Pfizer loses appeal over co-payment assistance for $225,000 per year heart drug – Endpoint News

The Second Circuit Court of Appeals Monday sided with the HHS inspector general and confirmed the district court’s decision that Pfizer cannot help patients pay $225,000 annually for the heart drug without violating the federal anti-bribery law.

The drug, known as tafamidis, treats a rare progressive heart condition known as transthyretin amyloid cardiomyopathy. It is estimated that an estimated 100,000 to 150,000 Americans, most of whom are elderly, suffer from the condition.

To make this expensive treatment more affordable, Pfizer has proposed an assistance program that will directly cover the $13,000 annual cost of a patient’s co-pay for tafamidis. Without help, many Medicare beneficiaries would not be able to take the drug, Pfizer said.

While Medicare beneficiaries will only pay $35 per month through the Co-Pay Assistance Program, Medicare will be responsible for collecting the rest of the $210,000-plus bill.

Monday’s decision from the Second Circuit noted that “even if the company cuts the price of tafamidine in half, the co-payment for Medicare would be about $8,000, which remains a significant financial disadvantage for many patients.” Pfizer even “pointed to one study indicating that 49% of cancer patients failed to refill their prescriptions when out-of-pocket costs exceeded $2,000.”

And although Pfizer said it would not order new patients for tafamidis, as part of the assistance program, the company’s HHS inspector general clarified in late 2019 that the assistance program would still violate federal anti-bribery law.

Pfizer took the case to court, arguing that the assistance program must have been run with “corrupt” intent in order to violate the AKS, and Pfizer defines “corrupt” intent as a barter that “improperly or corruptly” misrepresents a patient’s decision-making. The district court disputed, finding that the AKS text did not require corruption to exist in order for there to be a violation.

The Second Circuit also agreed, confirming the District Court’s decision, noting in its opinion, “Direct [pa­tient as­sis­tance] The program is specifically designed to urge Medicare beneficiaries to purchase Pfizer tafamides, a federally reimbursable drug. As such, the live program falls squarely within the AKS’ taboo.”

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