Jonathan Stempel

NEW YORK, Reuters – Judge dismissed Pfizer Inc (NYSE) challenges a U.S. antikickback law. Drugmaker Inc claims that this prevents them from helping Medicare patients pay for two drugs to treat a fatal condition in the heart. However, these drugs cost only $225,000 annually.

U.S. district judge Mary Kay Vyskocil of Manhattan ruled that Pfizer did not offer support for Vyndaqel patients.

Judge said that Pfizer’s plans to pay direct money to patients violated a federal ban against “knowingly or willingly” giving financial support in order to induce drug purchase, regardless of corrupt intent.

It was also premature for Pfizer, a New York company to fund an independent charity that would help copays. She said the details of the program were not clear and had not been subject to government review.

Pfizer filed a lawsuit against the U.S. Department of Health and Human Services (USDHS) in June 2020. They sought a declaration from the court that the programs were legal.

Pfizer stated in an email that Friday it was dissatisfied with the decision. It also said copay assistance was “an equitable method to lower our out-of pocket costs for this revolutionary treatment.”

Although drugmakers are not allowed to pay for copayments of Medicare-enrolled patients, independent non-profits may offer assistance with copays.

According to the government, a Pfizer ruling on its proposed direct assistance program would leave Medicare liable for all “astronomical” drug costs industrywide.

Vyndaqel, also known as tafamidis or Vyndamax, treat transthyretin-amyloid cardiomyopathy (also called tafamidis). This rare condition causes stiffening of the heart and impedes blood flow, which can eventually lead to heart failure.

In the first half this year, the drug sales totaled $953 millions. A February 2020 study https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.045093 by the American Heart Association called tafamidis the most expensive cardiovascular drug launched in the United States.

Pfizer reached an agreement in 2018 for $23.85m to settle U.S. civil claims that it had used a charity purportedly independent to pay copayments of three drugs.

Pfizer Inc v U.S. Department of Health and Human Services et al. U.S. District Court Southern District of New York. 20-04920