Clinical Policy: Donanemab-azbt (Kisunla)
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Defines medical necessity and prior authorization criteria for donanemab-azbt (Kisunla) in members with mild cognitive impairment due to Alzheimer disease or mild Alzheimer dementia for Health Net lines of business.
Initial approval criteria updated to require specialist prescriber, amyloid verification, specific baseline cognitive and functional scores, MRI requirements, and exclusions for concomitant anticoagulant/antiplatelet therapy and concurrent anti-amyloid antibodies.
Initial 3-month authorization duration clarified to cover the first 3 monthly infusions.
Specialist prescriber requirement was added for initial approval.
Exclusion against concomitant use with other anti-amyloid monoclonal antibodies was added.
Exclusion for concomitant use with anticoagulant or antiplatelet therapies was added (aligned with Leqembi policy).
Initial authorization duration clarified to cover the first 3 monthly infusions (not 4) per FDA labeling.
Follow-up MRI requirements for continued therapy were added/updated to identify new-onset ARIA.
Per-approval reauthorization interval for members with >=7 total infusions shortened from 12 infusions to 6 infusions per authorization.
Requirement for enrollment in an NIH-sponsored trial was removed for both initial and continued therapy.
Maximum dosing limits and approval durations were added/updated.
Exclusion against concomitant use with Aduhelm was removed.
Age limit of 60-85 years was removed.
Attestation requirement regarding discussion of ApoE4 status with the member was added.
Coverage Criteria for Donanemab-azbt (Kisunla)
Initial Therapy
Covered when ALL of the following are met:
Approval duration: 3 months (first 3 infusions)
Continuation Therapy
Continued coverage when ALL of the following are met:
MRI monitoring required before key infusions
Initial and Continued Therapy Criteria (summary)
Covered when ALL of the following are met (high-level summary from document revisions):
Specialist prescriber and exclusions added in 4Q2023 revisions.
Clarified in 07.05.23 and later updates.
Added/updated in 4Q2023 and 4Q2024 reviews.
Requests for indications that are not FDA‑approved and that are not specifically addressed in this policy are excluded unless coverage is supported through the applicable off‑label use policies or an evidence of coverage document (see referenced off‑label policies CP.CPA.09, HIM.PA.154, CP PMN.53).
Donanemab-azbt (Kisunla) must not be prescribed concurrently with other anti‑amyloid monoclonal antibodies (for example, Leqembi). Concomitant use with another anti‑amyloid monoclonal antibody is an explicit exclusion for both initiation and continuation of therapy.
Members who are currently taking anticoagulant or antiplatelet therapy are excluded from initiation and continuation of Kisunla. Concurrent anticoagulant or antiplatelet use is an explicit contraindication to coverage under this policy and must be reconciled prior to approval.
Donanemab-azbt (Kisunla) is contraindicated in individuals with a history of serious hypersensitivity to donanemab-azbt or to any of its excipients. Known serious hypersensitivity reactions preclude use under this policy.
Additional exclusions and safety‑related limitations include: no concurrent treatment with other anti‑amyloid monoclonal antibodies; no concurrent anticoagulant or antiplatelet therapy; and exclusion for members with pre‑existing neurologic conditions such as prior stroke, transient ischemic attack (TIA), or seizures as noted in the policy updates. Operational safety requirements include baseline and interval brain MRI monitoring for amyloid‑related imaging abnormalities (ARIA) and adherence to the policy’s maximum dosing limits and infusion‑based reauthorization cadence.
Use of Kisunla for non‑FDA indications that are not specifically covered by this policy is not supported by this policy and is subject to off‑label adjudication per the referenced off‑label use policies; absent such coverage determinations, those uses are not authorized under this policy.
Use of Kisunla in patients who meet any of the explicit exclusion criteria listed in this policy (for example, concurrent anti‑amyloid monoclonal antibody therapy, concurrent anticoagulant/antiplatelet therapy, known serious hypersensitivity, or relevant pre‑existing neurologic conditions) is considered not medically necessary and will be denied.
Coding and Dose Limits
| J0175 | Injection, donanemab-azbt, 2 mg |
| J0175 | Injection, donanemab-azbt 2 mg |
Provider Actions, Prior Authorization, and Documentation
Prior Authorization Required
Prior authorization is required for initiation of Kisunla. Initial approvals cover the first 3 monthly infusions (approval duration = 3 months / 3 doses). Continued authorization is required for ongoing treatment and is contingent on required MRI monitoring and clinical response criteria.
- Initial approval duration: 3 months (first 3 monthly infusions).
- Continued authorization: MRI-contingent reauthorization schedule per criteria; see Continued Therapy for reauthorization windows (up to 4th, up to 7th, then 6 infusions per PA approval for members with ≥7 total infusions).
- Prior authorization must document specialist prescriber status and all required baseline tests and imaging.
Concomitant Therapy and Medical‑History Exclusions
Do not prescribe Kisunla concomitantly with other anti‑amyloid monoclonal antibodies or with anticoagulant or antiplatelet therapy. Members with a history of stroke, TIA, or seizures are excluded. Providers must confirm current medications and relevant medical history prior to approval.
- Prohibited concomitant therapies: other anti‑amyloid monoclonal antibodies (e.g., Leqembi) and anticoagulants/antiplatelets.
- Medical‑history exclusions: prior stroke, TIA, or seizures.
- Prescriber attestation: discussion with member about ApoE4‑related ARIA risk required.
Formulary / Off‑Label Pathway
Route requests through the appropriate formulary / off‑label adjudication pathway: follow the line‑of‑business policies for formulary, non‑formulary, and off‑label uses. If the drug is on the formulary/PDL follow the applicable no‑coverage criteria policy; if not on formulary follow the non‑formulary policy; if use is off‑label and not otherwise addressed, route per the off‑label use policy.
- Formulary on PDL: follow CP.CPA.190 (commercial), HIM.PA.33 (HIM), CP PMN.255 (Medicaid) as applicable.
- Non‑formulary: follow CP.CPA.190 (commercial), HIM.PA.103 (HIM), CP PMN.16 (Medicaid).
- Off‑label requests: follow CP.CPA.09 (commercial), HIM.PA.154 (HIM), CPPMN.53 (Medicaid) when the indication is not specifically authorized.
Step Therapy / Sequencing Notes
Step‑therapy and sequencing rules: Kisunla may not be used concurrently with other anti‑amyloid antibodies and is contraindicated with anticoagulant/antiplatelet concomitant use. Sequencing should ensure Kisunla is not prescribed at the same time as Leqembi or other anti‑amyloid agents; prior exposures should be documented and reviewed before authorization.
- Exclusion for concomitant anti‑amyloid antibodies (e.g., Leqembi).
- Exclusion for concomitant anticoagulant or antiplatelet therapy.
- Document prior biologic exposure and sequencing rationale in the PA submission.
Definitions and Assessment Tools
Background
Donanemab-azbt (Kisunla) is a human monoclonal antibody targeting amyloid beta indicated for treatment of patients with mild cognitive impairment due to Alzheimer disease or mild Alzheimer dementia when prescribed and monitored consistent with the policy criteria. The policy aligns approval criteria with clinical‑trial populations and requires specialist prescriber oversight, amyloid verification, baseline cognitive and functional testing, and MRI monitoring for amyloid‑related imaging abnormalities (ARIA).
Revision History
Per-approval reauthorization interval for members with >=7 total infusions shortened from 12 infusions to 6 infusions; exclusion against concomitant use with Aduhelm removed; references and HCPCS code updated to J0175.
Initial authorization duration clarified to cover the first 3 monthly infusions (not 4) to align with FDA labeling.
Specialist prescriber requirement, exclusions for concomitant use with other anti-amyloid antibodies and anticoagulant/antiplatelet therapy, ApoE4 discussion attestation, and MRI/cognitive monitoring requirements were added as part of 4Q2023 updates to align criteria with TRAILBLAZER-ALZ 2 and CMS registry requirements.
Policy created pre-emptively establishing initial clinical criteria, dosing limits, and monitoring expectations for donanemab-azbt (Kisunla).
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