Novel ‘Pay If You Clear’ scheme introduced in England for new hepatitis C treatment OLYSIO (simeprevir)
A new hepatitis C medicine, called simeprevir, is now available that the NHS in England will only pay for if patients successfully clear the virus.
The ‘pay if you clear’ reimbursement scheme, agreed with NHS England, refunds the cost of simeprevir for patients who do not successfully clear the virus after 12 weeks. The introduction of this scheme allows patients in England, who are infected with hepatitis C virus (HCV) genotype 1, access to a new treatment option. Simeprevir is a next generation protease inhibitor (PI) that is used in combination with other medicines to treat HCV infection.1
Janssen is keen to state that the ‘pay if you clear’ scheme that has been agreed with NHS England is separate from the current and ongoing review by the National Institute for Health and Care Excellence (NICE).
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 triple-therapy treatment at 4 weeks should discontinue treatment. Those patients who are not likely to benefit can then be offered alternative treatments. Together, the reimbursement scheme and pre-treatment blood tests for patients will provide a framework to ensure the optimal use of simeprevir, saving NHS resources and also sparing patients from a treatment that is unlikely to clear the virus.
Charles Gore, Chief Executive of The Hepatitis C Trust said: “The availability of an additional treatment option in hepatitis C is very welcome news for patients. We know that only 3 per cent of those with hepatitis C are currently receiving treatment for their infection. This leaves the majority of patients at risk of long term complications of hepatitis C infection such as cirrhosis and liver cancer.”
Peter Barnes, Medical Director of Janssen UK, commented: “We now have excellent clearance rates in hepatitis C. Ensuring clinicians are equipped with pre-treatment blood tests that determine which patients are most likely to benefit, and treating only those in whom the medicine is working, optimises the use of this hepatitis C medicine and hopefully improves the patient experience. It means the right patients get the right choice of medicine, at the right time and reduces the likelihood of NHS wastage. Most importantly, we believe it spares patients a course of treatment that may not clear the virus.”
Mark Hicken, Managing Director of Janssen UK, commented: “This unique scheme to make simeprevir and a predictive blood test available in England, with the NHS paying only for successful outcomes, is a great example of an innovative, collaborative partnership that can deliver benefits to both patients and healthcare providers. At Janssen we are committed to exploring and implementing new approaches that focus on the additional value that we can add to both patients and the NHS, beyond simply the medicine itself.”
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.1 Simeprevir can also be used as part of an all oral 12-week interferon-free DAA regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment.1
Although the licence for simeprevir includes treatment of hepatitis C infection with both genotypes 1 and 4 infection, the scheme approved by NHS England covers the treatment of patients with genotype 1 only, and not in conjunction with the use of sofosbuvir.
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-12, QUEST-23 and PROMISE4, 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 3 study, COSMOS, in treatment naïve patients5. 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.5
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).1 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.1
About pre-treatment testing
The success of treatment with simeprevir can be predicted by the results of a new type of test for hepatitis C administered before treatment starts. This test identifies whether the virus has a feature known as Q80K, and should the virus show this, healthcare professionals know that simeprevir is less likely to be effective.1
1 Olysio SmPC http://www.medicines.org.uk/emc/medicine/28888/SPC/OLYSIO+150mg+hard+capsules/ Accessed May 2014.
2 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.
3 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.
4 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
5 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. Lancet 2014. http://www.sciencedirect.com/science/article/pii/S0140673614610369 Accessed November 2014.