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Janssen statement in response to the NICE FAD on the use of Olysio™ for hepatitis C

Janssen welcomes the Final Appraisal Determination (FAD) from the National Institute for Health and Care Excellence (NICE) published that recommends the use of Olysio™ (simeprevir), for the treatment of chronic hepatitis C genotype 1 and 4 infection in combination with other medicines to treat HCV infection. (1)

At this stage a decision on the use of simeprevir in combination with sofosbuvir (as part of a 12-week interferon-free regimen with our without ribavirin (RBV) in patients who are intolerant to or ineligible to interferon) has been postponed, whilst additional real-world observational data on this regimen mature. (1) Janssen is committed to working with NICE, and providing the evidence it requires, so that, if positive, NICE will extend its recommendation to provide an option for patients who cannot receive interferon-containing regimes.

This decision follows a Scottish Medicines Consortium (SMC) recommendation made in October 2014, which approved simeprevir as cost effective for use in the treatment of genotype 1 and 4 chronic hepatitis C, with other medicinal products, including sofosbuvir, who have not previously had treatment, and adult patients for whom treatment has previously failed. (2)

Peter Barnes, Medical Director at Janssen, commented: “We are pleased that simeprevir has been recommended by NICE for the treatment of patients with genotypes 1 and 4 hepatitis C, when used in combination with peginterferon and ribavirin.
We will continue working with NICE to provide the real world data they have requested, with the hope that it will be accepted and NICE will extend its recommendation to provide access to patients not suitable for interferon-containing regimes. We believe that there is a high unmet need in this patient group that simeprevir can help address, and that our submission to NICE demonstrated the cost-effectiveness of its use in this population.

Charles Gore, Chief Executive of the Hepatitis C Trust, says: “We welcome today’s decision from NICE as it represents a notable step forward in our campaign to eliminate hepatitis C. It means that patients will now have access to another important treatment, which is generally well tolerated and offers a better chance of clearing hepatitis C than some older therapeutic options.

We really hope that this positive decision from NICE signals the start of an exciting year for hepatitis C in England, where we are also expecting NHS England and Public Health England’s joint Improvement Framework to be published very soon.


  1. Hepatitis C (chronic) – simeprevir [ID668]. NICE Final Appraisal Consultation Document. Accessed January 2015.
  2. Scottish Medicines Consortium. Advice simeprevir (Olysio) October 2014.…. Accessed January 2015.
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