Pfizer Vyndaqel and Vyndamax co-pay litigation to impact industry drug pricing

Pricing of two of Pfizer's fast-growing and expensive heart drugs, Vyndaqel and Vyndamax, has been a hot topic since it was approved by the FDA in 2019.
, two drugs became the core product of a federal Medicare-paid lawsuit that could have repercussions across the industry.
Vyndaqel and Vyndamax have the same active part of tfamidis, which was approved in May last year for the treatment of cardiomyopathy (ATTR-CM) in adults due to amyloid degeneration caused by artificial or hereditary thyroxine egg whites.
the company sued the U.S. Department of Health and Human Services (HHS) after it introduced a list pricing of $225,000 a year, asking the agency to provide co-payments to Medicare patients.
Drugmakers cannot provide co-payments directly to medicare beneficiaries under federal law' Anti-Kickback Act, a move that regulators are concerned could cost taxpayers the rest of the cost of expensive drugs.
Pfizer's direct choice to file a lawsuit could cause a "big earthquake" for the pharmaceutical industry.
Varma, head of Pfizer's rare diseases business, said there were "fundamental inequalities" in the regulations that prevented the company from providing financial support to patients in the federal health insurance system to help them buy drugs smoothly.
lawsuit, Pfizer hopes to provide co-payment cards or coupons to Medicare patients who need to buy drugs, and to provide funding to independent charities that help resolve co-payments to help them with funding difficulties in buying drugs.
, however, regulators think the opposite.
HHS inspector general said in an advisory opinion last month that there were high levels of doubt about Pfizer's proposal.
HHS noted that Pfizer's plan covers up to 800 percent of patients on the federal poverty line, resulting in more than 90 percent of Medicare patients qualifying for the company's financial aid.
advice also said that such cash payments from drugmakers would leave "health insurance and taxpayers with the enormous financial impact of unrestricted drug prices".
HHS believes that if Pfizer wins the case, other companies may take the same approach.
years, pharmaceutical companies have been unable to directly contribute to drug co-payments for Medicare patients because of regulatory restrictions, mostly by donating to third-party charities.
However, such partnerships have come under successive federal sanctions after the federal government signed settlements with several drugmakers, including Pfizer, all of alleged violations of the Anti-Kickback Act by promoting drug sales through donations to independent agencies.
Pfizer's lawsuit aims to provide medicare patients with co-payments directly to ensure they receive the medication they need.
another idea, david Mitchell, founder of Patients for Affordable Drugs, wants Medicare to negotiate prices with drug makers so that they can be priced for all Americans.
source: Pfizer Vyndaqel copay lawsuit can bring drug drug pricing shockwaves.