The Swedish county councils has established a risk-sharing agreement with research-based pharmaceutical company Medivir AB for the medication Olysio (simeprevir) for hepatitis C, including its treatment costs, as a way of making it available for a larger amount of people. Specially indicated for the treatment of chronic hepatitis C infection as part of a combination antiviral therapeutic regimen, Olysio is a NS3/4A protease inhibitor that was developed by both Medivir AB and Janssen R&D Ireland.
The risk-sharing agreement aims to provide the county councils and Medivir predictability concerning hepatitis C treatment costs and the use of Olysio, including both therapeutic results and the numbers of patients treated. The medication has been approved in several countries due to its efficacy as a therapy for HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease including cirrhosis. The Swedish county councils expect to provide treatment to a larger population of hepatitis C patients.
“Treatment with Olysio has already helped to cure a large number of people from hepatitis C both in Sweden and globally. I believe that the agreement will help to ensure equal treatment across all of Sweden’s county councils and that more hepatitis C patients will get the opportunity to become cured through treatment with Olysio wherever they live,” explained Henrik Krook, EVP Commercial at Medivir.
The New Pharmaceutical Product Therapies (NLT) group is already working with a set of recommendations for use of the medication. As the group from the Swedish Association of Local Authorities and Regions tasked to assess new pharmaceutical products and therapies, the NLT will release a protocol for structured introduction of Olysio.
The decision to sign the risk-sharing agreement was based on a study from the Dental and Pharmaceutical Benefits Agency (TLV), which conducted a health economic evaluation of medication. The investigators demonstrated the benefit of Olysio as a therapy for HCV genotypes 1 and 4 with METAVIR scores of F3-F4 irrespective of previous treatment, especially from a health economics viewpoint.
In addition, the efficacy of the medication also has been evaluated by Janssen R&D Ireland and Medivir AB, based on research that established it as a therapy for HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. Olysio has already been approved as a treatment for chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease including cirrhosis, in countries like Japan, Canada, US, Russia, Mexico, and Australia.
Last May, the therapy received marketing authorization from the European Commission for the treatment of adult patients with genotype 1 or genotype 4 chronic HCV, and it is already available in several EU countries with reimbursement. In September, the British National Institute of Health and Care Excellence (NICE) also released a Appraisal Consultation Document (ACD) for its use on patients with genotype 4 chronic HCV, but not on genotype 4.