Gilead Subsidiary to Launch Authorized Generics of Epclusa and Harvoni for the Treatment of Chronic Hepatitis C
25 September 2018 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) plans to launch authorised generic versions of Epclusa (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni (ledipasvir 90mg/sofosbuvir 400mg), Gilead's treatments for chronic hepatitis C virus, in the United States, through a newly created subsidiary, Asegua Therapeutics LLC, the company said.

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

Since the launch of Gilead's first HCV medication in 2013, 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 healthcare system, however, these discounts provided by Gilead may not always translate into lower costs for patients.

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 authorised generics are priced to more closely reflect the discounts that health insurers and government payers receive currently.

Insurers will have the choice of offering either the authorised generics or the branded medications for both Epclusa and Harvoni.

In the Medicare Part D setting, the authorized generics could save patients up to USD 2,500 in out-of-pocket costs per course of therapy.

The authorised 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.

Gilead Sciences has operations in more than 35 countries worldwide, with headquarters in Foster City, California.