HCV cures will now come as generics

Gilead Sciences, Inc. recently announced that it will release generic versions of sofosbuvir 400 mg/velpatasvir 100 mg (Epclusa^®) and ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni^®) in January 2019, through a subsidiary called Asegua Therapeutics LLC. These direct-acting antiviral (DAA) drugs are leading treatments for chronic hepatitis C in the United States, with the authorized generics to be listed at $24,000 per course of therapy. For comparison, the list price for Epclusa is $75,000 and Harvoni $94,500.

Public list prices have dropped by more than 60% on these drugs ever since Gilead introduced its first hepatitis C virus (HCV) medication in 2013, according to the company. Due to the structure of the health-care system, however, Gilead claims that these savings can fail to impact consumers. Existing contracts, as well as laws linked with government pricing policies, also make it difficult to reduce prices of a drug already on the market.

Gilead plans to price the generic alternatives more comparably to what government payers and health insurers currently pay in light of discounts. With the authorized HCV generics, the out-of-pocket savings to a senior on Medicare Part D will be up to $2,500 for a course of treatment.

Insurers will be able to choose between either the authorized generics or the brand-name drugs. Importantly, state-managed Medicaid plans that have not negotiated rebates will benefit from the cost savings.

Gilead is especially interested in dropping the price of, and opening access to, the single-pill combination of sofosbuvir and velpatasvir, which has a wide clinical profile covering various genotypes.

“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 health-care system and our business,” said John F. Milligan, PhD, president and chief executive officer, Gilead Sciences. “This launch also will, hopefully, help increase transparency by more closely aligning our medications’ list prices with their cost.”