Gilead Limits Enrollment in Hepatitis C Drug Patient Assistance Program

Company claims insurers are taking advantage of program to shift cost of Sovaldi.

Drug maker Gilead Sciences further fueled the controversy surrounding its landmark hepatitis C drugs Sovaldi and Harvoni last week when it announced plans to limit enrollment into its Patient Assistance Program (PAP) for the high cost drugs.

Controversy has swirled around Sovaldi since it launched with an $84,000 price tag for a 12-week treatment course that carries cure rates in excess of 90%. Gilead’s assistance program helps patients with high copays or whose insurers don’t fully cover the drug.

In a letter sent earlier this month to patients and providers, Gilead stated that some insurers who have used the program are doing so to shift the cost of the drugs from insurers back to the company. Gilead said the PAP was being used to deny access and refer patients who insurers declined to cover.

“While we have approved many of these patients in the past, we feel it is necessary to establish more specific guidelines for patient eligibility,” Coy Stout, vice president of managed markets at Gilead, wrote in the letter. “Our [program] was designed to help uninsured patients with the most need, and changes are necessary to remain true to that mission. We believe these changes also will help increase access among those payers who continue to restrict access.”

Despite saving money on long term costs for liver disease, the short term pain from Gilead’s costly drugs has been a major issue for stakeholders throughout the specialty drug landscape. Late last year, Express Scripts announced an update to its National Preferred Formulary to expand access to Viekira Pak, which was immediately added as the exclusive option for patients with genotype 1 hepatitis C, regardless of symptoms or disease progression.

Sovaldi and Harvoni were excluded from the Express Scripts formulary, however the drugs continue to be available for patients who have already begun treatment.

In the letter announcing changes to the PAP, Gilead said patients who are insured and who do not meet their payer’s coverage criteria will no longer be eligible for support. Insurance providers have limited access to Sovaldi and Harvoni based on several criteria cited by Gilead in the letter, including:

• Fibrosis score restrictions
• Preferring or exclusively covering another product on formulary (ie, Viekira Pak preferred)
• Limiting coverage to a maximum treatment duration or denying subsequent treatment after a patient has failed therapy
• Step-therapy requirements
• Clinical criteria (eg, psychiatric requirements, drug and alcohol testing)

“While we have approved many of these patients in the past, we feel it is necessary to establish more specific guidelines for patient eligibility,” Stout wrote in the letter. “Our PAP was designed to help uninsured patients with the most need, and changes are necessary to remain true to that mission. We believe these changes also will help increase access among those payers who continue to restrict access.”

The AIDS Healthcare Foundation released a statement criticizing Gilead’s decision.

“In essence, Gilead is holding hepatitis C patients hostage as a negotiating strategy with health insurers for drugs that they ridiculously overpriced in the first place, so whatever discounts Gilead offered are most likely rendered moot,” said Michael Weinstein, president of AIDS Healthcare Foundation.

Gilead said the company would assist patients in submitting appeals, peer reviews, and in-person hearings to fight for access to the drugs.

“Gilead continues to support open access to hepatitis C therapies with prescribing decisions made by a physician in partnership with his or her patient,” Stout wrote in the letter. “We will continue to work with payers to provide information that conveys the profile of our hepatitis C medications and the benefit of curing individuals living with the virus. We believe that payers should take the responsibility to provide coverage for their insured patients based on the treatment decisions of their healthcare providers.”