Medicine eligibility criteria
To be eligible for listing on the LSDP, medicines must meet the criteria in the LSDP Procedure Guidance. In summary these are:
- The Therapeutic Goods Administration has approved the medicine to treat an ultra-rare disease (prevalence of 1:50,000 people or less in the Australian population – around 500 people).
- Treating physicians can identify the disease with reasonable diagnostic precision, and 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 the medicine is clinically effective, and
- rejected Pharmaceutical Benefits Scheme (PBS) listing for cost effectiveness reasons.
- There is no other medicine listed on the PBS, or available for public hospital inpatients, that treating physicians can use as a life-saving treatment for the disease. (New medicines can be included on the LSDP 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.
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 should submit their applications to the LSDP Expert Panel (the panel) secretariat.
The panel 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.
Sponsors receive confirmation of the CMO’s recommendation, noting that the final decision is up to the Minister for Health and Aged Care. We post the outcome of each application on the outcomes of new medicine applications page.
After the Minister agrees to list a medicine, the panel secretariat will work with the sponsor to:
- enter into a Deed of Agreement
- develop application and treatment guidelines based on the advice of the panel.
When the panel 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. The LSDP does not cover:
- transport, storage, or administration fees
- hospital or medical expenses associated with the use of the medicine
- any other expenses associated with managing the disease or condition.