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He said that once implemented, the prices on negotiated drugs will decrease for up to 9 million seniors who currently pay as much as $6,497 in out-of-pocket costs per year for these prescriptions. This kicks off the negotiation process for the 10 drugs whose new prices will go into effect in 2026. U.S. laws had prohibited Medicare from negotiating pharmaceutical prices as part of its prescription drug program that began about 20 years ago. CMS Director Dr. Meena Seshamani said Medicare plans to use a review process to make sure insurance companies keep clinically appropriate access to negotiated drugs. Two analysts said they expect the negotiated prices to move beyond Medicare and affect commercial markets for these drugs by 2026, when they come into effect.

Persons: Joe Biden, Jonathan Ernst, Biden, Joe Biden’s, Januvia, Xarelto, Johnson, Boehringer Ingelheim, Eli Lilly's, Jardiance, Mohit Bansal, Entresto, Eli Lilly, Merck, Bristol Myers, Giovanni Caforio, Caforio, enrollees, Meena Seshamani, Stelara, Amgen, Evan Seigerman, Patrick Wingrove, Mike Erman, Manas Mishra, Nandita Bose, Caroline Humer, Bill Berkrot Organizations: Social Security, University of Tampa, REUTERS, U.S, Bristol Myers Squibb, Pfizer, Merck, Co's, Johnson, Novo Nordisk, NYSE Arca Pharmaceutical, U.S . Centers, Medicare, Medicaid Services, Reuters Graphics Wells, Novartis, AstraZeneca, Bristol, J, U.S . Department of Health, Human Services, BMO Capital, Thomson Locations: Tampa , Florida, U.S, Amgen's, Jardiance, Germany, Bengaluru, Washington

The Biden Administration’s signature drug pricing reform, part of the Inflation Reduction Act (IRA), aims to save $25 billion through price negotiations by 2031 for Americans who pay more for medicines than any other country. The first ever Medicare drug price reduction process begins in September, when the Centers for Medicare and Medicaid Services(CMS) identifies its 10 most costly drugs. Reuters has seen responses to CMS from five of the world's top drugmakers raising legal concerns with the law and the agency's proposed roadmap. Former CMS head Andy Slavitt, who now works at a venture capital company focused on healthcare, said the Medicare agency would have consulted lawyers. One said the Medicare roadmap, which did not go through a formal process with proposed and final rules, could be challenged in court for being unlawful as well.

It failed to meet its goal of non-inferiority compared to the conventional vaccine for the B/Victoria and B/Yamagata-lineage strains, the drugmaker said. "We have always said our goal is to produce a flu vaccine, and then to iterate it, and to fine tune it over time to really make it exceptional," Chief Medical Officer Paul Burton said in an interview. Seventy percent of those who received Moderna's shot reported mostly mild adverse reactions compared to 48% for the conventional flu vaccine. The company also has an ongoing late-stage efficacy study on the mRNA-1010 flu vaccine, which could have data within weeks. The flu, an infection of the nose, throat and lungs, kills 290,000 to 650,000 people worldwide annually.

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