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NICE backs Merck Sharp & Dohme's hep C drug Victrelis

Final draft guidance recommends the treatment for NHS use against chronic hepatitis C

The UK's National Institute of Clinical Excellence (NICE) has recommended Merck Sharp & Dohme's Victrelis (boceprevir) for NHS use against chronic hepatitis C.

The cost effectiveness watchdog's final draft guidance backed Victrelis in combination with peginterferon alfa and ribavirin after an accelerated assessment.

Victrelis was recommended as a treatment option for genotype 1 chronic hepatitis C in adults with compensated liver disease who are previously untreated or in whom previous treatment has failed.

Meindert Boysen, programme director technology appraisals at NICE, said: “The significant improvement in sustained virological response rates seen with boceprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone represents a major benefit for people with genotype 1 chronic hepatitis C.

“In the past, patients have declined treatment because the perceived chance of a sustained virological response with peginterferon alfa plus ribavirin was too low for them to accept the associated side effects.”

NICE's recommendation was based on two pivotal phase III studies, HCV RESPOND-2 and HCV SPRINT-2, involving 403 patients who had failed previous therapy and 1,097 untreated patients.

These showed that adding Victrelis to standard therapy of peginterferon alfa and ribavirin for those who had failed previous treatment, almost tripled the number of patients achieving sustained virologic response, which is considered to be equivalent to a cure. In previously untreated patients, the addition of boceprevir nearly doubled the number of patients clearing the virus compared to standard therapy alone.

Approximately 85% of hepatitis C patients develop chronic infection, which affects 173,000 people in England and Wales and genotype 1 is the most common subtype of hepatitis C – affecting 40–50% of people with hepatitis – and the most resistant to treatment.

The condition suffers from poor diagnosis rates, low treatment compliance rates and a high annual incidence of new infection, presenting a major public health challenge.

Victrelis was launched in the UK last August and is priced at £2,800 for a 28-day, 336-tablet pack and costs £30,800 for a 44-week course. The combination with peginterferon alfa and ribavirin adds an estimated additional cost to treatment of around £11,000.

NICE's evaluation committee concluded that, despite a total cost for treatment of over £40,000, Victrelis with peginterferon alfa and ribavirin still showed a cost per QALY gained of below £20,000, making it a cost-effective use of NHS resources.

If the final guidance is upheld, the NHS in England and Wales will generally have to fund Victrelis within three months of it being published.

Final NICE guidance on Victrelis is expected in April and NICE is also appraising Janssen's Incivo (telaprevir) for which preliminary guidance is expected to be published in June.

9th March 2012

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