Pfizer sues for U.S. permission to assist patients needing expensive heart drugs

On June 26, Pfizer filed a lawsuit in Manhattan federal court calling for the federal government to allow it to assist Medicare beneficiaries afford two of its drugs for treating transthyretin amyloid cardiomyopathy (ATTR-CM), a rare heart condition.

On June 26, Pfizer filed a lawsuit in Manhattan federal court calling for the federal government to allow it to assist Medicare beneficiaries afford two of its drugs for treating transthyretin amyloid cardiomyopathy (ATTR-CM), a rare heart condition. In its complaint, Pfizer said its aim was to ensure that patients receive required treatment rather than to persuade physicians to prescribe its drugs more frequently. The company also said the government's restrictions violate its constitutional rights to due process and free speech. Pfizer said HHS' Office of Inspector General is preventing it from offering financial aid to patients unable to afford copayments for its drugs because it views such assistance as an illegal kickback. Drug companies cannot subsidize copayments for patients enrolled in Medicare, although they may donate to independent nonprofits that offer copay assistance. The two drugs, tafamidis meglumine (Vyndaqel ) and tafamidis (Vyndamax), cost $225,000 annually. If left untreated, ATTR-CM can lead to heart failure and death. FDA approved both drugs last year, but Pfizer has been criticized for their costs.