A box of Ozempic and contents sits on a table in Dudley, North Tyneside, Great Britain, October 31, 2023.
George Frey | Reuters
The Biden administration on Friday unveiled the next 15 prescription drugs that will be subject to price negotiations between manufacturers and Medicare, kicking off the second phase of a groundbreaking process that aims to make expensive drugs more affordable for seniors.
Be at the top of the list Novo Nordisk's blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, which are considered one product in the conversations because they all share the same active ingredient: semaglutide. These treatments have fueled the rise of the red-hot obesity market and are difficult for patients to access due to cost, insurance coverage and supply constraints.
The agreed prices for the second wave of drugs are expected to come into effect in 2027.
Here are the 15 drugs that are the subject of the first 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, made by GSKis an inhaler used for chronic obstructive pulmonary disease and asthma
- Xtandi, made by Pfizeris used to treat prostate cancer in men
- Pomalist, made by Bristol Myers Squibbis 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 types of breast cancer
- Ofev, made by Boehringer Ingelheim, is used to treat chronic lung diseases in adults.
- lentils, made by AbVie And Ironwood pharmaceutical productsis used to treat irritable bowel syndrome and chronic constipation
- Calquence, made by AstraZenecais used to treat certain types of blood cancer
- Austedo, Austedo XR, made by Teva Pharmaceuticalsis used to treat involuntary movements caused by tardive dyskinesia or Huntington's disease
- Breo Ellipta, made by GSK and Theravanceis an inhaler used to treat chronic obstructive pulmonary disease
- Tradjenta, made by Boehringer Ingelheim and Eli Lillyis used to treat type 2 diabetes
- Xifaxan, made by Salix Pharmaceuticals, it is used to treat diarrhea caused by travel or irritable bowel syndrome
- Vraylar, made by AbbVie, is used to treat schizophrenia, bipolar I disorder, and major depressive disorder.
- Janumet, Janumet XR, made by Merckis used to treat type 2 diabetes
- Otezla, made by Amgenis used to treat plaque psoriasis, psoriatic arthritis and oral ulcers
President Joe Biden's Inflation Reduction Act gave Medicare the power to negotiate 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 this change as many seniors across the country struggle to afford care.
About 5.3 million people with Medicare Part D coverage used the 15 drugs in the second round of discussions to treat various conditions, such as asthma, cancer and type 2 diabetes, between Nov. 1, 2023 and Oct. 31, 2024, according to a release from the department of Health and Human Services on Friday. The drug group also was responsible for about $41 billion, or 14%, of total Part D prescription drug costs during that period, the release said.
Combined with the 10 drugs selected for the first negotiation cycle, the 25 products represent 36% of all Medicare Part D drug costs during that period, the news 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 on the first ten drugs selected in the program, and the new prices will go into effect next year. In August, the Biden administration said it expects these negotiated prices to save approximately $1.5 billion in out-of-pocket costs for Medicare enrollees in 2026 alone. The administration also expects the awards to result in approximately $6 billion in net savings for the Medicare program by 2026, or a total of 22% net savings.
But it is unclear whether President-elect Donald Trump could try to change or roll back some provisions of the law when he takes office next week.
The negotiating program has also faced a barrage of – so far unsuccessful – legal challenges from the pharmaceutical industry, which sees the process as a threat to its sales growth, profits and drug innovation.
Medicare covers about 66 million people in the U.S., and 50.5 million patients are currently enrolled in Part D plans, according to health policy research organization KFF.
Nearly 10% of Medicare enrollees age 65 and older, and 20% of those under 65, report problems paying for medications, a senior administration official told reporters last year.
'Last year we proved that negotiating lower drug prices works. Now we plan to build on that
record by negotiating lower prices on 15 additional important medications for seniors,” HHS Secretary Xavier Becerra said in a news release. “Today's announcement is critical: the Inflation Reduction Act lowers prices for people on Medicare. HHS will continue to negotiate in the best interests of people with Medicare to access innovative, life-saving treatments at a lower cost.”
Patient advocacy groups, such as nonprofit AARP, cheered the announcement Friday.
“For too long, big pharmaceutical companies have padded their profits by setting excessive prices at the cost of American lives, forcing seniors to skip prescriptions they could not afford,” AARP said in a statement. “The first round of Medicare drug price negotiations made clear that this process will lower prices on these important products and deliver billions of dollars in savings for Medicare and its beneficiaries.”
What's next in the Medicare price talks?
Drugmakers have until February 28 to decide whether they want to participate in the program. If a drug manufacturer refuses to negotiate, it must either pay an excise tax of up to 95% of U.S. sales of its drugs or withdraw all its products from the Medicare and Medicaid markets.
Those who participate will be involved in a lengthy negotiation process involving months of price offers with Medicare. The federal program determines the initial supply for each drug based on, among other things, sales volume data, the level of federal financial support for the drug's development, and data on pending or approved patent applications and exclusivities.
After the second round is completed, Medicare can negotiate prices for an additional 15 drugs that will go into effect in 2028. The number will increase to 20 negotiated medicines per year from 2029.
The administration will select only Medicare Part D drugs for the first two rounds of negotiations. In 2028, more specialty medications covered by Medicare Part B and typically administered by physicians will be added.
But drugmakers will have more options to negotiate with Medicare, based on final guidelines released last year for the second round of price talks. The first optional negotiation meetings will take place after Medicare makes its initial price offers for the 15 drugs, which must be presented by June 1.