This article is more than 5 years old. Information may no longer be current.

Study shows Medicaid restrictions for Sovaldi create barriers for care

In a new study published in Annals of Internal Medicine, researchers found that Medicaid coverage restrictions for Sovaldi may not be allowing certain patients with hepatitis C virus infection to receive proper care.

“Federal Medicaid law requires coverage, yet reimbursement criteria for Medicaid programs effectively deny access,” Lynn E. Taylor, MD, director of the HIV/Viral Coinfection program at The Miriam Hospital in Providence, Rhode Island, said in a press release. “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.”

Lynn E. Taylor

Taylor and colleagues analyzed data from state Medicaid websites between June and December 2014. The data extracted included Medicaid reimbursement criteria for Sovaldi (sofosbuvir, Gilead Sciences) for all 50 states and the District of Columbia. The data showed whether sofosbuvir was covered and coverage criteria based on liver disease stage, HIV co-infection, prescriber type and presence of drug and alcohol use.

Forty two states and the District of Columbia had public data available.

“Nevada is the only state that does not require prior authorization for sofosbuvir,” the researchers wrote. “Nine states have unknown criteria, with neither the prior authorization nor eligibility information publicly available.”

The most common restrictions for reimbursement from the 42 states included the level of fibrosis, substance use and abstinence from alcohol or drug use together with toxicology screening and provider limitations.

Of the 42 states, 27 restrict sofosbuvir reimbursement to persons with advanced fibrosis or cirrhosis; 34 restrict sofosbuvir reimbursement on the basis of liver disease stage; and in four states, sofosbuvir reimbursement is restricted to only persons with cirrhosis. Two states had reimbursement provided for patients with moderate fibrosis and one state reimbursed to patients with mild fibrosis. Eight states had no reimbursement criteria based on disease stage.

According to the release, a quarter of the 42 states require HIV/HCV co-infected persons to be receiving antiretroviral therapy or have no evidence of HIV to be reimbursed and two thirds 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,” Jason Grebely, PhD, associate professor of the Kirby Institute at UNSW Australia, and co-author of the study, said in the release. “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.”

Taylor added that: “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. Based on the study findings, states need to review and revise their access criteria to align with clinical recommendations.” – by Melinda Stevens

Disclosures: Taylor reports financial disclosures with Gilead Sciences and Health Practice Research Institute. Grebely reports grants from Abbvie, Bristol-Myers Squibb and grants and personal fees from Gilead Sciences and Merck, outside of the study. Please see the full study for a list of all other authors’ relevant financial disclosures.