CMS Proposes Coverage Determination for PET Amyloid-ß Imaging for Alzheimer Therapies

Following the traditional approval of lecanemab (Leqembi; Eisai), the Centers for Medicare and Medicaid Services (CMS) proposed to remove its national coverage determination (NCD) at § 220.6.20, ultimately permitting Medicare coverage determinations for PET amyloid-ß (Aß) imaging. With the proposed decision memorandum posted, the 30-day public comment period has begun.¹

Lecanemab, an antiamyloid therapy, is only available to those with a diagnosis of mild cognitive impairment or mild Alzheimer disease (AD) that is supported by documentation of Aß in the brain. Typically, out-of-pocket amyloid PET scans average $3000 per test or greater.

In the proposed memo, CMS wrote, "We believe removal of NCD 220.6.20 will allow appropriate coverage of amyloid PET scans and will greatly reduce provider and patient burden from the existing requirements and test limitation. Stakeholders and patients have particularly emphasized the constraints on choice of treatments and appropriate management of proven antiamyloid treatments due to the once in a lifetime limitation. As new treatments directed against amyloid for patients with AD, whether monoclonal antibodies, inhibitor drugs, nanotechnology or other new technology, are developed and approved by the FDA, the Medicare Administrative Contractors (MACs) are able to promptly respond to the evidence on proven treatments for individual patients."

A removal of the 2013 NCD on amyloid-ß PET imaging would allow local MACs to make coverage determinations regarding the use of this imaging technique to include covering more than 1 scan per patient’s lifetime and use within or outside the context of a CMS-approved study. By including useful diagnostic tests that can detect Aß in the brain, harms of antiamyloid therapies would be avoided because the drug would not be given to patients that do not have brain amyloid and potentially stopped when brain amyloid was completely removed.

In recent years, several of the trials assessing amyloid-targeting therapies have required biomarker evidence of amyloid pathology. The importance of this requirement was exemplified by the early solanezumab trials, in which an analysis of secondary outcomes reported that roughly 25% of the trial participants did not have positive brain amyloid on PET scans and may have never had AD.

"A treatment aimed at improving cognition and function for AD patients, precisely because it modifies underlying AD pathophysiology, is not likely to succeed if it is not AD from brain amyloid that is causing the patients’ symptoms in the first place," the memo stated. "Other types of treatments that are not classified as monoclonal antibodies are in accelerated development, as well, such as inhibitor drugs and nanotechnology."

In accordance with CMS’ NCD, Medicare will cover lecanemab when physicians and clinical teams actively participate in collecting real-world evidence through a registry. Researchers will have access to this information in order to conduct studies aimed at advancing the understanding of how these drugs can benefit Medicare beneficiaries, and addressing the research questions outlined in the NCD.²

Patients under the original Medicare will have a standard 20% coinsurance for the Medicare-approved amount of lecanemab that will be applied once Part B of their deductible is met. The expenses may be different for patients who have Medicare supplemental coverage including those under Medigap plans or other secondary insurance or enrolled in Medicare Advantage plans. Thus, patients should contact the respective plans they are under for more detailed information on the costs.

REFERENCES
1. Beta amyloid positron emission tomography in dementia and neurodegenerative disease. Medicare Coverage Database. July 17, 2023. Accessed July 18, 2023. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=308
2. Statement: Broader Medicare Coverage of Leqembi Available Following FDA Traditional Approval. News Release. Centers for Medicare & Medicaid Services. Published July 6, 2023. Accessed July 18, 2023. https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval