After an appeals court snubbed Pfizer’s proposed copay assistance programs for costly heart meds Vyndaqel and Vyndamax, the New York pharma turned to the Supreme Court. Now, as it awaits the justices’ decision on whether they'll hear the case, Pfizer’s bid to challenge U.S. anti-kickback laws has garnered the attention of industry giants.
Monday, trade group PhRMA, plus Johnson & Johnson and prescription coupon administrator TrialCard, fired off three separate amicus briefs backing Pfizer’s cause.
The lower court’s current interpretation of the U.S.’ Anti-Kickback Statute (AKS) “is an object lesson in overcriminalization,” PhRMA argued (PDF) near the top of its brief. The decision against Pfizer’s patient assistance program “threatens beneficial programs designed to improve patient access to needed treatments,” the lobbying group said.
As it stands, U.S. kickbacks laws prohibit pharmaceutical companies from paying patient copays in government healthcare programs. Government officials have worried that allowing pharma companies to pay patients' share of costs could incentivize higher drug prices.
J&J, for its part, called the second circuit’s decision “erroneous,” warning (PDF) “efforts to improve access through patient assistance are now hopelessly disrupted as a result of the broad reading" of the AKS.
Pfizer is asking the high court to decide whether its prospective program to help Medicare patients pay out-of-pocket costs for its tafamidis drugs Vyndaqel and Vyndamax would run afoul of federal anti-kickback laws.
Vyndaqel/Vyndamax currently cost $225,000 a year, and, under Medicare’s formula, patients are responsible for a co-pay of about $13,000 per year. Pfizer’s proposed assistance program would lower the out-of-pocket cost to $35 per month, according to the company.
The Department of Health and Human Services (HHS) rejected Pfizer’s proposal in 2019, ruling that such an arrangement would violate a criminal ban on financial support to patients for a federally reimbursed healthcare product.
After Pfizer sued to overturn that verdict, it suffered two consecutive losses, which prompted the company to petition the Supreme Court in July.
The time for the Supreme Court to take up the case “is now,” PhRMA argued. The trade group echoed Pfizer’s earlier claims that the Vyndaqel and Vyndamax case is an “ideal vehicle” to iron out the scope of the AKS.
If the Supreme Court decides not to intervene, the current ruling against Pfizer could deal a blow to the company's blockbuster tafamidis franchise. Most target patients get Vyndaqel and Vyndamax under Medicare, given that the potentially fatal heart muscle problem transthyretin amyloid cardiomyopathy disproportionally affects older people.
As for the argument against Pfizer, a ruling in the company’s favor would have been detrimental to drug pricing control in the U.S., Bass, Berry & Sims lawyer Jennifer Michael said in a 2021 interview with Fierce. Because cost sharing is “really the only check against pricing,” if drugmakers were allowed to “greatly reduce or even eliminate those cost-sharing obligations, there would be essentially no economic cap on pricing,” she argued.
Michael previously led the industry guidance branch counseling the HHS Office of Inspector General.