NICE Committee Nixes Olysio on 2 Indications

In a somewhat bittersweet result for drugmaker Janssen, a United Kingdom health agency has recommended funding its hepatitis C drug for some patients but not for others.

Janssen said it is disappointed that the National Institute of Health and Care Excellence (NICE) did not recommend Olysio for the treatment of hepatitis C genotype 4, according to a company response to the British health agency’s assessment.

In May, Janssen was granted European approval to market Olysio with or without ribavirin and pegylated interferon for the treatment of genotypes 1 and 4 chronic hepatitis C virus (HCV) infection and in combination with Sovaldi in some patients.

But a preliminary decision from a NICE appraisal committee failed to recommend simeprevir— Olysio’s generic name – for treatment of HCV patients with genotype 4 and requested more evidence from Janssen. The health agency is tasked with assessing the value of drugs and whether they will be covered under the United Kingdom health care system.

“The Committee recommends that NICE requests a detailed rationale from the company about whether the clinical effectiveness in people with genotype 1 hepatitis C virus (HCV) can be generalised to people with genotype 4 HCV,” states a NICE committee report recently posted online.

The committee also decided not to recommend use of simeprevir in combination with Solvaldi, sold by Gilead Sciences, even though it is within Janssen’s marketing authorization for treatment of genotype 1 or 4 chronic HCV. It did, however, recommend simeprevir for patients with HCV genotype 1.

The response issued from Janssen on Sep. 22 and included in the committee report said the company has “mixed feelings” about the recommendations and is “extremely disappointed” that the committee has not recommended the use of simeprevir in two of its three licensed indications.

"We are pleased that simeprevir has been recommended for the treatment of patients with genotype 1 hepatitis C when used in combination with peginterferon and ribavirin,” Peter Barnes, Janssen’s medical director said in the response. “However, we are disappointed with the preliminary recommendations from NICE for genotype 4 patients and those who are intolerant to interferon, and could therefore benefit from the use of a treatment regime that does not include it.

“We believe there is an unmet need in these patient groups that simeprevir can help address and that our submission to NICE demonstrates the cost-effectiveness of its use. However, we will attempt to address NICE's concerns around this evidence, and hope its position will change.”

The Janssen response contends that the recommendation against the combination treatment of simepevir and sofosbuvir will prevent access to effective new therapy to patients with HCV genotypes 1 or 4 who can’t tolerate an interferon based regimen, risking further disease progression until new drug combinations are approved. The company vowed to continue to work with NICE to find a solution for that patient population, noting that its decision is still preliminary.