CMS announces next 15 drugs for price negotiations

The list of drugs includes:

• Ozempic, Rybelsus, and Wegovy for Type 2 diabetes and weight loss
• Trelegy Ellipta, an asthma treatment
• Xtandi, for prostate cancer
• Pomalyst, a chemotherapy drug
• Ibrance, a breast cancer drug
• Ofev, for idiopathic pulmonary fibrosis
• Linzess, a chronic constipation drug
• Calquence, a cancer drug
• Austedo and Austedo XR for Huntington's disease
• Breo Ellipta, a COPD drug
• Tradjenta, a diabetes drug
• Xifaxan, for diarrhea and irritable bowel syndrome
• Vraylar, an antipsychotic drug
• Janumet and Janumet XR for diabetes
• Otezla, a psoriatic arthritis drug

Drugmakers will have until the end of February to sign an agreement saying they'll participate in the negotiation process and will then be given time to submit required data, including a drug's research and development costs, sales, and revenue.

The government's opening bid will be given on June 1, and negotiations will continue until the end of October when the companies either accept or reject the final offer. The final prices will take effect in January of 2027.

According to former HHS Secretary Xavier Becerra, the 15 new drugs combined with the 10 drugs negotiated earlier this year represent around a third of Medicare Part D spending on prescription drugs.

"It is important to remember that for some people, this is a big deal," Becerra said. "Some folks have to cut the pills in half or skip a dose in their prescription so that they can make their prescription last longer until they can afford to buy the next batch of drugs."

It will be up to the Trump administration to head the negotiation process this year. If confirmed, Robert F. Kennedy Jr., Trump's pick to lead HHS, would be in charge of the negotiation process. Kennedy has spoken critically about drug company profiteering and has been vocally critical of Ozempic, which he has argued is inferior to eating healthy food, though he has acknowledged that such drugs "have a place" in addressing obesity.

Former CMS Administrator Chiquita Brooks-LaSure said that she doesn't believe the Trump administration will switch which drugs will be negotiated once they've been announced.

"The law is very prescriptive about how we choose the next 15 drugs, and we followed the law and all of our steps," she said. "And so there should be no reason why the administration would want to make any changes."

Currently, weight-loss medications like Ozempic and Wegovy are only covered under Medicare for specific uses like diabetes and heart disease, and without insurance coverage, their cost can run more than $1,000 a month.

"It's obviously a big deal that Medicare will be negotiating the price for Ozempic and Wegovy," said Ben Rome, a physician and health policy researcher at Harvard Medical School. "This is a tremendous opportunity for the Medicare program to negotiate a fair price that will allow the drug to be affordable for patients and for the government."

Advisory Board's Chloe Bakst said it's unsurprising that Ozempic, Rybelsus, and Wegovy are among the selected drugs for this round of price negotiations, and said she'll be "watching to see how the maximum fair price influences commercial coverage of these drugs, especially Wegovy."

"Negotiations for the past 10 drugs were reportedly fairly amicable," Bakst added. "It will be interesting to see how a different administration approaches the negotiations and how that will impact the ultimate maximum fair price."

In a statement, a spokesperson for Novo Nordisk said the company remains opposed to the price negotiation program and pledged to "work with the incoming administration" to address its concerns.

"That is why we are deeply concerned about the price-setting process, which could negatively impact patients' ability to access their medicines and threatens to stifle future scientific development of life-changing medicines," the spokesperson said.

Stephen Ubl, president and CEO of the drug industry trade group Pharmaceutical Research and Manufacturers of America, said the drug price negotiation process "is dangerous for millions of Americans who rely on innovative treatments and created unnecessary, costly bureaucracy. In rushing out this list in their final days, the Biden administration once again fails to address the true challenges facing seniors and Medicare."