Better health and ageing for all Australians

Alternative Arrangements for Medicines

Other supply arrangements outside the Pharmaceutical Benefits Scheme (PBS)

The following page describes the drugs available through the Life Saving Drugs Program (LSDP).

In this section:

Life Saving Drugs Program

Background Through the LSDP, the Australian Government provides subsidised access, for eligible patients, to expensive life saving drugs for very rare life-threatening conditions.

Before a drug is made available on the LSDP it must generally be accepted by the Pharmaceutical Benefits Advisory Committee as clinically effective, but not recommended for inclusion on the Pharmaceutical Benefits Scheme due to unacceptable cost-effectiveness.

Review of the LSDP

In 2009 a review of the LSDP was completed by an Interdepartmental Reference Group. The purpose of the review was to examine the LSDP with a view to ensuring consistent procedures and a sustainable program. A summary of the outcomes of the review can be found at:
Summary of outcomes from the review of the LSDP

Access to the LSDP

Subsidised access through the LSDP is granted in accordance with specified eligibility criteria and subject to certain conditions:
Life Saving Drugs Program Criteria and Conditions

The above funding criteria and conditions were revised on 10 May 2010 following the review of the LSDP.

LSDP Consent and Agreement Forms

LSDP Submission Guidelines

The LSDP Submission Guidelines is a resource for sponsors when developing the submission applying for LSDP listing. Sponsors are still required to follow the current procedure when applying for listing a new drug on the Pharmaceutical Benefits Schedule (PBS), in that the drug must first be accepted by the PBAC as clinically effective, but rejected for PBS listing because it fails to meet the required cost effectiveness criteria.

Administrative Requirements for proposals to fund a drug through the LSDP

The Administrative Requirements document provides information for sponsors about the process involved from the time the submission is made to the PBAC, through to the negotiation of a Deed of Agreement, drafting of Condition Guidelines, establishment of a Disease Advisory Committee, consideration by Government and, if approved, commencement of the listing through the LSDP.

Administrative Requirements for proposals to fund a drug through the LSDP
LSDP Condition Guidelines (PDF 576 KB)
LSDP Condition Guidelines (Word 248 KB)

LSDP Master Deed Template

The LSDP Master Deed sets out the standard clauses and conditions, required by the Department of Health and Ageing for the supply of the drug through the LSDP. The clauses in the Master Deed are designed to ensure the Department meets its obligations under the Financial Management and Accountability ACT 1997 (FMA)

Supply shortage of agalsidase-beta (Fabrazyme®) and imiglucerase (Cerezyme®)

Since June 2009 the Department has been working closely with Genzyme to manage the supply of agalsidase-beta and imiglucerase (Cerezyme®) in Australia, in response to global shortages of these drug.

Drugs currently available through the LSDP

Currently, funds are specifically made available on an annual basis for the following therapies:
Imiglucerase (Cerezyme®), Velaglucerase (VPRIV®) and Miglustat (Zavesca®) for the treatment of Gaucher disease
Agalsidase alfa (Replagal®) and Agalsidase beta (Fabrazyme®) for the treatment of Fabry disease
Laronidase (Aldurazyme®) for the treatment of Mucopolysaccharidosis Type I (MPS I)
Idursulfase (Elaprase®) for the treatment of Mucopolysaccharidosis Type II (MPS II)
Galsulfase (Naglazyme®) for the treatment of Mucopolysaccharidosis Type VI (MPS VI)
Alglucosidase alfa (Myozyme®) for the treatment of Infantile-onset Pompe disease
Eculizumab (Soliris®) for the treatment of Paroxysmal Nocturnal Haemoglobinuria (PNH)

Imiglucerase (Cerezyme®), Velaglucerase (VPRIV®) and Miglustat (Zavesca®) for the treatment of Gaucher Disease

Access the LSDP Consent and Agreement Forms.

Cerezyme®, VPRIV® and Zavesca® Product Information is available at the Therapeutic Goods Administration EBS website.
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Agalsidase alfa (Replagal®) and Agalsidase beta (Fabrazyme®) for the treatment of Fabry Disease

Access the LSDP Consent and Agreement Forms.
Fabrazyme® and Replagal® Product Information is available at the Therapeutic Goods Administration EBS website.

Laronidase (Aldurazyme®) for the treatment of Mucop olysaccharidosis Type I (MPS I)

Access the LSDP Consent and Agreement Forms.

Aldurazyme® Product Information is available at the Therapeutic Goods Administration EBS website.

Idursulfase (Elaprase®) for the treatment of Mucopolysaccharidosis Type II (MPS II)

Access the LSDP Consent and Agreement Forms.

Elaprase® Product Information is available at the Therapeutic Goods Administration EBS website.

Galsulfase (Naglazyme®) for the treatment of Mucopolysaccharidosis Type VI (MPS VI)

Access the LSDP Consent and Agreement Forms.

Naglazyme® Product Information is available at the Therapeutic Goods Administration EBS website.

Alglucosidase alfa (Myozyme®) for the treatment of Infantile-onset Pompe Disease

Access the LSDP Consent and Agreement Forms.

Myozyme® Product Information is available at the Therapeutic Goods Administration EBS website.

Eculizumab (Soliris®) for the treatment of Paroxysmal Nocturnal Haemoglobinuria (PNH)

Access the LSDP Consent and Agreement Forms.
Soliris® Product Information is available at the Therapeutic Goods Administration EBS website.
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Further Information
Life Saving Drugs Program
Phone: (02) 6289 2336
Fax: (02) 6289 8537
Email: LSDP team

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