CMS Makes the Right Call, Restricts Medicare Coverage for Unproven Alzheimer’s Disease Drug

On Jan. 11, 2022, the Centers for Medicare and Medicaid Services (CMS) proposed limiting Medicare coverage for the drug aducanumab (ADUHELM) to beneficiaries with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia who enroll in a randomized, controlled clinical trial of the drug.[1]

The Food and Drug Administration (FDA) approved aducanumab in June 2021 under the agency’s accelerated approval pathway based on findings that the drug reduced amyloid plaques (deposits) in the brains of Alzheimer’s disease patients — a so-called surrogate endpoint. In doing so, the FDA disregarded the nearly unanimous conclusion of an independent panel of experts convened by the agency in November 2020 that there was inadequate evidence that the drug is effective for slowing cognitive decline in Alzheimer’s disease patients.[2]

The CMS proposal to strictly limit Medicare coverage for aducanumab was widely supported by many scientists, physicians, Medicare beneficiaries and consumer advocacy groups, including Public Citizen. In contrast, Biogen (the pharmaceutical company that markets aducanumab), other drug companies, pharmaceutical industry trade groups, and industry-funded “patient” groups like the Alzheimer’s Association lobbied fiercely against CMS’ proposal and opposed any limits on Medicare coverage for aducanumab.

Fortunately, CMS stood its ground in the face of Big Pharma’s intense lobbying campaign and on April 7, 2022, issued a final national coverage decision that restricts Medicare coverage for aducanumab along the lines proposed in January.[3] CMS appropriately concluded that there is insufficient evidence from prior clinical trials that aducanumab provides clinical benefits to Alzheimer’s disease patients, such as slowing the decline in cognitive function, and therefore use of the drug did not meet the agency’s legal standard that Medicare-covered treatments be “reasonable and necessary.”

CMS’ science-based action will significantly mitigate the damage done by the FDA’s inexcusable decision to approve aducanumab despite the lack of evidence that the drug provides any clinically meaningful benefit to Alzheimer’s disease patients and unmistakable evidence that it can cause serious brain injury.

The FDA’s approval of the drug raised false hope for millions of Alzheimer’s disease patients and their families and threatened to bankrupt the Medicare program because of the drug’s exorbitant price. Notably, the standard monthly Medicare Part B premium for all beneficiaries spiked by 15% in 2022 in large part because of the potential costs of covering aducanumab for the millions of Medicare patients who have Alzheimer’s disease.[4]

CMS’ April decision to restrict coverage for aducanumab to patients enrolled in clinical trials is a win for patients, Medicare beneficiaries, the American taxpayer and evidence-based medicine.
 

References

[1] Centers for Medicare and Medicaid Services. National coverage analysis proposed decision memo: Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, CAG-00460N. January 11, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305. Accessed April 11, 2022.

[2] Food and Drug Administration. Final summary minutes of the Peripheral and Central Nervous System Drugs Advisory Committee meeting. November 6, 2020. https://www.fda.gov/media/145690/download. Accessed April 11, 2022.

[3] Centers for Medicare and Medicaid Services. National coverage analysis decision memo: Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease, CAG-00460N. April 7, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=305. Accessed April 11, 2022.

[4] Centers for Medicare and Medicaid Services. 2022 Medicare Parts A & B premiums and deductibles/2022 Medicare Part D income-related monthly adjustment amounts. November 12, 2021. https://www.cms.gov/newsroom/fact-sheets/2022-medicare-parts-b-premiums-and-deductibles2022-medicare-part-d-income-related-monthly-adjustment. Accessed April 11, 2022.