ii) during the initial period of dose titration — a quantity of units sufficient to provide for a single dose;

(iii) for a patient whose dose has been stable for a period of 4 weeks — a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

paragraph 24(2)(l)

substitute:

(l) for HSD pharmaceutical benefits that have the drug romiplostim, for initial PBS-subsidised treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Romiplostim was commenced:

(i) at the time of the initial written authority application — a quantity of units that are sufficient, based on the weight of the patient, to provide for a single dose of 1 microgram per kilogram;

(ii) during the initial period of dose titration — a quantity of units sufficient to provide for a single dose;

(iii) for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks — a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks;

(iv) for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS-subsidy — a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.

paragraph 24(2)(m)

substitute

(m) for HSD pharmaceutical benefits that have the drug romiplostim, for the first period of continuing treatment or re-initiation of interrupted PBS subsidised treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS-subsidised treatment — a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks treatment.

paragraph 24(2)(n)

substitute

(n)for HSD pharmaceutical benefits that have the drug romiplostim, for the second and subsequent periods of continuing treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Romiplostim — a quantity of units that are sufficient, based on the weight of the patient and the dose, for up to 4 weeks of treatment.

after paragraph 24(2)(q)

insert:

(r) for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS-subsidised treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;

(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;

— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

(s) for HSD pharmaceutical benefits that have the drug eltrombopag, for initial PBS-subsidised treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with Eltrombopag was commenced):

(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;

(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;

— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

(t) for HSD pharmaceutical benefits that have the drug eltrombopag, for the first period of continuing treatment or re-initiation of interrupted PBS subsidised treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with Eltrombopag during the initial period of PBS-subsidised treatment:

(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;

(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;

— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

(u) for HSD pharmaceutical benefits that have the drug eltrombopag, for the second and subsequent periods of continuing treatment as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) of severe thrombocytopenia in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who continues to display a sustained platelet response to treatment with Eltrombopag:

(i) with the form Tablet 25 mg (as olamine) – up to 28 tablets;

(ii) with the form Tablet 50 mg (as olamine) – up to 28 tablets;

— a quantity of units that are sufficient for up to 4 weeks of treatment, as long as the total period of treatment that has been authorised does not exceed 24 weeks.

(v) for HSD pharmaceutical benefits that have the drug tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis – a quantity of units sufficient for up to 1 month of treatment with the drug.

[10] paragraph 25(2)(p)

substitute:

(p) for romiplostim for initial treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

(i) at the time of the initial written authority application — 1 repeat supply;

(ii) during the initial period of dose titration — 1 repeat supply;

(iii) for a patient whose dose has been stable for a period of 4 weeks — up to 4 repeat supplies.

[11] paragraph 25(2)(q)

substitute:

(q) for romiplostim for initial PBS-subsidised treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with Romiplostim prior to 1 April 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with romplostin was commenced:

(i) at the time of the initial written authority application — 1 repeat supply;

(ii) during the initial period of dose titration — 1 repeat supply;

(iii) for a patient in the titration phase of treatment whose dose has been stable for a period of 4 weeks — up to 4 repeat supplies;

(iv) for a patient whose dose had been stable for a period of at least 4 weeks at the time of the initial application for PBS-subsidy — up to 5 repeat supplies.

[12] paragraph 25(2)(r)

substitute:

(r) for romiplostim for the first period of continuing treatment or re‑initiation of interrupted PBS-subsidised treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with Romiplostim during the initial period of PBS‑subsidised treatment:

(i) at the time of the initial written authority application — up to 5 repeat supplies;

(ii) where less than 5 repeat supplies are requested in the initial written authority application — sufficient repeat supplies to complete a maximum of 24 weeks treatment.

[13] paragraph 25(2)(s)

substitute:

(s) for romiplostim for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with Romiplostim — up to 5 repeat supplies.

[14] after paragraph 25(2)(u)

insert:

(v) for eltrombopag for initial treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP):

(i) if the circumstances permit a course of up to a maximum of
24 weeks of treatment to be authorised — up to 5 repeat supplies.

(w) for eltrombopag for initial PBS-subsidised treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment in the circumstances can be demonstrated to have been met at the time his or her treatment with eltrombopag was commenced:

(i) if the circumstances permit a course of up to a maximum of
24 weeks of treatment to be authorised — up to 5 repeat supplies.

(x) for eltrombopag for the first period of continuing treatment or re‑initiation of interrupted PBS-subsidised treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who has displayed a sustained platelet response to treatment with eltrombopag during the initial period of PBS‑subsidised treatment:

(i) if the circumstances permit a course of up to a maximum of
24 weeks of treatment to be authorised — up to 5 repeat supplies;

(ii) where less than 5 repeat supplies are requested in the initial written authority application — sufficient repeat supplies to complete a maximum of 24 weeks treatment.

(y) for eltrombopag for the second and subsequent periods of continuing treatment of severe thrombocytopenia as the sole PBS-subsidised thrombopoetin receptor agonist (TRA) in an adult with severe chronic immune (idiopathic) thrombocytopenic purpure (ITP) who continues to display a sustained platelet response to treatment with eltrombopag — up to 5 repeat supplies.

(z) for tocilizumab, for the treatment of patients with severe active systemic juvenile idiopathic arthritis:

(i) if the circumstances permit a course of up to a maximum of
16 weeks of treatment to be authorised — up to 3 repeat supplies;

(ii) If the circumstances permit a course of up to a maximum of
24 weeks of treatment to be authorised — up to 5 repeat supplies.

[15] Schedule 1, entry for Darunavir

omit:

Tablet 300 mg (as ethanolate)

Oral

Prezista

EMP

C3594 C3595

240

[16] Schedule 1, entry for Eltrombopag

substitute:

Eltrombopag	Tablet 25 mg (as olamine)	Oral	Revolade	GK	EMP	C3855 C3856 C3857 C3858	See Note 1	See Note 2	D
Tablet 50 mg (as olamine)	Oral	Revolade	GK	EMP	C3855 C3856 C3857 C3858	See Note 1	See Note 2	D

[17] Schedule 1, entry for Etravirine

substitute:

Etravirine

Tablet 200 mg

Oral

Intelence

EMP

C3596 C3597

120

[18] Schedule 1, entry for Mycophenolic Acid in the form of Tablet containing mycophenolate mofetil 500 mg

insert after entry for the brand Mycophenolate Sandoz:

Pharmacor

Mycophenolate 500

EMP

C1650 C1651 C3355 C3356

300

[19] Schedule 1, entry for Tocilizumab in the column headed ‘Circumstances’

substitute:

C3716 C3825 C3826 C4025 C4026 C4027 C4028

[20] Schedule 2, after entry for CJ

Insert:

Pharmacor Pty Limited

58 121 020 835

[21] Schedule 3, entry for Abacavir with Lamivudine and Zidovudine, circumstances code C3979

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[22] Schedule 3, entry for Abacavir with Lamivudine and Zidovudine, circumstances code C3980

Omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

Substitute:

Compliance with Written or Telephone Authority Required procedures

[23] Schedule 3, entry for Abacavir with Lamivudine and Zidovudine, circumstances code C3981

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3981

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3981

[24] Schedule 3, entry for Abacavir with Lamivudine and Zidovudine, circumstances code C3982

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3982

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3982

[25] Schedule 3, entry for Adefovir, circumstances code C3971

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[26] Schedule 3, entry for Adefovir, circumstances code C3972

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[27] Schedule 3, entry for Adefovir, circumstances code C3973

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3973

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3973

[28] Schedule 3, entry for Adefovir, circumstances code C3974

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3974

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3974

[29] Schedule 3, entry for Darunavir, circumstances code C3940

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[30] Schedule 3, entry for Darunavir, circumstances code C3941

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3941

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3941

[31] Schedule 3, entry for Deferasirox, circumstances code C3828

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3828

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3828

[32] Schedule 3, entry for Deferasirox, circumstances code C3829

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[33] Schedule 3, entry for Eltrombopag, circumstances code C3855

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with modified Authority Required procedures

[34]Schedule 3, entry for Eltrombopag, circumstances code C3856

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with modified Authority Required procedures

[35]Schedule 3, entry for Eltrombopag, circumstances code C3857

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with modified Authority Required procedures

[36]Schedule 3, entry for Eltrombopag, circumstances code C3858

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with modified Authority Required procedures

[37] Schedule 3, entry for Entecavir, circumstances code C3959

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[38] Schedule 3, entry for Entecavir, circumstances code C3960

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[39] Schedule 3, entry for Entecavir, circumstances code C3961

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3961

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961

[40] Schedule 3, entry for Entecavir, circumstances code C3962

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3962

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962

[41]Schedule 3, entry for Entecavir, circumstances code C3963

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[42]Schedule 3, entry for Entecavir, circumstances code C3964

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3964

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3964

[43]Schedule 3, entry for Entecavir, circumstances code C3965

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[44]Schedule 3, entry for Entecavir, circumstances code C3966

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3966

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3966

[45]Schedule 3, entry for Filgrastim, circumstances code C3833

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[46]Schedule 3, entry for Filgrastim, circumstances code C3834

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3834

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3834

[47]Schedule 3, entry for Interferon Alfa-2a, circumstances code C3959

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[48]Schedule 3, entry for Interferon Alfa-2a, circumstances code C3960

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[49]Schedule 3, entry for Interferon Alfa-2a, circumstances code C3961

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3961

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961

[50]Schedule 3, entry for Interferon Alfa-2a, circumstances code C3962

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3962

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962

[51]Schedule 3, entry for Interferon Alfa-2b, circumstances code C3959

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[52]Schedule 3, entry for Interferon Alfa-2b, circumstances code C3960

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[53]Schedule 3, entry for Interferon Alfa-2b, circumstances code C3961

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3961

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961

[54]Schedule 3, entry for Interferon Alfa-2b, circumstances code C3962

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3962

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962

[55]Schedule 3, entry for Lamivudine, circumstances code C3586

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[56]Schedule 3, entry for Lamivudine, circumstances code C3587

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[57]Schedule 3, entry for Lamivudine, circumstances code C3588

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3588

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3588

[58]Schedule 3, entry for Lamivudine, circumstances code C3589

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3589

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3589

[59]Schedule 3, entry for Lamivudine, circumstances code C3959

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[60]Schedule 3, entry for Lamivudine, circumstances code C3960

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[61]Schedule 3, entry for Lamivudine, circumstances code C3961

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3961

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3961

[62]Schedule 3, entry for Lamivudine, circumstances code C3962

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3962

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3962

[63]Schedule 3, entry for Natalizumab, circumstances code C3423

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with modified Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[64]Schedule 3, entry for Pegfilgrastim, circumstances code C3833

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[65]Schedule 3, entry for Pegfilgrastim, circumstances code C3834

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3834

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3834

[66]Schedule 3, entry for Peginterferon Alfa-2a, circumstances code C3975

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[67]Schedule 3, entry for Peginterferon Alfa-2a, circumstances code C3976

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[68]Schedule 3, entry for Peginterferon Alfa-2a, circumstances code C3977

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3977

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3977

[69]Schedule 3, entry for Peginterferon Alfa-2a, circumstances code C3978

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3978

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3978

[70]Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b, circumstances code C3413

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3413

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3413

[71]Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b, circumstances code C3948

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[72]Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b, circumstances code C3949

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3949

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3949

[73]Schedule 3, entry for Telbivudine, circumstances code C3967

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[74]Schedule 3, entry for Telbivudine, circumstances code C3968

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[75]Schedule 3, entry for Telbivudine, circumstances code C3969

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3969

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3969

[76]Schedule 3, entry for Telbivudine, circumstances code C3970

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3970

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3970

[77]Schedule 3, entry for Tenofovir, circumstances code C3586

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[78]Schedule 3, entry for Tenofovir, circumstances code C3587

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[79]Schedule 3, entry for Tenofovir, circumstances code C3588

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3588

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3588

[80]Schedule 3, entry for Tenofovir, circumstances code C3589

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3589

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3589

[81]Schedule 3, entry for Tenofovir, circumstances code C3967

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[82]Schedule 3, entry for Tenofovir, circumstances code C3968

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[83]Schedule 3, entry for Tenofovir, circumstances code C3969

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3969

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3969

[84]Schedule 3, entry for Tenofovir, circumstances code C3970

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3970

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3970

[85]Schedule 3, entry for Tenofovir, circumstances code C3971

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[86]Schedule 3, entry for Tenofovir, circumstances code C3972

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[87]Schedule 3, entry for Tenofovir, circumstances code C3973

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3973

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3973

[88]Schedule 3, entry for Tenofovir, circumstances code C3974

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3974

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3974

[89]Schedule 3, entry for Tenofovir with emtricitabine and efavirenz, circumstances code C3983

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[90]Schedule 3, entry for Tenofovir with emtricitabine and efavirenz, circumstances code C3984

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[91]Schedule 3, entry for Tenofovir with emtricitabine and efavirenz, circumstances code C3985

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3985

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3985

[92]Schedule 3, entry for Tenofovir with emtricitabine and efavirenz, circumstances code C3986

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3986

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3986

[93] Schedule 3, entry for Tocilizumab

insert after last entry for Tocilizumab:

C4025	Where the patient is receiving treatment at/from a private or public hospital Systemic juvenile idiopathic arthritis — initial treatment 1 (new and recommencing patients after a break of more than 12 months) Initial treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of a patient under 18 years who: (a) has been diagnosed with systemic juvenile idiopathic arthritis; AND (b) has polyarticular course disease and either: (i) failure to achieve an adequate response to the following treatment regimen (see (1) below for definition of failure to achieve an adequate response): — 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 (ii) severe intolerance of, or toxicity due to, methotrexate (see (2) below for definition of severe intolerance and toxicity); OR (c) has 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 (d) has not received PBS-subsidised treatment with tocilizumab for this condition in the previous 12 months. (1) The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy and must be demonstrated in all patients at the time of the initial application: (a) in a patient with polyarticular course disease: (i) an active joint count of at least 20 active (swollen and tender) joints; OR (ii) at least 4 active joints from the following list: — 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) an active joint count of at least 2 active joints; AND (ii) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; AND/OR (iii) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN). (2) 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 to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonia, or serious sepsis. If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant Therapeutic Goods Administration (TGA)-approved Product Information, please provide details at time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of this toxicity at the time of application. 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. To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be provided for all subsequent continuing treatment applications. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following: (i) the date of assessment of severe active systemic juvenile idiopathic arthritis; (ii) details of prior treatment including dose and duration of treatment; (iii) pathology reports detailing CRP and platelet count where appropriate; and (3) a signed patient or authorised guardian acknowledgement form. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application. A maximum of 16 weeks of treatment will be authorised under this restriction. 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 two infusions (one month supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. Where fewer than 3 repeats are requested at the time of initial application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment may be requested by telephone. Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Chief Executive Medicare no later than 4 weeks from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab. If a patient fails to respond to 2 courses of treatment in a treatment cycle they will not be eligible to receive further PBS-subsidised tocilizumab therapy in that treatment cycle. A patient may re-trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised treatment was stopped and the date of the first application under a new treatment cycle	Compliance with modified Authority Required procedures
C4026	Where the patient is receiving treatment at/from a private or public hospital Systemic juvenile idiopathic arthritis — initial treatment 2 (retrial or recommencement of treatment after a break of less than 12 months) Initial PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of a patient who: (a) has a documented history of systemic juvenile idiopathic arthritis; AND (b) has received PBS-subsidised treatment with tocilizumab for this condition in the previous 12 months; AND (c) has not failed PBS-subsidised therapy with tocilizumab for this condition more than once in the current treatment cycle. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following: (i) pathology reports detailing C-reactive protein (CRP) and platelet count where appropriate. Applications for a patient who has received PBS-subsidised treatment with tocilizumab in this treatment cycle and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment, within the timeframes specified below. A maximum of 16 weeks of treatment will be authorised under this restriction. 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 two infusions (one month supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. Where fewer than 3 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with tocilizumab may be requested by telephone. An assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Chief Executive Medicare no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criteria. Where an assessment is not submitted to the Chief Executive Medicare within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with tocilizumab. Where a response assessment is not undertaken and submitted to the Chief Executive Medicare within these timeframes, the patient will be deemed to have failed to respond to that course of tocilizumab. If a patient fails to respond to 2 courses of treatment they will not be eligible to receive further PBS-subsidised tocilizumab therapy in this treatment cycle. A patient may re-trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised treatment was stopped and the date of the first application under a new treatment cycle	Compliance with modified Authority Required procedures
C4027	Where the patient is receiving treatment at/from a private or public hospital Systemic juvenile idiopathic arthritis — initial treatment 3 Initial treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of a patient who: (a) has a documented history of systemic juvenile idiopathic arthritis; and (b) was receiving treatment with tocilizumab prior 1 November 2011; and (c) has demonstrated a response as specified in the criteria for continuing PBS-subsidised treatment with tocilizumab; and (d) is receiving treatment with tocilizumab at the time of application. To ensure consistency in determining response, the same indices of disease severity used to establish the baseline must be provided for all subsequent continuing treatment applications. The authority application must be made in writing and must include: (1) completed authority prescription form(s); and (2) a completed Systemic Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information Form which includes the following: (i) pathology reports detailing C-reactive protein (CRP) and platelet count where appropriate; and (3) a signed patient or authorised guardian acknowledgement form. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application. The baseline systemic juvenile idiopathic arthritis assessment must be provided and must be from immediately prior to commencing treatment with tocilizumab. Baseline measurements of the joint count, fever and/or CRP level and platelet count will be used to determine whether a response to treatment has been demonstrated. An assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Chief Executive Medicare no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criteria. Where an assessment is not submitted to the Chief Executive Medicare within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with tocilizumab. Patients are eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks providing they continue to sustain the response. 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 two infusions (one months supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Where fewer than 5 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by telephone. A patient may only qualify for PBS-subsidised treatment under this restriction once	Compliance with modified Authority Required procedures
C4028	Where the patient is receiving treatment at/from a private or public hospital Systemic juvenile idiopathic arthritis — continuing treatment Continuing treatment with tocilizumab, by a rheumatologist or under the supervision of a paediatric rheumatology treatment centre, of a patient who: (a) has a documented history of systemic juvenile idiopathic arthritis; AND (b) has demonstrated an adequate response to treatment with tocilizumab. 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 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 which includes the following: (i) baseline and current pathology reports detailing CRP and platelet count where appropriate. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 1 month old at the time of application. Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the Initial treatment restriction, the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must be provided to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased. Where the most recent course of PBS-subsidised tocilizumab treatment was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment must be submitted to the Chief Executive Medicare no later than 4 weeks from the date that course was ceased. Patients are eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks providing they continue to sustain the response. 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 two infusions (one month supply). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Where fewer than 5 repeats are requested at the time of initial application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be requested by. If a patient fails to respond to 2 courses of treatment they will not be eligible to receive further PBS-subsidised tocilizumab therapy in this treatment cycle. A patient may re-trial tocilizumab after a minimum of 12 months have elapsed between the date the last PBS-subsidised treatment was stopped and the date of the first application under a new treatment cycle	Compliance with modified Authority Required procedures

[94]Schedule 3, entry for Zoledronic Acid, circumstances code C3881

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures

substitute:

Compliance with Written or Telephone Authority Required procedures

[95]Schedule 3, entry for Zoledronic Acid, circumstances code C3882

omit from the column headed ‘Authority Requirements – Part of Circumstances’:

Compliance with Authority Required procedures – Streamlined Authority Code 3882

substitute:

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3882

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See

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Citations

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 3) (No. PB 31 of 2012) (Cth)

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