A controversial new drug is roiling the medical community and driving up Medicare premiums.
on whether Medicare should cover Aduhelm and other anti-amyloid monoclonal antibodies in development. CMS said a draft decision would be issued by Wednesday, with a final call in April.Usually, Medicare covers FDA-approved drugs without question. It is highly unusual for CMS to launch an inquiry into coverage of a drug.
The FDA and CMS use different criteria to assess medical treatments. The FDA determines whether a drug is “safe and effective,” while Medicare decides whether it is “reasonable and necessary.”Medicare is not supposed to consider cost — but that might be hard to ignore considering the program’s potential exposure. The vast majority of potential Aduhelm recipients are on Medicare. While some treatments, including cancer drugs, are more expensive, they are prescribed for fewer patients.
Medicare also could decide to cover the drug only for patients in clinical studies or tracked by registries established by hospitals or other organizations. This “coverage with evidence development” approach is designed to produce additional data on whether coverage should be continued. Such a move could have the effect of limiting the number of doctors willing to prescribe the medicine because it imposes time-consuming data requirements.
“Aduhelm presents at least three issues, and cost is just one,” said Schrag, of Vanderbilt. “I think the issues of efficacy and safety are going to remain, regardless of what happens with Medicare.”
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