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Published on 13 October 2014

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Novel ‘Pay If You Clear’ guarantee introduced in Scotland as SMC approves new hepatitis C treatment OLYSIO®

The Scottish Medicines Consortium (SMC) has 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)

The Scottish Medicines Consortium (SMC) has 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)

Simeprevir is a next generation protease inhibitor (PI) that is used in combination with other medicines to treat HCV infection. (2) This decision 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).

The decision from the SMC comes as manufacturer Janssen has provided NHS Scotland with a unique ’pay if you clear’ reimbursement scheme based on the cost of simeprevir for patients who do not successfully clear the virus after 12 weeks. The scheme will allow patients in Scotland, who are infected with hepatitis C virus (HCV) genotypes 1 and 4, access to a new treatment option.

In addition, Janssen is funding pre-treatment 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 wastes 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 alpha-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.5Hepatitis C is the most common reason for liver transplants in Europe. (6)

References:

  1.  The Scottish Medicines Consortium (http://www.scottishmedicines.org.uk/Home), accessed October 2014
  2. Simeprevir Summary of Product Characteristics (SmPC) http://www.medicines.org.uk/emc/medicine/28888/SPC/OLYSIO+150mg+hard+capsules/ Accessed October 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 October 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 October 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,
  9. Gastroenterology (2014), doi: 10.1053/j.gastro.2014.02.051.
  10. 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.


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