Other supply arrangements outside the Pharmaceutical Benefits Scheme (PBS) – the Life Saving Drugs Program

Page last updated: 28 April 2020

Update to LSDP 2020 Reapplication Process - COVID-19

The Department is aware of concerns about patient vulnerability at this time and in some cases the availability of certain tests in the lead up to the 1 May deadline for the standard annual reapplication process. To support existing LSDP patients at this time, the deadline for patient reapplications will be extended for up to six months. All reapplications will be due by 1 November 2020.

Existing LSDP patients will continue to be supplied their usual LSDP treatment during this period.

If you would like further information please contact the LSDP, via the LSDP inbox ([email protected]) or by telephone (02) 6289 2336.

Please note eligibility criteria requirements continue for any new patient applications.

What is the Life Saving Drugs Program (LSDP)?

The Australian Government provides fully subsidised access for eligible patients with rare and life-threatening diseases to essential medicines through the LSDP.

There are currently sixteen medicines available to eligible patients for the treatment of ten conditions.

To access medicines funded under the LSDP, treating physicians must apply for access on behalf of their patient. Once approved, the medicines are delivered to a nominated pharmacy (usually a hospital) for dispensing to the patient.

If you:
  • have been diagnosed with a rare condition that is treated with a medicine on the LSDP;
  • are a doctor prescribing or wishing to prescribe a medicine on the program; or
  • are a pharmacy that has been nominated to supply an LSDP medicine;
more information can be found on the Information for patients, prescribers and pharmacists page.

Consumer input to the LSDP Medicine Reviews (for patients and carers)

Please be advised we have extended the deadline for patients to provide input to the medicine reviews. Peak consumer groups will be asked to provide feedback on the draft evaluation report for the associated condition. If you would like to provide comment on the draft report specifically, please liaise with your peak consumer group. The draft report is not accessible via the Department website.

Note one Term of Reference for each review looks at patient relevant outcomes. In particular, what outcomes are most important to patients who are being treated with LSDP medicines?

Patients and carers can also provide general input into the medicine reviews. This will allow patients to provide any details of their experiences living with their disease or taking the LSDP medicine.

Input to the Fabry review was open until 14th February 2020. Input for all other Tranche I and II reviews will be accepted until 8th June 2020. Please email your input to the [email protected]

Input to the Tranche III reviews will be accepted until 5th October 2020. Please email your input to the [email protected]

The Department will advise when the draft reports for the remaining reviews are provided to the appropriate peak consumer group.

Further information on the LSDP Expert Panel can be found on the Expert Panel page.

LSDP reform activities

In 2014, the Minister for Health announced a Review of the LSDP. The main objectives were to review the access, equity, value for money and future administration of the program with a view to facilitating continued subsidy to important and necessary medicines for patients.

On 28 January 2018 the Minister for Health, the Hon Greg Hunt MP, announced the outcomes of the Review of the LSDP and provided the Government response.

These documents are available at the Review of the Life Saving Drugs Program (LSDP) page.

In response to this review, a number of improvements are being implemented to ensure eligible patients retain access to medicines through the LSDP and that the program remains sustainable. Improvements commenced 1 July 2018, and include:
  • the adoption of a rare diseases definition of 1:50,000 people or less in the Australian population;
  • the implementation of transparent and rigorous assessment processes and guidance, including the establishment of an Expert Panel to advise the Commonwealth Chief Medical Officer;
  • the introduction of a review of medicines 24 months after listing to ensure use and performance of the medicine is in line with the expectations at listing;
  • a similar review of existing medicines to be completed within two years from the commencement of the new program;
  • the negotiated application of pricing policies to new and existing medicines, similar to those applied to Pharmaceutical Benefits Scheme (PBS) medicines; and
  • streamlining administration processes to deliver certainty to patients and stakeholders.

Agreement with Industry

The Australian Government and Medicines Australia (MA), on behalf of sponsors of medicines on the LSDP, entered into an agreement on 8 May 2018 to implement these reforms to the program.

The agreement with MA will provide policy stability, transparency and certainty for industry and the rare diseases medicines sector. The agreement enables savings to Government through price reductions for medicines funded through the LSDP, and supports the introduction of broader policies similar to Pharmaceutical Benefits Scheme (PBS) medicines.

The Government will continue to consult with key stakeholders in implementing the improvements as outlined in the agreement.

LSDP Agreement between the Government and Medicines Australia (PDF 378KB)
LSDP Agreement between the Government and Medicines Australia (Word 27KB)

Procedure guidance for medicines funded through the LSDP

This guidance document delivers on the commitments made in the above agreement between the Government and Medicines Australia to develop a clearly defined and transparent process and associated timelines for consideration of medicines seeking funding through the LSDP. This guidance further delivers on the commitment to assist sponsors in preparing an application to make a rare disease medicine available on the LSDP; ensuring access to treatment for people with rare diseases is not unnecessarily delayed.

LSDP guidance document (Version 1.0) (PDF 1077 KB)
LSDP guidance document (Version 1.0) (Word 258 KB)

LSDP Expert Panel

On 28 August 2018, the Minister for Health announced the membership of an Expert Panel for the LSDP to provide assistance and advice to the Commonwealth Chief Medical Officer (CMO) on both new medicine applications and the review of existing medicines. This advice will inform the CMO’s recommendations on medicine funding to the Commonwealth Minister for Health. The Expert Panel includes suitably qualified experts including clinicians, a consumer representative, an industry nominee and a health economist.

The Expert Panel page contains more information on membership, meeting dates, meeting agendas, the progress of new medicines/medicine reviews through the Panel and how to submit a consumer submission.

Applying for new medicines to be funded on the LSDP

Before a medicine can be considered for funding under the LSDP, it must first be considered by the Pharmaceutical Benefits Advisory Committee (PBAC) for subsidisation under the PBS. If a medicine is found by PBAC to be clinically effective but fails to meet the cost effectiveness criteria, the sponsor can apply for subsidisation through the LSDP. The Commonwealth Chief Medical Officer (CMO) will consider advice from the LSDP Expert Panel, and provide a recommendation on the suitability of a medicine for funding under the LSDP. The final decision for funding lies with the Minister for Health.

Sponsors are to contact the LSDP Expert Panel secretariat at [email protected] to submit their applications to the LSDP. The New Medicine Application page contains more information for sponsors when applying to have a new medicine funded under the LSDP.

Reviews of LSDP Medicines

The Government response to the LSDP review outlined that from 1 July 2018, medicines listed on the LSDP will be subject to a review of usage and financial costs after 24 months, and similar reviews will be undertaken on all existing LSDP medicines. These reviews aim to ensure use and performance of the medicine is in line with the recommendations and expectations at the time of listing, and are supported through the Compact with Medicines Australia.

An active review of an existing LSDP medicine does not prevent other processes from being undertaken, such as considering new medicines for the same disease or patient access to the medicine.

More information on the review processes can be found within the LSDP Guidance Document. Progress of the reviews of existing LSDP medicines can be found on the Expert Panel page.

Further Information

Life Saving Drugs Program
Phone: (02) 6289 2336
Fax: (02) 6289 8537
Email: LSDP team

If you would like to be notified of updates to the LSDP webpages, please email the LSDP team.