Australian government announces funding available for Soliris

The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Australian government that Soliris (eculizumab) - the new and novel treatment for atypical hemolytic uremic syndrome (aHUS) from US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) - be subsidized on the Pharmaceutical Benefits Scheme (PBS).

The PBAC has made detailed recommendations for the PBS listing of Soliris for those patients that meet the clinical criteria for treatment. aHUS is a serious and often fatal disease with around 35 new cases, including children, diagnosed each year in Australia.

The Minister for Health Peter Dutton said today the government had accepted the recommendations of the independent PBAC and would make funding available to list eculizumab on the PBS in line with those recommendations. The Department of Health remains in negotiations with the sponsor of the drug, Alexion, regarding the implementation of the recommendations of the expert PBAC.

Mr Dutton said the Federal Cabinet has approved and was prepared to make A$63 million ($57 million) available over the next four years to provide the drug on the PBS.

Average treatment cost of over A$500,000

Soliris can be a breakthrough treatment for some patients not only controlling symptoms and the severity of attacks, but it can restore critical organ function and in some patients can have the effect of putting the disease into remission. However, at an average cost of over A$500,000 a year per patient, this treatment is beyond the reach of most Australians.

In March the expert PBAC recommended that Soliris be listed on the PBS at the full asking price per patient per year of treatment due to the significant clinical outcomes that could be achieved in those patients that responded to the drug. In doing so, the Committee noted that there was limited clinical information about the long term use of the drug and set criteria for starting, continuation and reinitiating of the drug treatment reflecting principles of good medical practice.

The Department of Health has convened extensive negotiations since March involving the company, clinicians and patient representatives to work through the criteria for listing on the PBS. The PBAC reconsidered the matter in August and provided its recommendations to the government. The government has acted upon the PBAC’s expert advice and as a result aHUS patients should be aware that the government is ready to make this treatment available to them and is awaiting the response of the drug sponsor Alexion to the independent PBAC’s recommendation for the listing of Soliris.