PBAC decision to hold off on recommending simeprevir/sofosbuvir combination for PBS

In documents released today, the Pharmaceutical Benefits Advisory Committee (PBAC) explains it's decision to defer any recommendation to list simeprevir in combination with sofosbuvir on the Pharmaceutical Benefits Scheme (PBS).

The makers of simeprevir lodged a submission to the July 2015 meeting of PBAC for the PBS listing of simeprevir in combination with sofosbuvir for the treatment of hepatitis C, genotype 1 for people who have compensated liver disease.

The PBAC recommended deferral of the submission given that a positive Therapeutic Goods Administration (TGA) Delegate’s Overview was not available at the time of consideration. The PBAC was of a mind to recommend listing of simeprevir, in combination with sofosbuvir, but decided to wait for finalisation of the TGA registration process to determine the circumstances of listing. 

The PBAC considered that the conditions and circumstances of the listing of simeprevir in combination with peginterferon alfa and ribavirin should be reassessed to align this listing with a listing in combination with sofosbuvir. 

It is also important to note that sofosbuvir was submitted to the PBAC in March 2015 and was recommend for listing on the PBS. However, it is yet to be approved by the Government due to protracted price negotiations with the pharmaceutical companies.