Massachusetts AG threatens Gilead with legal complaint over hep C drug prices
- Biotech giant Gilead is facing a pair of threats against two of its biggest therapeutic franchises: hepatitis C and HIV/AIDS.
- Massachusetts Attorney General Maura Healey on Wednesday threatened to file a commercial conduct complaint against the company barring a price reduction for Sovaldi and Harvoni, the Gilead hepatitis C medications which have ignited a firestorm of pricing-related criticism despite their 95%-plus cure rates.
- Separately, the AIDS Healthcare Foundation, a longtime Gilead critic, filed a federal suit against the company over its new HIV/AIDS drug Genvoya (approved in 2015) in an effort to invaildate patents associated with a component of the drug, called tenofovir, which AHS claims Gilead is attempting to evergreen.
Healey's letter is particularly interesting because it's a fairly unusual action for a state Attorney General to take.
"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 the eradication of this life-threatening disease in the United States," wrote Healey.
Healey's specific threat here is to launch a commercial conduct complaint against the firm, citing the fact that Gilead offers Sovaldi and Harvoni at much lower prices in developing markets and that the drugs' costs are putting an unsustainable crunch on Massachusetts' Medicaid and healthcare budget.
"Despite the introduction of similar direct-acting antiretroviral meications and the subsequent round of negotiations motivated by the advent of market competition, Gilead has not negotiated with any entity a discount large enough to allow for the type of expanded access that could lead to eradication [of HCV]," she wrote.
State Medicaid programs and some officials who run them have taken a hard line against Gilead's drugs and their prices. For example, many hep C patients insured through Medicaid (and many patients are insured through the program) must be in an advanced disease stage before receiving the pricey treatments, which cost (at list price) $84,000 for a 12-week course of Sovaldi and nearly $95,000 for a 12-week course of Harvoni. Federal government officials have pushed back on this tactic, noting federal law requires Medicaid to cover any drugs deemed safe and effective by the FDA.
As for the Genvoya case: The controversy here lies in the fact that Stribild, another (earlier) fixed-dose combination HIV/AIDS treatment from Gilead, contains a different formulation of the tenofovir compound. Beyond this difference, Genvoya contains the same ingredients as Stribild.
Gilead says that the new tenofovir formulation is less toxic than previously approved versions, while the AIDS Healthcare Foundation asserts that this is an attempt by Gilead to evergreen its patent on the compound and thus bolster sales on Genvoya.
Gilead shares are down about 3% in Wednesday afternoon trading.