Gilead to Sell Authorized Generic Versions of Hep C Treatments

Officials with Gilead Sciences, Inc. plan to launch authorized generic versions of sofosbuvir 400 mg/velpatasvir 100 mg (Epclusa) and ledipasvir 90mg/sofosbuvir 400 mg (Harvoni), Gilead’s leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics LLC, according to a press release from the company.

The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019.

The brand-name versions have been the subject of much debate since the launch of Gilead’s first HCV medication in 2013, but the average price paid for each bottle of medicine in the United States has decreased by more than 60% off of the public list prices, across health insurers and government payers. "Due to the complexity and structure of the US health care system, however, these discounts provided by Gilead may not always translate into lower costs for patients," according to the statement. Further, existing contracts, together with laws associated with government pricing policies, make it challenging to quickly lower a product’s list price once it is on the market.

The authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today, according to information in the press release. Insurers will have the choice of offering either the authorized generics or the branded medications for both Epclusa and Harvoni. In the Medicare Part D setting, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy. The authorized generics will also offer substantial savings to state managed Medicaid plans that do not currently benefit from negotiated rebates and that represent a significant number of people in need, potentially opening up access to our medications to beneficiaries who were previously denied coverage.

Beyond the company’s efforts to reduce patient costs, Gilead is continuing to pursue innovative collaborations and long-term financing models, such as a potential subscription model, that could not only expand access, but aim to eliminate HCV in the United States and around the world.

Reference

Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C [news release]. Foster City, Calif. Gilead Sciences; Sept. 24, 2018. Accessed at: http://www.gilead.com/news/press-releases/2018/9/gilead-subsidiary-to-launch-authorized-generics-of-epclusa-sofosbuvirvelpatasvir-and-harvoni-ledipasvirsofosbuvir-for-the-treatment-of-chronic-hepatitis-c