Access to Hepatitis C Therapy Listening Session with Community Stakeholders

Content From: Ronald Valdiserri, M.D., M.P.H., Deputy Assistant Secretary for Health, Infectious Diseases, and Director, Office of HIV/AIDS and Infectious Disease Policy, U.S. Department of Health and Human ServicesPublished: January 12, 20153 min read


Ronald Valdiserri
Dr. Ronald Valdiserri
Last month, the Department of Health and Human Services (HHS) convened a listening session on the important issue of access to curative treatment for hepatitis C virus infection. While the advent of more effective, second-generation direct-acting antivirals for the treatment of hepatitis C represents a tremendous scientific accomplishment and a potential public health triumph, community leaders and other stakeholders have raised serious concerns about barriers to treatment access. Many of these concerns had been expressed in a community sign-on letter sent to HHS Secretary Sylvia Burwell in early September 2014.

The listening session was hosted by the Office of the Assistant Secretary for Health and led by Dr. Wanda Jones, Principal Deputy Assistant Secretary for Health. The Acting Assistant Secretary for Health, Dr. Karen DeSalvo, was able to attend the initial portion of the meeting, which took place at the Humphrey Building on December 9, 2014. Twelve stakeholders representing healthcare providers, advocates, persons infected with HCV, representatives of professional organizations, and national leaders from a variety of disciplines joined federal leaders from across HHS to share information about HCV treatment access barriers and their impact on people living with chronic viral hepatitis.

The stakeholders who attended the meeting were especially concerned about restrictions on access to the new HCV treatments put in place by payers, which, in the stakeholders’ opinion, do not appear to be medically justified. Listed below are three examples of restrictions, shared by the community stakeholders:
  • Restrictions based on degree of liver fibrosis – some insurers and other payers require evidence of advanced liver fibrosis or cirrhosis before granting access to HCV treatment.
  • Restrictions based on alcohol and drug use/abuse – some insurers and other payers have instated various restrictions ranging from requirements of three months to one year of documented abstinence from alcohol and/or drug use as well as monitoring requirements during HCV therapy.
  • Restrictions based on the type of prescriber – many insurance plans and some other payers require specialists to prescribe HCV treatment which can limit access due to the limited number of specialists, especially in rural areas.
Although there are no easy or quick solutions to the issues raised during the discussion, hearing directly from our partners helps us better understand these complicated issues and informs our thinking about potential avenues to mitigate—or remove—the stated barriers. Shortly after the meeting, on Friday, December 19, 2014, the FDA approved a second all-oral treatment regimen for chronic HCV and more new therapeutic options are expected to be approved in 2015. These developments underscore that this is a quickly evolving arena. HHS remains committed to collaborating with all stakeholders, inside and outside of government, to implement the Viral Hepatitis Action Plan , and to improve the diagnosis, treatment and prevention of viral hepatitis in the United States.