Clinical Policy: Aducanumab-avwa (Aduhelm)

Reference Number: CP.PHAR.468
Effective Date: 06.07.21
Last Review Date: 05.26
Line of Business: HIM/ICHRA, Medicaid

[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Aducanumab-avwa (Aduhelm™) is a monoclonal antibody targeting amyloid beta.

FDA Approved Indication(s)*

Aduhelm is indicated for the treatment of Alzheimer’s disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease, the population in which treatment was initiated in clinical trials.

This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

*Biogen, manufacturer of Aduhelm, has discontinued Aduhelm to reprioritize its resources (see Appendix E)

Policy/Criteria

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.

II. Continued Therapy*

*The manufacturer has discontinued Aduhelm (see Appendix E).

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace/ICHRA and CP.PMN.53 for Medicaid, or evidence of coverage documents.

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

CMS: Centers of Medicare and Medicaid Services
FDA: Food and Drug Administration

Appendix B: Therapeutic Alternatives

Not applicable

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): none
• Boxed warning(s): amyloid related imaging abnormalities

Appendix D: Diagnosis of Alzheimer’s disease

• Alzheimer’s disease
  
  • Interference with ability to function at work or at usual activities
  • A decline from a previous level of functioning and performing
  • Not explained by delirium or major psychiatric disorder
  • Cognitive impairment established by history-taking from the patient and a knowledgeable informant; and objective bedside mental status examination or neuropsychological testing
  • Cognitive impairment involves a minimum of two of the following domains:
    
    • ■ Impaired ability to acquire and remember new information
    • ■ Impaired reasoning and handling of complex tasks, poor judgment
    • ■ Impaired visuospatial abilities
    • ■ Impaired language functions (speaking, reading, writing)
    • ■ Changes in personality, behavior, or comportment
  • Insidious onset (gradual onset over months to years, not over hours to days)
  • Clear-cut history of worsening
  • Initial and most prominent cognitive deficits are one of the following:
    
    • ■ Amnestic presentation (impairment in learning and recall of recently learned information)
    • ■ Non-amnestic presentation in either a language presentation (prominently word-finding deficits), a visuospatial presentation with visual deficits, or executive dysfunction (prominently impaired reasoning, judgment and/or problem solving)
  • No evidence of substantial concomitant cerebrovascular disease, core features of dementia with DLB, prominent features of behavioral variant FTD or prominent

CLINICAL POLICY

Aducanumab-avwa

features of semantic or nonfluent/agrammatic variants of primary progressive aphasia (PPA), or evidence of another concurrent, active neurologic or non-neurologic disease or use of medication that could have a substantial effect on cognition

• Mild cognitive impairment due to Alzheimer’s disease – core clinical criteria
  
  • Concern regarding change in cognition obtained from the patient, from an informant who knows the patient well, or from a skilled clinician observing the patient
  • Objective evidence of impairment in one or more cognitive domains that is not explained by age or education
  • Preservation of independence in functional abilities
  • Impairments do not meet criteria for dementia

Appendix E: Discontinuation of Aduhelm

• Aduhelm received accelerated approval from the FDA in June 2021. Biogen considered the time and investment required for the post-marketing confirmatory ENVISION study, a requirement of FDA accelerated approval, and the likely advancements in the field by the time of potential Aduhelm FDA traditional approval. Consequently, Biogen announced it will reprioritize its resources, continue to advance Leqembi® (lecanemab-irmb), and accelerate development of potential new treatment modalities. The company will discontinue the development and commercialization of Aduhelm and will terminate the ENVISION clinical study. This decision is not related to any safety or efficacy concerns. Patients currently receiving Aduhelm will have access to the drug via the commercial route until November 1, 2024.

V. Dosage and Administration

VI. Product Availability

Vial for injection (single-dose): 170 mg/1.7 mL, 300 mg/3 mL

CLINICAL POLICY

Aducanumab-avwa

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 6, 2024.
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 6, 2024.
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.
7. Biogen press release. Biogen to realign resources for Alzheimer's disease franchise. Available at: https://investors.biogen.com/news-releases/news-release-details/biogen-realign-resources-alzheimers-disease-franchise. Accessed February 6, 2024.

CLINICAL POLICY

Aducanumab-avwa

Important Reminder