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Patient advocacy groups protest limits of Gilead's support program

SAN FRANCISCO — At the Liver Meeting 2015, patient advocacy groups stood in protest of restrictions implemented this summer to the patient support program, demanding reinstatement of free treatment access to all patients with hepatitis C virus.

Diana L. Sylvestre, MD, assistant clinical professor at the University of California, San Francisco, also runs OASIS, a clinic in Oakland, California, which took a lead role in organizing the protest because, as she told Healio.com/Hepatology: “People can’t get access to these medications. It’s just not right. It’s not profiting. It’s profiteering.”

She said, “We chose to take on Gilead because it has come to the point that we cannot afford to treat hepatitis C. Gilead, despite projecting profits of $30 billion in 2015 … cut back their patient assistance program drastically. That made it hard for people who needed the medications and might spread hepatitis C to other people; it made it difficult for them to get the medications. What that means to a clinic like ours is we can’t do our work.”

Cara Miller, spokesperson for Gilead, said the company is still committed to its support program.

“Gilead has established one of the most comprehensive patient assistance programs to help enable access to care. The Support Path program helps to ensure that cost is not a barrier to Sovaldi or Harvoni therapy for patients without insurance or those who deal with high copays.  The program provides Sovaldi and Harvoni at no charge for eligible uninsured patients,” Miller told Healio.com/Hepatology. “Gilead has always been an advocate for patient access to therapies in the areas in which we work, and we share the goal of enabling access to effective cures for all patients who are living with HCV — with prescribing decisions made by a physician in partnership with their patient.”

With chants of “Don’t be greedy, treat the needy” and handing out “Fake-ovir,” the protestors surrounded the entrance to the Moscone Center, garnering attention from attendees. The protestors called attention to those who inject drugs, the uninsured and others at high risk of infection, reinfection and further transmission.

“We know these drugs cost pennies to make and they’re being sold for thousands. People are dying because they don’t have access,” Tracy Swan, hepatitis/HIV project director at Treatment Action Group, told Healio.com/Hepatology. “Drug companies can still profit and save lives. This is excessive.”

On July 1, 2015, Gilead sent a letter to its providers, explaining that patients who were insured, but did not meet their payer’s coverage criteria, would no longer be eligible for support via the patient assistance program, Support Path. The letter went on to explain that patients could be denied due to fibrosis score restrictions, preference for or exclusive coverage of another product on formulary, limited coverage to a maximum treatment duration,  denying additional treatment after therapy failure, step-therapy requirements or clinical criteria such as psychiatric requirements or drug and alcohol testing.

Sylvestre said, “We decided that we needed to do something about that and we went out there to demand that Gilead reinstate the patient assistance program, especially for high-risk individuals so we can end the epidemic. If we don’t treat that patient population, then the epidemic proceeds. We think it’s very irresponsible for Gilead to institute policy that allows the epidemic to continue.”

As Swan did, other advocacy groups lent their voices to the protest as well.

“This really speaks for itself that you have people who are personally impacted by hepatitis C, some of them who do not have access to the drugs because of restrictive insurance practices and high prices and policies — in this case where Gilead has put exclusions in their patient assistance program. It’s wonderful that they’re out here advocating for themselves,” Chris Taylor, senior director of viral hepatitis with the National Alliance of State and Territorial AIDS directors, told Healio.com/Hepatology. “If there’s anyone who is troubled or angered by this — about people speaking up — that’s not what they should be angry about. They should be angry that people don’t have access to a cure.”

“The Gilead support program is an important program and it should be reinstated. It is unacceptable that they pulled their funding,” Dawn Fishbein, MD, MS, attending physician, Infectious Diseases, at MedStar Washington Hospital Center, told Healio.com/Hepatology. “The advocate voices in HCV are so small compared to HIV. … I’m glad to see that there are advocates out here being strong.” – by Katrina Altersitz

Disclosures: Fishbein reports various financial relationships with AbbVie, Boehringer Ingelheim and Gilead. Sylvestre, Swan and Taylor report no relevant financial disclosures.