January 28, 2016—The Senate Finance Committee’s senior Democrat and a senior Republican member want to hear from the healthcare and patient communities about the negative financial and health impacts of highly expensive breakthrough drugs such as Gilead Sciences’ Sovaldi and Harvoni hepatitis C treatments. [ms-protect-content id=”2799″]
Sens. Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) issued the call for public comments on Jan. 21. Last month, they released the findings of their yearlong investigation of how Gilead developed, priced, marketed, and sold the hepatitis C drugs. In a related development, Massachusetts Attorney General Maura Healey announced on Jan. 22 that she has opened an inquiry into whether Gilead’s pricing for those drugs violated state unfair trade practice laws.
“Our investigation showed that in considering how to price its drugs, Gilead prioritized revenue and profit maximization over patient access,” Senators Wyden and Grassley wrote last week in their open letter to healthcare professionals and patients. “Furthermore, the company was determined to keep the drugs’ wholesale prices high and payer discounts low ‘whatever competitors do or whatever the headlines.’ Gilead’s pricing and sales strategy led many insurers to strictly limit access for Sovaldi and Harvoni. As a result, ‘patients who could benefit from these drugs did not receive them due to the high cost.'”
The senators want feedback on these five issues:
- What are the effects of a breakthrough, single source innovator drug on the marketplace?
- Do the payers in the programs have adequate information to know the cost, patient volume, and increases in efficacy of a new treatment regimen?
- What role does the concept of ‘‘value’’ play in this debate, and how should an innovative therapy’s value be represented in its price?
- What measures might improve price transparency for new higher-cost therapies while maintaining incentives for manufacturers to invest in new drug development?
- What tools exist, or should exist, to address the impact of high cost drugs and corresponding access restrictions, particularly on low-income populations and state Medicaid programs?
Responses in PDF format are due on March 4. They should be emailed to Report_Feedback@finance.senate.gov. [/ms-protect-content]