Life Saving Drugs Program for medicine sponsors

Information for pharmaceutical companies on what medicines are eligible for the Life Saving Drugs Program (LSDP) and how to apply for listing.

The Life Saving Drugs Program (LSDP) provides access to essential and very expensive medicines for eligible patients with rare and life-threatening diseases. The program provides these life-saving medicines at no expense to the patients or their families.

Medicine eligibility criteria

Medicines must meet these criteria to be listed under the LSDP:

  • The Therapeutic Goods Administration has approved the medicine to treat a rare disease (prevalence of 1:50,000 people or less in the Australian population – around 500 people).
  • Doctors can identify the disease with reasonable diagnostic precision. Studies show that the disease reduces patients’ age-specific life expectancy.
  • Evidence predicts that a patient’s life will be longer if they use the medicine.
  • The Pharmaceutical Benefits Advisory Committee (PBAC) has:
    • accepted that the medicine is clinically effective
    • rejected PBS listing for cost effectiveness reasons.
  • There is no other medicine listed on the PBS, or available for public hospital inpatients, that doctors can use as a life-saving treatment for the disease. However, it is possible to list new medicines on the LSDP even if there are already other LSDP medicines that treat the same condition.
  • There are no non-drug treatments (like surgery or radiotherapy) that medical authorities regard as suitable and cost-effective for the condition.
  • The cost of the medicine would be an unreasonable financial burden for the patient or their guardian. We define cost as the cost per dose multiplied by the expected number of doses in a 1-year period for the patient.

Listing a medicine on the LSDP

See our procedure guidance for detailed guidance on how to apply to list a medicine on the LSDP.

The guidance includes:

  • details of the application process
  • pricing and deeds of agreement
  • guidelines for treatment through the LSDP
  • information about medicines reviews
  • a template for new medicine applications.

Sponsors submit their applications to the Life Saving Drugs Expert Panel (LSDPEP) secretariat.

The LSDPEP considers applications for listing on the LSDP and advises the Chief Medical Officer (CMO).

The CMO makes a recommendation for or against subsidisation through the LSDP within 2 to 6 weeks of receiving the panel’s advice and the sponsor’s response.

Sponsors receive verbal confirmation of the CMO’s recommendation, noting that the final decision is up to the Minister for Health. We post the outcome of each application on the LSDPEP page.

After the Minister agrees to list a medicine, the LSDP secretariat will work with the sponsor to:

  • enter into a Deed of Agreement
  • develop application and treatment guidelines based on the advice of the LSDPEP.

This flow diagram provides an overview of the assessment process for a new medicine.

New medicines assessment process

Flowchart of procedure to consider new medicines for subsidy through the LSDP

The new-medicine assessment process consists of 3 phases. 

  1. In the pre-application phase, the Pharmaceutical Benefits Advisory Committee (PBAC) rejects the sponsor’s application for PBS listing for the drug. PBAC must find that the drug is clinically effective but not cost effective. The PBAC minutes become available within 5 weeks of the meeting. In the following 4 weeks, there is an optional post-PBAC meeting and pre-LDSP meeting. The PBAC outcome will be published on the web. 
  2. In the assessment phase, the sponsor sends an LDSP application to the LDSP Expert Panel secretariat. They take 2 weeks to prepare an overview. They publish a meeting agenda 4 weeks prior to the panel meeting. The panel meet and hold a stakeholder forum. Two weeks after that the Expert Panel send advice and a consumer summary to the sponsor. The sponsor responds 1 week later. 
  3. In the recommendation phase, the Chief Medical Officer provides a recommendation to the Minister for Health, 2 to 6 weeks after the sponsor response. 

Stakeholder input

The LSDPEP welcomes input from patients, their carers and their treating physicians. Once we publish the agenda for the upcoming LSDPEP meeting, any interested parties can email their input directly to the secretariat.

All stakeholder comments received throughout the PBAC process are sent to the LSDPEP. This means stakeholders do not need to duplicate responses.

We provide a summary of the stakeholder input to the sponsor, along with the advice from the LSDPEP.

Pricing

In 2018, we made an agreement between the Government and Medicines Australia to ensure the future sustainability of the LSDP.

When the LSDPEP reviews applications, it considers:

  • the proposed price of the medicine compared with the effective price of the medicine in comparable overseas markets
  • the proposed cost of the medicine compared with the cost of comparable medicines, if any, that are already funded through the LSDP.

The LSDP only subsidises the cost of the medicine. This may include a factor for importation and transportation of the medicine by the manufacturer direct to the place of administration to the patient. LSDP subsidisation does not cover any other:

  • transport, storage, or administration fees
  • hospital or medical expenses associated with the use of the medicine
  • expenses associated with managing the disease or condition.

Medicine reviews

The LSDPEP reviews the use and cost of any new medicines listed on the LSDP after 2 years. This checks that the medicine:

  • is being used according to the recommendations made when it was listed
  • is providing the expected results.

The panel has also reviewed existing LSDP medicines.

The panel provides its advice to the CMO, who then advises the Australian Government Minister for Health.

Key resource

Procedure guidance for medicines funded through the Life Saving Drugs Program (LSDP)

This guidance document outlines our process and associated timelines to consider medicines seeking funding through the LSDP. It helps sponsors to prepare an application to make a rare disease medicine available on the LSDP.

Contact

Life Saving Drugs Program Expert Panel secretariat

Contact the secretariat with submissions to the Life Saving Drugs Program Expert Panel.

LSDPEP [at] health.gov.au

View contact

Last updated: 
3 February 2021

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