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Pfizer loses lawsuit over U.S. limits on drug copay assistance By Reuters

Pfizer loses lawsuit over U.S. limits on drug copay assistance © Reuters. FILE PHOTO: Pfizer logo seen outside their building in Manhattan, New York City, New York, U.S., March 2, 2021. REUTERS/Carlo Allegri

By Jonathan Stempel

NEW YORK (Reuters) – A judge dismissed Pfizer Inc (NYSE:PFE)’s challenge to a U.S. anti-kickback law that the drugmaker said prevents it from helping Medicare patients afford two drugs that treat a sometimes fatal heart condition, but which cost $225,000 a year.

In a Thursday night decision, U.S. District Judge Mary Kay Vyskocil in Manhattan rejected Pfizer’s request to offer two copay support programs for patients taking its Vyndaqel and Vyndamax drugs.

The judge said Pfizer’s plan to offer direct payments to patients ran afoul of a federal ban on “knowingly or willfully” providing financial support to induce drug purchases, even absent corrupt intent.

She also called it premature to let New York-based Pfizer fund an independent charity to help with copays, saying the program had not undergone government review and its details were “ill-defined and vague.”

Pfizer had sued the U.S. Department of Health and Human Services in June 2020, seeking a court declaration that both programs were legal.

In an email on Friday, Pfizer said it was disappointed in the decision, and that copay assistance was “an equitable way to lower out-of-pocket costs for this breakthrough treatment.”

Drugmakers cannot subsidize copayments for patients enrolled in Medicare, the government-run healthcare program for older Americans, but may donate to independent nonprofits that offer copay assistance.

The government argued that a ruling for Pfizer on the proposed direct assistance program could leave Medicare on the hook for “astronomical” drug prices industrywide.

Also known as tafamidis, Vyndaqel and Vyndamax treat transthyretin amyloid cardiomyopathy, a rare condition that causes the heart to stiffen, impedes blood flow and can lead to progressive heart failure.

Sales of the drugs totaled $953 million in the first half of this year. A February 2020 study https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.045093 by the American Heart Association called tafamidis the most expensive cardiovascular drug launched in the United States.

Pfizer agreed in 2018 to pay $23.85 million and enter a corporate integrity agreement to resolve U.S. civil charges it used a purportedly independent charity to cover copayments for three other drugs.

The case is Pfizer Inc v U.S. Department of Health and Human Services et al, U.S. District Court, Southern District of New York, No. 20-04920.