After the Third Circuit Court of Appeals’ rejection of AstraZeneca’s lawsuit alleging the Inflation Reduction Act’s Medicare drug price negotiation program violates the drug maker’s due process, Joel White spoke with Inside Drug Policy about how the IRA’s price-setting scheme will impact Americans’ access to treatments.
Groups like the Council for Affordable Health Coverage, however, remain opposed to further implementation of the drug price negotiation program, even as several courts have sided with the government and deemed the program to be running in a constitutional manner.
CAHC President Joel White told IDP that he believes aspects of the IRA, such as the prohibition of judicial review of CMS’ implementation of drug price negotiations, do violate the APA and that the options drug companies have to either participate in the negotiation program or pull all their products from Medicare and Medicare while also paying a hefty excise tax do represent a taking of a drug company’s patented drug products and compelled speech.
“If you start layering these policies one on top of the other–IRA, best price, 340B, MFN — eventually, companies are going to throw up their hands and say, ‘We’re going to go live somewhere else, or we’re not going to sell into Medicaid,’ which means you can’t sell in the Medicare. And who loses at that point? The patient,” White told IHP. “I can’t speak to what the courts are doing. But I hope the case is made aggressively that this law violates basic concepts of how our government ought to operate in a democracy for the people.”
White says President Donald Trump’s executive order on lowering drug prices includes a handful of drug pricing reforms the government should pursue instead of negotiation or other price controls, such as accelerating FDA approvals for generics, biosimilars and new brand products that can create price competition upon entry into the market, or exploring and incentivizing the use value-based payments arrangements for drugs.
White also recommends the government identify the best way to finance cell and gene therapies, and says certain policies being used in China might also prove to be helpful, like efforts to make it easier for patients to enroll in a clinical trial to get the front-end cost of developing a drug product down, and ensuring low out-of-pocket costs for patients once coverage is secured.