Hep C Treatment Pipeline (updated 27 April 2015)
On 24th April 2015 the Pharmaceutical Benefits Advisory Council (PBAC) publicly released its recommendations to the Australian Government for the listing of new medicines on the Pharmaceutical Benefits Scheme (PBS). This included three new medicines for the treatment of hepatitis C.
The PBAC recommendations are a major step toward seeing these new medicines become available at an affordable cost to the Australian public. However, this is not a guarantee of PBS listing. The government must now work with the relevant pharmaceutical companies to negotiate pricing of the new medicines before final approval for a PBS listing is granted. How long this process take? The government (current and previous) has committed to reducing the time from PBAC recommendation to final listing and access.
It is important to note that it is the Therapeutic Goods Administration that approves the overall use of a medicine in Australia. PBAC only recommends whether the drugs should or shouldn't be subsidised under the PBS, making the medicines affordable for Australians.
So what are the medicines in question?
The PBAC has recommended to the Minister for Health that the following medicines be listed on the PBS.
Sofosbuvir is produced by Gilead Sciences and is approved for use in Australia by the TGA but had previously been rejected for listing on the PBS.
Sofosbuvir is generally used in combination with other medicines and in some cases (depending on hepatitis C genotype) may still require the use of peginterferon. Currently the TGA states sofosbuvir is to be used with ribavirin for genotype 2 and 3 and to be used with peginterferon alfa and ribavirin for genotype 1 and 4 hepatitis C.
Sofosbuvir+ledipasvir (known as Harvoni® in other countries)
This is a combination of two medicines (sofosbuvir and ledipasvir) in the one pill. It is produced by Gilead Sciences and is approved for use in Australia by the TGA. It is currently indicated for use on its own to treat hepatitis C genotype 1.
Daclatasvir is produced by Bristol Meyers Squibb and is approved for use in Australia by the TGA. It is currently indicated, in combination with other medicinal products, for the treatment of chronic HCV in adults with compensated liver disease (including cirrhosis).