How CMS’s coverage decision on Alzheimer’s mAbs could evolve
Removing restrictions unlikely, but clarifying what CMS wants would help avoid slowdowns in other amyloid programs
The next 30 days will bring passionate arguments for and against CMS’s decision to restrict coverage of anti-amyloid mAbs to Alzheimer’s patients participating in clinical trials. But the more productive discussion may be what CMS can do to clarify its requirements so that companies can adjust ongoing trials accordingly.
CMS stunned the field when it took the unprecedented action of proposing the narrowest coverage of amyloid mAbs possible without barring coverage altogether. The agency’s draft National Coverage Determination released Tuesday contains a coverage with evidence development (CED) requirement that limits use of Aduhelm aducanumab-avwa and future therapies in the class to patients participating in randomized-controlled clinical trials that meet certain design criteria...