Novel 'Pay If You Clear' guarantee offered in Scotland as
SMC approves new hepatitis C treatment OLYSIO® (simeprevir) for use within NHS Scotland1
SMC Approval provides opportunity for a unique scheme to be introduced that will prevent unneccessary costs of treating hepatitis C, genotypes 1 and 4, with standard combination therapy
High Wycombe, 13th October 2014 - Today the Scottish Medicines Consortium (SMC) has independently recommended that OLYSIO® (simeprevir) should be made available for the treatment of genotype 1 and 4 chronic hepatitis C, with other medicinal products, in adults in Scotland who have not previously had treatment and adult patients for whom treatment has previously failed.1
Separately from the SMC decision, manufacturer Janssen has offered NHS Scotland a unique 'pay if you clear' reimbursement scheme, refunding the cost of simeprevir for patients who do not successfully clear the virus after 12 weeks. The scheme, if approved, would allow patients in Scotland, who are infected with hepatitis C virus (HCV) genotypes 1 and 4, access to a new treatment option. The scheme is awaiting a formal decision by NHS Scotland.
Simeprevir is a next generation protease inhibitor (PI) that is used in combination with other medicines to treat HCV infection.2 The SMC decision, made independently of the reimbursement scheme, now offers more patients infected with genotype 1 and 4 chronic hepatitis C in Scotland the chance of clearing the virus (achieving sustained virologic response, SVR).
In addition, Janssen is funding pre-treatment Q80K blood tests for patients that can predict whether simeprevir is likely to be effective before treatment is initiated, and recommends that any patient not achieving a good response to treatment at 4 weeks should discontinue. Those patients who are not likely to benefit can then be offered alternative treatments, thus potentially saving NHS resources, and also sparing patients a treatment that is unlikely to clear the virus.
It is estimated that Scotland spends up to 44 million each year on medicines for all conditions that are unused, ineffective or which aren't taken correctly.3
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. Simeprevir can also be used 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.
Dr John F Dillon, Consultant Hepatologist and Gastroenterologist, University of Dundee Ninewells Hospital, says: "I welcome the news that simeprevir can now be prescribed for patients with chronic hepatitis C, genotypes 1 or 4, who live in Scotland. This decision provides us with another treatment option which is convenient for patients and more affordable to NHS Scotland than some other treatments. To be able to predict a person's response to treatment, prior to them embarking on the medicine, is a particularly useful factor in managing hepatitis C care. It means we can select the most appropriate treatment option in a cost-efficient manner."
We have made great strides in the management of hepatitis C in Scotland over the last five years, and the approval of simeprevir as another treatment is a positive step forward to help us in reducing the disease burden of the virus," added Dr Dillon.
Charles Gore, Chief Executive of The Hepatitis C Trust, says: "The positive decision from SMC means that patients can now have access to another vital treatment which is generally well tolerated and offers a better chance of clearing hepatitis C than some older therapeutic options. Decisions such as this from the SMC provide us with a key milestone for our campaign to eliminate hepatitis C. However, we must not forget the importance of prevention, earlier diagnosis and better testing strategies."
Of the estimated 37,100 people living in Scotland with chronic HCV infection, just over half (55%) were thought to have been diagnosed by 2013.4 The virus is a significant public health threat; it is highly infectious, often has no symptoms and can lead to fatal liver conditions. Of those who develop hepatitis C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation.5 Hepatitis C is the most common reason for liver transplants in Europe.6
Notes to the Editor:
Simeprevir (OLYSIO™) is accepted for use within NHS Scotland.
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 inactive1.
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.2 Simeprevir can also be used 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.
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-1, QUEST-27 and PROMISE8, 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.
The licence for the combination of simeprevir and sofosbuvir also contains the Phase 2 study, COSMOS, in treatment naïve patients. This was based upon prior null responder and treatment-naïve patients, with an interferon-free regimen of simeprevir (150 mg once daily) in combination with sofosbuvir (400 mg once daily), with or without ribavirin, in genotype 1 HCV patients including those with cirrhosis. This 12-week combination led to overall SVR rates >90% in genotype 1 patients including prior null responders with advanced fibrosis / cirrhosis.9 This is one of the first licensed interferon-free combinations in hepatitis C, and a refund on the cost of simeprevir will also apply for those who do not clear the virus when the medicine is used in this setting.
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). The data also supports the same treatment regimen for patients co-infected with HIV.2 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.2
About pre-treatment testing
The likelihood of treatment success with simprevir can be improved by the use of a predictive test before treatment starts. This test identifies whether the virus has a feature known as Q80K, and should the virus show this, clinical researchers know that simeprevir is less likely to be effective.2
More information about simeprevir is available in the Summary of Product Characteristics (SmPC): http://www.medicines.org.uk/emc/medicine/28888/SPC/OLYSIO+150mg+hard+capsules/
OLYSIO® received approval from the European Commission on the 20th March 2014.
About hepatitis C and available resources
More information about hepatitis C can be found on www.helpeverypersonc.co.uk including a first of its kind interactive map which provides data for Scotland and the rest of the UK on prevalence of hepatitis C, details of local support groups, treatment centres and stories from people living with hepatitis C, their friends, family and carers.
In addition the website offers downloadable questionnaires and factsheets about hepatitis C which people who have any questions may take to their healthcare professional to aid their discussion about hepatitis C.
Janssen is dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes).
Driven by our commitment to patients, Janssen develops sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
More information can be found on www.janssen.co.uk
1. The Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home), accessed September 2014
2. Simeprevir Summary of Product Characteristics (SmPC) http://www.medicines.org.uk/emc/medicine/28888/SPC/OLYSIO+150mg+hard+capsules/ Accessed May 2014.
3. Dispensed but unopened medications: BMA 2011 policy. BMA website. http://bma.org.uk/about-the-bma/how-we-work/professional-activities-and-special-interest/patient-liaison-group/dispensed-but-unopened-medications. Accessed August 2014.
4. Hepatitis C in the UK. 2014 Report. Public Health England. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/337115/HCV_in_the_UK_2014_24_July.pdf Accessed September 2014
5. TA200: Peginterferon Alfa and Ribavirin for the treatment of chronic hepatitis C. Part review of NICE technology appraisal guidance 75 and 106. Issued September 2010
6. Lang K, Weiner DB. Immunotherapy for HCV infection: next steps. Expert Rev Vaccines. 2008;7(7): 915-923
7. Foster GR et al. Simeprevir (TMC435) with peginterferon/ribavirin for the treatment of chronic HCV genotype 1 infection in treatment-naïve European patients in the QUEST 1 and QUEST 2 Phase III studies. Abstract 1127. Poster presentation at the European Association for the Study of the Liver 2014.
8. 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,
8.Gastroenterology (2014), doi: 10.1053/j.gastro.2014.02.051.
9. Lawitz E et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. The Lancet, 2014 10.1016/S0140-6736 Epub ahead of print.