On the heels of their December 1, 2015, report on Gilead Sciences’ pricing of Hepatitis C drugs Sovaldi and Harvoni, United States Senate Finance Committee leadership, namely Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), have asked for public comments from the patient and healthcare stakeholder community on the report’s findings.
As a refresher, the report determined that Gilead had priced their products by prioritizing revenue and maximizing profit over patient access. The way Gilead prioritized revenue and profit over patient access wound up severely limiting patient access, particularly among beneficiaries who are covered by public benefit programs. The Finance Committee argued that Gilead “was determined to keep the drugs’ wholesale prices high and payer discounts low ‘whatever competitors do or whatever the headlines.'”
The report stated that, “the public and private payer community continue to face a higher cost for the prevailing (new) standard of care, and higher overall costs because the new generation of HCV drugs is better tolerated and will most likely be far more widely prescribed.”
Many of the questions Senators Grassley and Wyden are requesting answers for center around how to address policy issues, including the financial ramifications of high prices of breakthrough drugs, while still ensuring patient access and market transparency.
“Thoughtful feedback” is requested on the following topics: (1) the possible effects of a breakthrough, single source, innovator drug on the marketplace; (2) whether the payers in the programs have adequate information to know and understand the cost, patient volume, and increases in efficacy of a new treatment regimen; (3) what kind of role does the concept of “value” play in this pricing debate and how should an innovative therapy’s value be represented through its price; (4) what kind of measures can be put in place to improve price transparency for new higher-cost therapies while maintaining incentives for manufacturers to invest in new drug development; (5) what kind of tools currently exist, or should exist, to address the impact of high cost drugs and the corresponding access restrictions, especially on low-income populations and state Medicaid programs.
While these questions did appear in the final report, this is the first time the Senators are making known that their request to the medical community for answers was a serious one, and that they are interested in making policy decisions with industry input. By asking for input, hopefully any policy changes that are made will be palatable and both patient- and industry-centric.
More information on these questions can be found in Section 7 of the report, pages 117 through 123. If you have any responses to offer, the Committee on Finance is requesting that you submit any responses in PDF format to Report_Feedback@finance.senate.gov by the close of business on March 4, 2016.
Things to Keep in Mind
As we have previously written, the cost of Sovaldi, while costly, is potentially lifesaving and though expensive may actually even wind up being a long term cost saver. Hepatitis C is the leading cause of cirrhosis, liver cancer, and liver transplantation. Those diseases and the surrounding procedures/complications are not only painful for patients, but also extremely costly in their own right. Medical costs associated with liver disease can be lifelong, and pricey, expenses.
Not only can costly drugs like Sovaldi and Harvoni wind up being long term cost savers, but there has always been an unsustainable cost burden on society for treating patients with hepatitis C; this is not a new problem specific to Gilead drugs. It was estimated that without new cures and treatments for hepatitis C, such as Sovaldi and Harvoni, annual medical costs for patients with hepatitis C would almost triple over the course of twenty years.
Prior to Sovaldi, hepatitis C therapies not only carried numerous, difficult to deal with, side effects, but also carried low success rates. Cure rates for Sovaldi, on the other hand, were nearly 90% in clinical trials, with far fewer complications, making the prescription, and in turn the patient’s quality of life, much more enjoyable.
Cost and the burden on the healthcare system is always a concern, but it is important to always view therapies, treatments, and drugs, through the lens of the entire healthcare ecosystem. While Sovaldi may be a large initial expense, it will curb patient suffering, prevent future liver transplants, and keep patients out of the hospitals, leading potentially productive lives.