CurrentCignaPolicy IP0200

Neurology - Aduhelm

Cigna coverage policy for use of Aduhelm for Alzheimer's disease for members of Cigna-administered health benefit plans. It provides the coverage stance, rationale, safety considerations, coding guidance and requirements that affect utilization review and prior authorization decisions.

Policy Summary

PayerCigna

PolicyNeurology - Aduhelm

Policy CodePolicy IP0200

Change TypeAnnual revision (consolidated listings, title update)

Effective DateSep 1, 2024

Next Review Date

Key ActionObtain and document a brain MRI within 1 year prior to initiating Aduhelm and obtain MRIs prior to the 7th and 12th infusions to monitor for ARIA; document findings and clinical evaluations.

SourceLink

POLICY UPDATE CHANGES

Consolidated Alzheimer’s disease stage listings into a single 'Alzheimer's Disease' aggregate and updated policy title to 'Neurology - Aduhelm' (annual revision 9/1/2024).

IP0200Coverage Policy Number

2024-09-01Effective date

1Drug listed as experimental/unproven

Coverage Determination

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Overview - Coverage Determination Summary

Coverage determination based on available clinical efficacy and safety data:

ALL of the following

Current Aduhelm efficacy information is insufficient to determine clinically meaningful benefit.
Due to lack of clinical efficacy data and safety concerns, approval is not recommended for Aduhelm.

Conditions Not Covered (Experimental/Investigational/Unproven)

Aducanumab (Aduhelm) is considered experimental, investigational, or unproven for any condition, including:

ANY of the following

Alzheimer's Disease (all stages aggregate).
Policy consolidated prior separate stage listings into single Alzheimer's Disease aggregate.

Safety and Imaging Requirements (Informational)

Safety and Imaging Requirements (Informational - Not a coverage criterion since drug is considered unproven)

Manufacturer and safety information referenced in the policy — surveillance guidance related to ARIA:

ALL of the following

Obtain a recent (within 1 year) MRI of the brain prior to initiating treatment to evaluate for ARIA (edema) and ARIA-H (microhemorrhage, superficial siderosis).
Enhanced clinical vigilance recommended during first eight doses, particularly during titration, because most ARIA observed during this time.
Obtain MRIs prior to the 7th infusion (first dose of 10 mg/kg) and 12th infusion (sixth dose of 10 mg/kg) to evaluate for asymptomatic ARIA.
Radiographic severe ARIA-H conditions noted
- Presence of pretreatment localized superficial siderosis.
- Ten or more brain microhemorrhages prior to treatment.
- Brain hemorrhage > 1 cm within one year prior to treatment.
If ten or more new incident microhemorrhages or greater than two focal areas of superficial siderosis are observed, treatment may be continued only after clinical evaluation and follow-up MRI demonstrate radiographic stabilization (no increase in size or number of ARIA-H).

Provider Requirements & Risks

Documentation Required

Pre-treatment MRI

Obtain and document a brain MRI performed within 1 year prior to initiating Aduhelm to evaluate for ARIA (edema) and ARIA‑H (microhemorrhage, superficial siderosis). Document MRI date and findings in the medical record.

Documentation Required

Monitoring MRIs during treatment

Obtain MRI scans prior to the 7th infusion (first 10 mg/kg dose) and prior to the 12th infusion (sixth 10 mg/kg dose) to evaluate for asymptomatic ARIA, and document the imaging findings in the medical record.

Denial Risk

Coverage denials for Aduhelm

Requests for Aduhelm are likely to be denied because the drug is considered experimental, investigational, or unproven due to insufficient evidence of safety and clinical efficacy.

Affected code: J0172 — Injection, aducanumab‑avwa, 2 mg

Documentation Required

Management of severe ARIA-H findings

If radiographic severe ARIA‑H is observed (ten or more new microhemorrhages or greater than two focal areas of superficial siderosis), continue treatment only after a clinical evaluation and a follow‑up MRI demonstrate radiographic stabilization (no increase in size or number of ARIA‑H); document the clinical assessment and follow‑up imaging in the medical record.

>= 10 new microhemorrhages
">2 focal areas of superficial siderosis"

Key Thresholds and Defined Terms

Thresholds (safety and imaging) - Aduhelm

Pre-treatment MRI recencyObtain and document a brain MRI within 1 year prior to initiating Aduhelm to assess for ARIA and ARIA‑H.

MRI monitoring scheduleObtain MRIs prior to the 7th infusion (first 10 mg/kg dose) and prior to the 12th infusion (sixth 10 mg/kg dose) to evaluate for asymptomatic ARIA and document findings.

Severe ARIA-H radiographic threshold (new incident)>= 10 new microhemorrhages OR >2 focal areas of superficial siderosis; if observed, continue treatment only after clinical evaluation and follow‑up MRI demonstrate radiographic stabilization (no increase in size or number of ARIA‑H).

Definitions

ARIAAmyloid related imaging abnormalities, including ARIA‑E (edema) and ARIA‑H (hemorrhage/microhemorrhage and superficial siderosis), detected on MRI.

Clinical Background

Aduhelm (aducanumab-avwa) is an amyloid beta-directed monoclonal antibody that received accelerated FDA approval based on demonstration of a reduction in amyloid beta plaques observed in treated patients. Continued approval is contingent on confirmatory (post‑marketing) trials to verify clinical benefit.

Results from the two Phase III trials (ENGAGE and EMERGE) were mixed. A planned interim analysis met futility criteria and the trials were stopped early; a post‑hoc analysis showed that the high‑dose arm of EMERGE reached statistical significance on the primary endpoint, but the observed absolute difference (0.39 on the CDR‑SB) did not meet generally accepted thresholds for a clinically meaningful change. Efficacy was not demonstrated in the low‑dose arm of EMERGE or in either arm of ENGAGE, and overall the available efficacy information is considered insufficient to establish clinically meaningful benefit.

Safety concerns have been identified in clinical trials, most notably amyloid‑related imaging abnormalities (ARIA), including ARIA‑E (edema) and ARIA‑H (microhemorrhage and superficial siderosis). Because of these risks, recommendations include obtaining a recent (within 1 year) brain MRI prior to initiating treatment, enhanced clinical vigilance during the first eight doses (particularly during titration), and scheduled MRIs prior to the 7th infusion (first 10 mg/kg dose) and 12th infusion (sixth 10 mg/kg dose) to evaluate for asymptomatic ARIA. The safety of Aduhelm in patients with pretreatment localized superficial siderosis, ≥ 10 brain microhemorrhages, or a brain hemorrhage > 1 cm within one year has not been established.

The combination of inconclusive evidence for clinical benefit and demonstrated safety concerns supports the policy determination that Aduhelm is considered experimental, investigational, or unproven for Alzheimer's disease and other conditions and is not recommended for approval under the current evidence base.

Policy Update Changes

2024-09-01revisedLatest

Consolidated prior separate listings for 'Alzheimer's disease, mild cognitive impairment or dementia stage of disease' and 'Alzheimer's disease, moderate or severe cognitive impairment or dementia stage of disease' into a single 'Alzheimer's Disease' aggregate and updated the policy title to 'Neurology - Aduhelm'.

Policy Summary

PayerCigna

PolicyNeurology - Aduhelm

Policy CodePolicy IP0200

Change TypeAnnual revision (consolidated listings, title update)

Effective DateSep 1, 2024

Next Review Date

SourceLink

On This Page

OpenPayer

Neurology - Aduhelm

Coverage Determination

Safety and Imaging Requirements (Informational)

Coding Guidance

Provider Requirements & Risks

Key Thresholds and Defined Terms

Clinical Background

Policy Update Changes