CurrentHealthPartnersPolicy CAG-00460N

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (CAG-00460N)

Medicare national coverage determination establishing coverage with evidence development (CED) for FDA-approved monoclonal antibody drugs directed against amyloid for treatment of Alzheimer's disease in patients with MCI due to AD or mild AD dementia with confirmed amyloid pathology, when furnished in accordance with approved clinical trials.

Policy Summary

PayerHealthPartners

PolicyMonoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (CAG-00460N)

Policy CodePolicy CAG-00460N

Change TypeNew national coverage determination (CED)

Effective DateApr 7, 2022

Next Review Date

Key ActionProviders must ensure patients are enrolled in an approved clinical trial meeting CMS CED requirements before Medicare will cover the FDA-approved anti-amyloid monoclonal antibody treatment.

POLICY UPDATE CHANGES

CMS established national coverage determination for FDA-approved monoclonal antibodies directed against amyloid for AD under CED for patients with MCI due to AD or mild AD dementia with confirmed amyloid pathology.

1FDA-approved drugs noted

2Covered clinical diagnoses

1Coverage condition (trial enrollment)

Coverage Summary

Scope: Medicare national coverage determination (CAG-00460N) establishing coverage with evidence development (CED) for FDA-approved monoclonal antibody drugs directed against amyloid for treatment of Alzheimer's disease in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia with confirmed amyloid pathology, when furnished in accordance with approved clinical trials.

Coverage stance: Covered with criteria — Medicare will cover FDA-approved anti-amyloid monoclonal antibodies for eligible patients only under the CED requirements specified in the NCD.

Subject: Monoclonal antibodies directed against amyloid for Alzheimer's disease (anti-amyloid drugs).

Overview: CMS issued national coverage determination CAG-00460N effective April 7, 2022, permitting Medicare coverage of FDA-approved monoclonal antibodies targeting amyloid for treatment of Alzheimer's disease only when furnished in accordance with coverage with evidence development (CED) — i.e., for patients meeting the clinical criteria (MCI due to AD or mild AD dementia with confirmed amyloid pathology) and enrolled in an approved clinical trial.

Key facts

Policy numberCAG-00460N

Effective date2022-04-07

StatusCURRENT

Covered clinical diagnosesMCI due to Alzheimer's disease; mild Alzheimer's disease dementia (both with confirmed amyloid pathology)

Coverage conditionCoverage with Evidence Development (CED) — treatment covered only when furnished in an approved clinical trial and patient is enrolled per CED requirements

Provider Actions / Requirements

Prior Authorization

Enrollment in approved clinical trial required

Providers must ensure the patient is enrolled in an approved clinical trial that meets CMS Coverage with Evidence Development (CED) requirements before Medicare will cover an FDA‑approved anti‑amyloid monoclonal antibody for Alzheimer’s disease.

Documentation Required

Confirm diagnosis and amyloid pathology

Document in the medical record a clinical diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia, and confirm amyloid beta pathology (for example, amyloid PET or CSF) per the CED requirements.

Name	Number	Effective Date
Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease	CAG-00460N	2022-04-07

Background

Background: CMS issued national coverage determination CAG-00460N to permit Medicare coverage, under coverage with evidence development (CED), of FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease for patients with a clinical diagnosis of MCI due to AD or mild AD dementia with confirmed amyloid beta pathology consistent with AD.

Aduhelm (aducanumab): The memo identifies Aduhelm™ (aducanumab) as the only drug in this class that had been granted FDA approval for the treatment of Alzheimer's disease at the time of the decision.

CED requirements: Medicare coverage is conditional on the drug being furnished in accordance with the CED framework — specifically that patients who receive these FDA-approved anti-amyloid monoclonal antibodies are enrolled in an approved clinical trial meeting CMS CED requirements and that confirmatory evidence of amyloid pathology is documented in the medical record per the CED criteria.

Definitions

Coverage with Evidence Development (CED)A Medicare coverage policy requiring that items or services be furnished in the context of approved clinical studies or registries that address evidence gaps.

Revision History

2022-04-07addedLatest

CMS established national coverage determination for FDA-approved monoclonal antibodies directed against amyloid for Alzheimer's disease under coverage with evidence development (CED) for patients with mild cognitive impairment (MCI) due to AD or mild AD dementia with confirmed amyloid pathology. Effective April 7, 2022, Medicare will cover such drugs only when furnished in approved clinical trials.

2022-04-07NCD establishedLatest

National Coverage Determination CAG-00460N: Medicare will cover FDA-approved anti-amyloid monoclonal antibody drugs for treatment of Alzheimer's disease for patients meeting criteria and enrolled in an approved clinical trial; Aduhelm (aducanumab) identified as the only FDA-approved drug in this class at the time of the memo.