Here are the top takeaways:
1. The Senate is trying to advance a health care package in 2024.
“We need to do it,” Kaine said, pointing to health care workforce and pharmacy benefit manager bills that passed out of the HELP Committee last year. “The discussion that’s happening right now on the committee is — could we take both of those bills and put them together in a broader health care bill — possibly with some other elements.”
Guthrie, the House Energy and Commerce Health Subcommittee chair, said he plans to soon hold a hearing that includes the reauthorization of the BOLD Act.
“There’s not that many legislative days until the full campaign season kicks in,” Guthrie said. “So we’re trying to do as hard as we can to get things done this spring.”
2. Lawmakers want treatments and tests that can pass FDA muster.
“First things first, let’s get diagnostics and treatments that really work,” Kaine said, adding that he doesn’t want to see the agency reduce its quality standards for drugs being reviewed under its accelerated approval pathway.
3. Republicans are focused on Medicare coverage for Alzheimer’s disease treatments, which they contend inappropriately restrict access to treatments greenlit by the FDA.
Guthrie argued that after the FDA grants accelerated approval to a drug, Medicare should focus its efforts to tweak coverage to individual treatments rather than a class of pharmaceutical products.
“I don’t want to see a class of drugs banned,” Guthrie said.
4. Biogen’s decision to discontinue Aduhelm puts more focus on early detection.
George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s, said that the decision by drugmaker Biogen to discontinue development and marketing for Aduhelm, a controversial Alzheimer’s disease treatment, reflects the consequences of Medicare’s coverage decisions.
“The reason it’s coming off the market is because people can’t afford this out-of-pocket and Medicare didn’t cover it,” Vradenburg said. “And that’s just a shame.”
But Nathaniel Chin, associate professor at the University of Wisconsin-Madison Alzheimer’s Disease Research Center, said he was not surprised by the news, given other treatments coming to market.
“Whether a person agreed with [Aduhelm] or not, it certainly put a focus on Alzheimer’s disease,” Chin said. “It put a new emphasis on early detection.”
5. Emphasis is needed on diversity and access for rural areas.
Drugmakers are focused on ensuring diversity in trials for Alzheimer’s treatments, disease advocates said. But more must be done to ensure they enroll participants in geographically diverse locations — not just urban centers, they said.
“One of the problems is that a lot of the academic sites around the country are located in big urban settings that are not accessible for minority rural populations,” Vradenburg said.
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