National Health Act 1953 Arrangements made under subparagraph 100(1)(b)(i) Highly specialised drugs program (No. PB 47 of 2007) (Cth)
COMMONWEALTH OF AUSTRALIA
National Health Act 1953
ARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)
HIGHLY SPECIALISED DRUGS PROGRAM
No. PB 47 of 2007
I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing and delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at private hospitals as non-admitted patients, day admitted patients or patients on discharge:
These Arrangements commence on 1 July 2007.
The Arrangements under subparagraph 100(1)(b)(i) of the National Health Act 1953 made on
12 March 2007 with effect from 1 April 2007 (No. PB 25 of 2007), as amended on 30 March 2007 with effect from 1 May 2007 (No. PB 36 of 2007), are, in these Arrangements, referred to as the Principal Arrangements.
Schedule 1 to the Principal Arrangements is amended:
(a) by omitting the details in respect of the highly specialised drug Lanreotide Acetate and substituting the following details:
| Column 1 Name of highly specialised drug | Column 2 Circumstances |
| Lanreotide Acetate | In respect of the powder for suspension for injection equivalent to 30 mg lanreotide with diluent ampoule: Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and: (a) after failure of other therapy including dopamine agonists; or (b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or (c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (6 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Treatment must cease if IGF1 is not lower after 3 months’ treatment In respect of the injection equivalent to 60 mg lanreotide in single dose pre-filled syringe, injection equivalent to 90 mg lanreotide in single dose pre-filled syringe and injection equivalent to 120 mg lanreotide in single dose pre-filled syringe: Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and: (a) after failure of other therapy including dopamine agonists; or (b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or (c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated |
| In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose). Lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Treatment must cease if IGF1 is not lower after 3 months' treatment Functional carcinoid tumour causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose |
(b) by omitting the details in respect of the highly specialised drug Octreotide Acetate and substituting the following details:
| Column 1 Name of highly specialised drug | Column 2 Circumstances |
| Octreotide Acetate | In respect of the injection equivalent to 50 micrograms octreotide in 1 mL, injection equivalent to 100 micrograms octreotide in 1 mL and injection equivalent to 500 micrograms octreotide in 1 mL: Active acromegaly in a patient with persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre and: (a) after failure of other therapy including dopamine agonists; or |
| (b) as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or | |
| (c) if the patient is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated | |
| In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks. Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Treatment must cease if IGF1 is not lower after 3 months’ treatment at a dose of 100 micrograms 3 times daily | |
| Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) causing intractable symptoms. The patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents, and surgery or antineoplastic therapy must have failed or be inappropriate Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | |
| In respect of the injection (modified release) equivalent to 10 mg octreotide, vial and diluent syringe, injection (modified release) equivalent to 20 mg octreotide, vial and diluent syringe and injection (modified release) equivalent to 30 mg octreotide, vial and diluent syringe: Acromegaly in a patient controlled on Sandostatin subcutaneous injections In a patient treated with radiotherapy, treatment must cease if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose) Octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission Treatment must cease if IGF1 is not lower after 3 months of treatment | |
| Functional carcinoid tumour or vasoactive intestinal peptide secreting tumour (VIPoma) with symptom control on Sandostatin subcutaneous injections Treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with Sandostatin subcutaneous injections. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose |
Dated this 7th day of June 2007.
STEPHEN DELLAR
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Delegate of the Minister for Health and Ageing
0
0
0