The demo idea is also endorsed by Joseph Ross, the advisory committee’s vice chair and a Yale School of Medicine professor.
“My point of view is that if this product is going to be available on the market, then anyone who gets it should be entered into a clinical trial or some type of study for us to better understand the outcomes that are associated,” he told CQ Roll Call. “The challenge of it being just a study of patients who get this therapy is that to be able to observe changes in the progression of Alzheimer’s, any slowing of the decline in cognitive status would be really difficult to disentangle without a control arm.”
Melissa Garrido, a research associate professor at the Boston University School of Public Health and an advisory committee member, said she wasn’t sure CMS would determine that the drug is medically necessary. Some type of decision factoring in a requirement for additional evidence and data is possible, she said, although a demonstration would need to account for differentiating factors such as income and geographic disparities. Patients will receive the drug through monthly infusions and also need access to MRIs and PET scans to track progress and potential side effects.
“If a difference in outcomes is observed across the treatment and comparison group, there’s a chance it could be due to socioeconomic factors and not necessarily the drug itself,” she said.
It’s not guaranteed that Bach, Ross or Garrido would be on the advisory committee if CMS calls on the panel for help. The agency chooses a handful of experts from MEDCAC to analyze a product depending on the members’ expertise in a particular field. The drug’s detailed trial data is not yet public, and CMS could also overrule the committee’s recommendations like the FDA overruled its own advisory panel.
"Demo" - Google News
June 22, 2021 at 04:30PM
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Medicare demo emerges as coverage option for Alzheimer's drug - Roll Call
"Demo" - Google News
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