CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Kisunla (donanemab-azbt) (Intravenous) — Coverage Criteria

Clinical coverage policy governing use, dosing, authorization length, and monitoring requirements for Kisunla for Neighborhood Health Plan of Rhode Island members (Medicaid, Commercial, Medicare-Medicaid Plan).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyKisunla (donanemab-azbt) (Intravenous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with baseline cognitive assessment, baseline brain MRI, and amyloid confirmation (PET or CSF) as required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization length

700→1400dosing schedule

J0175HCPCS

00002-9401-xxNDC

G30.x, G31.84Covered diagnoses

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Initial Approval Criteria

Covered when ALL of the following are met

Initial approval: Patient is at least 18 years of age;

Initial approval: Physician has assessed baseline disease severity utilizing at least ONE objective measure/tool (e.g., MMSE, ADAS-Cog-13, ADCS-ADL-MCI, CDR-SB, MoCA);

Initial approval: Patient does not have risk factors for intracerebral hemorrhage suggestive of cerebral amyloid angiopathy (prior cerebral hemorrhage > 1 cm in greatest diameter, > 4 microhemorrhages, superficial siderosis, or vasogenic edema);

Initial approval: Patients receiving antithrombotic therapy (aspirin, other antiplatelets, or anticoagulants) have been on a stable dose for at least 4 weeks prior to initiating Kisunla;

ApoE ε4 testing or counseling: Either: patient has been tested for apolipoprotein E ε4 status and prescriber has informed the patient that ApoE ε4 homozygotes have higher ARIA risk; OR genotype testing has not been performed and prescriber has informed the patient that ApoE ε4 homozygosity cannot be determined and ARIA risk is therefore unknown;

Either branch satisfies this requirement.

Initial approval: Must be prescribed by, or in consultation with, a specialist in neurology or gerontology;

Initial approval: Patient has received a baseline brain MRI prior to initiating treatment (and will undergo periodic MRIs during therapy per prescribing information);

Initial approval: Patient does not have a clinically significant and unstable psychiatric illness in the past 6 months;

Initial approval: Patient has not had a stroke, transient ischemic attack (TIA), or seizures in the past 12 months;

Initial approval: Patient does not have a history of alcohol or substance abuse in the preceding year;

Initial approval: Kisunla will not be used concurrently with other anti-amyloid immunotherapies (e.g., lecanemab);

Initial approval: Medicare patients only: patient is included in the CMS-approved Coverage with Evidence Development (CED) registry (provide registry number, submission date, and submission number, if applicable);

Diagnostic confirmation and cognitive criteria

AND diagnostic confirmation and cognitive severity thresholds

Diagnostic confirmation: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer disease or mild Alzheimer’s dementia (insufficient evidence for moderate or severe AD);

Biomarker confirmation: Positive amyloid PET demonstrating amyloid beta plaque OR CSF assessment positive for hybrid ratios (Aβ42/40) or CSF p-tau181/Aβ42 or CSF t-tau/Aβ42;

Cognitive severity thresholds (one required): One of: CDR-Global 0.5–1.0 with Memory Box ≥ 0.5; OR MMSE 20–28 inclusive; OR MoCA 18–25 inclusive;

Alternative cognitive tests not listed will be reviewed case-by-case.

Exclude non-AD etiologies: Other conditions mimicking Alzheimer disease (e.g., vascular dementia, dementia with Lewy bodies, frontotemporal dementia, normal pressure hydrocephalus) have been ruled out;

Renewal Criteria

Covered when ALL of the following renewal criteria are met

Renewal: Patient continues to meet the universal and other indication-specific criteria identified for initial approval;

Renewal: Absence of unacceptable toxicity (examples: ARIA‑E, ARIA‑H, intracerebral hemorrhage >1 cm, severe hypersensitivity/anaphylaxis);

Renewal: Evidence of response compared with pretreatment baseline defined as improvement, stability, or slowing of cognitive and/or functional decline on measures such as ADAS‑Cog‑13/14, ADCS‑ADL‑MCI, MMSE, CDR‑SB, or MoCA;

Amyloid stopping rule: Discontinue treatment when amyloid PET shows either: <11 Centiloids on a single PET scan OR 11 to <25 Centiloids on two consecutive PET scans;

ARIA (E and H) management

Guidance for management of ARIA during therapy

ARIA-E management: If patient is asymptomatic or mildly symptomatic with mild radiographic ARIA‑E severity: may continue dosing per clinical judgment; If asymptomatic or mildly symptomatic with moderate to severe radiographic ARIA‑E: suspend dosing until MRI demonstrates radiographic resolution and symptoms (if present) resolve; If patient has moderate to severe symptoms with any radiographic severity: suspend dosing until radiographic resolution and symptom resolution. Consider follow-up MRI 2–4 months after initial identification to assess resolution;

Radiographic severity definitions (mild/moderate/severe) are used to guide actions.

ARIA-H management: If asymptomatic with mild ARIA‑H radiographic severity: may continue dosing; If asymptomatic with moderate ARIA‑H: suspend until MRI demonstrates radiographic stabilization and symptoms (if present) resolve; If symptomatic with mild to moderate ARIA‑H: suspend until stabilization and symptom resolution; Severe ARIA‑H: suspend until stabilization and symptom resolution. In cases of intracerebral hemorrhage >1 cm during treatment, suspend dosing until MRI demonstrates radiographic stabilization and symptoms resolve. Consider follow-up MRI 2–4 months after initial identification;

ARIA‑H severity defined by counts of new microhemorrhages and focal superficial siderosis.

General Coverage Criteria

Neighborhood adopted clinical coverage criteria to ensure Kisunla is used according to FDA labeling and relevant clinical literature; criteria apply to non‑Medicare members and to INTEGRITY (Medicare‑Medicaid Plan) members only when no NCD/LCD exists.

Core policy logic: Use must align with FDA‑approved labeling AND relevant clinical literature; prescriber must provide information for individual consideration to the plan; criteria aim to minimize adverse effects and favor cost‑effective alternatives when appropriate;

Apply applicable NCD/LCD for Medicare beneficiaries when present.

Coverage is excluded when treatment is requested for patients with moderate or severe Alzheimer's disease; the evidence and FDA‑approved indication are limited to mild cognitive impairment (MCI) due to AD or mild Alzheimer's dementia. Concurrent use with other anti‑amyloid immunotherapies (for example, lecanemab/Leqembi) is not permitted.

These coverage criteria are intended for non‑Medicare determinations. Medicare Part B/NCD/LCD determinations take precedence; where a National Coverage Determination or Local Coverage Determination exists, those Medicare policies must be followed for Medicare beneficiaries. For Medicare‑Medicaid Plan (INTEGRITY) members, Neighborhood's criteria apply only in the absence of an applicable NCD or LCD.

Treatment with Kisunla is explicitly not supported for moderate or severe stages of Alzheimer's disease. The plan requires a diagnosis of MCI due to AD or mild Alzheimer's dementia to meet indication criteria because there is insufficient evidence for benefit in more advanced stages.

Requests that are inconsistent with FDA labeling or the relevant clinical literature may be considered not medically necessary. Prescribers must provide documentation demonstrating use aligned with the FDA‑approved indication and supporting evidence; Neighborhood will give individual consideration but may deny coverage when submitted information does not justify use outside labeled or literature‑supported indications.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kisunla. Requests will be reviewed for consistency with the FDA-approved labeling and relevant clinical literature; Neighborhood will give individual consideration to each request based on submitted prescriber information and available plan data.

Prior authorization required for initial and renewal requests
Individual consideration will be given when documentation demonstrates use consistent with FDA labeling and clinical literature

Billing Rule

Authorization Length and Dosing / Billing Codes

Authorizations are issued for 6 months for initial approvals and may be renewed if renewal criteria are met. Dosing follows the FDA-recommended schedule and associated billing units should reflect the product strengths and HCPCS/units described by the plan.

Authorization length: 6 months (initial)
Dosing: 700 mg IV every 4 weeks for first three doses, then 1400 mg every 4 weeks
NDC quantity limit example: Kisunla 350 mg/20 mL — 2 vials every 4 weeks for three doses, then 4 vials every 4 weeks
HCPCS/units: 700 mg (350 units) every four weeks for first three doses; 1400 mg (700 units) every four weeks thereafter

Denial Risk

Denial Risk if Coverage Criteria Not Met

Requests may be denied if submitted information does not demonstrate that use is consistent with FDA labeling, clinical literature, or the plan's specified coverage criteria.

Potential denial if age, diagnosis (MCI due to AD or mild AD), biomarker confirmation (amyloid PET or qualifying CSF results), or cognitive score thresholds are not met
Potential denial if baseline MRI or required specialist involvement is not documented
Potential denial if safety requirements (e.g., ApoE ε4 assessment or documented counseling regarding ARIA risk, stability of antithrombotic therapy, absence of recent stroke/TIA/seizure) are not met
Potential denial if concurrent use with other anti-amyloid immunotherapies is documented

Documentation Required

Documentation to Support Requests

Prescribers must submit documentation to support medical necessity and allow prompt review. Include objective baseline assessments, imaging and biomarker results, specialist consultation, and prior treatment history as applicable.

Baseline objective cognitive assessment (e.g., MMSE, ADAS-Cog-13, ADCS-ADL-MCI, CDR-SB, MoCA) with scores
Baseline brain MRI prior to initiating treatment and documentation of MRI schedule per prescribing information
Amyloid confirmation: positive amyloid PET or qualifying CSF biomarker results (Aβ42/40 ratio, p-tau181/Aβ42, or t-tau/Aβ42)
ApoE ε4 testing status or documentation that testing was not performed and the patient was counseled about increased ARIA risk in homozygotes
Specialist involvement: prescribing or documented consultation with neurology or gerontology
For Medicare members, CMS CED registry inclusion details (registry number, CED submission date, submission number) when applicable
Documentation of current antithrombotic therapy stability (if applicable) and absence of recent stroke/TIA/seizures or unstable psychiatric illness

Step Therapy

Step Therapy Exception and Preference

Step therapy exceptions and preferences are applied to promote appropriate, cost-effective use while recognizing recent prior use.

Step therapy exception: Members who received Kisunla within the past 365 days are not subject to step therapy requirements
Step therapy preference: When clinically appropriate and cost-effective alternatives exist, preference should be given to lower-cost options before Kisunla unless an exception applies

Definitions and Severity Grading

ARIA-E radiographic severity

Mild ARIA-EFLAIR hyperintensity confined to sulcus and/or cortex/subcortex white matter in one location < 5 cm

Moderate ARIA-EFLAIR hyperintensity 5 to 10 cm in greatest dimension, or more than one site of involvement each < 10 cm

Severe ARIA-EFLAIR hyperintensity > 10 cm with associated gyral swelling and sulcal effacement; may include multiple separate sites

ARIA-H microhemorrhage severity

Mild ARIA-H (microhemorrhage)≤ 4 new incident microhemorrhages

Moderate ARIA-H (microhemorrhage)5 to 9 new incident microhemorrhages

Severe ARIA-H (microhemorrhage)≥ 10 new incident microhemorrhages

Superficial siderosis gradingMild = 1 focal area; Moderate = 2 focal areas; Severe = >2 focal areas

Covered Diagnosis Codes (ICD-10)

G30.0Alzheimer's disease with early onset (ICD-10)

G30.1Alzheimer's disease with late onset (ICD-10)

G30.8Other Alzheimer's disease (ICD-10)

G30.9Alzheimer's disease, unspecified (ICD-10)

G31.84Mild cognitive impairment, so stated (ICD-10)

CMS applicability

Medicare governanceMedicare coverage for outpatient (Part B) drugs is governed by the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 and by applicable NCDs/LCDs

NCD/LCD precedenceWhen an applicable NCD or LCD exists, those determinations take precedence over plan criteria for Medicare members

Plan criteria applicabilityNeighborhood's criteria are intended for non-Medicare coverage determinations and for Medicare-Medicaid Plan members only when no NCD/LCD exists

ResourcesCMS coverage database may be consulted for NCD/LCD/LCA documents (https://www.cms.gov/medicare-coveragedatabase/search.aspx)

OpenPayer

Kisunla (donanemab-azbt) (Intravenous) — Coverage Criteria

Coverage Criteria for Kisunla (donanemab-azbt)

Coding and Diagnostic Codes

Provider Requirements, Prior Authorization, and Documentation

Definitions and Severity Grading

Background: Drug and Clinical Context

Revision History and Rationale

G30.0	Alzheimer's disease with early onset
G30.1	Alzheimer's disease with late onset
G30.8	Other Alzheimer's disease
G30.9	Alzheimer's disease, unspecified
G31.84	Mild cognitive impairment, so stated