CurrentCommunity-CarePolicy N/A

Donanemab (Kisunla) — Medical Benefit Medication Utilization Policy (Alzheimer disease)

This policy governs medical benefit coverage and utilization management for donanemab (Kisunla) for treatment of Alzheimer disease for Community-Care members, including initial and continuation criteria, quantity limits, and authorization periods.

Policy Summary

PayerCommunity-Care

PolicyDonanemab (Kisunla) — Medical Benefit Medication Utilization Policy (Alzheimer disease)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 1, 2024

Key ActionObtain prior authorization documenting neurologist involvement, confirmed amyloid PET, baseline and serial MRIs, and qualifying cognitive scores.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MMSE 22-30 / CDR-SB 0.5-6Acceptable cognitive scores for eligibility

Up to 4 vialsQuantity limit (28 days)

Baseline + serialMRI monitoring

1 yearAuthorization period

J0175Billing code

Coverage Criteria for donanemab (Kisunla)

Initial Therapy

Covered when ALL of the following are met for initial approval:

Initial Approval Criteria: Prescribed by, or in consultation with, a neurologist.

Initial Approval Criteria: Diagnosis of Alzheimer disease.

Initial Approval Criteria: Confirmed presence of amyloid pathology via PET imaging.

Initial Approval Criteria: Baseline MRI conducted prior to treatment initiation and prior to 2nd, 3rd, 4th, and 7th infusions to assess for amyloid-related imaging abnormalities (ARIA).

Policy Summary

PayerCommunity-Care

PolicyDonanemab (Kisunla) — Medical Benefit Medication Utilization Policy (Alzheimer disease)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateDec 1, 2024

Key ActionObtain prior authorization documenting neurologist involvement, confirmed amyloid PET, baseline and serial MRIs, and qualifying cognitive scores.

SourceLink

On This Page

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This policy covers donanemab (Kisunla) for initial approval only when all of the following criteria are documented: the therapy is prescribed by or in consultation with a neurologist; there is a documented diagnosis of Alzheimer disease; the presence of amyloid pathology is confirmed via PET imaging; a baseline MRI is completed prior to treatment initiation and MRIs are performed prior to the 2nd, 3rd, 4th, and 7th infusions to assess for amyloid-related imaging abnormalities (ARIA); and the patient meets the policy’s cognitive-stage thresholds for mild impairment—either an MMSE 22–30 or a CDR‑SB 0.5–6.

Provider Actions, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate the patient meets initial approval criteria including neurologist involvement and confirmation of amyloid pathology prior to initiation.

Prescribed by, or in consultation with, a neurologist
Diagnosis of Alzheimer disease documented
Confirmed presence of amyloid pathology via PET imaging
Baseline MRI completed prior to treatment initiation and before 2nd, 3rd, 4th, and 7th infusions to assess for ARIA
MMSE 22–30 OR CDR‑SB 0.5–6 for mild cognitive impairment

Note

Provider Action

Submit PA requests with clear documentation of the consulting or prescribing neurologist and explicit statements linking the diagnosis and amyloid confirmation to the requested therapy. Include anticipated infusion schedule and plan for MRI monitoring.

Include neurologist name, NPI, and role (prescribing vs consulting)
Attach PET imaging report confirming amyloid pathology
Provide planned infusion dates and MRI schedule to coincide with baseline and pre-2nd/3rd/4th/7th infusions

Documentation Required

Required Documentation

Documentation must include diagnosis of Alzheimer disease, confirmation of amyloid pathology via PET imaging, and baseline and serial MRI reports as specified. For continuation requests, include objective evidence of clinical benefit and ongoing monitoring.

Diagnosis documentation (clinical note/problem list)
PET imaging report confirming amyloid pathology
Baseline MRI prior to first infusion and MRI reports prior to 2nd, 3rd, 4th, and 7th infusions
Baseline cognitive testing (MMSE or CDR‑SB) and subsequent assessments to show benefit for continuation
For continuation: documentation that member is being monitored and demonstrating benefit to treatment

Denial Risk

Triggers for Denial

Denial may occur if required diagnostic or monitoring documentation is missing or if eligibility criteria are not met.

Lack of confirmed amyloid pathology via PET imaging
Absence of required baseline or serial MRIs per schedule
Missing documentation of neurologist involvement
Failure to meet cognitive score criteria (MMSE 22–30 or CDR‑SB 0.5–6) for initial approval
No evidence of clinical benefit or monitoring for continuation requests

Background

Donanemab (Kisunla) is an anti-amyloid monoclonal antibody indicated for the treatment of Alzheimer disease when amyloid pathology is confirmed by PET imaging. Treatment under this policy requires neurologist involvement and scheduled MRI monitoring to evaluate for amyloid-related imaging abnormalities (ARIA). Cognitive staging to determine eligibility is based on either the Mini‑Mental State Examination (MMSE) score 22–30 or the Clinical Dementia Rating Scale Sum of Boxes (CDR‑SB) 0.5–6. If approved, donanemab is authorized with a quantity limit of up to 4 vials per 28 days (1,400 mg/28 days) and authorization is granted for 1 year.

OpenPayer

Donanemab (Kisunla) — Medical Benefit Medication Utilization Policy (Alzheimer disease)

Coverage Criteria for donanemab (Kisunla)

Coding and Quantity Limits

Provider Actions, Documentation, and Denials

Background

Definitions and Clinical Thresholds