Fierce Pharma Politics—Pfizer Vyndaqel copay lawsuit could bring drug pricing shockwaves

Pfizer sign
In a lawsuit against HHS, Pfizer is seeking to be able to provide copay support for Medicare patients. (Tracy Staton)

Welcome to the Fierce Pharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. 

Pfizer’s fast-growing and costly heart meds Vyndaqel and Vyndamax have been the subject of drug pricing scrutiny since their launch in 2018. Now, they’re at the center of a Medicare copay lawsuit that could reverberate around the industry, Barron’s reports

After launching the meds list with prices of $225,000 per year, the company is suing the U.S. Department of Health and Human Services in an attempt to help with Medicare patients with their copays. 

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Currently, kickbacks laws prohibit drugmakers from assisting with Medicare patient copays; companies can financially help patients on commercial insurance. The laws are designed to keep a check on drug prices, and one expert told Barron’s a ruling in Pfizer's favor “would be a major earthquake” for the industry. 

Pfizer's rare disease business unit head Suneet Varma told the publication it's a "fundamental inequity" that the company can't provide financial support to Medicare patients. With its lawsuit, the company aims to provide copay cards or coupons, and to fund an independent charity that would help with copays.

In an advisory opinion last month, HHS’ inspector general said Pfizer’s proposed program is “highly suspect,” Barron’s reports. Since the program would cover patients making up to 800% of the federal poverty level, more than 90% of Medicare patients would be eligible. Such payments from the drugmaker would let the “the Medicare program and taxpayers bear the financial brunt of an unchecked drug price,” the advisory opinion said. 

RELATED: Pfizer's blockbuster-to-be Vyndaqel is too costly for heart patients, study suggests 

Further, if the drugmaker prevails, other companies might take up the issue, Barron’s reports. 

Instead of directly helping with Medicare patients’ copays, drug companies for years have been donating to third-party charities. Those relationships have come under fire from the federal government, which has inked several settlements with drugmakers, including Pfizer, over alleged kickbacks violations. 

While Pfizer aims to directly help Medicare patients with copays, Patients for Affordable Drugs founder David Mitchell has another idea. He’d like to see Medicare be able to negotiate with drugmakers, and then have those prices apply to all Americans, he told Barron’s.

RELATED: As Trump touts his 'great' COVID-19 drugs, the pharma cash flows to Biden, not him 

Meanwhile, while President Donald Trump has been praising drugmakers including Regeneron for their COVID-19 research, a report from Kaiser Health News shows that his Democratic challenger Joe Biden is winning more financial support from the industry. Regeneron’s employees and a political action committee have given $177,000 so far during the cycle, with 80% going to Democrats, KHN reports. 

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