Hepatitis C Virus (Primary Care Physicians in an Interferon-Free World: How Will the Availability of Safer and More Effective Oral Therapies Impact the Role of PCPs in Treating HCV Patients?) | Physician & Payer Forum | US | 2014

The market opportunity for hepatitis C virus (HCV) is marked by a large prevalent population and high unmet medical need due to the suboptimal tolerability and efficacy of early, interferon-based HCV antiviral therapies. Protease, polymerase, and NS5A inhibitors have become the most promising drug classes in development, and agents from these classes are being combined to provide convenient, tolerable, and highly efficacious treatment regimens. The HCV treatment landscape in the U.S. has been dramatically altered by the recent approval of two novel anti-HCV therapies, Gilead’s polymerase inhibitor, Sovaldi (sofosbuvir), and Johnson & Johnson/Janssen’s protease inhibitor, Olysio (simeprevir). In particular, the launch of Sovaldi marks the first all-oral, interferon-free regimen approved to treat HCV patients in the United States. With the launch of additional interferon-free regimens expected in 2014, HCV treatments that are safer, shorter, and more effective than currently available interferon-based therapies will be a reality for many HCV patients. These newer therapies could allow primary care physicians (PCPs) to treat HCV patients who had previously been served almost exclusively by specialists, primarily hepatologists and gastroenterologists. As a result, treatment of HCV may change dramatically, resulting in major effects on specific branded agents in the HCV market.

This report surveys PCPs and specialists (gastroenterologists and hepatologists) as well as managed care organization (MCO) pharmacy and medical directors (PDs/MDs) and examines PCP knowledge of and current involvement in HCV diagnosis and management. Further, this report probes physician and payer expectations around and level of comfort with a greater role for PCPs in treating HCV patients with currently available and emerging all-oral, interferon-free antiviral regimens.  Analysis is derived from a survey of 100 PCPs, 51 specialists (44 gastroenterologists, 7 hepatologists), and 30 MCO PDs/MDs. Physician surveys assesses PCP screening, diagnosis, and referral patterns, the impact of HCV screening recommendations and treatment guidelines on PCPs’ willingness to prescribe antiviral therapy to HCV patients, and the factors influencing specialist support for increased PCP involvement in managing HCV patients. The survey of MCO PDs/MDs provides insight into the formulary status of current HCV antiviral therapies, coverage for screening and/or diagnostic tests performed by PCPs for commercial and Medicare Advantage plans, and the formulary restrictions that payers have placed, and anticipate placing, on current and emerging HCV therapies in efforts to control costs. In addition, these surveys assess physician and payer interest in two emerging interferon-free therapies in late-stage clinical development: Gilead’s Sovaldi/ledipasvir and AbbVie’s ritonavir-boosted ABT-450, ombitasvir (ABT-267), and dasabuvir (ABT-333).