A lawsuit was recently filed by a Philadelphia-area law firm against Gilead Sciences, Inc. (“Gilead”) on behalf of the Southeastern Pennsylvania Transportation Authority (“SEPTA”) due to the sale and pricing of Sovaldi®, Gilead’s groundbreaking Hepatitis C drug.
Sovaldi is the very first FDA-approved (Food and Drug Administration) drug that does not require injections for treatment of several types of hepatitis C infections. This drug cures 90 percent of the patients infected with the most common forms of Hepatitis C in 3 to 6 months; it also has much less side effects associated if compared to the other available treatments.
Gilead has been selling their Sovaldi 12-week regimen for $84,000 (about $1,000 for each pill) in the U.S.. This price is much higher than the original price projection for Sovaldi, and higher than the prices for the drug in other countries. The company wants to make Sovaldi available in 91 developing countries at much lower prices; the drug is also available in Egypt for a price that is 99 percent below the one in the U.S. This discrepancy is being assessed by the Senate Finance Committee.
Orphan drugs are also expensive, but they are usually for rare conditions that affect a small group of patients; charging high prices is a method to recoup the money invested in development and research for a very small patient population. Sovaldi, however, treats a common condition that affects between 2.7-5.2 million people in the U.S. alone, and about 185 million people throughout the world. This high pricing scheme could lead to bankruptcy for some U.S. healthcare system segments and could exclude some patients from getting the treatment, especially those with lower incomes. The lawsuit filed against Gilead says that the company has recorded $8.5 billion in Sovaldi sales in 2014 alone.
Under these circumstances, the complaint emphasizes that the pricing is unbearable for U.S. consumers. According to the press release: “The lawsuit seeks class action status on behalf of all persons and entities that have paid some or all of the purchase price of Sovaldi, and those who have been prevented from obtaining a needed Sovaldi regimen due to its excessive price. The complaint asserts causes of action for unjust enrichment, for violations of provisions in the Sherman Antitrust Act and Affordable Care Act, and based on a breach of contract theory.”