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Gilead subsidiary to launch authorized generics of Epclusa and Harvoni
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Dear Colleague,
Today we announced plans to launch authorized generics of our HCV treatments Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni®(ledipasvir 90mg/sofosbuvir 400mg) through a newly created subsidiary of our company called Asegua Therapeutics. The authorized generics will have a list price of $24,000 for the most common course of therapy and will be available in January 2019.
We believe that introducing these authorized generics is the fastest way to lower list prices for our HCV cures without significant disruption to the healthcare system and our business, as a bridge to longer term solutions aimed at reducing patients' out-of-pocket medication costs.
This action is specific to these HCV medicines because they are in a unique situation. The average price paid for each bottle of our medications has dropped by more than 60 percent off of list prices, but the discounts we have provided may not always translate into lower costs for patients.
Starting in January, health insurers will have the choice of covering our branded medications or the authorized generics. This choice can lower out-of-pocket costs and open up access to our medications for patient populations with greatest need. 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 will also 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. This is particularly important because we want to ensure that patients across all payer segments can benefit from Epclusa - a medication we believe has the right profile to help contribute to the elimination of HCV.
Moving forward, we are committed to working with all participants in the healthcare system to help enable list price reductions for Epclusa and Harvoni and find better solutions to reduce patients' out-of-pocket costs and improve access. At the same time, we are also continuing to pursue collaborations and long-term financing models that can help our treatment better reach the patients who need them, and support our shared goal of eliminating HCV in the US and around the world.
You can read more about the authorized generics in our press release. Please do let us know if you have any questions, and we look forward to our continued collaboration.
Best,
Advocacy Team
Gilead Subsidiary to Launch Authorized Generics of Epclusa® (Sofosbuvir/Velpatasvir) and Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C
-- List Price of Authorized Generics to Reflect Discounts in the System Today --
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 24, 2018-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today plans to launch authorized generic versions of Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni® (ledipasvir 90mg/sofosbuvir 400mg), Gilead's leading treatments for chronic hepatitis C virus (HCV), in the United States, through a newly created subsidiary, Asegua Therapeutics LLC. The authorized generics will launch at a list price of $24,000 for the most common course of therapy and will be available in January 2019.
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 percent off of the public list prices, across health insurers and government payers. 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 will also 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.
"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 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. 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."
Beyond the company's efforts to reduce patient costs, Gilead is continuing to pursue innovative collaborations and long-term financing models, such as a potential subscription model, that could not only expand access, but aim to eliminate HCV in the United States and around the world.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Investors
Sung Lee, 650-524-7792
or
Media
Amy Flood, 650-522-5643
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