Judge denies Pfizer's request to run 2 programs to subsidize patients for expensive heart drug

Pfizer’s efforts to blunt the anti-kickback policies of the U.S. government took a hit Friday as a federal district court dismissed its plan to assist Medicare patients in paying for one of the company's most expensive drugs.

In ruling in favor of the Department of Health and Human Services (HHS), Southern District of New York Judge Mary Kay Vyskocil denied Pfizer clearance to run two programs that would reimburse patients for their pricey heart medications Vyndaqel and Vyndamax, which cost $225,000 annually.

"Because the stated intent of the payments Pfizer proposes here are to increase the number of Medicare beneficiaries who purchase the drug, the Court is unable to issue the declaratory judgment Pfizer seeks or to issue judgment in its favor," Vyskocil wrote.

Of one of the programs, which would provide direct copay support to patients, Vyskocil said that the Anti-Kickback Statute clearly prohibits “any renumeration intended to induce someone to purchase or receive a drug or medical service.”

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The other program would allow Pfizer to fund an independent charity to assist with copays. Vyskocil rejected Pfizer’s claim there, saying it wasn’t “ripe for adjudication” in the court.

The fight is an old one for Pfizer. In 2018, it had to cough up $24 million to settle a government lawsuit over donations to patient charities. The recent push was an attempt to challenge the laws that the company previously violated.

In barring drugmakers from helping patients with drug costs, the U.S. is propagating a “fundamental inequity” in the U.S. coverage scheme, said Pfizer’s rare disease chief Suneet Varma.

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By limiting drugmakers’ donations to charities but not those of other industries, the HHS is violating free speech guarantees, Pfizer has maintained.