On April 7, the Centers for Medicare and Medicaid Services (CMS) released a decision for Medicare coverage of Aduhelm (aducanumab).
CMS will cover Aduhelm under coverage with evidence development (CED). This means Aduhelm is covered for those who are participating in clinical trials.
The Penn Memory Center plans to be a testing site for ENVISION, the study to verify the clinical benefit of Aduhelm.
Penn Memory Center Co-Director Dr. Jason Karlawish said the CMS plan came from a position of “reasonableness and proportionality.” His complete reflection on the announcement can be found below.
Aduhelm was FDA-approved in June 2021 for the treatment of Alzheimer’s disease. You can read more about the history of Aduhelm and the science behind the drug on our Aduhelm question and answer page.
If you have questions about the CMS coverage decision, please send them to PennMemoryCenter@pennmedicine.upenn.edu. We will answer them as quickly as possible and post answers to our Aduhelm question and answer page.
The following is a response by Penn Memory Center Co-Director Dr. Jason Karlawish:
CMS’s plans for coverage with evidence development are a set of guidances that, collectively, address a number of considerations and challenges to successfully translating novel Alzheimer’s treatments into clinical practice. Their overall themes are reasonableness and proportionality.
The weaker the evidence that a drug is safe and effective, the more evidence will need to be developed. Such is the case with aducanumab, which has not been approved as safe and effective. A clinical trial is needed to prove that, and Medicare will cover the cost of a patient who desires to be part of that trial.
If FDA approves a drug as safe and effective, then Medicare will ask patients to participate not in a clinical trial, but in a registry. A registry is an observational study designed to better understand a drugs’ benefits and risks. The rigor of that registry — the intensity of the data gathered — will depend on the strength of the evidence that led FDA to approve the drug as safe and effective.
FDA has decided on aducanumab using accelerated approval. It needs a clinical trial. In the coming 12 months, FDA will decide on three other drugs: gantenerumab, lacenemab and donenemab.
For aducanumab, in some sense, we’re right back to where we were on the eve of FDA approval. In the hours leading up to the surprise decision, the general consensus was: not yet; the drug may work; it may not. Further study is needed.
And that is where we are. We’re back to June 6th, 2021.
The journey we traveled these past 9 months was like Job’s. Houses have been divided and relationships riven. Our values and willingness to speak up were tested. We’re changed.