National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 3) (PB 22 of 2018) (Cth)
PB 22 of 2018
National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 3)
National Health Act 1953
___________________________________________________________________________
I, KAREN HALL, Assistant Secretary (Acting), Private Health Insurance and Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.
Dated 26 March 2018
KAREN HALL
Assistant Secretary (Acting)
Private Health Insurance and Pharmacy Branch
Technology Assessment and Access Division
Department of Health
___________________________________________________________________________
Name of Instrument
(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2018 (No. 3).
(2)This Instrument may also be cited as PB 22 of 2018.
Commencement
This Instrument commences on 1 April 2018.
Amendment of National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)
Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule 1 Amendments
Schedule 1, entry for Abacavir with Lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg
insert in the columns in the order indicated and in alphabetical order for the column headed “Brand”:
Abacavir/
Lamivudine MylanAF EMP C4527 C4528 60 5 D
Schedule 1, entry for Ganciclovir
insert in the columns in the order indicated and in alphabetical order for the column headed “Brand”:
GANCICLOVIR SXP HN EMP C4972 C4990 C4999 C5025 10 1 D
Schedule 1, entry for Ibandronic acid
omit from the column headed “Responsible Person”: RO substitute: IX
Schedule 1, entry for Lanreotide in each of the forms: Injection 60 mg (as acetate) in single dose pre filled syringe; Injection 90 mg (as acetate) in single dose pre filled syringe; and Injection 120 mg (as acetate) in single dose pre filled syringe
insert in numerical order in the column headed “Circumstances”: C7509 C7532
Schedule 2, details relevant to Responsible Person code GO
omit from the column headed “Responsible Person”: BGP Products Pty Ltd substitute: Mylan Health Pty Ltd
Schedule 2, after details relevant to Responsible Person code GZ
insert:
HN Horizon Hospital Healthcare Pty Ltd 60 148 910 883
Schedule 3, entry for Lanreotide
insert in numerical order after existing text:
C7509 Functional carcinoid tumour
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be causing intractable symptoms; AND
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
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The 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.Compliance with Authority Required procedures - Streamlined Authority Code 7509 C7532 Acromegaly
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy 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); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.Compliance with Authority Required procedures - Streamlined Authority Code 7532
0
0
0