A federal appeals court unanimously rejected a Novo Nordisk challenge to Medicare’s drug price negotiation program, a ruling that will allow the government to lump together products with the same ingredient for the purpose of choosing drugs for negotiation.
The drug industry has been on a losing streak on this issue, at least in the courtroom. Judges have ruled against pharmaceutical companies at least 15 times since the law governing negotiations went into effect in 2023, according to Patients for Affordable Drugs, which supports letting Medicare negotiate lower drug prices. In its cases, the industry has alleged that the program runs afoul of First Amendment speech protections, the Fifth Amendment requirement that the government follow a fair process before taking property or other rights, and the Eighth Amendment’s prohibition on “excessive” government fines.
Novo Nordisk’s lawsuit included an unusual challenge to the way Medicare chooses drugs for negotiation. Medicare was allowed to pick 10 drugs for negotiation in its first year, and is now negotiating prices for an additional 15 drugs. By the fourth year, 20 new drugs will be chosen, and that will remain the maximum number of new drugs subject to negotiation each year.
That restriction on the number of eligible drugs is at the heart of the lawsuit.
The Biden administration directed Medicare to count six of Novo’s insulin products as one because they contain the same active ingredient. Novo argued that the federal government should negotiate the price for each of its insulin products separately.
The three-judge panel of the U.S. Court of Appeals for the Third Circuit ruled that the Inflation Reduction Act, which created the program, does not allow the courts to weigh in on Medicare’s selection of drugs. In effect, this decision allows Medicare to negotiate lower prices for more drugs than it otherwise could.
The court’s ruling could have a big impact because, although the lawsuit focuses on insulin products from the first year of the program, Medicare also lumped together three of Novo’s blockbuster diabetes and weight loss products — Ozempic, Rybelsus, and Wegovy — in the second round of negotiations. Semaglutide is the active ingredient in all of them.
The ruling also might bode well for a policy the Trump administration is considering that would build on the Biden administration’s legislation. Medicare officials this year said they might consider products eligible for the program even when a new ingredient is added to an old ingredient, if the combination does not result in clinically meaningful difference.
Hyaluronidase combination biologics are a good example of products that could be impacted by that policy. In recent years, several biologics have been reformulated with hyaluronidase so that they can be given as quick subcutaneous injections, rather than infused via IVs.
However, the Trump administration delayed implementing that policy for at least one more year.