Pfizer has tried to clear the name of its copay assistance programs for pricey heart drugs Vyndaqel and Vyndamax. But a federal appeals court didn't buy the argument.
Instead, the 2nd U.S. Circuit Court of Appeals said a lower court acted properly when it rejected Pfizer’s plan to help Medicare patients pay out-of-pocket costs for its tafamidis sister drugs. Under current anti-kickback law, drugmakers aren't allowed to offer copay assistance to patients with federal health coverage.
The ruling could be a blow to Vyndaqel and Vyndamax, a blockbuster franchise based on the acitive ingredient tafamidis. Because the potentially fatal heart muscle problem transthyretin amyloid cardiomyopathy (ATTR-CM) disproportionally affects older people, most target tafamidis patients get their drugs under Medicare.
In a statement emailed to Fierce Pharma, Pfizer said it’s disappointed in the appeals court verdict. Pfizer “continues to believe that providing copay assistance to eligible patients who have been prescribed tafamidis would represent a fair and effective way to lower out-of-pocket costs and help ensure affordable access to this important medicine,” the company said.
Pfizer sells Vyndaqel and Vyndamax at an annual list price of $225,000, the lawsuit said. Under existing Medicare payment structure, a patient has to personally pay about $13,000 per year to use the drugs.
To help middle-income patients who wouldn’t qualify for income-based copay assistance, Pfizer proposed to roll out a direct program that would limit eligible patients' outlay to $35 per month. The program would also remove a big hurdle to prescription growth.
But anti-kickback law prohibits “knowingly and willfully” offering financial support to “induce” an individual to purchase federally reimbursable drugs. So Pfizer sought a special opinion from the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG), hoping to get an exception for its copay offer. The IG rejected the idea, and the New York pharma sued in June 2020 to run the program.
A U.S. district court dismissed Pfizer’s argument that punishment under the anti-kickback law requires an element of “corrupt” intent. And now, the appeals court has sided with the HHS OIG again, saying that not all anti-kickback violations are inherently “corrupt.”
A ruling in Pfizer’s favor would have been detrimental to drug pricing control in the U.S., lawyers familiar with HHS practices previously told Fierce Pharma.
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,” Bass, Berry & Sims lawyer Jennifer Michael said in an interview last year. Michael previously led the industry guidance branch counseling HHS OIG.
Vyndaqel and Vyndamax are currently the only FDA-approved ATTR-CM drugs on the market. Last year, sales from the two sister meds jumped 56% year over year to $2 billion. But competition is on the way.
Alnylam is slated to read out data for its phase 3 Apollo-B trial soon. If successful, the trial could help expand the biotech’s RNA interference therapy Onpattro from hereditary ATTR-polyneuropathy to ATTR-CM.
Compared with the Onpattro ATTR-CM trial, industry watchers have pegged higher hopes for another phase 3 ATTR-CM trial, dubbed Helios-B, for Alnylam’s Amvuttra, which just got FDA approval for hereditary ATTR-polyneuropathy. That study could report results early 2024.
Editor's Note: The story has been updated to reflect that Pfizer didn't roll out the copay program.