HHS Presses Supreme Court to Say No to Pfizer’s Anti-Kickback Statute Appeal

The Department of Health and Human Services (HHS) is pressing the Supreme Court to squash Pfizer’s appeal challenging the U.S. anti-kickback statute, filing a petition which lays out the department’s opposition to the patient assistance program Pfizer created to cover costs of its highest-priced drug.

The drugmaker wants the court to reconsider a ruling that stops it from providing rebates to Medicare patients for its cardiovascular drugs Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis), which got the FDA’s approval for treatment of transthyretin amyloidosis in 2019.

Tafamidis costs $225,000 a year, with a $13,000 Medicare Part D annual copay. Using the rebate program Pfizer would like to offer, eligible patients would pay $35 a month.

But HHS has argued since taking Pfizer to court over the issue in 2019 that such a program would violate a criminal ban on any remuneration to induce purchase of any item “for which payment may be made in whole or in part under a federal health care program.”