The U.S. Centers for Medicare and Medicaid Services has named Novo Nordisk’s Wegovy, Ozempic and Rybelsus as part of the second round of the IRA drug price negotiation program, even as the pharma challenges the program.
Novo Nordisk on Monday asked the U.S. Court of Appeals for the Third Circuit to accelerate its ongoing legal complaint against the Inflation Reduction Act’s drug price negotiation program.
The motion comes a month ahead of the Feb. 28 deadline for pharma companies to confirm their participation in the second cycle of the negotiations. Earlier this month, the Centers for Medicare and Medicaid Services released its list of the 15 drugs set to undergo negotiations next. Three Novo drugs made the list: Ozempic, Wegovy and Rybelsus, all of which carry the active ingredient semaglutide.
According to CMS, there are more than 2 million Medicare Part D enrollees taking these drugs, which together accumulated almost $14.5 billion in gross Part D spending from November 2023 to October 2024.
Novo first sued the government to block the IRA pricing program in September 2023, which resulted in a legal defeat in August 2024. In its request on Monday, Novo blasted CMS for its announcement of the second cycle, saying that the agency “again defied the Inflation Reduction Act’s plain text by announcing that it intends to impose a new round of price controls on more products than the statute authorizes.” The pharma also took issue with how CMS aggregated its three products and considered them as a single entry in the list of nominated drugs for the second round of negotiations.
“CMS’s continued defiance of the statute’s requirements adds urgency to the important issues raised in this appeal,” Novo’s motion read, asking the court to “expedite oral argument and decision in this matter.”
While Novo’s current case is focused specifically on the number of products that CMS may subject to the second round of its negotiations, several pharma companies have lodged legal complaints against the federal agency seeking to block the drug pricing program.
The industry’s success has been limited, however. In October 2024, a New Jersey judge dismissed Novartis’ lawsuit against the CMS program, maintaining that participation in the program is voluntary of drugmakers, and that in leveraging its purchasing power to secure better deals, the federal government is not in violation of the constitution.
Several other companies have likewise failed to secure the backing of the courts, including Boehringer Ingelheim, AstraZeneca, Johnson & Johnson and Bristol Myers Squibb.
