Aduhelm (aducanumab-avwa) (Intravenous) Coverage Criteria
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This policy governs coverage and prior authorization for Aduhelm (aducanumab-avwa) intravenous treatment and states the payer's stance on its medical necessity for Alzheimer's disease and related indications.
No material clinical or coverage changes in this revision.
Coverage Determination
Investigational — All Indications
Not covered / investigational
Insufficient clinical evidence for demonstrated efficacy.
Aduhelm (aducanumab-avwa) is not covered. This policy designates Aduhelm as investigational for all indications, including, but not limited to, treatment of Alzheimer's disease (AD), cognitive impairment due to AD, and AD dementia.
The rationale for the investigational designation is that there is insufficient clinical evidence demonstrating efficacy of Aduhelm for the treatment of Alzheimer's disease or related cognitive impairments.
Billing and Diagnosis Codes
| J0172 | Injection, aducanumab-avwa, 2 mg; 1 billable unit = 2 mg |
| 64406-0101-xx | Aduhelm 170 mg/1.7 mL (100 mg/mL) solution in a SDV NDC (package) |
| 64406-0102-xx | Aduhelm 300 mg/3 mL (100 mg/mL) solution in a SDV NDC (package) |
| G30.0 | Alzheimer's disease with early onset |
| G30.1 | Alzheimer's disease with late onset |
| G30.9 | Alzheimer's disease, unspecified |
| G31.84 | Mild cognitive impairment, so stated |
Provider Requirements and Impact
Prior authorization required for Aduhelm
Prior authorization is required for Aduhelm (aducanumab-avwa).
No step therapy — investigational designation
No step therapy pathways are specified; the policy designates Aduhelm investigational for all indications.
Prior authorization, billing codes, and diagnosis documentation
Submit a prior authorization request for Aduhelm and bill using HCPCS code J0172 (Injection, aducanumab-avwa, 2 mg; 1 billable unit = 2 mg). Use the listed NDCs for vial sizes: 64406-0101-xx (170 mg/1.7 mL) and 64406-0102-xx (300 mg/3 mL). Diagnosis coding should align with Appendix 1 (examples: G30.0, G30.1, G30.9, G31.84).
- Prior authorization: Aduhelm must have prior authorization before administration.
- Billing HCPCS: J0172 — Injection, aducanumab-avwa, 2 mg (1 billable unit = 2 mg).
- NDCs: 64406-0101-xx (170 mg/1.7 mL), 64406-0102-xx (300 mg/3 mL).
- Diagnosis codes: follow Appendix 1 (e.g., G30.0, G30.1, G30.9, G31.84).
Investigational — denial risk for all indications
Requests for Aduhelm will be denied as investigational for all indications, including treatment of Alzheimer's disease and cognitive impairment due to AD.
Clinical Background
Aduhelm (aducanumab-avwa) is a monoclonal antibody therapy that targets aggregated forms of amyloid-beta in the brain. It was evaluated for use in Alzheimer's disease because accumulation of amyloid-beta plaques is a central pathological feature of AD; however, clinical trials have not provided consistent evidence of meaningful clinical benefit, and the policy therefore considers the treatment investigational.
Definitions
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