Janssen has released a statement saying they are 'extremely disappointed' with NICE's decision to recommend Olysio (simeprevir) for only one out of three of its licenced indications for hepatitis C.
NICE's appraisal consultation document (ACD) has recommended the drug for the treatment of chronic hepatitis C genotype 1 infection, but did not recommend it for use in combination with sofosbuvir for patients who are unable to tolerate an interferon-based regimen with genotypes 1 or 4 hepatitus C.
Around one in three people infected with hepatitis C will eventually develop liver cirrhosis, when normal liver tissue is replaced by scar tissue. The aim of treatment is to clear the virus from the blood to prevent the progression of liver disease and to prevent the transmission of the virus.
Peter Barnes, medical director at Janssen, said: “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.
“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,” he added.
The setback comes after Johnson & Johnson – Janssen's parent company -reported a 21% increase in pharma turnover in the second-quarter of 2014, with $831m worth of sales driven by rocketing sales of Olysio.
The appraisal committee recommended that NICE requests a detailed rationale from the company about whether the clinical effectiveness in people with genotype 1 can be generalised to people with genotype 4 hepatitis C. NICE also recommends that clinical data, including genotype and sustained virological response at 12 weeks, is collected for all people treated with Olysio in the NHS.
Janssen said it continues to work with NICE and other stakeholders to try to find a solution to change their preliminary decision.