Gilead to launch authorized generics of Epclusa, Harvoni for hepatitis C

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Gilead to launch authorized generics of Epclusa, Harvoni for hepatitis C

By Sandra Levy - 09/25/2018
Gilead Sciences plans to unveil authorized generic versions of Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) and Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Gilead’s leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics.

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

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, according to the company.

According to Gilead, due to the complexity and structure of the U.S. 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 authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today. 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 also will 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, the company said.

“Launching these authorized generics is the best solution available to us today to quickly introduce a lower-priced alternative to our HCV medications without significant disruption to the healthcare system and our business,” Gilead Sciences president and CEO John Milligan said in a statement. “This launch also will hopefully help increase transparency by more closely aligning our medications’ list prices with their cost. Our ultimate goal is to lower the list price of Epclusa — a medication we believe is of great importance given its clinical profile across genotypes — and Harvoni. We are committed to working with all of our partners in the healthcare system to help enable list price reductions of our HCV medications and find better solutions to reduce patients’ out-of-pocket costs.”

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