Hello, everyone, and welcome to this week’s edition of Excelsior Solutions’ ICER Update.
Here is this week’s ICER recap:
ICER has posted a Draft Scoping Document outlining a planned review of the comparative clinical effectiveness and value of aducanumab (Biogen) for Alzheimer’s disease. The FDA is expected to make a decision on aducanumab in early 2021.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to publiccomments@icer-review.org and must be received by 5PM ET on November 10, 2020. All comments submitted must meet ICER’s formatting specifications.
ICER’s Patient Participation Guide and Manufacturer Engagement Guide provide additional guidance for submitting public comments, including suggestions for what types of information may be most useful.
In addition to comments on the scope, ICER also welcomes submissions from stakeholders on examples of low-value care practices within this clinical area. These submissions will inform a report section focused on strategies to reduce waste and preserve resources for high-value, potentially higher-cost treatments.
EXCELSIOR ACTION POINT: Prior to the COVID-19 pandemic, no product, with the possible exception of Roctavian for Hemophilia A, loomed larger in the specialty pipeline than aducanumab. Considering the relatively wide prevalence of Alzheimer’s (an estimated 5.8 million Americans of all ages were living with Alzheimer’s dementia in 2019), combined with current uncertainty over the number of those individuals whom the FDA will deem appropriate candidates for aducanumab treatment, and the drug’s eventual price should it be approved, the potential impact to Pharmacy benefit plans is starkly evident. We will be sharing an article in our next client newsletter on aducanumab, so please look for it soon.
As always, if you would like to discuss the potential impact of these, or any prior, ICER reports, or any other aspects of your Pharmacy Benefit Plan, simply reach out to your Excelsior Solutions account team and we will be happy to quickly set up a call.
Until next time!
Bob Kordella, RPh, MBA