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.

Table of contents

  • Hepatitis C Virus - Access & Reimbursement - Detailed, Expanded Analysis (US)

Author(s): James Heeres, PhD

James is a part of the infectious, niche markets, and rare diseases team at DRG. His work involves evaluating treatment landscape, unmet needs, emerging therapy positioning, commercial potential, drug development opportunities, and company competitiveness. Currently, his concentration is in hepatitis C virus (HCV) infection in US and EU5 markets.

James earned his Ph.D. in biochemistry from the University of Illinois at Urbana-Champaign while studying high-throughput screening technologies and small-molecule inhibitors of apoptosis. Prior to joining DRG, his postdoctoral studies involved drug discovery and development in neurodegenerative diseases at both Harvard Medical School and Boston University School of Medicine.