On Tuesday, January 11, the Centers for Medicare and Medicaid Services (CMS) announces that it proposes to cover U.S. FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (AD) under Coverage with Evidence Development (CED) in CMS-approved randomized controlled trials. The decision does not require a beta-amyloid PET scan before or during treatment; however, CMS will cover one beta amyloid PET scan per patient for those participating in CMS-approved trials—or trials supported by the NIH—that include a beta amyloid PET scan as part of the protocol.

In reaction to the decision, SNMMI has issued the following statement:

In our first round of comments to CMS, we stressed the greater benefits of beta amyloid PET scans for early and accurate diagnosis of Alzheimer’s disease (compared to cerebrospinal fluid and blood biomarkers). Currently, PET is the only FDA-approved biomarker for identifying beta amyloid plaque.

Beta amyloid PET is critical in the process of selecting patients who can benefit from therapy with aducanumab. Patients who are clinically thought to have Alzheimer’s disease but who show no evidence of brain amyloid in a PET scan do not have Alzheimer’s; they very likely would not be helped by the drug, and they could be negatively affected by drug-related toxicities. Although amyloid PET was not required by recent FDA prescribing information, the trials that led to approval of aducanumab required PET biomarker confirmation of positive amyloid status before therapy.

National coverage of beta amyloid PET will increase patient access to this therapy and will also more clearly identify patients who are amyloid negative and would not be eligible for most trials. Currently, three FDA-approved radiopharmaceuticals are approved for use with PET to identify beta amyloid plaque: 18F-florbetapir, 18F-flutemetamol, and 18F-florbetaben. Their very limited use currently is covered under CED through the New IDEAS Study,1 a successor to the IDEAS Study that is focused on minority populations. Outside of this trial, however, these tracers are not covered by CMS.

We are concerned that CMS did not significantly change their CED requirement for beta amyloid PET scans. This may continue to limit access of patients to clinical trials of the drug. Removing the CED requirement would have been timely—given the approval of aducanumab and the coverage of tau PET diagnostics as of January 1—and would also have helped ensure equitable access to the new therapy. In addition, the current limited CMS coverage pays the provider far less than the cost of the imaging agent, a situation that limits access to the scans for our most vulnerable populations.

SNMMI is continuing to review the proposed NCD and will be submitting comments to CMS. Our preliminary thoughts are that CMS’s decision to cover Alzheimer’s therapy under CED is an incomplete solution rather than a productive resolution that would allow widespread and equitable patient access to monoclonal antibody therapy or clinical trials of that treatment. We hope CMS will change its position in its final decision, due in April 2022. The society seeks broad national coverage of the scans either by a positive NCD or at Medicare Administrative Contractor discretion.