Gilead Implements Contract Pharmacy Integrity Initiative for Branded Hepatitis C Products
Foster City, Calif., March 15, 2022 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company will launch a Contract Pharmacy Integrity Program that aims to improve transparency in the 340B Federal Drug Pricing Program and address duplicate discounts and diversion.
Gilead recognizes the important role of the 340B program in providing medicines for individuals with low incomes. The 340B program has grown rapidly in recent years, and a well-documented lack of program oversight has elevated concerns among stakeholders about the program’s integrity and sustainability. Over time, Gilead has seen duplicate discounts and diversion of its hepatitis C products distributed through contract pharmacies with increased frequency. This means multiple discounts have been improperly applied to the same single bottle of Gilead medicine, and/or discounts are being claimed on bottles dispensed to individuals who are not patients of a 340B covered entity.
Under the integrity program, Gilead is requesting that 340B covered entities provide claims level data for units of Gilead’s hepatitis C products, Epclusa® (sofosbuvir / velpatasvir), Harvoni® (ledipasvir / sofosbuvir), Sovaldi® (sofosbuvir) and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) dispensed from contract pharmacies as of May 2, 2022. This integrity program does not apply to the authorized generics of Epclusa® and Harvoni® offered by our subsidiary, Asegua Therapeutics. Sharing of claims level data is a necessary step toward achieving greater transparency in the 340B program and will help Gilead address inappropriate duplicate discounts and diversion while also bolstering the integrity and sustainability of the program. The claims level data being requested is similar to the data Gilead receives from other purchasers and payers; the data request is tailored to minimize burdens on covered entities while mitigating duplicate discount and diversion concerns.
We have sent a letter with additional information regarding program implementation directly to covered entities that can be found here. We look forward to working closely with covered entities to provide access to our medicines for all those who could benefit, in a transparent and sustainable way.
U.S. Prescribing Information for EPCLUSA, HARVONI, SOVALDI and VOSEVI, including BOXED WARNINGS, are available at www.gilead.com.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.