NICE Recommends Janssen’s Olysio for Hepatitis C

The UK’s health-cost watchdog has recommended coverage of Janssen hepatitis C drug Olysio, but also has asked for more data proving its effectiveness in certain patient populations.

In a preliminary guidance, the National Institute for Health and Care Excellence (NICE) this week recommended the drug be funded in combination with peginterferon alfa and ribavirin for patients with genotype 1 hepatitis C. NICE is holding off on genotype 4, however, until Janssen can prove that the drug is effective in that patient population.

Olysio (simeprevir) received European marketing authorization in conjunction with other medicines for patients with genotypes 1 and 4 hepatitis C, with or without cirrhosis, and in patients who also have HIV.

In its submission to the UK, Janssen told the agency that the UK’s genotype 4 population is very small and that data from genotype 1 patients could automatically be applied to those with genotype 4. The appraisal committee found this assertion “highly uncertain,” and asked NICE to request that Janssen provide evidence of the natural history of genotype 4 and its response to drug treatment as compared with genotype 1.

NICE also said it has doubts about the drug’s effectiveness for either genotype when combined with Gilead Sciences’ Sovaldi (sofosbuvir), with or without ribavirin. Janssen supported this indication with an open-label, single-arm trial with too few patients, none of whom had genotype 4, the appraisal committee said.

Janssen plans to continue discussing clinical data for genotype 4 and for the sofosbuvir combination with NICE, spokesman Hans Vanavermaete said. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.