HFA welcomes the recommendation of the PBAC to add simeprevir (Olysio™) to the Pharmaceutical Benefits Scheme (PBS) for the treatment of genotype 1 chronic hepatitis C.
However, we were disappointed to see that the PBAC rejected sofosbuvir (Sovaldi™) for the treatment of genotypes 1 to 6 chronic hepatitis C on the basis of its high cost and limited information about cost-effectiveness.
Listing these new hepatitis C drugs on the PBS would mean the cost is subsidised by the Australian Government. The PBAC is the government Advisory Committee for the PBS.
Both drugs have already been approved by the Therapeutic Goods Administration for use in Australia. But without subsidies they are out of reach for most people with bleeding disorders and hepatitis C.
You may recall that HFA surveyed community members on these new treatments and made a submission to PBAC with their answers about the potential impact of these drugs on people with bleeding disorders and hepatitis C.
About sofosbuvir and simeprevir
Sofosbuvir and simeprevir are part of the new wave of direct acting anti-viral (DAA) hepatitis C drugs. In clinical trials they had very high success rates, few side-effects, and shorter treatment courses (eg, 12 or 24 weeks). They need to be taken in combination with other medications (eg, interferon, ribavirin, ledipasvir) to be effective. Professor Ed Gane from New Zealand explained more about these new DAAs at a recent conference in Brisbane.
How safe and effective are these new treatments for people with bleeding disorders? Sofosbuvir has had encouraging results - in a small study in of people with bleeding disorders in New Zealand, it has been shown to be both safe and highly effective when it was combined with ribavirin and ledipasvir, including for people who have previously had unsuccessful treatment (1).
Advancing liver disease and limited treatment options is a real problem for some of our community members with hepatitis C. Treatment that can cure their hepatitis C is a high priority.
HFA will be following up with more representation to government on these new treatments. The first step is to arm ourselves with some more detailed information about the potential benefits of these treatments for our community members in particular, and we will speak to hepatitis specialists about this. We have also asked the Australian Haemophilia Centre Directors’ Organisation (AHCDO) for their advice and help with understanding the situation for people with bleeding disorders and hepatitis C nationally. This involves clarifying the data and producing a report that does not identify individuals but gives solid evidence of the reality for our community members.
1 Kulkarni, R, Mauser-Bunschoten, EP, Stedman, C, Street, A. Medical co-morbidities and practice. Haemophilia 2014;20(Suppl. 4):130-136.