Janssen receives NICE approval for hepatitis C drug

Janssen has been granted approval for the use of its Olysio hepatitis C treatment on the NHS, but the drug is subject to some restrictions. 

Also known by its chemical name simeprevir, the medicine was first approved across Europe in May for the treatment of patients with HCV genotypes 1 and 4, as well as in conjunction with Gilead Sciences' Sovaldi. Together, the two formed the first ever 12-week, all-oral, once-daily, interferon-free solution for patients.

However, draft guidelines published by the National Institute for Health and Care Excellence (NICE) yesterday show the UK cost regulator has only backed Olysio in combination with peginterferon alfa and ribavirin as a treatment option for patients with genotype 1.

More information has been requested in order to assess the drug's use for this group of hepatitis C patients, focusing specifically on whether "a detailed rationale" can be formed to determine whether the clinical effectiveness among those with genotype 1 can be generalised to genotype 4 patients.

In addition, NICE indicated the evidence provided is not sufficient in order to approve Olysio's use alongside Sovaldi.