ModifiedmhnPolicy CP.PHAR.594

Donanemab-azbt (Kisunla)

Defines medical necessity criteria, prior authorization and continuation requirements for Kisunla (donanemab-azbt) for members with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia across Centene-affiliated lines of business.

Policy Summary

Payermhn

PolicyDonanemab-azbt (Kisunla) - Clinical Policy

Policy CodePolicy CP.PHAR.594

Change TypeMultiple operational and clinical updates (coding, authorization durations, MRI requirements, dosing, exclusions)

Effective DateJul 2, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation meeting initial approval criteria including diagnosis, biomarker confirmation, baseline cognitive/functional scores, and recent MRI.

SourceLink

POLICY UPDATE CHANGES

Updated HCPCS code to J0175 for injection, donanemab-azbt.

Initial approval duration clarified to cover the first 3 monthly infusions (3-month auth) per FDA labeling.

Continued therapy MRI schedule, discontinuation thresholds, and MRI-contingent reauthorization updated to reflect Kisunla prescribing information.

Perpetual reauthorization duration shortened from 12 infusions to 6 infusions for members with ≥7 total infusions.

Removed age limit of 60-85 years.

Follow-up pre-infusion MRIs requirement changed to be done within the prior week instead of within the prior month.

Removed requirement for follow-up MRIs in the Continued Therapy section (later update).

Extended initial and continued approval durations to 6 and 12 months respectively for Medicaid/HIM; Commercial remains 6 months per renewal.

Added Leqembi Iqlik as an alternative formulation that should not be used concomitantly with Kisunla.

Added ICHRA line of business.

Updated recommended dosing regimen per the Prescribing Information.

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Coverage Criteria for Kisunla (donanemab-azbt)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial AD criteria: 1. Diagnosis of MCI due to AD or mild AD dementia; 2. Prescribed by or in consultation with a geriatrician or neurologist; 3. Documentation of beta-amyloid plaques verified by PET scan OR cerebrospinal fluid testing; 4. Baseline cognitive test: MMSE score 20-28 OR MoCA score ≥16; 5. Baseline functional test: FAQ score ≤9 OR FAST score 3-4 OR CDR-SB 0.5-9; 6. Recent (within 1 year) brain MRI demonstrating ALL of: absence of ARIA-E; ≤4 cerebral microhemorrhages; ≤1 area of superficial siderosis; absence of any macrohemorrhage; absence of severe white matter disease; 7. No history of TIA, stroke, or seizures within the past 12 months; 8. Not currently taking concomitant anticoagulant or antiplatelet therapy; 9. Prescriber attestation that ARIA risk has been discussed for ApoE4 homozygotes; 10. Not prescribed concurrently with Leqembi or Leqembi Iqlik; 11. Dose does not exceed 1,050 mg every 4 weeks.all conditions required

Approval duration: 6 months

Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met

Continued AD therapy: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy as evidenced by slowed decline in cognition; 3. Recent (within 1 month) cognitive test: MMSE score 20-28 OR MoCA score ≥16; 4. Recent (within 1 month) functional test: FAQ score ≤9 OR FAST score 3-4 OR CDR-SB 0.5-9; 5. Not currently taking concomitant anticoagulant or antiplatelet therapy; 6. Kisunla is not prescribed concurrently with Leqembi or Leqembi Iqlik; 7. If request is for a dose increase, new dose does not exceed 1,400 mg every 4 weeks.all conditions required

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to renewal date

Uses for non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid, or other evidence of coverage documents.

This policy excludes concomitant use of Kisunla (donanemab‑azbt) with other anti‑amyloid monoclonal antibodies. The exclusion explicitly names Leqembi and the alternative formulation Leqembi Iqlik as agents that must not be prescribed concurrently with Kisunla. Additionally, the policy excludes use in members receiving concomitant anticoagulant or antiplatelet therapy, and excludes members with recent (< 12 months) history of TIA, stroke, or seizures as specified in the clinical criteria.

Members currently taking concomitant anticoagulant or antiplatelet therapy are not eligible for coverage under the policy; initial and continued therapy criteria both require the member to be off these agents. The policy also notes that denials may occur when prescriber or enrollment requirements — including exclusions for anticoagulant/antiplatelet therapy, recent stroke/TIA, or seizure history — are not met, and providers must attest to meeting these clinical exclusions during prior authorization.

Services billed without the appropriate HCPCS code J0175 (Injection, donanemab‑azbt, 2 mg) or without meeting the policy's prior authorization and required documentation are considered not medically necessary. Providers must submit documentation supporting that the member meets all required clinical criteria (diagnosis, biomarker confirmation, baseline and recent cognitive and functional testing, MRI results, prescriber attestation) as part of the prior authorization process; inclusion of coding in this policy does not by itself guarantee coverage.

Coding, Imaging and Product Details

HCPCS CodesHCPCSCovered

J0175

Injection, donanemab-azbt, 2 mg

Cognitive and functional scores — thresholds

MMSEScore 20-28 required for baseline or recent (within 1 month for continued therapy)

MoCAScore ≥16 required for baseline or recent (within 1 month for continued therapy)

Functional assessments (FAQ / FAST / CDR-SB)FAQ ≤9 OR FAST 3-4 OR CDR‑SB 0.5–9 required at baseline and for continued therapy (recent within 1 month)

Use for stagingScores are used to define eligibility for initial approval (MMSE/MoCA + FAQ/FAST/CDR‑SB) and to document response on continuation (same instruments, recent results)

MRI recency and required imaging documentation

Baseline MRI recencyBrain MRI within the last year required for initial approval; must document absence of ARIA‑E and specified hemorrhagic findings

Prior Authorization, Documentation, Dosing and Denial Risk

Billing Rule

Titration / Dosing Requirements

Kisunla is administered IV every 4 weeks using a titration schedule; dosing must not exceed the stated maximums.

Infusion 1: 350 mg IV
Infusion 2: 700 mg IV
Infusion 3: 1,050 mg IV
Infusion 4 and beyond: 1,400 mg IV
Maximum dose: 1,400 mg every 4 weeks
Initial authorization covers the first 3 monthly infusions (initial 3-month auth)
If requesting a dose increase on continuation, new dose cannot exceed 1,400 mg every 4 weeks

Background on Donanemab-azbt (Kisunla)

Donanemab‑azbt (Kisunla) is a monoclonal antibody directed against amyloid beta and is indicated for treatment in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia. The policy requires biomarker confirmation of beta‑amyloid plaques (by PET or CSF) and uses standardized cognitive and functional assessments (for example, MMSE 20–28 or MoCA ≥16; FAQ ≤9, FAST 3–4, or CDR‑SB 0.5–9) to determine eligibility and response. Dosing follows the product titration schedule (see prescribing information) with specified dose limits and monitoring for amyloid‑related imaging abnormalities (ARIA); prior authorization is required and the HCPCS code for billing is J0175.

Key Definitions and Safety Terms

ARIA and boxed warning — definitions

ARIA‑E definitionAmyloid‑related imaging abnormalities — edema (ARIA‑E)

ARIA‑H definitionAmyloid‑related imaging abnormalities — hemosiderin deposition (ARIA‑H)

Boxed warning summaryKisunla (donanemab‑azbt) carries a boxed warning for increased risk of ARIA

MCI due to AD — definition and staging notes

Definition of MCI due to ADMild cognitive impairment due to Alzheimer's disease: cognitive decline not meeting dementia criteria with preservation of independence in functional abilities per Appendix E

Diagnostic requirementsDiagnosis must be consistent with Appendix E criteria including objective cognitive impairment and insidious onset