Print“Our concern is that a treatment will not cure patients if they cannot afford it,” write the lawmakers. “These costs are likely to be too high for many patients, both those with public insurance and those with private insurance.”
On March 20, 2014, three members of the U.S. House of Representatives Energy and Commerce committee, Henry Waxman (D-CA), Frank Pallone (D-NJ), and Dianna DeGette (D-CO), sent a letter to John Martin, CEO of Gilead Sciences asking it to justify the cost of its hepatitis C therapy Sovaldi. Gilead has priced the once-daily pill at $1,000, with a standard 12-week costing $84,000.
News of the letter sparked a broad selloff of biotech stocks on Friday, as concerns mount over a push-back to the rising costs of biotech drugs. As health systems around the world move toward value-based pricing, public and private payers are increasingly targeting the cost of these specialty drugs because they see them as the fastest growing portion of the healthcare bill.
Hepatitis C affects about 3.2 million people in the United States and causes about 15,000 deaths a year from cirrhosis of the liver or liver cancer. Sovaldi received accelerated approval for marketing from the U.S. Food and Drug Administration in December 2013 under both Priority Review and Breakthrough Therapy designations. The Breakthrough Therapy designation is given to experimental medicines that demonstrate significant improvement over available therapies or treat diseases for which no therapy exists.
The representatives note that evidence points to Sovaldi’s effectiveness in treating hepatitis C and that it could be a lifesaver but not if it is unaffordable. “Our concern is that a treatment will not cure patients if they cannot afford it,” write the lawmakers. “These costs are likely to be too high for many patients, both those with public insurance and those with private insurance,” they write. Because infection is more prevalent among low-income and minority patients, “the affordability problems are likely to be particularly acute for state Medicaid programs and those patients served by these programs.”
Several states have already said they will limit its use because of the price, and pharmacy benefits manager Express Scripts has advised doctors in its network to delay prescribing Solvadi.
The lawmakers asked Gilead to provide the method by which it established Sovaldi’s pricing; the value it received from regulators’ expedited review and how that affected Sovaldi’s price; how much and how often it provides discounts to low-income patients and public and private buyers of the drug; and the public health impact of insurers’ and public health programs’ decisions not to cover its cost for all patients with hepatitis C.
The lawmakers requested an answer by April 3. Gilead has not stated whether or not it will respond to their letter. Earlier in March, the not-for-profit California Technology Assessment Forum said that while the new hepatitis C drugs Sovaldi and Olysio from Johnson & Johnson are superior to standard of care, the costs of the drugs don’t justify their benefits.
March 23, 2014
http://www.burrillreport.com/article-lawmakers_ask_gilead_for_details_on_pricing_sovaldi_.html
