Wyden, Grassley Request Comments on Sovaldi Report

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By Bronwyn Mixter

Jan. 25 — Sens. Ron Wyden (D-Ore.) and Charles Grassley (R-Iowa) Jan. 21 sent a letter to the health-care and patient community requesting responses to the policy questions in their report on the price of the hepatitis C drug Sovaldi.

The report, “The Price of Sovaldi and Its Impact on the U.S. Health Care System,” was released on Dec. 1, 2015 (13 PLIR 1698, 12/4/15). The report examined how Gilead Sciences Inc. developed, priced, marketed and sold Sovaldi and its follow-on drug Harvoni.

The report said the company pursued a marketing strategy and final wholesale price of Sovaldi—$1,000 per pill, or $84,000 for a single course of treatment—that it believed would maximize revenue. Building on that price, Harvoni was later introduced at $94,500 for a single course of treatment.

“We launched this investigation largely out of concern about the challenges that Gilead's pricing decisions posed for public payers and the negative impact that restricted access had on patients within those systems,” the letter said. “Now we seek to gather information from the public about how to address policy issues including the financial impact of high prices of breakthrough drugs, ensuring patient access, and improving marketplace transparency.”

Wyden is the ranking member of the Senate Finance Committee and Grassley is a senior committee member.

Specific Questions

The senators asked for responses to the following questions:

• 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 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?


The senators requests that all responses be sent in PDF format to Report_Feedback@finance.senate.gov by the close of business on March 4. All submissions will be considered part of the public record.

At the time the report was released, Foster City, Calif.-based Gilead said that it stands behind the pricing of its therapies because of the benefit they bring to patients and the significant value they represent to payers, providers and the entire health-care system by reducing the long-term costs associated with managing chronic hepatitis C virus.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Nancy Simmons at nsimmons@bna.com

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