CurrentEmblemHealthPolicy N/A

Kisunla (Donanemab) intravenous infusion

This policy governs EmblemHealth coverage for Kisunla (donanemab) IV infusion for treatment of Alzheimer's disease, specifying coverage stance for Commercial, Medicaid, and Medicare members and listing codes and diagnosis mappings. It affects providers submitting preauthorization or claims to EmblemHealth/ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyKisunla (Donanemab) intravenous infusion

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateMar 26, 2025

Key ActionThe treating physician or primary care provider must submit clinical evidence that the member meets the treatment criteria to EmblemHealth to enable preauthorization or review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

NCD/LCDMedicare guidance

1Procedure codes

1NDCs

4Diagnosis mappings

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Coverage Determinations

Coverage stance

Policy coverage statements:

Commercial_and_Medicaid: EmblemHealth will not cover Kisunla for Commercial and Medicaid due to lack of conclusive evidence confirming clinical efficacy.

From policy statement

Medicare: Coverage guidance for Medicare members is determined by applicable National Coverage Determinations (NCD) and Local Coverage Determinations (LCD).

From policy statement

Indication_population: Kisunla is indicated for the treatment of Alzheimer’s disease; treatment should be initiated in patients with mild cognitive impairment or mild dementia, the population in which treatment was initiated in the clinical trials.

From definitions

For Commercial and Medicaid members: EmblemHealth will not cover Kisunla (donanemab).

The policy cites a lack of conclusive evidence confirming clinical efficacy as the reason for noncoverage of Kisunla for Commercial and Medicaid members.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for the requested treatment or procedure. Without this documentation, EmblemHealth will not be able to properly review the request for preauthorization or perform an adequate post-payment review.

Applies to Commercial and Medicaid members.
EmblemHealth will not cover Kisunla for Commercial and Medicaid due to lack of conclusive evidence of clinical efficacy.

Note

Provider Submission Requirements

Provider action: submit a formal prior authorization request when seeking coverage for the service. Include treating physician/PCP contact information and a clear statement of the requested service.

Include member demographics and benefit information.
Specify the exact service/procedure and proposed date of service.

Documentation Required

Clinical Evidence Submission

Clinical evidence must be submitted by the treating physician or PCP for review. EmblemHealth’s clinical review criteria are used to determine medical necessity; these criteria are based on current peer-reviewed literature, guidelines, regulatory status, and expert opinion. The absence of required clinical evidence will prevent proper review.

Attach relevant clinical notes, diagnostic test results, imaging, prior treatments, and rationale for the requested intervention.
If available, include peer-reviewed literature or specialty society guidance supporting the request.

Denial Risk

Documentation Required for Review

Documentation required for review: requests lacking the required clinical evidence and supporting documentation will be denied or deferred pending submission. The determination that a service is medically necessary does not guarantee coverage if the member’s benefit program excludes the service.

Failure to provide complete documentation will prevent preauthorization and may lead to non-coverage determination.
For Medicare members, coverage is governed by applicable NCDs and LCDs; verify Medicare guidance prior to submission.