Increased market competition has prompted Gilead Sciences to launch authorized generics of their chronic hepatitis C virus (HCV) treatments Epclusa and Harvoni. The generic drugs will be sold through a specially-created subsidiary – named Asegua Therapeutics – starting in early 2019.
“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,” said Dr. John F. Milligan, 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.”
Both Epclusa and Harvoni topped the list of the most expensive drugs in the US in 2017, with list prices of $73,300 and $87,800, respectively. While the average price of these hepatitis C medications has come down significantly in the past year – with GoodRx reporting a $31,500 price tag for Harvoni and a cost as low as $24,748 for Epclusa – Gilead has seen an overall decline in sales.
In Q2 2018, chronic hepatitis C product sales for Gilead totalled $1 billion, compared to $2.9 billion in Q2 2017. These figures include sales of Gilead’s other hepatitis C drugs, such as Vosevi and Sovaldi, however sluggish sales of Harvoni, Epclusa and Sovaldi were largely to blame for the decline in revenue.
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In an attempt to compete against AbbVie’s new hepatitis C drug, Mavyret, Gilead’s authorized generics will be made available at a list price of $24,000. Gilead says that since 2013, the average price of its hepatitis C medications has decreased by 60 percent, however these discounts don’t always trickle down to patients.
By offering health insurance companies and other payers the choice between covering the branded or authorized generic forms of Epclusa and Harvoni, the company claims patients could see significant savings in out-of-pocket costs. For example, those covered under the Medicare Part D program could save as much as $2,500 on their hepatitis C treatment.
“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,” said Milligan. “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.”
The hope is that these authorized generics could also help patients previously denied coverage access the potentially-curative therapies. A study published earlier this year in the journal Open Forum Infectious Diseases found that more than half of privately-insured patients were denied coverage to direct-acting antivirals like Harvoni, with 15 percent of those covered under Medicare facing similar issues to accessing hepatitis C treatment.
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