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Janssen statement in response to the NICE FAD
on the use of Olysio™ for hepatitis C - press release
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High Wycombe, UK, 16 January 2015 - Janssen welcomes the Final Appraisal Determination (FAD) from the National Institute for Health and Care Excellence (NICE) published today 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 mature1. 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 failed2.
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."
For more information, please contact:
NOTES TO EDITORS:
About simeprevir
Simeprevir is an NS3/4A protease inhibitor (antiviral drug) developed jointly by Janssen R&D Ireland and Medivir AB. It prevents viral replication by binding to the enzyme responsible for HCV replication thus rendering it inactive.
Simeprevir is indicated for the treatment of chronic hepatitis C infection in combination with peginterferon alfa-2a (pegIFN) and ribavirin (RBV) in genotype 1 and genotype 4 HCV-infected patients with compensated (a diseased liver that is still functioning) liver disease, including all stages of liver fibrosis.3 Simeprevir is also licensed for use as part of an all oral 12-week interferon-free Direct Acting Antiviral (DAA) regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment.3
The licence for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three pivotal Phase 3 studies, with over 1,000 patients. The trials; QUEST-14, QUEST-25 and PROMISE6, explored the use of simeprevir in combination with PegIFN/RBV in treatment-naïve patients and patients who have relapsed after prior interferon-based treatment. All three studies met their primary endpoints and demonstrated that simeprevir, in combination with PegIFN/RBV, achieves significant viral clearance rates when compared with PegIFN/RBV alone.
Simeprevir is taken once-daily for 12 weeks, with treatment-naïve and prior-relapser patients receiving pegylated interferon and ribavirin for 24 weeks, and for 48 weeks total by those shown to be prior non-responder patients (including partial and null responders). It is generally well tolerated, with the most common adverse events reported in clinical trials (incidence ≥ 5%) including nausea, rash, pruritus, dyspnoea, hyperbilirubinemia and photosensitivity reaction.3
About hepatitis C
Hepatitis C is a treatable blood-borne virus that can lead to damage of the liver, and potentially result in liver conditions such as cirrhosis (destruction of normal liver tissue) and liver cancer.7 It is regarded as a public health issue that leads to significant morbidity and mortality and burden to the NHS, with Public Health England (PHE) estimating there are 215,000 people in the UK infected with hepatitis C8.
Despite being a curable disease, hepatitis C is often dubbed a 'silent killer' as symptoms may go unnoticed for many years, and only 3% of people with hepatitis C receive treatment each year7.
About Janssen
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. The legal entity for Janssen in the UK and Ireland is Janssen-Cilag Ltd. Please visit www.janssen.co.uk for more information.
For further information on hepatitis C
· The Hepatitis C Trust
www.hepctrust.org.uk
· Help Every Person C
www.helpeverypersonc.co.uk
· Liver4Life
www.liver4life.org.uk
* Please note that Janssen is not responsible for the content of independent websites.
REFERENCES:
1. Hepatitis C (chronic) - simeprevir [ID668]. NICE Final Appraisal Consultation Document. https://www.nice.org.uk/guidance/indevelopment/gid-tag455. Accessed January 2015.
2. Scottish Medicines Consortium. Advice simeprevir (Olysio) October 2014. https://www.scottishmedicines.org.uk/SMC_Advice/Advice/988_14_simeprevir_Olysio/simepresim_Olysio. Accessed January 2015.
3. Olysio SmPC http://www.medicines.org.uk/emc/medicine/28888/SPC/OLYSIO+150mg+hard+capsules/ Accessed January 2015.
4. Jacobson, I. et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; 384; 9941: 403-413.
5. Manns, M., et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2014; 384: 414-426.
6. Forns, X, et al. Simeprevir With Peginterferon and Ribavirin Leads to High Rates of SVR in Patients With HCV Genotype 1 Who Relapsed After Previous Therapy: A Phase 3 Trial. Gastroenterology 2014;146:1669-1679
7. The Uncomfortable Truth. Hepatitis C in England: The State of the Nation. The Hepatitis C Trust, October 2013. http://www.hepctrust.org.uk/Resources/HepC%20New/The%20Trust/The%20Uncomfortable%20Truth.pdf , Accessed September 2014
8Hepatitis C in the UK: Public Health England Annual Report 2013. http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317139502302
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