Other supply arrangements outside the Pharmaceutical Benefits Scheme (PBS)

Page last updated: 01 June 2016

Life Saving Drugs Program (LSDP)

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

The treating physician must submit a completed reapplication form to the LSDP by 1 May every year if they wish their patients to continue to receive subsidised treatment through the LSDP.

Reapplication must include:
  • Patient details with signed patient consent to collection of sensitive information
  • Updated dosing details
  • Annual reapplication section, including the treating physician’s declaration
  • Submit excel spreadsheet (in MS format) with supporting source data

LSDP Funding Criteria and Conditions

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.

Submissions for a drug to be considered for inclusion in the LSDP must be lodged in conjunction with submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for PBS listing. In addition the Chief Medical Officer (CMO) advises the Minister for Health on drugs proposed to be included in the LSDP.

Medicines currently funded through the LSDP

There are currently eleven medicines available to eligible patients for the treatment of eight conditions. To view the Guidelines and application forms, visit: For information regarding the management and dispensing of these expensive life saving drugs, please view the Drug Supply Fact Sheet (PDF 384 KB), Drug Supply Fact Sheet (Word 510 KB).

Imiglucerase (Cerezyme®), Velaglucerase (VPRIV®), Taliglucerase (Elelyso®) and Miglustat (Zavesca®) for the treatment of Gaucher disease (Type 1)


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Gaucher disease (Type 1) (PDF 2088 KB)
MS Excel spreadsheet for Gaucher disease (Type 1) (Excel 11 KB)

Cerezyme®, VPRIV®, Elelyso® and Zavesca® Product Information is available at the Therapeutic Goods Administration EBS website.

Agalsidase alfa (Replagal®) and Agalsidase beta (Fabrazyme®) for the treatment of Fabry Disease


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Fabry disease (PDF 1720 KB)
MS Excel spreadsheet for Fabry disease (Excel 11 KB)

Fabry disease Pain Diary (PDF 39 KB)
Fabry disease Pain Diary (Word 22 KB)

Fabrazyme® and Replagal® Product Information is available at the Therapeutic Goods Administration EBS website.

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


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Mucopolysaccharidosis Type I (PDF 1267 KB)
MS Excel spreadsheet for Mucopolysaccharidosis Type I (Excel 76 KB)

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

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


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Mucopolysaccharidosis Type II (MPS II) (PDF 2709 KB)
MS Excel spreadsheet for Mucopolysaccharidosis Type II (MPS II) (Excel 76 KB)

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

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


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Mucopolysaccharidosis Type VI (MPS VI) (PDF 1272 KB)
MS Excel spreadsheet for Mucopolysaccharidosis Type VI (MPS VI) (Excel 76 KB)

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

Alglucosidase alfa (Myozyme®) for the treatment of Infantile-onset, Juvenile Late-onset or Adult Late-onset Pompe Disease


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Infantile-onset, Juvenile Late-onset or Adult Late-onset Pompe Disease (PDF 2221 KB)
MS Excel spreadsheet for Infantile-onset Pompe Disease (Excel 12 KB)
MS Excel spreadsheet for Juvenile Late-onset Pompe Disease (Excel 12 KB)
MS Excel spreadsheet for Adult Late-onset Pompe Disease (Excel 11 KB)

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

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


Life Saving Drug Program (LSDP) guidelines and application form for subsidised treatment for Paroxysmal Nocturnal Haemoglobinuria (PNH) (PDF 1267 KB)
MS Excel spreadsheet for Paroxysmal Nocturnal Haemoglobinuria (PNH) (Excel 11 KB)

Meningococcal Vaccination Certificate (PDF 31 KB)
Meningococcal Vaccination Certificate (Word 504 KB)

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

Nitisinone (Orfadin®) for the treatment of Hereditary Tyrosinaemia Type I


Life Saving Drugs Program (LSDP) guidelines and application for subsidised treatment for Hereditary Tyrosinaemia Type I (HTI) (PDF 2134 KB)
MS Excel spreadsheet for Hereditary Tyrosinaemia Type I (HTI) (Excel 9 KB)

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

Post-market review of the Life Saving Drugs Program

Background

On 9 April 2014, the Minister for Health, the Hon Peter Dutton MP, announced that the post-market review of the Life Saving Drugs Program (LSDP Review) would proceed.

The LSDP Review is an opportunity to review the current program in order to ensure that Australians with very rare conditions continue to have subsidised access to much-needed, expensive medicines.

The Review will examine important issues such as access and equity, value for money and the future administration of the program.

During the LSDP Review, patients currently treated through the LSDP will continue to receive access to treatment, new patients may continue to apply for access to treatment and applications for new medicines seeking LSDP listing will continue to be considered as they arise.

The terms of reference of the Review can be found on the Department’s post-market reviews website.

What is the process for the LSDP Review?

This review will be conducted as part of the Government’s post-market reviews program.

The Review, to be conducted by health experts, consumer representatives and an ethics advocate, is expected to be completed within 12 months.

Arrangements for managing the Life Saving Drugs Program during the Review

From 1 May 2014, the five Disease Advisory Committees (DACs) will no longer be used to provide recommendations to the Department about the initial and continued eligibility of individual patients to receive subsidised treatment through the LSDP.

As the LSDP Review is underway, ceasing the DACs will allow former Committee members who are clinical experts in the relevant disease area to participate fully in the LSDP Review and to freely advocate on behalf of their patients.

Consistent with the Government’s deregulation agenda, current LSDP administration processes will be streamlined in order to reduce the present administrative burden on all DAC members. Ceasing the DACs will reduce the need for all applications to go through a committee process.

For treating physicians, there will be no increase in the administration when seeking access to subsidised treatments through the LSDP for patients.

Treating physicians routinely use their clinical knowledge and experience to make decisions about which Pharmaceutical Benefits Scheme (PBS) medicines are most appropriate to treat their patients’ medical conditions, so these changes to the LSDP application process will give these medical professionals similar autonomy to assess and access the most appropriate treatment for individual patients.

These arrangements parallel well established processes with the PBS complex authority prescribing.

Each new patient application requesting access to subsidised treatment through the LSDP will be examined by Departmental staff for completeness and processed.

The Department retains access to individual medical specialists with clinical expertise in the relevant disease area on a case by case basis, as needed.

Submissions for a drug to be considered for inclusion in the LSDP must be lodged in conjunction with submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for PBS listing. In addition the Chief Medical Officer (CMO) advises the Minister for Health on drugs proposed to be included in the LSDP.

The Government is committed to the collection of evidence to support ongoing eligibility to receive subsidised treatment and to enhance knowledge of rare diseases. The requirement for treating physicians to submit evidence to demonstrate initial and ongoing eligibility for their patients to receive subsidised treatment through the LSDP will remain.

Further Information

Further information regarding post-market reviews is available from the Department’s post-market reviews website

Please direct queries to PBS Post-Market. However, all media enquiries should be addressed to the News team.

Further Information

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