On July 12, 2021, after market close, CMS posted an announcement that it will carry out a national coverage determination and analysis for aducanumab (Aduhelm). See the CMS website here:
The request was "internally generated" meeting CMS doesn't have to meet any particulars that might have been initiated by an extramural request letter.
The protocol is multi-stage and the key dates are as follows:
- July 12, 2021: Announcement
- July 12-August 11: Initial Public Comment Period
- January 12, 2022: Proposed Decision Memo Due Date
- This will trigger a second comment period, circa Jan. 12-Feb 11
- April 12, 2022: Final Decision Memo Posted
- For a four-minute video, see me on YouTube, here.
The NCD will be generic - "[present and future] monoclonal antibodies directed against amyloid," not specific to aducanumab.
Stat Plus quotes "a source close to Biogen" as saying, "This is good for Biogen because it will give everyone a blueprint for coverage. Everyone follows CMS on something like this. And it will prevent differences in regional coverage,” said the source. “Remember, this is a buy-and-bill product and some physicians worried whether they would get reimbursed. This will greatly increase their assurance.”