PB 2 of 2011
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 1)
National Health Act 1953
___________________________________________________________________________
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
___________________________________________________________________________
1 Name of Amendment Instrument
(1) This Instrument is the National Health (Highly
specialised drugs program for hospitals) Special Arrangement
Amendment Instrument 2011 (No.1).
(2) This Instrument may also be cited as PB 2 of 2011.
2 Commencement
This Instrument commences on 1 February 2011.
3 Amendments to PB 116 of 2010
Schedule 1 amends PB 116 of 2010.
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 | CJ | EMP
| C3668 C3669 | | See Note 1 | See Note 2 | D |
[6] Schedule 1, entry for Doxorubicin – Pegylated Liposomal
omit from the column headed ‘Responsible Person’:
SH
and insert:
JC
[7] Schedule 1, entry for Stavudine
omit:
| | Powder for oral solution 1 mg per mL, 200mL | Oral | Zerit | BQ | EMP | C1820 C1821 C3309 C3310 | | 24 | 5 | D |
[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
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003.
See http://www.frli.gov.au.