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.
Alzheimer’s disease is a progressive, currently irreversible brain disorder that slowly degrades memory, cognitive function, and ability to carry out tasks of daily living. It is the most common cause of dementia among older adults. In Alzheimer’s disease, brain cell functioning is disrupted resulting in failure of brain cells to communicate with one another, leading eventually to cell death. Although many molecular and cellular changes are associated with the onset and progression of Alzheimer’s disease, aggregates of beta amyloid are thought to play an important role in its pathophysiology.
On June 7, 2021, the Food and Drug Administration (FDA) approved, using accelerated approval, aducanumab (brand name Aduhelm™) with an indication for the treatment of Alzheimer’s disease. Aducanumab is a monoclonal antibody directed against amyloid beta to reduce amyloid accumulations.
CMS is initiating a national coverage determination (NCD) analysis for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. When making NCDs under section 1862(a)(1)(A) of the Social Security Act, Medicare does not consider the cost of the treatment in the analysis.
CMS is soliciting public comment relevant to the analysis. We are particularly interested in comments that include scientific evidence and that address the following questions regarding the treatment of individuals with Alzheimer’s disease with monoclonal antibodies directed against brain amyloid:
- Which health outcomes are important, and what degree of improvement in them is meaningful for patients receiving treatment?
- What characteristics of patients with Alzheimer’s disease are important to optimizing the likelihood of positive health outcomes from treatment?
- What issues of equity and inclusion must be accounted for in the diagnosis and treatment of Alzheimer’s disease?
- What health care providers should be included as part of the patient’s treatment team? Should medical specialists be included in the care team of patients receiving treatment? If so, which specialists should be included in the care?
- In what setting(s) should treatment and care be given?
CMS is following a long-standing statutory process that includes multiple opportunities for the public to participate and submit comments about the proposed topic on the CMS Coverage website. During the two public comment periods [this initial one and one on the draft policy in January], you can submit comments using the orange “Comment” button at the top of the page. The initial 30-day public comment period begins with the posting date of this tracking sheet. The posting of the proposed NCD initiates another 30-day public comment period.
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.”
