FDA FULLY GREEN-LIGHTS LEQEMBI — The FDA granted traditional approval to Leqembi on Thursday — a move that will broaden Medicare coverage of the $26,500-a-year Alzheimer’s treatment. Earlier this year, the FDA granted the Alzheimer's drug, made by Eisai and Biogen, accelerated approval based on preliminary data. Medicare said it would cover Leqembi only for patients enrolled in a randomized trial — but none are taking new participants. Leqembi’s new traditional approval is based on late-stage data showing the drug moderately slows the debilitating disease’s progression. Now, Medicare will cover the drug for patients whose providers track their progress and side effects in a national registry. Last month, CMS said the registry would be free and the only data required would be information health care providers routinely collect — such as measurements of patients’ cognitive abilities over time. “With FDA’s decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “CMS today affirms our commitment to help people with Alzheimer’s disease have timely access to innovative treatments that may lead to improved care and better outcomes.” It’s unclear how many people will have access to Leqembi even with broader Medicare coverage. Eisai previously told POLITICO it estimated 10,000 patients would receive the drug would receive the drug by next April. Roughly 6.7 million people are living with Alzheimer's disease, and hundreds of thousands of patients in the disease’s early stage will be eligible to receive the drug. “Access to FDA-approved therapies — including Medicare and insurance coverage — is a number-one priority of the Alzheimer’s Association,” said Joanne Pike, president and CEO of the Alzheimer’s Association. The association formally requested CMS broaden its coverage of Leqembi and similar drugs on the grounds that late-stage trial data showed they measurably slowed the disease. But CMS maintained its position, though other groups, including the American Academy of Neurology, have since asked the agency to reconsider — again. As do some lawmakers: “The Centers for Medicare and Medicaid Services should already be covering key Alzheimer’s treatments that have been cleared under the FDA’s accelerated approval pathway, which already meet the FDA’s gold standard of safety and effectiveness,” Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee, said in a statement. Situational awareness: Leqembi’s approval comes days before the annual Alzheimer’s Association International Conference, which kicks off July 16 in Amsterdam. We’ll be watching for new trial data related to other Alzheimer’s therapies, including those similar to Leqembi. IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. What do you think of Threads? Do we now have too many Twitter alternatives? We don’t know what to think. Send news, tips and social media predictions to David Lim (dlim@politico.com or @davidalim or @david.a.lim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, your host Katherine talks with Daniel Payne, who recently spoke with Jesse Ehrenfeld, the newly inaugurated president of the American Medical Association — one of the most influential groups in Washington — about his plans to focus on the political pressures doctors face as well as on their pay.
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