Pharma, Payers

Gilead Sciences to launch authorized generics of two hepatitis C drugs

The authorized generics, announced amid HCV product pricing pressures, will cost $24,000 – less than one-third the branded drugs’ prices – to reflect discounts given to payers.

Money pile and medicine pills representing medical expenses

More than a decade ahead of their patents’ expiration dates, Gilead Sciences is releasing authorized generics of two of its hepatitis C drugs.

The Foster City, California-based drugmaker said Monday that it would launch authorized generics of Harvoni (ledipasvir/sofosbuvir) and Epclusa (sofosbuvir/velpatasvir), both of which are used to treat chronic hepatitis C infection. The launch will take place in January 2019 through a newly created subsidiary, Asegua Therapeutics, for a list price of $24,000. Harvoni’s total cost as of last year was $94,500 for a 12-week course of therapy, according to Pharmacy Times, while a University of Washington hepatitis C information site states Epclusa’s wholesale acquisition cost is $74,760 for a 12-week course.

The launch is planned to happen more than a decade ahead of when Harvoni and Epclusa’s patents expire, which will take place in 2030 and 2032, respectively. Whereas generic drugs are knock-offs of branded drugs made to be therapeutically equivalent to their branded counterparts, an authorized generic is essentially the branded drug marketed at a lower price, either by the same manufacturer or a third-party company operating under contract.

The company said that since the 2013 launch of another hepatitis C drug, Sovaldi (sofosbuvir), the average price paid for each bottle of medicine in the US has decreased by 60 percent, but the complexity and structure of the healthcare system means those discounts do not always translate into lower costs for patients. As such, it said, the authorized generics’ $24,000 list price is meant to more closely reflect the discounts that commercial and government payers receive for the branded products. Compared with the branded drugs, the authorized generics could save patients up to $2,500 in out-of-pocket costs per course of therapy, the company said, while also offering savings to state Medicaid programs.

The news comes as revenues from Harvoni in particular have suffered due to pricing pressures, as well as a decline in the number of new patients starting therapy since the drug’s launch in 2015 that the company anticipates will continue, according to the company’s 2018 annual report, published in February. Harvoni’s sales in 2015 were $13.86 billion worldwide, but fell to $9.08 billion the next year and $4.37 billion in 2017. The company attributed the decreases to lower sales volume and, in the US, a lower average net selling price. Meanwhile, Epclusa’s sales have risen, from $1.75 billion in 2016 to $3.51 billion last year.

Overall, the company’s hepatitis C segment, which also includes Vosevi (sofosbuvir/velpatasvir/voxilaprevir), accounted for 36 percent of total product sales in 2017.

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