FOR IMMEDIATE RELEASE
Date: December 3, 2015 – The US Senate Finance Committee ranking member Ron Wyden (D-OR) and senior committee member Chuck Grassley (R-IA) issued a scathing bipartisan investigative report on December 1, 2015, revealing a Gilead Sciences, Inc. pricing strategy showing little concern for patient access to its lifesaving drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir).
“The report, which took 18 months to complete, is amazingly thorough and comprehensive, worthy of the US Senate and a Pulitzer Prize for investigative reporting,” said FPC co-chair Lynda Dee.
Sovaldi was approved by the FDA on December 6, 2013—a first-in-class hepatitis C drug that helped usher in a new era of short-course, all-oral, well-tolerated, and highly curative treatment.
Unfortunately, Gilead turned this long-awaited treatment option into a perfect storm of near-impossible drug access, marked by public and private insurance roadblocks in the form of prior approval, fibrosis, and strict sobriety requirements. These were instituted because government and industry payers could not afford the unconscionable cost of Sovaldi (a wholesale acquisition cost of $1,000 per pill for a total of $84,000 for a typical course of hepatitis C treatment) and later Harvoni ($94,500 for a typical treatment course).
Dee, cured of hepatitis C using a Sovaldi-inclusive regimen, explained: “With tears in my eyes, I literally begged Gilead at their FDA approval hearing to price Sovaldi reasonably so that it could be accessed by the hundreds of thousands of people who had been waiting so long for effective, less toxic hepatitis C treatments. The FPC met with Gilead before the launches of both Sovaldi and Harvoni, urging them to set their prices reasonably to avoid the cost-containment firestorm that is now the new normal for hepatitis C drugs. What was a dream scenario is currently a nightmare of bureaucratic insurance barriers.”
The Senate investigation found that Gilead provided supplemental rebates to only five Medicaid programs in 2014. “The poorest people in most of the country face the greatest access barriers to all the new hepatitis C regimens,” said FPC Co-Chair Murray Penner. “These barriers have worsened as Gilead recently narrowed eligibility for its Support Path program to exclude patients who have any form of insurance, even if that insurance denies access to Sovaldi and Harvoni. These barriers all result from unsustainable drug prices initiated by Gilead.”
The Senate report also provides clear evidence of Gilead’s greed and blatant disregard of stakeholder insight, stating: “Based on all of the information reviewed, it appears that in pricing its line of [hepatitis C] drugs Gilead may have underestimated the warnings of patient groups, insurers, health care providers, and other organizations about the potential impact that price would have on access…While publicly saying it prioritized patient access, Gilead set Sovaldi’s price at a level where ultimately many patients would not receive treatment. Sovaldi was on the market for almost a year without serious competitors, allowing Gilead to maintain a high effective price despite efforts by many payers to negotiate volume or treatment discounts or rebates.”
Additionally, according to the Wyden-Grassley report:
- More than $1.3 billion was spent by Medicaid programs for Sovaldi in 2014, but only 2.4% of Medicaid patients with hepatitis C were actually treated because of the excessive price of Sovaldi.
- In the 18 months that Gilead’s drugs have been on the market, Medicare’s monthly spending on hepatitis C treatments increased more than six-fold from $116.4 million in January 2014 to $793.2 million in June 2015.
- Medicare’s average pre-rebate monthly spending on hepatitis C drugs grew to $765 million during the first six months of 2015, more than double the average monthly expenditure of $349.5 million.
- Prisoners in the US Bureau of Prisons (BOP) system were also adversely affected. In fiscal year 2014, the year Sovaldi became available to treat prisoners with hepatitis C, the BOP’s spending on hepatitis C drugs increased 14%, even though the number of patients treated decreased 52%.
“This remarkable investigative report is an indictment against Gilead and the US drug pricing system which allows lifesaving drugs to be priced beyond what the market can reasonably bear,” said Dee.
At his press conference, Senator Wyden observed that drugs for other diseases like Alzheimer’s, diabetes, and cancer are in the pipeline. He noted that prices similar to those for the newest hepatitis C drugs are clearly not sustainable by private insurance companies and government payers.
The FPC wishes to thank Senators Wyden and Grassley, the Minority Staff of the Senate Finance Committee, and Senator Grassley’s staff for their Herculean efforts in compiling this investigative bipartisan report on hepatitis C drug pricing based on over 20,000 documents. The FPC was delighted to assist in this investigation
The full Senate Finance Committee report is available at: http://www.finance.senate.gov/newsroom/ranking/release/?id=3f693c73-0fc2-4a4c-ba92-562723ba5255. A press conference given by Senators Wyden and Grassley can be viewed at: https://www.youtube.com/watch?v=rxd_PTFoouo.
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The Fair Pricing Coalition, founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues and to help control drug costs for patients who are privately insured, underinsured and uninsured. The FPC also works to ensure access for recipients of state ADAPs, Medicare, and Medicaid as well as for other underinsured and uninsured individuals. For more information about the Fair Pricing Coalition and its history, visit: fairpricingcoalition.org.