Semaglutide (Shanxi Jiayuan)

The government on Tuesday announced final prices for the second round of drugs negotiated by Medicare under the Inflation Reduction Act, including for Novo Nordisk’s blockbuster semaglutide products Ozempic and Wegovy. The negotiated prices are up to 85% lower than the list prices for the drugs. The announcement gives the first substantive look at how IRA negotiations transpired under the Trump administration, which has pledged to use multiple approaches to lower drug prices. CMS said it accepted drugmakers’ revised counteroffers for seven of the drugs. The government said that when the prices take effect in 2027, patients enrolled in Medicare prescription drug coverage will save an estimated $685 million in out-of-pocket costs. If the negotiated prices had taken effect in 2024, CMS estimates that they would have saved Medicare $12 billion in net prescription drug costs. That figure doesn’t account for  spending on the Coverage Gap Discount Program, which ended in 2025. When taking that program into account, estimated savings would have been about $8.5 billion. In the first negotiation round that’s set to take effect in January, the government secured discounts of up to 79% from the list price. CMS Administrator Mehmet Oz said in a news release that the agency took a “bolder direction” in this year’s negotiations, though details about how either negotiation cycle played out have been limited. “Whether through the Inflation Reduction Act or President Trump’s Most Favored Nation policy, this is what serious, fair, and disciplined negotiation looks like,” CMS Deputy Administrator and Medicare Director Chris Klomp said in the release. The negotiated monthly IRA price for Novo Nordisk’s Ozempic, Rybelsus and Wegovy products is $274, CMS announced on Tuesday. The negotiated price may be applied differently across dosage forms and strengths. For example, for three commonly used forms and doses of semaglutide, the prices will be: $276.78 per package for a 4 mg/3mL Ozempic pen; $276.78 per 7 mg, 30-tablet package of Rybelsus; and $385.63 per 2.4 mg/0.75 mL, four-pen package of Wegovy. Earlier this month, Novo reached a deal with the White House to sell Ozempic and Wegovy to Medicare for $245 per month, starting in 2026, with a $50 copay for qualifying Medicare beneficiaries. It wasn’t immediately clear how the IRA-negotiated price, once it takes effect in 2027, will impact that number. Novo also recently dropped its cash-pay prices for the two GLP-1s to $349 a month. Novo said in an emailed statement that the IRA prices apply specifically to Medicare Part D, which currently doesn’t cover anti-obesity drugs when prescribed for obesity. It said its “most favored nation” deal with the White House “reflects a broader effort to expand access to obesity care across Medicare and Medicaid.” The company added that it looks forward to “additional clarity from CMS on how pricing and coverage will work together to support patient access as details are finalized.” Spokespeople for HHS and the White House didn’t immediately respond to requests for comment. A Bristol Myers Squibb spokesperson told Endpoints News on Tuesday that the negotiated price for its cancer drug Pomalyst “does not reflect the substantial clinical and economic value of this treatment.” “We maintain our position that the price-setting portion of the IRA is deeply flawed and could have negative, long-term implications on patient access, R&D and future innovation,” the spokesperson said. GSK said the company is “pleased to have reached an agreement with CMS,” and remains “committed to working with” the agency. Boehringer Ingelheim said it remains “committed to ensuring that our medications are accessible and affordable to all patients who need them.” Other drugmakers did not immediately respond to requests for comment. Drugmakers are persisting in their legal battle against IRA negotiations, despite federal appeals courts rejecting several challenges this year. AstraZeneca was the first company to bring its case to the Supreme Court in September, and Bristol Myers Squibb has also said it would appeal its Third Circuit loss to the high court. Some pharma companies have argued that the negotiations restrict their free speech and due process rights, but the government has prevailed in every case where judges have ruled on the merits of those claims. Meanwhile, GSK CEO Emma Walmsley said on an October earnings call that negotiations for its Trelegy Ellipta and Breo Ellipta inhaler products had already been “fully factored into our outlook.” The pharma giant’s chief commercial officer Luke Miels, who is set to replace Walmsley in January, said on the call that the Trelegy negotiations were “in line with expectations.” Teva CEO Richard Francis also told Endpoints in early November that the negotiations “ended up with a discount that’s within what we modeled.” Editor’s Note: This story was updated with additional reporting throughout.

Novo Nordisk’s amylin combination shot amycretin allowed patients with diabetes to lose up to 14.5% of their body weight in just over eight months. Patients in the same mid-stage trial who were given a pill form of the drug lost up to 10.1% of their weight at the same time point. Novo said Tuesday that these weight-loss figures are statistically significant compared with injected and oral placebos, which yielded weight loss of 2.6% and 2.5%, respectively. The pharma company is planning to start an “extensive” Phase 3 program for amycretin in “multiple indications” next year. The drug could one day generate considerable sales for Novo, with 2032 sales forecasts in excess of $4 billion, according to Evaluate Pharma. Novo’s stock ticked up as much as 4% on the Copenhagen exchange Tuesday, a day after it took a hit when its gamble on GLP-1 for Alzheimer’s disease failed to pay off . In the Phase 2 trial, patients given Novo’s drug also had better blood glucose control than the placebo subjects. Those on injected amycretin had their glycated hemoglobin levels reduced by up to 1.8% by the end of the study; those taking the pill form had reductions of up to 1.5%. The respective decreases with the injected and oral placebos were 0.2% and 0.4%. Up to 89.1% of those given the shot achieved glycated hemoglobin levels below 7%, which is generally considered a good target for most diabetes patients. Among patients given the oral form, 77.6% hit this goal. The estimated improvements in blood sugar were all statistically significant versus placebo, Novo said, meaning the trial hit its primary endpoints. Novo did not give details on the specific dose levels that produced the results on weight loss and blood sugar. The trial’s dosing scheme called for six dose levels of the injected form, with patients in the highest dose cohort receiving once-weekly shots titrated up to 40 mg per week. These patients maintained the 40 mg dose for four weeks, Novo said. Of the subjects given the pills, the high-dose cohort received 50 mg per day. The Phase 2 trial is the first for amycretin in type 2 diabetes. It enrolled 448 patients who were not well controlled on standard care, consisting of metformin with or without an SGLT2 inhibitor. Both forms of amycretin appeared safe and well-tolerated, Novo said , with the most common side effects being gastrointestinal, the “vast majority” of which were mild to moderate. Amycretin is a single molecule that activates the receptors of both GLP-1 and amylin. It differs from Novo’s higher-profile drug CagriSema, which is a two-drug combo of the amylin analog cagrilintide and the GLP-1 agonist semaglutide. Amycretin has already proven itself effective in obesity. In a Phase 1/2 study in that condition, patients given injected amycretin lost 22% of their body weight at about eight months. In a Phase 1 trial of the oral form of amycretin in overweight or obese patients, those given two 50 mg amycretin pills a day had a 13.1% drop in body weight at three months. CagriSema is in a suite of Phase 3 trials in patients with diabetes but not obesity, though none have yet reported data. In a late-stage study in patients with both conditions, CagriSema resulted in a 15.7% weight loss. Of the two drugs, CagriSema is projected to be the more lucrative — its 2032 sales forecasts stand at around $25 billion.