Hepatitis C Treatment Access Limited By State Restrictions

Illegal barriers may be being imposed by State-run insurance programs for the low-income, blocking individuals with hepatitis C from getting a new treatment, a recent study suggests.

The study analyzed Medicaid policies for hepatitis C virus treatment with sofosbuvir, also known as Solvadi. It found that most polices should change to expand access to the treatment.

Lead author Lynn E. Taylor, M.D., director of The Miriam Hospital‘s HIV/Viral Hepatitis Coinfection Program, said:

“Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access. The denial of treatment by most states violates the spirit of the law. In our analysis, we found that most states with known sofosbuvir Medicaid reimbursement requirements impose undue restrictions on eligible recipients.”

The Hepatitis C virus affects over three million Americans, and globally an estimated 120 to 150 million people have chronic hepatitis C. When left untreated, the infection can lead to liver failure, cirrhosis, and liver cancer.

Marketed since 2013, Sofosbuvir, sold under the brand names Sovaldi, Hepcinat, Resof, Hepcvir, SoviHep, is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C infections. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy.

The most common access restrictions, the study found, fall into one of three categories:

  • The level of fibrosis (i.e., scarring of the liver)
  • Substance use and abstinence from alcohol/drug use together with toxicology screening
  • Provider limitations, which limit the physicians allowed to prescribe sofosbuvir

Co-author Robert Greenwald, J.D., director of Harvard Law School’s Center for Health Law and Policy Innovation, said:

“Ultimately, we found that access restrictions are not based on scientific evidence, current treatment guidelines, or clinical data. Notably, 74 percent of the 42 state Medicaid programs for which information is available limit treatment to individuals with advanced fibrosis or cirrhosis. Such restrictions contradict the American Association for the Study of Liver Disease and the Infectious Disease Society of America treatment guidelines which support treatment for all hepatitis C-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related diseases.”

Taylor concluded:

“Access to treatment should be based on clinical criteria and medical evidence. The current restrictions do not make clinical, public health, or long-term economic sense, and should be removed. It is critically important that patients have access to highly effective drugs that not only cure them but will also lower the associated costs of long-term management of the disease. Based on the study findings, states need to review and revise their access criteria to align with clinical recommendations.”

Lauren A. Canary, MPH; R. Monina Klevens, DDS, MPH; and Scott D. Holmberg, MD, MPH
Limited Access to New Hepatitis C Virus Treatment Under State Medicaid Programs
Ann Intern Med. [Epub ahead of print 30 June 2015] doi:10.7326/M15-0320

Illustration:Dr. Erskine Palmer, USCDCP