UPDATE Thursday, March 24, 2022, 2:10 p.m.—A Gilead spokesperson disputed AIDS Healthcare Foundation’s statement that, under Gilead’s new conditions on 340B contract pharmacy pricing on its branded hepatitis C treatments, the company will give 340B discounts to covered entities only “if they turn over sensitive data about the providers’ patients. Providers who don’t submit this data are shut out.”
Gilead said that entities that decide not to provide claims level data on their contract pharmacy utilization and that do not have an in-house pharmacy “will have the option to select a single contract pharmacy location.”
AIDS Healthcare Foundation (AHF), the world’s largest AIDS provider organization, held a demonstration yesterday in front of drug manufacturer Gilead’s San Francisco Bay area headquarters protesting the company’s new conditions on 340B contract pharmacy pricing on its branded hepatitis C treatments.
“The 340B statute gives providers the undeniable legal right to access discounted drugs for their patients, Laura Boudreau, AHF’s Chief of Operations/Risk Management and Quality Improvement, said in a statement about the protest march. “Drug manufacturers have absolutely no right to place conditions on this access—but they are constantly trying to devise new ways to do so. This latest move hurts safety net providers who do not have their own in-house pharmacy, but instead rely on outside pharmacies to make drugs available to their patients. Gilead will only provide these providers access to discounts if they turn over sensitive data about the providers’ patients. Providers who don’t submit this data are shut out—contrary to the letter and spirit of the 340B program.”
Under Gilead’s new policy, starting May 2, hospital and grantee 340B covered entities will have to provide claims level data for Gilead’s branded hepatitis C products to be able to continue to be eligible for bill to / ship to orders for multiple contract pharmacies. The affected products are Epclusa, Harvoni, Sovaldi, and Vosevi. Authorized generics of Epclusa (sofosbuvir / velpatasvir) and Harvoni (ledipasvir / sofosbuvir) sold by Gilead subsidiary Asegua Therapeutics are excluded.
“Gilead cares more about money than lives,” said Jesse Brooks, AIDS advocate and AHF mobilizer. In response to Gilead’s and other manufacturers restrictions on 340B access, AHF is asking Congress and the FDA to conduct a formal investigation of Gilead as well as increased scrutiny of the actions of pharmaceutical companies.
Gilead told entities in its letter announcing the new policy that it made the change “because of the acute impact of duplicate discounts and diversion.”
“Over time, Gilead has seen duplicate discounts and diversion of our medicines distributed through contract pharmacies occurring with increased frequency,” Gilead said. “This means that multiple discounts have been improperly applied to the same single bottle of Gilead medicine, and/or that discounts are being claimed on bottles dispensed to individuals who are not patients of a 340B covered entity. Sharing of claims level data with manufacturers is a necessary step toward achieving greater transparency in the 340B program and will help Gilead address duplicate discounts and diversion while also bolstering the integrity and sustainability of the program.”
