In a recent court filing, Teva Pharmaceuticals USA, Inc., and Teva Neuroscience, Inc. (collectively, Teva), noted that active talks were taking place to settle a Department of Justice (DOJ) anti-kickback lawsuit. In the lawsuit, the DOJ alleged that the Teva used patient assistance charities as a way to pay kickbacks to boost sales of its multiple sclerosis drug, Copaxone.
While companies may make donations to non-profits that provide co-pay assistance to patients, the charities must be independent. Pharmaceutical companies are prohibited from subsidizing co-payments for patients enrolled in Medicare. However, the government has alleged that many pharmaceutical manufacturers – and others – have used patient assistance charities as a method to improperly pay co-pay obligations of Medicare patients who use their prescription drugs.
According to the DOJ, Teva paid the Chronic Disease Fund and The Assistance Fund more than $350 million from 2016 to 2017 to cover patient co-pays for Copaxone, pushing the charities into an entity that essentially paid kickbacks to patients to use the Teva drug. During that same time, Teva also drastically increased the price of Copaxone from roughly $17,000 per year to more than $73,000 annually, resulting in $3.8 billion in revenue in 2017.
In the filing, Teva asked the 1st United States Circuit Court of Appeals to put its appeal on hold, noting that “the parties are actively engaged in settlement negotiations and Teva is optimistic that the parties can reach a resolution, but additional time is needed to do so.” Teva faced damages of up to $10 billion under the False Claims Act, though it has denied wrongdoing.
The case stems from a probe of pharmaceutical manufacturers’ financial support via patient assistance charities – a probe that has resulted in more than $1 billion in settlements with 12 different drug makers, four charities, and one pharmacy. Arguments were scheduled for July 22, 2024, but based on Teva’s filing, that hearing was stayed. As of the writing of this article, a settlement has not yet been announced.