Aducanumab-avwa (Aduhelm) Form

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. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. 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). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Aduhelm may be medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Alzheimer’s Disease (must meet all):

1. Diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia (see Appendix D);
2. Presence of beta-amyloid plaques verified by 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. II. Continued Therapy A. Alzheimer’s Disease (must meet all):

4. 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; Page 1 of 6

   CLINICAL POLICY Aducanumab-avwa b. Member is enrolled in a National Institute of Health-supported trial. 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 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
   None reported Appendix D: Diagnosis of Alzheimer’s disease • Alzheimer’s disease o Interference with ability to function at work or at usual activities o A decline from a previous level of functioning and performing o Not explained by delirium or major psychiatric disorder o Cognitive impairment established by history-taking from the patient and a knowledgeable informant; and objective bedside mental status examination or neuropsychological testing o 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 o Insidious onset (gradual onset over months to years, not over hours to days) o Clear-cut history of worsening o 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) o No evidence of substantial concomitant cerebrovascular disease, core features of dementia with DLB, prominent features of behavioral variant FTD or prominent 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 Page 2 of 6

   CLINICAL POLICY Aducanumab-avwa • Mild cognitive impairment due to Alzheimer’s disease – core clinical criteria o 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 o Objective evidence of impairment in one or more cognitive domains that is not explained by age or education o Preservation of independence in functional abilities o Impairments do not meet criteria for dementia V. Dosage and Administration
   Indication Dosing Regimen Alzheimer’s disease Initial dose should be titrated up as shown below: IV infusion (every 4 weeks) Aduhelm dosage (administered over approximately one hour) 1 mg/kg Infusion 1 and 2 3 mg/kg Infusion 3 and 4 Infusion 5 and 6 6 mg/kg Infusion 7 and beyond 10 mg/kg Maximum Dose 10 mg/kg every 21 days
   After an initial titration, the recommended maintenance dose is 10 mg/kg intravenously via a 0.2 or 0.22 micron in-line filer over approximately one hour every four weeks, and at least 21 days apart. VI. Product Availability
   Vial for injection (single-dose): 170 mg/1.7 mL, 300 mg/3 mL VII.