- The European Medicines Association (EMA) approved Olysio (simeprevir) in May for treatment of hepatitis C (HCV) genotypes 1 and 4, as well as part of combination therapy with Sovaldi (sofosbuvir).
- NICE has agreed to fund Olysio as part of combination therapy with interferon and ribavirin as a treatment option for genotype 1.
- NICE has requested additional information about the clinical effectiveness of Olysio in patients with HCV type 4.
NICE said that it does not feel that the evidence was strong enough to fund a combined Olysio/Sovaldi combo regimen---a 12-week, once-daily, oral, interferon-free treatment that cured 94% of clinical trial participants who had HCV genotype 1 and advanced liver cancer, according to data presented in April at the European Association for the Study of the Liver (EASL) meeting in London.
Despite NICE’s firm position on not funding the combo treatment, the agency ahs signaled interest in learning more about the HCV type 4 data, with the possibility of broadening coverage in the future.