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A box of Ozempic and its contents on a table in Dudley, North Tyneside, Britain, on October 31, 2023.
George Frey | Reuters
The Biden administration on Friday released the next 15 prescription drugs that will be subject to price talks between manufacturers and Medicare, beginning the second phase of a historical process which aims to make expensive medications more affordable for seniors.
Topping the list are NordiskThe successful Ozempic diabetes injection, Wegovy weight loss injection and Rybelsus diabetes pill, which are considered one of the products in the talks. since they all share the same active ingredient: semaglutide. Those treatments fueled the rise of the red-hot obesity market and have been difficult for patients to access due to cost, insurance coverage and supply limitations.
The agreed prices for the second wave of medicines are scheduled to come into force in 2027.
These are the 15 drugs subject to initial talks this year:
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 change, as many seniors across the country struggle to pay for care.
About 5.3 million people with Medicare Part D coverage used the 15 drugs in the second round of talks to treat various conditions, including asthma, cancer and type 2 diabetes, between Nov. 1, 2023 and Nov. 31. October 2024, according to a statement from the Department of Health and Human Services on Friday. The drug group also accounted for approximately $41 billion, or 14%, of the total cost of Part D prescription drugs during that period, the release added.
When combined with the 10 drugs selected for the first negotiating cycle, the 25 products account for 36% of all Medicare Part D prescription drug costs during that period, according to the release.
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, and the new prices will take effect next year. In August, the Biden administration said it expects those negotiated prices to save Medicare enrollees about 1.5 billion dollars in out-of-pocket costs in 2026 alone. The government also expects the pricing to generate about $6 billion in net savings for the Medicare program. in 2026or 22% net savings overall.
But it’s unclear whether President-elect Donald Trump might try to change or reduce some of the law’s provisions when he takes office next week.
The trading program has also faced an avalanche of legal challenges – so far unsuccessful – from the pharmaceutical industry, which sees the process as a threat to the growth of its revenues, profits and pharmaceutical innovation.
Medicare covers approximately 66 million people in the US and 50.5 million Patients are currently enrolled in Part D plans, according to health policy research organization KFF.
Nearly 10% of Medicare enrollees 65 and older, and 20% of those under 65, report difficulty paying for medications, a senior administration official told reporters last year.
“Last year we showed that negotiating lower drug prices works. Now we plan to take advantage of that
“Today’s announcement is critical: The Inflation Reduction Act is lowering prices for people with Medicare. HHS will continue to negotiate on behalf of people with Medicare so they have access to innovative, life-saving treatments at lower costs “.
Patient advocacy groups, such as the nonprofit AARP, applauded the announcement Friday.
“For too long, Big Pharma companies have increased their profits by setting outrageous prices at the expense of American lives, forcing seniors to avoid prescriptions they cannot afford,” AARP said in a statement. “The first round of Medicare drug price negotiations made clear that this process will reduce the prices of these important products and create billions of dollars in savings for Medicare and its beneficiaries.”
Drug makers will have until February 28 to decide whether to participate in the program. If a drug maker refuses to negotiate, it must pay an excise tax of up to 95% of sales of its drugs 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 will involve months of back-and-forth price bidding with Medicare. The federal program determines its initial offer for each drug using sales volume data, the level of federal financial support for the drug’s development, and data on pending or approved patent applications and exclusivities, among other information.
Once the second round concludes, Medicare can negotiate prices for another 15 drugs that will go into effect in 2028. The number increases to 20 negotiated drugs per year starting in 2029.
The government will only select Medicare Part D drugs for the first two rounds of negotiations. In 2028, it will add more specialty drugs covered by Medicare Part B, which are generally administered by doctors.
But drug makers will have more opportunities to negotiate with Medicare, based on the final orientation published last year for the second round of price negotiations. The first optional negotiation meetings will take place after Medicare makes its initial price offers for the 15 drugs, which must be submitted by June 1.