Gilead to launch generic versions of hepatitis C drugs

Gilead Sciences said Monday it will launch generic versions of Harvoni and Epclusa, its top-selling hepatitis C drugs.

Gilead will sell its chronic hepatitis C generics at a $24,000 list price for the most common course of therapy come January 2019. This represents a significant discount compared to the price for its branded alternatives, which can cost nearly $100,000 for a full course of treatment.

The authorized generics are priced to more closely reflect the discounts that health insurers and government payers receive today, the company said in a news release. 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. It could also save money for state-managed Medicaid plans that do not benefit from negotiated rebates, Gilead 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 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."

Expensive hepatitis C drugs like Harvoni, which was approved in 2014, have helped fuel criticism of the rising prices of branded specialty drugs. Prices of antiviral medication used to treat hepatitis C and HIV have increased 19% from 2010 to 2016, according to an analysis by the Blue Cross and Blue Shield Association. Harvoni's patent doesn't expire until 2030 while Epculsa's lasts until 2032.

Branded drugs with no generic alternatives, or single-source drugs, are the main driver of pharmaceutical spending, the study said. They are rising at an average annual rate of 25%, a total of 285% since 2010. These patent-protected drugs now make up 63% of total drug spending, up from 29% of total spending in 2010, despite the fact that they make up less than 10% of total prescriptions filled.

But Gilead's antiviral drug revenue has been falling. Insurers have even denied coverage of the drugs due to the high prices.

Sales of Harvoni, Epclusa, Sovaldi and Vosevi to treat hepatitis C accounted for approximately 36% of Gilead's total product sales in 2017, according to Gilead's year-end earnings report. Its HIV-related drugs made up about 55% of its total product sales.

Fewer patients have started hepatitis C treatment since the second quarter of 2015 and the company expects sales to continue to decline. Revenue could also take a hit from a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions, the company said.

Antiviral product sales, which include sales of its hepatitis B, hepatitis C and HIV drugs, were $23.3 billion in 2017 compared to $27.7 billion in 2016 . Hepatitis C sales were $9.1 billion in 2017 compared to $14.8 billion in 2016 due to increased competition and fewer prescriptions, according to Gilead's year-end earnings report.

Gilead is tied up in legal battles with Idenix Pharmaceuticals, Merck and the University of Minnesota, among others, over alleged patent infringement related to its hepatitis C drugs.