April 8, 2022
Reston, VA — On April 7, the Centers for Medicare & Medicaid Services (CMS) announced its final decision on coverage of U.S. Food and Drug Administration (FDA)–approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease under Coverage with Evidence Development (CED) in FDA-approved, CMS-approved, or NIH-sponsored controlled trials. The national coverage determination (NCD) was initially proposed in January.
To the disappointment of many in both the nuclear medicine and Alzheimer's disease advocacy communities, the decision included no additional coverage for beta-amyloid PET scans; they will continue to be subject to the current policy, which covers them only as required by clinical trial protocol, and, even then, only one per patient per lifetime. In stark contrast, the decision explicitly covers other tests for detection of beta amyloid (e.g., cerebral spinal fluid) without limitation, despite the fact that beta-amyloid PET is the standard of care—and, in fact, the only test approved by the FDA—for detecting beta amyloid.
In reaction to the final decision, SNMMI has issued the following statement:
In our first and second rounds of comments to CMS on this issue, we stressed the advantages of beta-amyloid PET scans—compared to cerebrospinal fluid and blood biomarkers—for early and accurate diagnosis of Alzheimer’s disease. Currently, beta-amyloid PET is the only biomarker approved by the Food and Drug Administration for identifying beta-amyloid plaque. It is also the only biomarker that can identify beta-amyloid plaque in the brain.
We are disappointed that in its final decision, CMS did not modify its original proposed coverage of one beta-amyloid PET scan per person per lifetime. We expressed our strong opposition to this proposal. There is no evidence to suggest that a single amyloid PET scan per patient is appropriate or that a scan performed years ago can provide the diagnostic information needed to determine whether a patient is currently a candidate for therapy. CMS should allow as many PET scans as are needed to ensure that any trial design is optimal and reliable and provides physicians with the information they need to make informed decisions about initiating and continuing therapy.
We are equally concerned that CMS was silent regarding the removal or retirement of the beta-amyloid PET NCD. As the standard of care for detecting amyloid in the brain, pre-trial beta-amyloid PET scans can definitively identify those patients who will NOT benefit from monoclonal antibodies, sparing them the stress and anxiety of participating in a clinical trial for a product that will not be beneficial as well as the potential negative effects of drug-related toxicities.
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. It is ironic that patients now have access to a potentially unlimited number of tau PET scans but are limited to only one amyloid PET scan, and, even then, only as part of a clinical trial. Further, access will be limited by current CMS rules that systematically under-reimburse for amyloid PET scans due to bundling in the outpatient hospital setting.
We do appreciate CMS’s clarification on the requirements surrounding a qualifying randomized controlled trial and that CMS is not restricting the location of service in the final NCD.
SNMMI is continuing to review the final NCD and will keep members informed about further conversations with CMS. Our preliminary thoughts are that CMS’s final decision to cover monoclonal antibodies that have been FDA approved based on clinical efficacy rather than surrogate biomarkers—and as part of a registry rather than a prospective randomized controlled clinical trial—is a step forward. Having access to amyloid PET before participating in a registry or randomized trial would help assure more equal access of patients to anti-amyloid therapies. We will continue to work for broad national coverage of amyloid PET scans by either a positive NCD or through Medicare Administrative Contractor discretion.
About the Society of Nuclear Medicine and Molecular Imaging
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) is an international scientific and medical organization dedicated to advancing nuclear medicine and molecular imaging, vital elements of precision medicine that allow diagnosis and treatment to be tailored to individual patients in order to achieve the best possible outcomes.
SNMMI’s members set the standard for molecular imaging and nuclear medicine practice by creating guidelines, sharing information through journals and meetings and leading advocacy on key issues that affect molecular imaging and therapy research and practice. For more information, visit www.snmmi.org.