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Daily Briefing

Around the nation: FDA delays decision on Eli Lilly Alzheimer's drug


FDA has delayed its approval decision for Eli Lilly's Alzheimer's drug donanemab, requesting that it first be evaluated by an independent panel of experts, in today's bite-sized hospital and health industry news from the District of Columbia and Maryland. 

  • District of Columbia: The Biden administration recently announced the expansion of its Cancer Moonshot program, as various health insurance companies and providers will increase access to and coverage for cancer navigators. According to advocates, navigators help patients and their families with medical appointments and other aspects of cancer care. Overall, 40 cancer care centers, including Dana-Farber Cancer Institute and Northwell Health, will offer navigator services to their patients. CMS will also cover cancer navigation services for older Americans on Medicare beginning this year. Seven large private health insurance companies, including Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health, and Select Health, have also agreed to cover the cost of cancer navigators. "This is about making sure that a growing number of Americans can get access as they need it," said Arati Prabhakar, director of the White House's Office of Science and Technology Policy. "The companies that have signed up to provide insurance coverage for these services ... reach 150 million Americans." (Alltucker, USA Today, 3/8)
  • Maryland: FDA has decided to delay its approval decision for Eli Lilly's Alzheimer's drug donanemab. Last year, Eli Lilly reported that donanemab slowed cognitive decline by 35% for patients in the early stages of the disease in a Phase 3 trial of roughly 1,700 patients. Although FDA was expected to approve donanemab this month, the agency has instead requested the drug first be evaluated by a panel of independent experts. According to Anne White, an EVP at Eli Lilly and the president of its neuroscience division, the company was not expecting this decision, but "look[s] forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab's strong efficacy in the context of safety." It will likely be a few months before the panel holds a hearing on donanemab, but "[t]he F.D.A. did commit to us to move quickly, so we would hope that they would then take action shortly after the advisory committee," White said. (Belluck, New York Times, 3/8; Bettelheim, Axios, 3/8)
  • Maryland: FDA has expanded the label for Novo Nordisk's weight-loss drug Wegovy to include potential cardiovascular benefits — marking the first time a weight-loss treatment has also been approved to help improve heart health. Under the updated label, Wegovy can also be used to reduce the risk of major cardiovascular complications, such as heart attack or stroke, for people who are overweight or obese and have an existing heart condition. According to FDA, the decision was based on a large, five-year clinical trial that found that Wegovy reduced the risk of cardiovascular problems by 20% among participants. Novo Nordisk has also filed for a similar label expansion in Europe, and a decision is expected sometime this year. (Chen, STAT+ [subscription required], 3/8)

3 opportunities to improve memory care in the United States

Memory care costs the healthcare industry billions of dollars each year, and costs will only rise as the population of older adults grows. Read on to learn three opportunities in the memory care patient journey that increase collaboration amongst stakeholders to improve outcomes and sustainably care for patients.


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