Eculizumab – Expert Reference Group and application process for patients and clinicians
Page last updated: 24 November 2015
The Australian Government is committed to the Pharmaceutical Benefits Scheme (PBS) listing of eculizumab (Soliris®) for the treatment of atypical Haemolytic Uraemic Syndrome. This is why the Government has invested $63 million listing eculizumab, the most expensive medicine in the world at a cost of $500,000 per patient per year, on the PBS.
The Minister for Health Sussan Ley has instructed the Department to implement the following to ensure there is no doubt whatsoever around a patient’s condition during the application process and to ensure no patient is delayed necessary treatment due to Government processes.
- In order to assist the Department of Human Services with the administration of requests for continuation or reinitiation of treatment beyond the initial 12 months of treatment, experts from the Haematology Society of Australia and New Zealand (HSANZ), the Australian and New Zealand Paediatric Nephrology Association (ANZPNA), and the independent Pharmaceutical Benefits Advisory Committee (PBAC) will form an Expert Reference Group.
- This Expert Reference Group will review applications to ensure there is an additional level of clinical support to ensure the correct decisions are made regarding an individual patient’s circumstances for applications seeking continuation and reinitiation of treatment beyond 1 December 2015.
- Applications for continuation or reinitiation of the medicine will be assessed within 72 hours of receipt where the correct and complete information is provided to allow proper assessment against PBAC-recommended criteria.
The PBAC is made up of clinical experts and provides the Government with independent advice. It is important that the Government listens to this advice when listing a medicine like eculizumab that has a high toxicity, so that patients are not unnecessarily exposed to long term side effects.
Contact details
If you are a clinician and would like to submit an application or enquire on your patient’s behalf for ongoing treatment, please contact the Department of Human Service’s PBS authorities line at 1800 700 270.
For other queries about the PBS listing of eculizumab, please email: pbs@health.gov.au
Further useful information about eculizumab
- The expert clinical criteria of eculizumab, developed by the PBAC, can be found on the PBS website
- The Public Summary Document (PSD) from the March 2014 PBAC meeting
- The Public Summary Document (PSD) from the July 2014 PBAC meeting
