Hepatitis C Virus | Access and Reimbursement | US | 2016
Chronic infection with hepatitis C virus (HCV) is a leading cause of advanced liver disease and hepatocellular carcinoma and a common indication for liver transplantation. The 2013-2015 FDA approvals of Gilead’s Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir), combined with Bristol-Myers Squibb’s Daklinza (daclatasvir) and AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir + dasabuvir), have ushered in the era of interferon (IFN)-free direct-acting antiviral (DAA) therapy for chronic HCV infection and completely reshaped the HCV therapeutic market. The January 2016 approval of Merck & Co.’s Zepatier (elbasvir/grazoprevir) provided a cost-competitive option for genotype 1,4 patients. The FDA’s recent approval of Gilead’s Epclusa (sofosbuvir/velpatasvir) provides the first FDC approved for all HCV genotypes. Hepatitis C Virus | Access & Reimbursement | U.S. examines the market access factors that influence the success of IFN-free DAA therapies in the U.S. market. The series is based on primary research with U.S. gastroenterologists, hepatologists, and infectious disease specialists, as well as PDs/MDs associated with U.S.-based MCOs. This research explores how payers and physicians interact and how reimbursement decisions influence the prescribing and uptake of specific therapies at the brand level.