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PB 16 of 2011 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (No. PB 116 of 2010) to provide for the definition of Complex Authority Required drugs to alphabetise the list of drugs contained within, and also provides for circumstances in which a prescription for the supply of pharmaceutical benefits with the listed drug Azacitidine may be written.
Administered by: Health
Registered 28 Feb 2011
Tabling HistoryDate
Tabled HR01-Mar-2011
Tabled Senate01-Mar-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 16 of 2011

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 2)

 

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 24 February 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.2).

 

(2)                This Instrument may also be cited as PB 16 of 2011.

 

2             Commencement

                             This Instrument commences on 1 March 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 (a) to (n) and insert:

(a)   abatacept;

(b)   adalimumab;

(c)    ambrisentan;

(d)   azacitidine;

(e)   bosentan;

(f)    epoprostenol;

(g)   etanercept;

(h)   iloprost;

(i)     infliximab;

(j)     lenalidomide;

(k)    rituximab;

(l)     sildenafil;

(m)  sitaxentan; and

(n)   tocilizumab.

 

[2]           Schedule 3, 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.