Minister for Health and Ageing
20 May 2010
SOLIRIS: MINISTER ASKS FOR FURTHER ADVICE ON NEW DRUG

I have made an urgent request for further advice from the Pharmaceutical Benefits Advisory Committee (PBAC) on the potential benefits of adding Soliris® (eculizumab) to the Government’s Life Saving Drugs program (LSDP).

The PBAC has recommended that Soliris be considered by the Government for inclusion on the LSDP, but it also noted a number of uncertainties in the evidence about the drug.
These included doubts on the extent that Soliris extends life compared to best supportive care, and the size of the benefit in reducing the incidence of blood clots –a serious and life-threatening component of the disease.

It is a condition of funding drugs under the LSDP that there must be evidence acceptable to the PBAC to predict that a patient’s lifespan will be substantially extended as a direct consequence of the use of the drug.

The Government understands that this is an important matter and it has asked the PBAC to re-consider Soliris as quickly as possible for potential subsidy through the LSDP.
This includes the PBAC asking the sponsor of the drug if any new evidence has become available as to its effectiveness.

Due to the uncertainty outlined by the PBAC on the effectiveness of Soliris the Government was not able to fund Soliris through the LSDP in the 2010-11 Budget.

Soliris is one of the world’s most expensive drugs and it is used to treat paroxysmal nocturnal haemoglobinuria.

Known as PNH, the condition is a very rare blood disorder that destroys red blood cells.  PNH has serious consequences for the estimated 75 Australians who suffer from it.

For more information contact the Ministers office on 02 6277 7220