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By Adrianne Appel
Jan. 27 — Massachusetts Attorney General Maura Healey (D) threatened to take legal action against Gilead Sciences Inc. unless the company agrees to lower the prices of its two hepatitis C (HCV) treatments.
Healey, in a Jan. 22 letter to Gilead Chief Executive Officer John Martin, said the prices of the California-based company's Sovaldi and Harvoni are so high as to possibly violate Massachusetts fair trade law.
“I write to encourage you to reconsider Gilead's pricing structure,” Healey said. “Because Gilead's drugs offer a cure for a serious and life-threatening infectious disease, pricing the treatment in a manner that effectively allows HCV to continue spreading through vulnerable populations as opposed to eradicating the disease altogether, results in massive public harm,” Healey wrote in the five-page letter.
Healey said her attorneys were examining a potential claim for unfair commercial conduct.
“We agree with the Attorney General about the importance of helping all HCV patients and that the advent of safe, effective regimens means we can now consider the possibility of eradicating the disease,” Amy Flood, Gilead spokeswoman, told Bloomberg BNA Jan. 27 in an e-mail.
Gilead has requested a meeting with Healey to discuss the issues she raised, Flood said.
Healey's office confirmed Jan. 27 in an e-mail to Bloomberg BNA that it expects to meet with Gilead representatives soon.
“The purpose of this letter is to urge Gilead to adjust its pricing strategy in a way that continues to generate substantial profits for the company, while also providing a clear pathway to eradication of this life-threatening disease in the United States,” Healey said in the letter.
Just 10 percent of the 2.7 million to 3.9 million people with HCV in the U.S. have been treated, Healey said. A treatment course of Sovaldi costs $84,000 and Harvoni costs $94,500, Healey said.
Medicaid, Medicare and state prisons have had to restrict access to the drugs because of the cost, and people are going without treatment, Healey said.
Healey called Gilead's profits “staggering.” Gilead sold $20.6 billion worth of the drugs in the U.S., after rebates, in the first 21 months that the drugs were on the market, she said. Sovaldi was launched in December 2013.
A company named Pharmasset had developed the drug, and Gilead purchased Pharmasset for $11.2 billion in 2012. Harvoni was launched in October 2014.
HCV infects the liver and can lead to liver damage and liver failure, according to the Centers for Disease Control and Prevention.
Healey is far from the first public official to raise the issue of the price of Gilead's two drugs. Sovaldi was approved by the Food and Drug Administration in December 2013. It was hailed for its effectiveness and ease of treatment, compared to older drugs. However, the company came under swift criticism by lawmakers, governors and others, for charging about $1,000 per pill (12 PLIR 1033, 7/18/14).
In 2015, a federal trial court in Pennsylvania ruled that Gilead's pricing of Sovaldi and Harvoni didn't violate the Affordable Care Act's anti-discrimination provision (13 PLIR 652, 5/8/15). In that case, the federal court rejected a complaint filed by a third-party payer, the Southeastern Pennsylvania Transportation Authority, and two hepatitis C patients.
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