Alternative Arrangements for Medicines

Other supply arrangements outside the Pharmaceutical Benefits Scheme (PBS)

Other supply arrangements outside the PBS which cover Lifesaving Drugs, Essential Drugs, Unapproved Drugs, Orphan Drugs, Mass Immunisation Vaccines, Syringes, Diagnostic Agents and Insulin Infusion Pump consumables, and Royal Flying Doctors Service Medical Chest supplies.

These arrangements cover:

Lifesaving Drugs

The Commonwealth Government provides funds under an appropriation item established for the specific purpose of assisting access to expensive and lifesaving drugs accepted by the PBAC as clinically effective, but not available as pharmaceutical benefits because of a failure to meet cost effectiveness criteria. Financial assistance for such drugs is approved in accordance with specified eligibility criteria and subject to certain conditions as agreed by the Ministers for Health and Finance.

The supply of life saving drugs under this special non-statutory arrangement commenced in May 1995 and evolved from the former Act of Grace payment arrangements administered by the Department of Finance under section 34A of the Audit Act 1901.

Currently, the funding arrangement is a limited appropriation each year from which funds are specifically made available for four drugs to treat rare inherited enzyme deficiencies:

• Imiglucerase (Cerezyme®), a drug for the treatment of Gaucher's disease; and
• Agalsidase - alfa (Replagal®) and Agalsidase - beta (Fabrazyme®) for the treatment of Fabry's disease
• Laronidase-rch (Aldurazyme®) for the treatment of mucopoly sacharcdosis type 1 (MPS1)

Criteria and conditions of elibility for these lifesaving drugs and application and registration forms can be accessed as follows:

Criteria and conditions applying to financial assistance under the Life Saving Drugs Program
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Gaucher's Disease

Guidelines for treatment of Gaucher Disease by Enzyme Replacement with Imiglucerase (PDF 55 KB)

Lifesaving Drugs Program - Gaucher Disease Patient Registration for Enzyme Replacement Therapy (PDF 81 KB)

Gaucher Disease - Protocol for Data Collection for Enzyme Replacement Therapy with Imiglucerase (PDF 26 KB)

Notes to Radiologists assessing Gaucher Disease patients with Magnetic Resonance Imaging (MRI).

Fabry's Disease

The Government has added Replagal® and Fabrazyme® to the Life Saving Drugs Program at a cost of $41.3 million over four years.

Cost of Treatment for Fabry's Disease

Drug name	Brand Name	Approx. Cost per Patient per year*	Vial Size	Cost per vial	Sponsor in Australia
Agalsidase - alpha	Replagal®	$232,000	3.5mg	$2,230.00	Orphan Australia Pty Ltd
Agalsidase - beta	Fabrazyme®	$313,000	35mg	$6,024.00	Genzyme Australia
			5mg	$946.00
(*) Based on fortnightly doses for a person weighing 70kg Replagal®: 0.2mg/kg body weight; and Fabrazyme®: 1mg/kg body weight.

Guidelines for Eligibility to receive treatment with Agalsidase through the Life Saving Drugs Program (PDF 117 KB)

Application Form for subsidised Enzyme Replacement Therapy for Fabry Disease (PDF 134 KB)
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MPS1 Disease

Guidelines For Eligibility To Receive Treatment Of Mucopolysaccharidosis Type 1 (MPS1) With Laronidase Through The Life Saving Drugs Program (PDF 33 KB)

MPSII Disease

Guidelines For Eligibility To Receive Treatment For Mucopolysaccharidosis TypeII (MPS-II) With Idursulfase Through The Life Saving Drugs Program (PDF 38 KB)

Syringes, Diagnostic Agents and Insulin Infusion Pump Consumables - National Diabetes Services Scheme

The Commonwealth Government subsidises the supply of insulin syringes, diagnostic agents and insulin infusion pump consumables under section 9A of the National Health Act 1953, to persons with diabetes registered with the National Diabetes Services Scheme. The Scheme is administered by Diabetes Australia which co-ordinates the supply of products to diabetics for the self-management of their condition, either through its network of agents and sub-agents or by mail in all States and Territories. A grant is paid to Diabetes Australia to cover administration and product purchase expenses and allows for a copayment to be paid by diabetics. Purchases do not count as eligible expenditure for PBS safety net purposes.