In this articleGSKABBVBMYPFENVONOVO.B-DKFollow your favorite stocksCREATE FREE ACCOUNTA box of Ozempic and contents sit on a table in Dudley, North Tyneside, Britain, October 31, 2023. George Frey | ReutersThe 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 landmark process that aims to make costly medications more affordable for seniors. Topping the list are Novo Nordisk’s blockbuster diabetes injection Ozempic, weight loss shot Wegovy and diabetes pill Rybelsus, which are considered one product 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 constraints. The agreed-upon prices for the second wave of drugs are scheduled to go into 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. Here are the 15 drugs subject to the initial talks this year: Ozempic, Wegovy, Rybelsus, (semaglutide,) made by Novo Nordisk, is used for Type 2 diabetes, weight management, and cardiovascular healthTrelegy Ellipta, made by GSK, is an inhaler used for chronic obstructive pulmonary disease and asthmaXtandi, made by Pfizer and Astellas Pharma, is used to treat prostate cancer in menPomalyst, made by Bristol Myers Squibb, is used to treat a blood cancer called multiple myeloma and a cancer that develops in people with HIVIbrance, made by Pfizer, is used to treat certain breast cancersOfev, made by Boehringer Ingelheim, is used to treat chronic lung diseases in adults.Linzess, made by AbbVie and Ironwood Pharmaceuticals, is used to treat irritable bowel syndrome and chronic constipationCalquence, made by AstraZeneca, is used to treat certain types of blood cancer Austedo, Austedo XR, made by Teva Pharmaceuticals, is used to treat involuntary movements caused by tardive dyskinesia or Huntington’s diseaseBreo Ellipta, made by GSK and Theravance, is an inhaler used to treat chronic obstructive pulmonary diseaseTradjenta, made by Boehringer Ingelheim and Eli Lilly, is used for Type 2 diabetes management Xifaxan, made by Salix Pharmaceuticals, is used to treat diarrhea caused by traveling or irritable bowel syndromeVraylar, made by AbbVie, is used to treat schizophrenia, bipolar I disorder, and major depressive disorderJanumet, Janumet XR, made by Merck, is used to manage Type 2 diabetesOtezla, made by Amgen, is used to treat plaque psoriasis, psoriatic arthritis, and oral ulcersPresident Joe Biden’s Inflation Reduction Act gave Medicare the power to directly hash out 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 around the country struggle to afford care.In an interview, Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure said the Biden administration carried out the law as written and added, “I hope that the incoming administration does the same.” She added that any revisions to the negotiation process would require Congress to change the law.CMS announced the list more than two weeks before a Feb. 1 deadline to do so. Brooks-LaSure said that timing gives companies, patient groups, academics and other stakeholders more “time to know they are on the list and really start getting prepared to make the decision to move forward.”The negotiation period ends in November, which “sounds like a long time but takes a number of steps,” she said.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 Nov. 1, 2023, and Oct. 31, 2024, according to a release from the Department of Health and Human Services on Friday.The group of medicines also accounted for roughly $41 billion, or 14%, of total Part D prescription drug costs during that time period, the release added. When combined with the the 10 medications selected for the first cycle of negotiations, the 25 products represent 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 set to go into effect next year. In August, the Biden administration said it expects those negotiated prices to save Medicare enrollees around $1.5 billion in out-of-pocket costs in 2026 alone. The government also expects the prices to lead to around $6 billion in net savings for the Medicare program in 2026, or 22% net savings overall.The negotiation program has also faced a flurry of – so far unsuccessful – legal challenges from the pharmaceutical industry, which views the process as a threat to its revenue growth, profits and drug innovation. Stephen Ubl, the CEO of the industry’s biggest lobbying group, PhRMA, said in a statement on Friday that the negotiations are “dangerous for millions of Americans who rely on innovative treatments and created unnecessary, costly bureaucracy.””In rushing out this list in their final days, the Biden administration once again fails to address the true challenges facing seniors and Medicare,” he added, contending that the price talks unfairly target drugs that come in pill form 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 drugmaker specifically criticized the decision to combine multiple products that “individually would not meet the requirements of the statute,” referring to Ozempic, Rybelsus and Wegovy being listed as a single product.Novo Nordisk said its lawsuit against the program is still pending, and it will work with the Trump administration to deliver “meaningful solutions for patients.”Medicare covers roughly 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.Almost 10% of Medicare enrollees ages 65 and older, and 20% of those under 65, report challenges in affording drugs, a senior administration official told reporters last year. “Last year we proved that negotiating for lower drug prices works. Now we plan to build on that record by negotiating for lower prices for 15 additional important drugs for seniors,” HHS Secretary Xavier Becerra said in a release. “Today’s announcement is pivotal – the Inflation Reduction Act is lowering prices for people on Medicare. HHS will continue negotiating in the best interest of people with Medicare to have access to innovative, life-saving treatments at lower costs.”Patient advocacy groups, such as nonprofit AARP, applauded the announcement on Friday.”For too long, big drug companies h …
