Effective Date:
a) This policy will apply to all services performed on or after the above revision date which will become the new effective date.
b) For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.
1) This policy applies only to the Federal Employee Health Benefits (FEHB) plan.
2) Aduhelm (aducanumab-avwa) requires prior authorization.
3) Aduhelm is used in the treatment of mild Alzheimer’s disease.
4) Aduhelm is specialty drug covered under the medical benefit.
Initial Approval Criteria
Aduhelm (aducanumab-avwa) is considered medically necessary when the member meets all of the following criteria:
1) Diagnosis of mild cognitive Alzheimer’s disease or mild Alzheimer’s disease dementia;
2) Presence of beta-amyloid plaques verifiedby one of the following (a or b):
a. Positron emission tomography scan;
b. Cerebrospinal fluid testing
3) Member meets one of the following (a or b):
a. Member is enrolled in a randomized, controlled trial conducted under an investigational new drug application;
b. Member is enrolled in a National Institute of Health-supported trial.
Continuation of Therapy Criteria (must meet all)
1) Member meets one of the following (a or b):
a. Member is enrolled ina randomized, controlled trial conducted under an investigational new drug application;
Codes Used In This BI:
J0172 Injection, aducanumab-avwa, 2mg
1. Aduhelm Prescribing Information. Cambridge, MA: Biogen, Inc.; July 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf. Accessed February 16, 2022.
2. Centers for Medicare & Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Medicare Coverage Database. CAG099469N; 2022. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305. Accessed April 19, 2022.
3. ClinicalTrials.gov. 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer`s Disease (ENGAGE). Available at: https://clinicaltrials.gov/ct2/show/NCT02477800. Accessed February 16, 2022.
4. ClinicalTrials.gov. 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer`s Disease (EMERGE). Last updated May 6, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02484547. Accessed February 16, 2022.
5. Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee Meeting. Combined FDA and Applicant PCNS Drugs Advisory Committee Briefing Document. November 6, 2020. Available at: https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2020-meeting-peripheral-and-central-nervous-system-drugs-advisory-committee-meeting#event-materials. Accessed February 16, 2022
6. Institute for Clinical and Economic Review: Final Evidence Report and Meeting Summary - Aducanumab for Alzheimer’s disease: Effectiveness and Value. August 5, 2021. Available at: https://icer.org/wp-content/uploads/2020/10/ICER_ALZ_Final_Report_080521.pdf. Accessed February 16, 2022.