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).

Questions Answered in This Report:

  • HCV screening, diagnosis, and referral practices. What patient groups are most likely to be tested for HCV by PCPs? In what percentage of adult patients do PCPs suspect possible HCV infection, and what percentage of these patients are ordered diagnostic tests? What patient populations are PCPs most likely to refer to a specialist for care? What percentage of PCP-referred cases are lost to follow-up (i.e., never go to see the specialist to whom they were referred)? What impacts have HCV screening recommendations and treatment guidelines had on physician and payer practice?

  • Key attributes influencing physician willingness to prescribe HCV antiviral therapy. What attributes have the greatest impact on PCPs’ and specialists’ comfort level when prescribing HCV antiviral therapy to their patients? What attributes have the greatest impact on specialists’ comfort level with PCPs prescribing HCV antiviral therapy to their patients? What impact do factors such as efficacy, dosing frequency, and treatment duration have on physicians’ willingness to prescribe HCV antiviral therapy? How receptive are MCO PDs/MDs to greater PCP involvement in managing HCV patients?

  • Formulary access and uptake of recently launched and emerging interferon-free therapies in the United States. What is the nature of coverage for current HCV brands by commercial and Medicare Advantage plans? What strategies do commercial and Medicare Advantage plans employ to control costs? What tasks are MCO PDs/MDs personally supportive of MCOs reimbursing when undertaken PCPs? How supportive are MCO PDs/MDs of PCPs prescribing emerging interferon-free treatment regimens to HCV patients? What criteria must be met for patients to be considered interferon-ineligible?


This U.S. Physician & Payer Forum report contains insights from a survey of 100 PCPs, 51 specialists (44 gastroenterologists, 7 hepatologists), and 30 MCO PDs/MDs and explores physician and payer dynamics that affect sales of recently launched direct-acting antivirals against HCV and how the availability of all-oral, interferon-free therapies will impact PCPs’ and MCOs’ prescribing and reimbursement practices, respectively, with respect to treatment of patients with chronic HCV infection.

Markets covered: United States.

Primary research: Online survey of 100 PCPs, 51 specialists, and 30 MCO PDs/MDs.

Author(s): Hannah E. Cummings, Ph.D.