CurrentCignaPolicy IP0200

Neurology - Aduhelm

Cigna Healthcare coverage policy for Aduhelm (aducanumab-avwa) intravenous infusion detailing clinical assessment of efficacy/safety, coverage determination (considered experimental/investigational/unproven), MRI safety monitoring recommendations, and billing code information for plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyNeurology - Aduhelm

Policy CodePolicy IP0200

Change TypeAnnual revision (title and conditions consolidated)

Effective DateSep 1, 2024

Next Review Date

Key ActionObtain and document a brain MRI within one year prior to initiating Aduhelm to assess for baseline ARIA and contraindicating findings.

POLICY UPDATE CHANGES

Annual Revision: Consolidated Alzheimer's disease indications into a single 'Alzheimer's Disease' aggregate and updated title to 'Neurology - Aduhelm'.

1HCPCS code listed as experimental

2030Expected confirmatory trial results year (FDA required)

Coverage Summary

Coverage Determination

Aducanumab (Aduhelm) coverage determination:

Coverage determination: Aducanumab (Aduhelm) is considered experimental, investigational, or unproven due to insufficient data establishing safety, efficacy, and improved health outcomes for any condition, including Alzheimer's disease.

Based on accelerated approval on surrogate endpoint and requirement for post-marketing confirmatory trial; results expected 2030.

Safety Monitoring and Documentation Requirements

Safety Monitoring / Imaging Recommendations

ALL of the following

Obtain a baseline brain MRI within the prior 12 months before initiating Aduhelm to assess for preexisting ARIA-H or other contraindicating findings.<= 12 months
Recent MRI recency threshold referenced for baseline assessment.
Monitor closely for amyloid-related imaging abnormalities (ARIA) during treatment, with enhanced vigilance during the first eight doses and particularly during dose titration when most ARIA events occur.
Scheduled on-treatment MRI timing
- Obtain an MRI prior to the 7th infusion (the first 10 mg/kg dose).
- Obtain an MRI prior to the 12th infusion (the sixth 10 mg/kg dose).
Radiographic severe ARIA-H criteria and required evaluation
- Ten or more new incident microhemorrhages observed on follow-up MRI (radiographic severe ARIA-H).>= 10 microhemorrhages
  Radiographic severe ARIA-H threshold referenced.
- Greater than two focal areas of superficial siderosis observed on follow-up MRI (radiographic severe ARIA-H).?> 2 focal areas
  Radiographic severe ARIA-H threshold referenced.
If radiographic severe ARIA-H is detected (per above thresholds), perform a clinical evaluation and obtain a follow-up MRI to document radiographic stabilization (no increase in size or number of ARIA-H) before considering continuation of treatment.

Documentation Required

MRI prior to initiation

Documentation required: Providers must document MRI timing and clinical evaluations as specified for Aduhelm initiation and during therapy. Failure to document may affect medical review.

Baseline MRI within 12 months prior to initiation (threshold: <= 12 months).
MRI prior to 7th infusion (first 10 mg/kg dose).
MRI prior to 12th infusion (sixth 10 mg/kg dose).
Clinical evaluation and follow-up MRI if radiographic severe ARIA-H detected (radiographic severe ARIA-H threshold: >= 10 new microhemorrhages or > 2 focal areas of superficial siderosis).

Documentation Required

MRI during treatment

Documentation required: Maintain records of on-treatment MRI results and clinical assessments; enhanced vigilance is recommended during the first eight doses and during titration.

Obtain MRI prior to 7th and 12th infusions as specified.
Document any ARIA findings and corresponding clinical assessments.

Documentation Required

Evaluation if severe ARIA-H detected

Documentation required: If severe ARIA-H is detected, document the clinical evaluation, follow-up MRI findings demonstrating radiographic stabilization, and clinical decision-making supporting continuation or discontinuation of therapy.

Radiographic severe ARIA-H thresholds: >= 10 new incident microhemorrhages or > 2 focal areas of superficial siderosis.
Follow-up MRI must show no increase in size or number of ARIA-H to support continuation.

Denial Risk

Coverage denial for Aduhelm

Denial risk: Coverage for Aduhelm may be denied when documentation requirements and safety monitoring (including required MRIs and evaluations for ARIA) are not met or when the drug is considered experimental/investigational per policy.

Relevant HCPCS/NDC/CPT: J0172 (Injection, aducanumab-avwa, 2 mg) — considered experimental/investigational per policy coding.
Failure to provide baseline MRI within 12 months or required on-treatment MRIs prior to the 7th and 12th infusions may result in denial.
Lack of documented clinical evaluation and follow-up MRI demonstrating stabilization after radiographic severe ARIA-H may result in denial of continued therapy.

Applicable Codes

Considered Experimental/Investigational/UnprovenHCPCSExperimental

J0172

Injection, aducanumab-avwa, 2 mg

Clinical Evidence Summary

0.39EMERGE high-dose absolute CDR-SB difference (22% relative reduction) — below MCID of 1–2 points

22%Relative reduction in CDR-SB reported for EMERGE high-dose vs placebo

Aduhelm (aducanumab-avwa) received accelerated FDA approval based on reduction in amyloid beta plaques observed in treated patients.

Cigna finds the current efficacy data insufficient to determine clinically meaningful benefit; Phase III trials (ENGAGE and EMERGE) were terminated early after an interim futility analysis and demonstrated inconsistent efficacy, with the only observed high-dose EMERGE absolute CDR‑SB difference of 0.39 (22% relative reduction) falling below commonly accepted minimum clinically important differences.

There are documented safety concerns including amyloid related imaging abnormalities (ARIA), specifically ARIA‑E (edema) and ARIA‑H (hemosiderin deposition, including microhemorrhage and superficial siderosis), and enhanced vigilance and MRI monitoring are recommended during early dosing.

The FDA has required post‑marketing randomized, controlled confirmatory trials to verify clinical benefit; results of these required trials are expected in 2030.

Definitions & Background

ARIA‑E: Amyloid related imaging abnormalities – edema.

ARIA‑H: Amyloid related imaging abnormalities – hemosiderin deposition, which includes microhemorrhage and superficial siderosis.

Scope: This policy describes Cigna Healthcare coverage determinations for Aduhelm (aducanumab‑avwa) intravenous infusion administered to members of plans run by Cigna Companies, including the assessment that Aduhelm is considered experimental/investigational/unproven for Alzheimer's disease due to insufficient evidence of safety and efficacy, recommended MRI safety monitoring and timing, and related billing/coding information.

Operational Thresholds

Operational thresholds (important)

MRI recency prior to initiating treatmentwithin 1 year

Radiographic severe ARIA-H>= 10 new microhemorrhages OR > 2 focal areas of superficial siderosis

Revision History

2024-09-01revisedLatest

Annual Revision: Consolidated Alzheimer's disease indications into a single 'Alzheimer's Disease' aggregate and updated title from 'Aducanumab' to 'Neurology - Aduhelm'. Marked non-material.

Policy Summary

PayerCigna

PolicyNeurology - Aduhelm

Policy CodePolicy IP0200

Change TypeAnnual revision (title and conditions consolidated)

Effective DateSep 1, 2024

Next Review Date

Key ActionObtain and document a brain MRI within one year prior to initiating Aduhelm to assess for baseline ARIA and contraindicating findings.

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