The list of Medicare drug price negotiations includes Ozempic

The Biden administration on Friday presented the following 15 prescription drugs which will depend on the price negotiations between manufacturers and Medicare, starting the second phase a iconic process which aims to make expensive drugs more affordable for the elderly.

Top the list Nova NordiskBlockbuster diabetes injection Ozempic, weight loss injection Wegovy and diabetes pill Rybelsus all considered as one product in talks since they all have the same active ingredient: semaglutide. These treatments fueled the red-hot obesity market and were difficult for patients to access due to cost, insurance coverage, and supply constraints.

The agreed prices for the second wave of drugs are scheduled to take effect in 2027. But it’s unclear whether President-elect Donald Trump will be able to try to change or reduce some of the law’s provisions when he takes office next week.

Here are 15 drugs that are in the first talks this year:

• Ozempic, Wegovy, Rybelsus, (Semaglutide,) manufactured by Novo Nordisk, used for type 2 diabetes, weight control, and cardiovascular health
• Trelegy Ellipta, done GSCis an inhaler used for chronic obstructive pulmonary disease and asthma
• Kstandi done Pfizer and Astellas Pharma, used to treat prostate cancer in men
• slow down done Bristol Myers Squibbused to treat a blood cancer called multiple myeloma and a cancer that develops in people with HIV
• ibrance, manufactured by Pfizer, is used to treat certain types of breast cancer
• Ophew, produced by Boehringer Ingelheim, is used to treat chronic lung diseases in adults.
• Linces, done AbbVie and Ironwood Pharmaceuticalsused to treat irritable bowel syndrome and chronic constipation
• calcification, done AstraZenecaused to treat certain types of blood cancer
• Austedo, Austedo XR, done Teva Pharmaceuticalsused to treat involuntary movements caused by tardive dyskinesia or Huntington’s disease
• Brea Ellipta, produced by GSK and Advance paymentis an inhaler used to treat chronic obstructive pulmonary disease
• tradition, made by Boehringer Ingelheim and Eli Lillyused to treat type 2 diabetes
• xifaxone, made by Salix Pharmaceuticals, used to treat diarrhea caused by travel or irritable bowel syndrome
• Vrays, made by AbbVie, used to treat schizophrenia, bipolar I disorder, and major depressive disorder
• Yanumet, Janumet XR, done Merkused to treat type 2 diabetes
• went away done Amgenused to treat psoriasis, psoriatic arthritis, and mouth ulcers

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

In an interview, Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-Lasure said the Biden administration followed the law as written, adding, “I hope the next administration will do the same.” She added that any changes to the negotiation process would require changes in the law from Congress.

CMS announced the list more than two weeks before the Feb. 1 deadline to do so. Brooks-LaSour said the timing gives companies, patient groups, scientists and other stakeholders more “time to find out what’s on the list and really start preparing for a decision to move forward.”

The negotiating period ends in November, which “sounds like a long time, but requires a number of steps,” she said.

About 5.3 million people with Medicare Part D coverage used 15 drugs in the second round of negotiations to treat conditions such as asthma, cancer and type 2 diabetes between November 1, 2023. until October 31, 2024. release from the Department of Health and Human Services on Friday.

This group of drugs also accounted for approximately $41 billion, or 14%, of total Part D prescription drug spending during that time period, the release added. Combined with the 10 drugs selected for the first round of negotiations, the 25 products account for 36% of all Medicare Part D prescription drug spending during that time period, the release said.

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 for the program, and the new prices will take effect next year. In August, the Biden administration said it expected those negotiated prices to save Medicare enrollees 1.5 billion dollars out of pocket only in 2026. The government also expects the prices to result in net savings of about $6 billion for the Medicare program in 2026or 22% net savings overall.

The negotiating program has also faced multiple – so far unsuccessful – legal challenges from the pharmaceutical industry, which sees the process as a threat to growing revenues, profits and drug innovation.

Stephen Uble, CEO of PhRMA, the industry’s largest lobbying group, said in a statement Friday that the negotiations “harm the millions of Americans who depend on innovative treatments and have created unnecessary, costly red tape.”

“By rushing to release this list in recent days, the Biden administration is once again failing to address the real issues facing seniors and Medicare,” he added, arguing that price negotiations unfairly target drugs that come in pill form much earlier than other types of medicine. medicine. PhRMA is committed to working with the Trump administration and Congress to “fix” this “pill penalty,” Ubl said.

In a statement Friday, Novo Nordisk said it opposes negotiations and has “significant concerns” about how the Biden administration is enforcing the law. The Danish drugmaker was particularly critical of the decision to combine several products that “individually would not meet the requirements of the statute,” citing Ozempic, Rybelsus and Wegovy, which are listed as one product.

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

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

Nearly 10% of Medicare enrollees age 65 and older and 20% of those younger than 65 report problems affording drugs, a senior administration official told reporters last year.

“Last year, we proved that drug price reduction negotiations work. Now we plan to build on that record by negotiating price reductions for 15 additional important drugs for seniors,” HHS Secretary Xavier Becerra said in a release. “Today’s announcement is important: The Inflation Reduction Act lowers prices for people who use Medicare. HHS will continue to negotiate on behalf of people who use Medicare to have access to innovative, life-saving treatments at a lower cost.”

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

“For too long, big pharmaceutical companies have boosted their profits by setting outrageous prices at the expense of American lives, forcing seniors to miss prescriptions they can’t afford,” Nancy Lemond, AARP’s chief advocacy and engagement officer, said in a statement. “The first round of Medicare drug price negotiations made it clear that this process will lower 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 CMS. the actual letter on Friday. Nearly 2.3 million enrollees used these drugs during the time period CMS used.

Brooks-Lasure said the inclusion of semaglutide could help people “see how important it is for Medicare to negotiate prescription drugs.”

Late last year, the Biden administration proposed allowing Medicare and Medicaid to begin covering Wegovy and other obesity drugs for weight loss, specifically. Brooks-Lasure said she hopes the Trump administration will finalize the proposal.

She said that would mean that the final Medicare agreed price for semaglutide would apply to all of its brand-name products, regardless of what they are prescribed for. Currently, Medicare does not cover Wegovy for weight loss, but it does cover a weekly injection to reduce the risk of cardiovascular events.

The plan also spent about $5.14 billion on the 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 drug, according to a news release.

Spending on Pomalyst was $2.07 billion, and only 14,000 participants used the drug. All other drugs listed cost the program less than $2 billion.

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

In separate filings, Bristol Myers Squibb, Teva Pharmaceuticals and Boehringer Ingelheim argued that the price talks could hurt patient access and future innovation in the industry.

Bristol Myers Squibb pointed to the insurance industry’s role in high health care costs, arguing that the talks overlook “the biggest patient affordability issue: how plans determine patients’ out-of-pocket costs.”

Meanwhile, AstraZeneca said in a statement that it did not believe Calquence was eligible for the program “as a result of recent innovations.” The company urged CMS to review drug selection.

But drug manufacturers will have more opportunities to negotiate with Medicare, based on the ultimate guide released last year for the second round of price negotiations. The first additional negotiation meetings will take place after Medicare makes its initial price proposals for the 15 drugs to be introduced June 1.

“I think for the most part we feel like a lot of the processes are working very well” after the first round of negotiations, Brooks-Lasure said. “I think some of the things we want to continue to strengthen is helping external stakeholders know what information is useful to the team.”