KISUNLA (donanemab-azbt) coverage and prior authorization
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Defines medical necessity, prior authorization requirements, and coverage criteria for KISUNLA (donanemab-azbt) for treatment of early Alzheimer's disease for HUSKY Health (Connecticut Medicaid) providers.
KISUNLA (donanemab-azbt) added to the policy as a covered amyloid beta-directed monoclonal antibody.
Age, prior stroke/TIA, seizure, and anticoagulation criteria were moved into medication-specific sections.
Procedure code J0175 (donanemab-azbt) added and prior code J0172 removed.
KISUNLA (donanemab-azbt) added to the policy.
ADUHELM (aducanumab) removed from the policy.
LEQEMBI removed from this policy and separated into its own policy.
A requirement for provider attestation was added to the procedure section.
Additional exclusion criteria were added (e.g., recent stroke, seizures, uncontrolled hypertension, certain immunologic conditions, active cancer interfering with treatment).
Coverage and Medical Necessity Criteria
inv-01: Initial Authorization
Covered when ALL of the following are met for initial authorization:
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inv-02: Reauthorization / Continuation Therapy
Reauthorization/Continuation criteria (assessed at six-month intervals):
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inv-03: KISUNLA (donanemab) initial coverage requirements
Policy updated to add KISUNLA with medication-specific eligibility and exclusions per CMS NCD and trial guidance.
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The following conditions are exclusions or general limits to KISUNLA coverage. Patients are not eligible if they have a bleeding disorder that is inadequately controlled, stroke or transient ischemic attack within the past 12 months, any history of seizures, or uncontrolled hypertension. Additional exclusions include autosomal dominant Alzheimer's disease when the mutation is associated with high cerebral amyloid angiopathy burden, Alzheimer's disease due to Down syndrome, any history of specified immunologic disease or current systemic treatment with immunosuppressants/immunoglobulins/monoclonal antibodies or their derivatives, active cancer that would interfere with the ability to comply with treatment, treatment with therapeutic anticoagulation (except prophylactic aspirin or standard antiplatelet agents such as clopidogrel, prasugrel, ticagrelor), and any contraindication to amyloid testing or MRI brain scan (e.g., metallic implants, pacemaker/defibrillator).
Additional exclusions were added to clarify medication-specific eligibility for donanemab. These explicitly list recent stroke (within the past 12 months), any history of seizures, uncontrolled hypertension, autosomal dominant Alzheimer’s disease, Alzheimer’s due to Down syndrome, prior or current immunologic disease or systemic immunosuppressive therapy, and active cancer that would prevent adherence to KISUNLA treatment. These conditions must be absent for authorization to be considered.
Use of KISUNLA outside the population studied in clinical trials is not supported. Specifically, initiation of therapy at stages earlier than mild cognitive impairment (MCI) or at stages later than mild Alzheimer's dementia is not supported by the policy on the basis of current safety and effectiveness data.
ADUHELM (aducanumab) has been removed from this policy because the drug was discontinued in November 2024; it is therefore no longer included among agents addressed by this coverage guidance.
Billing and Code Tables
| J0175 | Injection, donanemab-azbt, 2mg |
| J0175 | Drug code added to policy (donanemab billing) as noted in publication history |
| J0172 | Drug code removed from policy (previously used; removed) |
Prior Authorization, Documentation, and Provider Attestations
Prior authorization required for KISUNLA (J0175)
Prior authorization is required for KISUNLA (donanemab) billed under HCPCS J0175. Initial and reauthorization requests must include the clinical documentation and provider attestation specified in the procedure section.
- HCPCS code: J0175 (Injection, donanemab-azbt, 2mg) must be used for billing.
- Requests are reviewed according to physician‑administered drug procedures and coverage determinations are case‑specific.
Concomitant therapy prohibited
Do not administer KISUNLA concurrently with any other amyloid beta‑directed monoclonal antibody.
- Explicit example: KISUNLA must not be used in combination with LEQEMBI.
Follow FDA monitoring and registry participation
Providers must follow FDA dosing and monitoring requirements, including MRI monitoring for ARIA prior to the 2nd, 3rd, 4th, and 7th infusions and as needed for symptoms; participation in the CMS National Patient Registry is required when applicable.
- MRI schedule per FDA: prior to infusions 2, 3, 4, and 7 and symptom‑triggered scans.
- Treating physician and clinical team must participate in CMS registry or CMS‑approved study when required.
Required initial request documentation (form, order, medical records)
Submit a fully completed State of Connecticut HUSKY Health KISUNLA Prior Authorization Request form including the physician's order and signature, and attach medical records confirming diagnosis, amyloid testing, dementia rating scores, most recent brain MRI, and ApoE ε4 testing.
- Form must include physician order and signature.
- Initial request must include: diagnosis documentation, PET or CSF amyloid results, at least one dementia rating scale result, most recent brain MRI, and ApoE ε4 test results.
Reauthorization: physician letter and MRI results required
For reauthorization, include a signed letter from the ordering physician documenting ongoing clinical benefit and provide results from the most recent brain MRI per FDA monitoring protocol.
- Physician letter must attest to continued benefit (objective, validated longitudinal tests expected).
- Include MRI results as outlined in FDA monitoring requirements.
Provider attestation required on requests
A signed provider attestation is required with initial requests confirming discussion of ApoE ε4 risks and that the patient does not have excluded conditions listed in the policy.
- Attestation must confirm discussion of ApoE ε4 implications regarding ARIA risk with patient/caregiver.
- Attestation must confirm absence of exclusions such as recent stroke/TIA, uncontrolled bleeding disorders, history of seizures, uncontrolled hypertension, autosomal dominant AD, AD due to Down syndrome, certain immunologic diseases, active cancer interfering with treatment, or therapeutic anticoagulation.
Risk of denial if documentation or criteria missing
Requests that lack the required documentation or that do not meet the medical necessity criteria may be denied; include all specified clinical records and attestation to avoid denial.
- Coverage determinations are based on review of submitted case‑specific information.
- Ensure all initial and reauthorization documentation listed in the procedure section is included to prevent denial.
Authorization is not a guarantee of payment
Authorizations are granted based on medical necessity at the time of issuance and do not guarantee payment; payment depends on the member having active coverage and applicable benefits and policies on the date of service.
- Authorization is time‑bound to the medical necessity determination at issuance.
- Payment requires active coverage and applicable benefits at time of service.
Clinical Background
Alzheimer's disease is a progressive neurodegenerative disorder and the most common cause of dementia. Mild cognitive impairment (MCI) is recognized as a prodromal state that frequently precedes dementia. KISUNLA (donanemab-azbt) is an amyloid beta–directed monoclonal antibody authorized for treatment of early symptomatic Alzheimer's disease—defined here as MCI due to AD or mild Alzheimer's dementia—and its use requires confirmed amyloid pathology, baseline cognitive assessment, appropriate specialist involvement, and adherence to FDA monitoring guidance because of known risks such as ARIA.
Definitions and Drug Information
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