Many States Violate Law by Denying Coverage for High Cost Hepatitis C Drugs

Coverage restrictions on wrong side of Medicaid law requiring states to cover drugs consistent with FDA labels.

Coverage restrictions on wrong side of Medicaid law requiring states to cover drugs consistent with FDA labels.

The high cost of the breakthrough hepatitis C drug sofosbuvir (Sovaldi) has created myriad difficulties for patients attempting to access the drug due to coverage restrictions.

These restrictions, which allow coverage for only the sickest patients, may in fact be in violation of federal Medicaid law, according to a study published online recently in the Annals of Internal Medicine. When hepatitis C virus goes untreated, the virus can eventually lead to cirrhosis, liver failure, and liver cancer.

The researchers found that the majority of Medicaid coverage restrictions for sofosbuvir are in violation of a law requiring states to cover drugs consistent with FDA labels.

"Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access," said lead author Lynn E. Taylor, MD, director of The Miriam Hospital HIV/Viral Hepatitis Coinfection Program. "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."

With a price tag of approximately $1000 per pill, or $84,000 for a 12-week treatment course, sofosbuvir carries cure rates in excess of 90% in hepatitis C patients. The most common prerequisites for access to the drug include the level of fibrosis, substance and alcohol use in toxicology screening, and providers limiting the physicians allowed to prescribe sofosbuvir.

The researchers said that access is not being restricted based on scientific evidence, current treatment guidelines, or clinical data. Furthermore, the study found that 74% of 42 state Medicaid programs limit treatment to patients suffering from advanced fibrosis or cirrhosis.

These restrictions are in defiance of the American Association for the Study of Liver Disease and the Infectious Disease Society of America treatment guidelines, which favor treatment for all hepatitis C patients other than individuals with life expectancy of less than 12 months as a result of non-liver-related diseases.

"Rates of advanced liver disease complications and associated health care costs are rising in the US," Dr. Taylor said. "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 counter-intuitive as a public health strategy."

The study showed that among state Medicaid programs with information available, 88% include drug and alcohol use or abuse as part of eligibility criteria, with 50% requiring 3 to 12 months of abstinence and 64% requiring negative urine drug screening.

"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 said. "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 researchers evaluated data from state Medicaid websites from June 23 to December 7, 2014, including whether sofosbuvir was covered and criteria based on liver disease stage, HIV coinfection, prescriber type, and drug or alcohol use. The results showed that one-fourth of states require HIV/HCV coinfected persons to receive antiretroviral therapy or have suppressed HIV RNA levels, while two-thirds of states have restrictions based on prescriber type.

"The Medicaid restrictions generally apply to the poorest and most underserved patients with hepatitis C infection, are highly stigmatizing, and not based on evidence," said study co-author Jason Grebely, PhD. "The data suggests that state Medicaid policies for access to new hepatitis C therapies should be reviewed and revised in line with national and international clinical recommendations."

The researchers concluded that treatment access should be based upon clinical criteria to lower the costs associated with hepatitis C treatment over the long term versus the short term cost of sofosbuvir.

"It is unacceptable for treatment to be held hostage by state Medicaid programs,” said co-author and hepatitis/HIV project director at Treatment Action Group Tracy Swan. “Medicaid programs have never forced people to wait for treatment until they are so sick that they are left with a higher liver cancer risk even if they are cured. We would never refuse treatment for cancer or other infectious diseases, nor do we withhold treatment for these illnesses from people who drink alcohol or use drugs."