CurrentCignaPolicy IP0697

Alzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla

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This policy governs medical necessity, coding, and coverage criteria for Kisunla (donanemab-azbt) intravenous infusion for treatment of Alzheimer's disease for Cigna members. It affects providers seeking authorization and reimbursement for Kisunla.

Policy Summary

PayerCigna

PolicyAlzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla

Policy CodePolicy IP0697

Change TypeName and coverage clarificationsdocumentation added

Effective DateAug 15, 2026

Last ReviewAug 15, 2026

Next Review Date

Key ActionObtain prior authorization using HCPCS J0175 and include required documentation when requesting coverage for Kisunla.

SourceLink

POLICY UPDATE CHANGES

Policy name updated from 'Neurology - Kisunla' to 'Alzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla.'

Experimental, investigational or unproven statement updated to include 'regardless of U.S. Food and Drug Administration (FDA) approval status. Criteria will be updated as new published data are available.'

Documentation statement was added to the policy.

Alzheimer's Disease condition of approval was added; prior 'Conditions Not Covered: Alzheimer's' was removed.

J0175HCPCS code listed

2 mgStrength

5References

Policy Summary

PayerCigna

PolicyAlzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla

Policy CodePolicy IP0697

Change TypeName and coverage clarificationsdocumentation added

Effective DateAug 15, 2026

Last ReviewAug 15, 2026

Next Review Date

Key ActionObtain prior authorization using HCPCS J0175 and include required documentation when requesting coverage for Kisunla.

SourceLink

On This Page

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentCignaPolicy IP0697

Alzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla

Customize your policy alerts

Sign up for Cigna Policy IP0697 alerts

Get alerted when Policy IP0697 changes without checking for updates manually.

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Policy Summary

PayerCigna

PolicyAlzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla

Policy CodePolicy IP0697

Change TypeName and coverage clarificationsdocumentation added

Effective DateAug 15, 2026

Last ReviewAug 15, 2026

Next Review Date

Key ActionObtain prior authorization using HCPCS J0175 and include required documentation when requesting coverage for Kisunla.

SourceLink

POLICY UPDATE CHANGES

Policy name updated from 'Neurology - Kisunla' to 'Alzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla.'

Documentation statement was added to the policy.

Alzheimer's Disease condition of approval was added; prior 'Conditions Not Covered: Alzheimer's' was removed.

J0175HCPCS code listed

2 mgStrength

5References

Policy Summary

PayerCigna

PolicyAlzheimer's Disease - Amyloid Beta- Directed Antibodies - Kisunla

Policy CodePolicy IP0697

Change TypeName and coverage clarificationsdocumentation added

Effective DateAug 15, 2026

Last ReviewAug 15, 2026

Next Review Date

Key ActionObtain prior authorization using HCPCS J0175 and include required documentation when requesting coverage for Kisunla.

SourceLink

On This Page

Coverage Criteria for Kisunla (donanemab-azbt)

Medical Necessity Statement

Considered medically necessary when the criteria in the applicable policy statements are met:

Medical Necessity Statement: Kisunla is considered medically necessary only when the criteria in the applicable policy statements are met; any other use is not medically necessary.

See related policy statements for detailed clinical eligibility criteria and documentation requirements.

Kisunla (donanemab-azbt) is considered medically necessary when the criteria in the applicable policy statements are met. For purposes of billing and prior authorization, the HCPCS code associated with Kisunla is J0175 (Injection, donanemab-azbt, 2 mg) and prior authorization is required when the clinical criteria are satisfied.

Conditions Not Covered have been revised. Notably, the prior exclusion listing 'Alzheimer's' under Conditions Not Covered was removed as part of recent policy updates; the policy's revision history documents the addition of an Alzheimer's disease condition of approval and removal of Alzheimer's from the Conditions Not Covered list. Providers should refer to the revision history for effective dates of these changes.

Coding and Billing

Considered Medically Necessary HCPCSHCPCSCovered

J0175

Injection, donanemab-azbt, 2 mg

Provider Actions and Requirements

Prior Authorization

Prior authorization required for Kisunla (J0175)

Prior authorization is required for Kisunla (donanemab-azbt) when the policy's coverage criteria are met; billing must use HCPCS code J0175 (Injection, donanemab-azbt, 2 mg).

HCPCS: J0175 — Injection, donanemab-azbt, 2 mg

Billing Rule

Billing rule: confirm HCPCS code eligibility at time of service

Verify use and coding at the time of service and include HCPCS J0175 on claims; deleted or noneffective codes at the time of service may not be eligible for reimbursement.

Confirm code eligibility at time of service per policy note about code lists and deleted/noneffective codes.

Background

Donanemab (marketed as Kisunla) is an amyloid beta‑directed monoclonal antibody administered by intravenous infusion for the treatment of Alzheimer's disease. The policy notes that clinical criteria will be updated as new published data become available and that documentation requirements were added to support authorization requests.

Definitions

inv-10: Kisunla — donanemab-azbt intravenous infusion details (HCPCS J0175, 2 mg)

Generic namedonanemab-azbt

Brand nameKisunla

Route and formulationIntravenous infusion, billed as injection

HCPCS codeJ0175

Unit strength per HCPCS2 mg per J0175 unit