Monday, July 12, 2021

Aduhelm: CMS Announces National Coverage Decision Process (July 2021-April 2022)

 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
CMS could run faster than the timeline, but that's quite unusual.  From time to time, CMS has exceeded its posted times.  If CMS convenes a public advisory board (acronym MedCAC) that could occur in the fall and extend the analysis time by 6 months.

  • For a four-minute video, see me on YouTube, here.  

For the CMS press release, here.  For a rapid statement from the Alzheimer's Association, here.  Barron's here.   WSJ here.  Stat Plus here. Fierce Healthcare here.  A neurologist at Johns Hopkins discusses innovative clinical trial designs and innovative uses of biomarkers, Dr. Thambisetty, here.  Thambisetty in turn refers to an online copy of a MS. by Dr. Glymour of UCSF.  See also a February 2021 review in BMJ on amyloid as a surrogate for Alzheimer therapies here.


CMS will hold two national stakeholder calls, July 22 (9-11 am ET) and July 27 (2-4 pm ET).   CMS also posted the stakeholders for several recent meetings in commitment to transparency.  (Biogen, Alzheimer's Association, Duke Margolis Center, Johns Hopkins).   See the Transcript from the July 22 call posted on August 18 here.

The NCD will be generic - "[present and future] monoclonal antibodies directed against amyloid," not specific to aducanumab.

Coverage at Reuters here.

I've cut/pasted the CMS body of text below the break.

CMS Text follows.  Highlighting is my own.

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:

  1. Which health outcomes are important, and what degree of improvement in them is meaningful for patients receiving treatment?
  2. What characteristics of patients with Alzheimer’s disease are important to optimizing the likelihood of positive health outcomes from treatment?
  3. What issues of equity and inclusion must be accounted for in the diagnosis and treatment of Alzheimer’s disease?
  4. 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?
  5. 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.


Led me to loop back to a June 28 WSJ article, where Secr. Becerra was quoted as saying publicly, "Whether or not that drug will be covered by Medicare and Medicaid is an outstanding question, something HHS will have to deal with,” Department of Health and Human Services Secretary Xavier Becerra said during an interview live streamed on YouTube on Thursday.  “We’re going to be making some pretty heady decisions about how it’s treated, if it will be reimbursed, how much, and so forth,” he added.

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.”