Medicare drug price negotiations list includes Ozempic

The Biden administration filed on Friday the next 15 prescription drugs which will be subject to price negotiations between the producers and Medicare, start the second phase of a referral process which aims to make expensive medications more accessible to the elderly.

At the top of the list are Novo Nordisk‘s blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, which are considered a product in the talks since they all share the same active ingredient: semaglutide. Those treatments have fueled the rise of the obesity red market and have been difficult for patients to access due to cost, insurance coverage and supply limitations.

The agreed-upon prices for the second wave of drugs are expected to take effect in 2027. But it’s unclear whether President-elect Donald Trump could try to change or scale back some of the law’s provisions when he takes office next week next

Here are the 15 drugs subject to initial discussions this year:

• Ozempic, Wegovy, Rybelsus, (semaglutide,) made by Novo Nordisk, it is used for type 2 diabetes, weight management and cardiovascular health
• Trelegy Ellipta, done by GSKis an inhaler used for chronic obstructive pulmonary disease and asthma
• Xtandi done by Pfizeris used to treat prostate cancer in men
• slow down done by Bristol Myers Squibbit is used to treat a blood cancer called multiple myeloma and a cancer that develops in people with HIV
• Ibrance, made by Pfizer, is used to treat certain breast cancers
• Oof, made by Boehringer Ingelheim, is used to treat chronic lung diseases in adults.
• Linzess, done by AbbVie and Ironwood Pharmaceuticalsit is used to treat irritable bowel syndrome and chronic constipation
• Calquence, done by AstraZenecait is used to treat certain types of blood cancer
• Austedo, Austedo XR, done by Teva Pharmaceuticalsis used to treat involuntary movements caused by tardive dyskinesia or Huntington’s disease
• Breo Ellipta, made by GSK and The advanceis an inhaler used to treat chronic obstructive pulmonary disease
• tradition, made by Boehringer Ingelheim and Eli Lillyis used for the management of Type 2 diabetes
• Xifaxan, made by Salix Pharmaceuticals, is used to treat diarrhea caused by irritable bowel syndrome or travel.
• Vrays, made by AbbVie, it is used to treat schizophrenia, bipolar I disorder, and major depressive disorder.
• Janumet, Janumet XR, done by Merckis used to treat type 2 diabetes
• shut her up done by Amgenit is used to treat plaque psoriasis, psoriatic arthritis and oral ulcers

President Joe Biden’s Inflation Reduction Act gave Medicare the power to directly negotiate drug prices with manufacturers for the first time in the federal program’s nearly 60-year history. Some congressional Democrats and consumer advocates have long pushed for the change, as many seniors across the country struggle to afford care.

About 5.3 million people with Medicare Part D coverage used 15 drugs in the second round of discussions to treat various conditions, such as asthma, cancer and type 2 diabetes, between Nov. 1 of 2023 and October 31, 2024 a release from the Department of Health and Human Services on Friday. The drug group also accounted for about $41 billion, or 14%, of total Part D prescription drug costs during that time period, the book added.

When combined with the 10 medications selected for the first round of negotiations, the 25 products accounted for 36% of all Medicare Part D prescription drug costs during that time period, the release said.

The drugs have been on the market for at least seven years without generic competitors, or 11 years in the case of biological products such as vaccines.

Medicare has already completed negotiations for the first 10 drugs selected in the program, with new prices that will take effect next year. In August, the Biden administration said it expected negotiated prices to save Medicare enrollees around $1.5 billion in out-of-pocket costs alone in 2026. The government also expects the prices to lead to about $6 billion in net savings for the Medicare program in 2026or 22% net savings overall.

The negotiation program has also faced a flurry of – so far unsuccessful – legal challenges from the pharmaceutical industry, which sees the process as a threat to the growth of its revenues, profits and drug innovation .

Stephen Ubl, the CEO of the industry’s largest lobbying group, PhRMA, said in a statement Friday that the negotiations are “dangerous for millions of Americans who rely on innovative treatments and create unnecessary and costly red tape.” .

“In dealing with this list in its final days, the Biden administration is once again failing to address the real challenges of the elderly and Medicare,” he added, arguing that Price unfairly talks about drugs that come in the form of pill much earlier than other types of medicine. PhRMA is eager to work with the Trump administration and Congress to “fix” that “pill penalty,” Ubl said.

In a statement on Friday, Novo Nordisk said it is opposed to the negotiations and has “significant concerns” about how the Biden administration is implementing the law. The Danish drug specifically criticized the decision to combine several products that “individually do not meet the requirements of the statute”, referring to Ozempic, Rybelsus and Wegovy which are listed as a single product.

Novo Nordisk said its lawsuit against the program is still pending, and that it will work with the Trump administration to provide “meaningful solutions for patients.”

Medicare covers about 66 million people in the United States, and 50.5 million patients are currently enrolled in Part D plans, according to the health policy research organization KFF.

Nearly 10% of Medicare enrollees age 65 and older, and 20% of those under 65, report drug supply challenges, a senior administration official told reporters last year .

“Last year we showed that negotiating for lower drug prices works. Now we plan to build on that record to negotiate for lower prices for 15 additional important drugs for seniors,” HHS Secretary Xavier Becerra said in a statement. “Today’s announcement is pivotal – the Inflation Reduction Act will reduce prices for people on Medicare. HHS will continue to negotiate in the best interest of people with Medicare to have access to innovative treatments , life savers at lower costs.”

Patient advocacy groups, such as the nonprofit AARP, applauded the announcement Friday.

“For too long, big drug companies have made their profits by setting outrageous prices at the expense of American lives, forcing seniors to skip prescriptions they can’t afford,” Nancy LeaMond, the chief of advocacy and engagement of AARP, said in a statement. “The first round of Medicare drug price negotiations made it clear that this process will reduce the prices of these important products and create billions of dollars in savings for Medicare and its beneficiaries.”

Among the 10 drugs listed, Medicare Part D spent the most on Ozempic, Rybelsus and Wegovy, at $14.43 billion, according to a CMS. fact sheet on friday Nearly 2.3 million enrollees used these drugs during the time period CMS used.

The plan also spent about $5.14 billion on Trelegy Ellipta, which was used by 1.3 million enrollees. Xtandi cost Medicare Part D $3.16 billion despite only 35,000 enrollees using the medication, the report said.

Spending on Pomalyst was $2.07 billion, and only 14,000 enrollees used that drug. All other drugs listed cost the program under $2 billion.

Medicare Part D spent the least on Otezla at $995 million, with 31,000 enrollees using this medication, according to the fact sheet.

Drug manufacturers have until February 28 to decide whether to participate in the program. If a drug manufacturer refuses to negotiate, it must either pay an excise tax on up to 95% of its drug sales in the United States or pull all of its products from the Medicare and Medicaid markets.

Those who participate engage in a lengthy negotiation process that involves months of price bidding back and forth with Medicare. The federal program determines its initial bid for each drug using sales volume data, the level of federal financial support for drug development and data on pending or approved patent applications and exclusivity, among other things. information.

After the second round concludes, Medicare can negotiate prices for another 15 drugs that will enter into force in 2028. The number will rise to 20 medications negotiated annually starting from 2029.

The government will select only Medicare Part D drugs for the first two rounds of negotiations. It will add more specialty medications covered by Medicare Part B, which are typically administered by doctors, in 2028.

But drug manufacturers have more opportunities to negotiate with Medicare, based on the final guide released last year for the second round of price talks. The first optional negotiation meetings will take place after Medicare has made its initial price offers for the 15 drugs, which must be submitted by June 1.