Dapagliflozin

Court battles over Medicare drug price negotiations are coming to a head. Two drugmakers are up against deadlines next month to appeal their Inflation Reduction Act challenges to the US Supreme Court. Weeks after that, the first set of negotiated prices under the law is slated to take effect. Legal experts say it’s unlikely the Supreme Court will step in before new prices take effect on Jan. 1 for blockbuster drugs like AstraZeneca’s Farxiga and Bristol Myers Squibb’s Eliquis. But some lower court cases have yet to be resolved, and a high court decision after the fact could still change how the negotiated prices are implemented. “If they get a decision, even a year from now, to preclude these prices from being enforced in the longer term, that’s obviously still a victory for them,” Mintz associate Mitchell Clough told Endpoints News. Drugmakers have been fighting IRA negotiations in court for more than two years, challenging the process on a range of constitutional and statutory grounds. But in every case where judges have ruled on the merits, they’ve sided with the government. AstraZeneca has already appealed its Third Circuit loss to the Supreme Court. Bristol Myers and Johnson & Johnson have Dec. 19 deadlines to file their petitions. And Boehringer Ingelheim, Novo Nordisk and Novartis have deadlines in early January. A handful of these drugmakers have signaled their interest in petitioning the justices. An AstraZeneca spokesperson said their petition was “necessary to support and improve patients’ access to future life-saving medicines, and our rights as a company.” A Novo Nordisk spokesperson said the company is disappointed with its Third Circuit decision and is “assessing our options to appeal this ruling.” Spokespeople for other drugmakers didn’t respond to requests for comment. A spokesperson for trade group PhRMA declined to comment. Clough said drugmakers are likely still looking for a win on their constitutional claims. Meanwhile, the negotiation process has continued. Prices for the second round of negotiations are expected to be announced this week, and CMS is expected to select the next group of drugs for negotiation by Feb. 1. Whether the high court decides to take up the issue will be a pivotal moment, as it could put some of the drugmakers’ constitutional challenges to rest, said Andrew Twinamatsiko, director of the O’Neill Institute’s Center for Health Policy and the Law at Georgetown University. “Depending on how the court decides, there will be a tapering of the broader attacks,” he said. During the first negotiation round , which began in 2023, the government secured discounts of up to 79% off list price on blockbuster drugs. Some pharma companies have argued that the negotiation process unconstitutionally restricts their free speech and due process rights. Some have also challenged CMS’ interpretation of the IRA. For example, Novo Nordisk said CMS’ definition of a “qualifying single source drug” unlawfully allowed the agency to negotiate the price for multiple formulations of its Novolog and Fiasp insulin products. If the drugmakers succeed on some of their statutory challenges, CMS may need to “go back to the drawing board” to reinterpret some parts of the negotiation process, Clough said. A decision like that could affect certain drugs’ eligibility for negotiations, depending on the scope of the opinion and the relief granted, he said. Novo has argued that if CMS had interpreted the statute differently, its products wouldn’t have qualified, at least for the first round of negotiations. Mintz works with some of the drugmakers suing over the IRA, but is not representing them in any of the cases. Whether the Supreme Court will wade into the issue is an open question. Two opposing rulings at the appellate level — also known as a circuit split — would make the high court more likely to take up one or more of the cases, but that hasn’t occurred so far. Some cases have yet to be decided. Industry trade group PhRMA is expected to get a Fifth Circuit decision any day, and Teva recently appealed its case to the DC Circuit. Merck’s case is still working its way through a DC district court. Twinamatsiko said a Fifth Circuit decision in favor of PhRMA could represent a “tectonic shift” in these cases. “As long as the Fifth Circuit decision is pending, anything is possible before Jan. 1,” he said. The absence of a circuit split doesn’t necessarily preclude Supreme Court review. “They have complete discretion in terms of what cases they’re going to take,” Clough said. “They take up all kinds of cases that are not the result of circuit splits every year.” In a dissenting opinion in the J&J and Bristol Myers cases, Third Circuit judge Thomas Hardiman wrote that the IRA “forces the companies to turn over their property to Medicare beneficiaries by threatening them with ruinous excise tax liability” if they chose not to participate. If they had opted out of negotiations, companies would have faced withdrawing from Medicare and Medicaid altogether or paying a steep excise tax. Clough said it’s possible that Hardiman’s dissent could pique the Supreme Court’s interest, as could the “general media interest in the IRA negotiation program.” Whatever the Supreme Court chooses to do, legal experts say they don’t expect litigation challenging the IRA to dissipate completely, particularly as the next rounds come into play. “We knew [litigation] was coming” when the IRA was enacted, said Kristi Martin, a former chief of staff for Medicare who helped craft the agency’s guidance for the first round of negotiations. “That was just part of implementing something like this.”