Medicaid Violations Hinder Hepatitis C Drug Access

Many states implement unlawful and life-threatening restrictions on Medicaid coverage for the hepatitis C virus drug, sofosbuvir.

Many states implement unlawful and life-threatening restrictions on Medicaid coverage for the hepatitis C virus (HCV) drug, sofosbuvir (Solvaldi).

A new study published in the Annals of Internal Medicine checked state Medicaid websites from June 23 to December 7, 2014, seeking to determine each state’s coverage criteria for sofosbuvir based on liver disease stage, HIV co-infection, prescriber type, and drug or alcohol use.

Among the 42 state Medicaid programs for which information was available, nearly three-quarters limited treatment to HCV patients with advanced fibrosis or cirrhosis, contrary to guidelines set forth by the American Association for the Study of Liver Disease and the Infectious Disease Society of America.

“Although there is a high risk of progression to decompensated cirrhosis and liver cancer among patients with advanced fibrosis, limiting access to people who have already progressed to late-stage disease as compared to treating earlier to prevent these liver-related complications seems counterintuitive as a public health strategy,” stated lead study author Lynn E. Taylor, MD, director of The Miriam Hospital’s HIV/Viral Hepatitis Coinfection Program.

Nearly one-quarter of state Medicaid programs required patients with both HIV and HCV to have suppressed HIV RNA levels or receive antiretroviral therapy, while nearly two-thirds had restrictions based on prescriber type.

The researchers also discovered that 88% of state programs included eligibility criteria for drug and/or alcohol use, with 50% requiring a period of abstinence of 3 to 12 months, and 64% requiring negative urine drug screening. Of note, the National Institutes of Health’s 2002 hepatitis C guidelines support HCV treatment regardless of injection drug use.

“This is particularly concerning because the majority of new and existing cases of hepatitis C in the US exist among people who inject or have injected drugs,” Dr. Taylor stated. “Rather than excluding people who use alcohol or drugs from hepatitis C treatment, even those with cirrhosis, they should be a priority group due to both improved individual health outcomes and potential hepatitis cure as prevention benefit.”

The authors emphasized that these restrictions not only violate federal Medicaid law, which requires states to cover drugs consistent with their FDA-approved labels, but also have no basis in clinical data or current treatment guidelines. They added that such limitations tend to have a particularly negative impact on financially underserved HCV-infected patients.

“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,” Dr. Taylor said. “Based on the study findings, states need to review and revise their access criteria to align with clinical recommendations.”

In the meantime, Dr. Taylor told Pharmacy Times in an exclusive interview that pharmacists can serve as advocates against the restrictions highlighted in this study.

“Pharmacists have an enormous amount of influence as a group, and if they collectively come out in support of changes to current policies, they can improve patient access to potentially life-saving treatment,” she said.

Just as importantly, Dr. Taylor added, pharmacists play an essential role in combating HCV.

“Pharmacists are a very underutilized resource for patients with HCV,” she said. “Not only can they help patients access their treatment on an individual level and assist them in getting their refills on time, but they have also proven instrumental in improving adherence to medication.”