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Pfizer sues US for permission to help Medicare patients with rare heart conditions

pharmafile | June 29, 2020 | News story | Sales and Marketing Medicaid, Medicare, Pfizer 

Pfizer has filed a lawsuit against the US government to allow it to directly help with the copayments of Medicare recipients for the company’s cardiovascular drugs.

The drugmaker alleges that the US Department of Health and Human Services (HHS) and its Office of Inspector General has been blocking the company from helping the patients suffering with heart conditions with copayments for Vyndaqel and Vyndamax. These drugs treat transthyretin amyloid cardiomyopathy, which causes the heart to stiffen and reduces its ability to pump blood. It can cause progressive heart failure which can potentially lead to death.

The FDA originally approved the drugs in 2019, but a study in February from the American Heart Association said the treatments were some of the most expensive cardiovascular drugs launched in the US and its cost-effectiveness was uncertain.

Their study concluded: “Treatment with tafamidis is projected to produce substantial clinical benefit but would greatly exceed conventional cost-effectiveness thresholds at the current US list price. On the basis of recent US experience with high-cost cardiovascular medications, access to and uptake of this effective therapy may be limited unless there is a large reduction in drug costs.”

Under US law, drug companies cannot subsidise copayments for patients enrolled in the Medicare program, although they can donate to independent non-profits who offer copay assistance. In 2018, Pfizer agreed to $23.85 million settlement to resolve charges it used an independent charity to cover copayments for patients taking three of its drugs but did not admit liability.

Conor Kavanagh

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