Supreme Court rejects Pfizer's bid to review anti-kickback case
The Supreme Court shot down Pfizer’s petition on Monday to review a case that prevents it from providing financial assistance to help Medicare beneficiaries access its rare heart condition drug.
The case revolves around tafamidis, Pfizer’s drug for transthyretin amyloid cardiomyopathy (ATTR-CM), a rare condition that occurs when clumps of abnormal proteins build up in the heart, making it harder to pump. Symptoms may start with fatigue and shortness of breath but can become fatal, according to court documents.
While Pfizer’s drug, marketed as Vyndaqel and Vyndamax, costs roughly $225,000 per year, the pharma giant proposed an assistance program that would cover a majority of the $13,000 annual copay for certain Medicare beneficiaries who can’t afford the drug, limiting their costs to $35 a month. HHS, however, refused to allow it, citing the federal Anti-Kickback Statute. Lower courts sided with the government, leading Pfizer to bring the case to the Supreme Court back in October.
“This case is about how respondents’ overbroad interpretation of a criminal statute outlaws a wide swath of routine, beneficial conduct in connection with federally funded healthcare,” Pfizer wrote in its petition.
Further, the company argued that the “staggeringly overbroad construction of the AKS” would “curtail a range of routine commercial interactions and chill, or even foreclose, charitable efforts to enable access to essential medical care.”
The Supreme Court noted on Monday that the petition was denied. Pfizer was not immediately available for comment.
The news comes as the competition closes in on Pfizer in the ATTR-CM space. Alnylam submitted a supplemental new drug application just last month for its patisiran, currently sold as Onpattro for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
This marks the latest in a string of anti-kickback cases involving pharma companies, including Biogen, which paid $22 million in 2021 to settle claims that it schemed to convince patients into taking its multiple sclerosis drugs by sponsoring their Medicare copays.
Back in September, the company shelled out another $900 million to settle years-old allegations that it submitted false claims to Medicare and Medicaid by paying kickbacks to physicians for training or consulting, as part of efforts to encourage them to prescribe Biogen drugs.
Earlier that month, Bayer paid $40 million to settle two cases, one of which accused the company of paying kickbacks to doctors and hospitals to convince them to use Bayer drugs Trasylol and Avelox. At the time, Bayer said the settlement reflected a “business decision” and did not admit wrongdoing.
