National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 1)

National Health Act 1953

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I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated 26 January 2011

FELICITY MCNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

___________________________________________________________________________

Schedule 1 Amendments

[1] Section 4, definition of “CAR drug”

Omit paragraph (m) and insert:

(m) tocilizumab;

(n) azacitidine.

[2] Section 24

Omit paragraph 24(2)(i) and insert:

(i) for HSD pharmaceutical benefits that have the drug lenalidomide:

(i) with the form Capsule 5 mg – up to 84 tablets;

(ii) with the form Capsule 10 mg – up to 42 tablets;

(iii) with the form Capsule 15 mg – up to 21 tablets;

(iv) with the form Capsule 25 mg – up to 21 tablets;

(j) for HSD pharmaceutical benefits that have the drug azacitidine with the form Powder for injection 100mg – up to 14 units.

[3] Section 25

Omit paragraph 25(2)(n) and insert:

(n) for adalimumab for the treatment of a patient with 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 treatment to be authorised — up to 5 repeat supplies;

(o) for azacitidine:

(i) for initial treatment — up to 2 repeat supplies;

(ii) for continuing treatment — up to 5 repeat supplies.

[4] Schedule 1, entry for Apomorphine

omit from the column headed ‘Brand’:

APO-go

and insert:

Apomine

[5] Schedule 1, after entry for Atazanavir

insert in the columns in the order indicated:

Azacitidine

Powder for injection 100 mg

Injection

Vidaza

EMP

C3668 C3669

See Note 1

See Note 2

[6] Schedule 1, entry for Doxorubicin – Pegylated Liposomal

omit from the column headed ‘Responsible Person’:

and insert:

[7] Schedule 1, entry for Stavudine

omit:

Powder for oral solution 1 mg per mL, 200mL

Oral

Zerit

EMP

C1820 C1821 C3309 C3310

[8] Schedule 4, after entry for Atazanavir

insert in the columns in the order indicated:

Azacitidine

C3668

Where the patient is receiving treatment at/from a private or public hospital

Initial PBS-subsidised treatment of a patient with:
(1) Myelodysplastic syndrome classified as Intermediate-2 or high risk according to the International Prognostic Scoring System (IPSS); or
(2) Chronic Myelomonocytic Leukaemia (10% to 29% marrow blasts without Myeloproliferative Disorder); or
(3) Acute Myeloid Leukaemia with 20 to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.
Classification of a patient as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:
1. 11% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; or
2. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; or
3. 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; or
4. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; or
5. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; or
6. less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.
Classification of a patient as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:
1. 21% to 30% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; or
2. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; or
3. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; or
4. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.
The first authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Azacitidine PBS Authority Application - Supporting Information Form; and
(c) a copy of the bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome, chronic myelomonocytic leukaemia or acute myeloid leukaemia; and
(d) a copy of the full blood examination report; and
(e) for myelodysplastic syndrome, a copy of the pathology report detailing the cytogenetics demonstrating intermediate-2 or high risk disease according to the International Prognostic Scoring System (IPSS); and
(f) a signed patient acknowledgment form.
No more than three cycles may be authorised

Compliance with modified Authority Required procedures

C3669

Where the patient is receiving treatment at/from a private or public hospital

Continuing treatment of a patient with:
(1) Myelodysplastic syndrome classified as Intermediate-2 or high risk according to the International Prognostic Scoring System (IPSS); or
(2) Chronic Myelomonocytic Leukaemia (10% to 29% marrow blasts without Myeloproliferative Disorder); or
(3) Acute Myeloid Leukaemia with 20 to 30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification;
who has previously been issued with an authority prescription for azacitidine and does not have progressive disease.
Up to six cycles may be authorised per authority application

Compliance with modified Authority Required procedures

Note

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