The Medicare drug price negotiation list includes Ozempic

On Friday, the Biden administration revealed The following 15 medications Which will be subject to the price Negotiations Between manufacturers and Medicare, to begin Phase 2 of A Historical process It aims to make expensive medicines more accessible to the elderly.

Topping the list is Novo NordiskPopular diabetes injection Ozempic, weight loss injection Wegovy and diabetes pill Rybelsus are one product in talks Because they all share the same active ingredient: semaglutide. These treatments have fueled the emergence of the morbid obesity market, and have been difficult for patients to access due to cost, insurance coverage, and supply constraints.

Agreed prices for the second wave of drugs are scheduled to take effect in 2027. But it is unclear whether President-elect Donald Trump might try to change or scale back some provisions of the law when he takes office next week.

Here are the 15 drugs that will be subject to preliminary talks this year:

• Ozempic, Eugov, Repulsus (Semaglutide,) Manufactured by Novo Nordisk, it is used to treat type 2 diabetes, weight management, and cardiovascular health
• trilogy ellipta, Made by GlaxoSmithKlineIt is an inhaler used to treat chronic obstructive pulmonary disease and asthma
• xtandi Made by Pfizer Astellas Pharma is used to treat prostate cancer in men
• Slow down Made by Bristol Myers SquibbIt is used to treat a blood cancer called multiple myeloma and a cancer that develops in people with HIV
• iberace, Produced by Pfizer, it is used to treat some types of breast cancer
• Oviev, It is manufactured by Boehringer Ingelheim and is used to treat chronic lung diseases in adults.
• linzes, Made by AbbVie and Ironwood Pharmaceutical Industries– It is used to treat irritable bowel syndrome and chronic constipation
• calcoins, Made by AstraZeneca– It is used to treat certain types of leukemia
• Austedo, Austedo XR, Made by Teva PharmaceuticalsIt is used to treat involuntary movements caused by tardive dyskinesia or Huntington’s disease
• brio ellipta, Made by GlaxoSmithKline and ProgressIt is an inhaler used to treat chronic obstructive pulmonary disease
• tradition, Manufactured by Boehringer Ingelheim and Eli Lilly– It is used to treat type 2 diabetes
• shivaxan, Produced by Salix Pharmaceuticals, it is used to treat travel-related diarrhea or irritable bowel syndrome
• Fries, It is produced by AbbVie and is used to treat schizophrenia, bipolar disorder, and major depressive disorder.
• Janumet, janumet xr, Made by MerckIt is used to manage type 2 diabetes
• Otezla, Made by AmgenIt is used to treat plaque psoriasis, psoriatic arthritis, and mouth ulcers

President Joe Biden’s inflation-reducing law gave Medicare the ability to discuss drug prices directly with manufacturers for the first time in the federal program’s nearly 60-year history. Some Democrats in Congress and consumer advocates have long pushed for change, as many seniors across the country struggle to afford care.

In an interview, Centers for Medicare and Medicaid Services Director Chiquita Brooks-LaSure said the Biden administration had implemented the law as written and added: “I hope the next administration will do the same.” She added that any amendments to the negotiation process would require Congress to change the law.

CMS announced the list more than two weeks before the February 1 deadline to do so. The timing gives companies, patient groups, academics and other stakeholders more “time to know they’re on the list and really start preparing to make the decision to move forward,” Brooks-LaSure said.

She added that the negotiation period ends in November, which “seems like a long time but requires a number of steps.”

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

The drug group also accounted for approximately $41 billion, or 14%, of total Part D prescription drug costs during that time period, the statement added. When 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 costs 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 into the program, and the new prices are scheduled to take effect next year. In August, the Biden administration said it expected these negotiated prices to bail out Medicare enrollees $1.5 billion in out-of-pocket costs in 2026 alone. The government also expects the rates to generate about $6 billion in net savings for Medicare In 2026Or 22% net savings overall.

The negotiating program has also faced a wave of legal challenges – so far unsuccessful – from the pharmaceutical industry, which views the process as a threat to its revenue and profit growth and drug innovation.

The negotiations are “dangerous for millions of Americans who rely on innovative treatments and have created unnecessary and costly bureaucracy,” Steven Uppel, CEO of the industry’s largest lobbying group, PhRMA, said in a statement Friday.

He added: “With the Biden administration rushing to put forward this list in its final days, it once again failed to address the real challenges facing the elderly and medical care,” considering that the price talks unfairly target medications that come in the form of pills much earlier than other types. Of medicines. drug. PhRMA is eager to work with the Trump administration and Congress to “reform” the “pill penalty,” Ubl said.

Novo Nordisk said in a statement on Friday that it opposes negotiations and has “grave concerns” about how the Biden administration will implement the law. The Danish pharmaceutical company specifically criticized the decision to combine multiple products that “individually do not meet the requirements of the law,” referring to the inclusion of Ozempic, Rybelsus and Wegovy as one product.

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

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

A senior administration official told reporters last year that roughly 10% of Medicare enrollees ages 65 and older, and 20% of those under 65, reported challenges purchasing medications.

“Last year we demonstrated that negotiating lower drug prices works. Now we plan to build on that record by negotiating lower prices for 15 additional important drugs for seniors,” Health and Human Services Secretary Xavier Becerra said in a statement. “Today’s announcement is pivotal – the Inflation Control Act lowers prices for people with Medicare. HHS will continue to negotiate for people with Medicare to get innovative, life-saving treatments at lower costs.”

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

“For too long, Big Pharma has cornered their profits by setting exorbitant prices at the expense of Americans’ lives, forcing seniors to skip prescriptions they can’t afford,” Nancy LeMond, chief advocacy and engagement officer at AARP, said in a statement. “. “The first round of Medicare drug price negotiations has made clear that this process will lower prices for these important products and create billions of dollars in savings for Medicare and its beneficiaries.”

Of the 10 drugs listed, Medicare Part D spent the most on Ozempic, Rybelsus and Wegovy, at $14.43 billion, according to CMS. Fact sheet Friday. Approximately 2.3 million enrollees used these medications during the time period used by CMS.

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

The Biden administration proposed late last year to allow Medicare and Medicaid to begin covering Wegovy and other obesity medications for weight loss in particular. Brooks-LaSure said she hopes the Trump administration will finalize this proposal.

That means the final Medicare-negotiated price for semaglutide will apply to all brand-name products, regardless of why they are prescribed, she said. Medicare does not currently cover Wegovy for weight loss, but it does cover weekly injections to reduce the risk of cardiovascular disease.

The plan also spent nearly $5.14 billion on Trelegy Ellipta, which was used by 1.3 million enrollees. Xtandi cost Medicare Part D $3.16 billion even though only 35,000 enrollees used the drug, the fact sheet said.

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 who used the drug, according to the fact sheet.

In separate statements, Bristol-Myers Squibb, Teva Pharmaceuticals and Boehringer Ingelheim said the pricing talks could hurt patient access and future innovation in the industry.

Bristol-Myers Squibb pointed to the role the insurance industry plays in rising health care costs, claiming that the negotiations ignore “the biggest problem in patient affordability: how plans determine patient out-of-pocket costs.”

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

Drugmakers will 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 withdraw all of its products from the Medicare and Medicaid markets.

Those who participate will engage in a lengthy negotiation process that involves months of back-and-forth quotes with Medicare. The federal program determines its initial offering 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 information.

After the end of the second round, the Medicare program can negotiate the prices of 15 other medicines that will take effect in 2028. The number increases to 20 medicines to be negotiated annually starting in 2029.

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

But drug makers will have more opportunities to negotiate with Medicare, based on… Final guidance It was issued last year for the second round of price talks. The first discretionary negotiation meetings will be held after Medicare submits initial quotes for the 15 drugs it must provide June 1.

“I think for the most part we feel like a lot of the process is going very well” after the first round of negotiations, Brooks-LaSure said. “I think some of the things we want to continue to enhance is helping external stakeholders see what kind of information is useful to the team.”