NICE Recommends Janssen’s Olysio for Hepatitis C Genotype 1 and 4

The UK’s health cost-benefit watchdog is recommending coverage of Janssen’s drug Olysio as a treatment option for people with both genotype 1 and genotype 4 hepatitis C.

In final draft guidance, the National Institute for Health and Care Excellence recommended that Olysio (simeprevir) be funded in combination with peginterferon alfa and ribavirin.

The decision follows preliminary guidance last year that recommended the drug for patients with genotype 1 hepatitis C. At the time, NICE held off recommending it for treating genotype 4 pending more information, which Olysio has since supplied.

The recommendation for Olysio came one day after NICE recommended expanding the use of Gilead Sciences’ Sovaldi (sofosbuvir) for the same disease.

NICE is awaiting additional data on the use of simeprevir in combination with sofosbuvir before it issues guidance on treatment of people who cannot receive interferon-containing regimes. Janssen said it will work with NICE to provide real-world observational data on this regimen. A 12-week course of simeprevir plus peginterferon alfa and ribavirin for 24 weeks costs roughly $41,200.

Stakeholders now have the opportunity to make any appeals regarding the NICE’s recommendations on Olysio. The agency expects to publish final guidance in February. Read the final draft guidance at http://www.fdanews.com/01-15-NICE-Olysio.pdf. — Jonathon Shacat