Aducanumab-avwa (Aduhelm)

Policy ID: I-244-003

Section: Injections

Effective Date: July 01, 2021

Revised Date: November 22, 2021

Revision Effective Date: January 01, 2022

Last Reviewed: November 15, 2023

Applies To: Commercial Only

Description

Aducanumab-avwa (Aduhelm^TM) is a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody, directed against aggregated soluble and insoluble forms of amyloid beta. The accelerated approval of aducanumab-avwa (Aduhelm^TM) is based on a surrogate endpoint of reduction in brain amyloid plaques, which is a biomarker with little evidence that proves an association with clinical benefit, such as improvement in cognition. Continued approval of this agent by the FDA is contingent upon demonstrating clinical benefit in confirmatory trials.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Aducanumab-avwa (Aduhelm^TM) for any indication is considered experimental and investigational because of lack of sufficient clinical evidence supporting its use.

Procedure Codes

J0172

Diagnosis Codes

Not Applicable for this policy

ND Committee Review

Internal Medical Policy Committee 7-22-2021- Effective 7-01-2021

Adopted experimental/investigational policy

Internal Medical Policy Committee 11-23-2021- Effective 01-01-2022

Added new code J0172

Internal Medical Policy Committee 11-29-2022 Annual review, no clinical content change

Internal Medical Policy Committee 11-15-2023 Annual review, no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-244-002