CurrentmhnPolicy CP.PHAR.594

Donanemab-azbt (Kisunla) coverage for Alzheimer's disease

Defines medical necessity criteria, initial and continuation authorization requirements, dosing limits, exclusions, documentation and imaging requirements, and coding implications for Kisunla (donanemab-azbt) for commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyDonanemab-azbt (Kisunla) coverage for Alzheimer's disease

Policy CodePolicy CP.PHAR.594

Change TypeRevised; Removed; Revised

Effective DateJul 2, 2024

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria (diagnosis, prescriber specialty, amyloid confirmation, baseline cognitive and functional scores, recent MRI results and absence of exclusions).

POLICY UPDATE CHANGES

Criteria updated per FDA labeling after full approval; clarified initial 3-month authorization covers first 3 monthly infusions and updated HCPCS code and MRI/reauthorization schedule.

Removed age limit of 60-85 years.

Clarified continued therapy MRI schedule to require pre-infusion MRIs within the prior week and recent cognitive testing within the last month.

1Covered FDA Indication

3 monthsInitial approval duration

1,400 mgMaximum dose every 4 weeks

Per-authorization infusions (≥7 total)

Coverage Summary

coverage_stance: covered_with_criteria; subject: Donanemab-azbt (Kisunla) coverage for Alzheimer’s disease. scope_summary: Defines medical necessity criteria, initial and continuation authorization requirements, dosing limits, exclusions, documentation and imaging requirements, and coding implications for Kisunla (donanemab-azbt) for commercial, HIM and Medicaid lines of business. Brief: This policy covers Kisunla for patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild AD dementia when all criteria are met (diagnosis, specialty prescriber, amyloid confirmation, baseline cognitive and functional testing, MRI and exclusion criteria). The coverage criteria and populations align with the FDA prescribing information and the clinical trial populations used in the pivotal studies; policy dosing, MRI monitoring, and ARIA management are aligned to the product labeling and trial procedures.

Thresholds / Numeric Limits

MMSE20-28

MoCA≥ 16

FAQ≤ 9

FAST3-4

CDR-SB0.5-9

Cerebral microhemorrhages≤ 4

Superficial siderosis≤ 1 area

FLAIR hyperintensity size< 5 cm in any one location

Initial dosing limit (initial auth)Dose does not exceed 1,050 mg every 4 weeks

Maximum dose1,400 mg every 4 weeks

Initial Therapy Criteria

Initial Approval Duration

Approval duration: 3 months (3 doses of infusion only).3 months / 3 doses

Continuation Therapy Criteria

Continued Therapy Approval Durations

Members with < 4 total infusions: up to the 4th total infusion.

Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Contraindications & Exclusions

Contraindications and exclusions: Claims are at risk for denial when the member has any of the listed contraindications or exclusions. Specifically, requests may be denied if the member has a history of transient ischemic attack (TIA), stroke, or seizures within the past 12 months; is currently taking concomitant anticoagulant or antiplatelet therapy; or if Kisunla is prescribed concurrently with another anti-amyloid monoclonal antibody such as Leqembi. Providers must document required imaging and testing and meet all other policy criteria to avoid denial.

Applicable Codes

HCPCS - drug administration codeHCPCSCovered

J0175

Injection, donanemab-azbt, 2 mg

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Provider must submit documentation supporting that the member meets all approval criteria (diagnosis, prescriber specialty/consultation, amyloid confirmation, baseline cognitive and functional scores, recent MRI results, and absence of exclusions) as part of the prior authorization request.

J0175

Documentation Required

Baseline and ongoing testing documentation

Document baseline confirmation of beta‑amyloid by PET scan or CSF testing, record baseline cognitive testing (MMSE or MoCA) and baseline functional testing (FAQ, FAST, or CDR‑SB). For continued therapy, provide recent (within the last month) cognitive and functional test results to demonstrate the member remains in the mild stage of disease.

Clinical Evidence & References

TRAILBLAZER-ALZ 2Key trial cited (JAMA 2023) informing criteria and design alignment

NEJM 2021Foundational early AD donanemab trial informing efficacy/safety references

RegulatoryKisunla Prescribing Information + CMS NCD (200.3) referenced for approval and coverage framework

Evidence: Key trials referenced include TRAILBLAZER‑ALZ 2 (JAMA 2023) and the donanemab early AD trial (N Engl J Med 2021). The policy states alignment with the Kisunla Prescribing Information and the CMS National Coverage Determination for anti‑amyloid monoclonal antibodies. Treatment dosing and monitoring requirements (including ARIA risk management and scheduled MRIs) reflect the product labeling and the monitoring approaches used in the trials and CMS guidance.

Background & Definitions

Background: Donanemab‑azbt (Kisunla) is a monoclonal antibody targeting amyloid beta indicated for treatment of Alzheimer’s disease, with treatment initiated in patients with mild cognitive impairment (MCI) or mild dementia, the population studied in clinical trials. The policy is aligned to the FDA prescribing information and the trial populations and includes ARIA risk management and monitoring requirements consistent with the label and trial procedures.

Term	Definition
ARIA-E	Amyloid-related imaging abnormalities - edema
ARIA-H	Amyloid-related imaging abnormalities - hemosiderin deposition
FAQ	Functional Assessment Questionnaire
FAST	Functional Assessment Staging Test
CDR-SB	Clinical Dementia Rating - Sum of Boxes

Revision History

07.11.24criteria_update

Criteria updated per FDA labeling after full approval: clarified that the initial 3-month authorization covers the first 3 monthly infusions (not 4), updated the HCPCS code, and aligned continued therapy MRI schedule, treatment discontinuation thresholds, and MRI-contingent reauthorization durations to reflect the Kisunla prescribing information.

08.07.24policy_revision

4Q 2024 annual review: shortened perpetual reauthorization for members with ≥7 total infusions from 12 infusions per PA approval to 6 infusions per PA approval to align with Leqembi approach; removed exclusion against concomitant use with Aduhelm given market withdrawal; updated references.

10.25.24policy_revision

Policy Summary

Payermhn

PolicyDonanemab-azbt (Kisunla) coverage for Alzheimer's disease

Policy CodePolicy CP.PHAR.594

Change TypeRevised; Removed; Revised

Effective DateJul 2, 2024

Next Review Date

On This Page

Documentation Required

MRI timing for continued therapy

Prior to the 4th and 7th infusions, provide a brain MRI performed within the prior week demonstrating required ARIA/hemorrhage findings and document the member's ARIA symptom status (absence of macrohemorrhage, ARIA‑H symptom status and ≤ 4 microhemorrhages, ARIA‑E symptom status or only mild symptoms, and FLAIR hyperintensity confined and < 5 cm).

Denial Risk

Contraindications and exclusions

Claims are at risk for denial if the member has any of the following: history of TIA, stroke, or seizures within the past 12 months; is currently taking concomitant anticoagulant or antiplatelet therapy; or Kisunla is prescribed concurrently with Leqembi.

Billing Rule

Dose limit enforcement

Dose limits are enforced for prior authorization and billing.

Initial dosing limit: 1,050 mg every 4 weeks
Maximum dose: 1,400 mg every 4 weeks
Billing implications: use HCPCS code J0175 (Injection, donanemab-azbt, 2 mg)

Documentation Required

Prescriber specialty and attestation

Prescriber must be a geriatrician or neurologist or the request must include documentation of consultation with one. Prescriber must attest that they discussed the potentially increased risk of ARIA in ApoE4 genetic homozygotes with the member.

P&T documented removal of the age restriction (removed age limit of 60-85 years).

08.26.25criteria_update

4Q 2025 annual review: updated recommended dosing regimen per Prescribing Information; clarified that neurocognitive testing for continued therapy must be recent (within the last month) to ensure members remain in the mild stage.

08.26.25criteria_update

4Q 2025 annual review: aligned pre-infusion MRI timing with Leqembi approach by requiring follow-up pre-infusion MRIs to be performed within the prior week rather than the prior month.

ongoinghistoric_revisionsLatest

Multiple material historic revisions: added specialist prescriber requirement; excluded concomitant use with other anti-amyloid monoclonal antibodies and with anticoagulant/antiplatelet therapy; added prescriber ApoE4 attestation; established dosing limits (initial auth dose ≤1,050 mg every 4 weeks; max dose 1,400 mg every 4 weeks) and approval durations (initial 3-month/3-dose auth; tiered continued therapy approvals with 6-infusions PA for ≥7 total infusions).