Neighborhood Health Plan Kisunla Coverage & Prior Auth

Coverage and Medical Necessity Criteria

inv-01: Initial Approval Criteria

Covered when ALL of the following are met:

Initial approval: Patient is >= 18 years of age; AND prescriber is a specialist in neurology or gerontology (or treatment is in consultation with such specialist); AND baseline objective cognitive assessment documented using at least one validated tool (e.g., MMSE, ADAS-Cog, ADCS-ADL-MCI, CDR-SB, MoCA) prior to initiation; AND baseline brain MRI obtained prior to initiating treatment; AND no risk factors for intracerebral hemorrhage (prior cerebral hemorrhage >1 cm, >4 microhemorrhages, superficial siderosis, vasogenic edema); AND antithrombotic therapies (antiplatelet or anticoagulant) have been on a stable dose for >=4 weeks prior to initiation; AND ApoE ε4 status tested prior to treatment with documented counseling that homozygotes have higher ARIA risk, OR if genotype testing not performed, documented counseling that ApoE ε4 status is unknown and risk cannot be determined; AND not used concurrently with other anti-amyloid immunotherapies (e.g., lecanemab); AND Medicare patients enrolled in the CMS CED registry when applicable (provide registry number, submission date, and submission number if applicable); AND diagnosis of mild cognitive impairment due to Alzheimer’s disease (MCI due to AD) OR mild Alzheimer’s dementia with biomarker confirmation of amyloid pathology (positive amyloid PET OR CSF demonstrating Aβ42/40 ratio, p-tau181/Aβ42, or t-tau/Aβ42); AND one of the following cognitive severity criteria: CDR-global 0.5–1.0 with memory box >=0.5; OR MMSE 20–28 inclusive; OR MoCA 18–25 inclusive; AND other causes of cognitive impairment (e.g., vascular dementia, DLB, FTD, normal pressure hydrocephalus) have been reasonably excluded.

Uses cognitive tools, baseline MRI, ApoE counseling/testing, and biomarker confirmation as listed

inv-02: Renewal Criteria and ARIA Management

Authorization may be renewed if ALL of the following are met:

Renewal: Patient continues to meet the universal and indication-specific criteria from initial approval; AND absence of unacceptable toxicity (including ARIA-E, ARIA-H, intracerebral hemorrhage, severe hypersensitivity/anaphylaxis); AND evidence of clinical benefit defined as improvement, stability, or slowed decline on cognitive or functional measures compared with pretreatment baseline (examples: ADAS-Cog, ADCS-ADL-MCI, MMSE, CDR-SB, MoCA); AND monitoring MRIs obtained (pre-2nd, pre-3rd, pre-4th, and pre-7th infusions) for ARIA surveillance; AND treatment will be discontinued when amyloid PET shows plaque reduction to minimal levels, defined as either <11 Centiloids on a single scan OR 11 to <25 Centiloids on two consecutive scans; AND patient has not progressed to moderate or severe Alzheimer’s disease.

Includes MRI monitoring schedule and PET Centiloid thresholds for stopping

inv-03: ARIA Management Rules

Actions based on ARIA clinical and radiographic severity:

ARIA-E decision tree: Asymptomatic or mildly symptomatic with mild radiographic severity: may continue dosing at current dose and schedule; Asymptomatic with moderate–severe radiographic severity: suspend dosing until MRI demonstrates radiographic resolution and symptoms (if present) resolve; Symptomatic moderate–severe (any radiographic severity): suspend dosing until MRI demonstrates radiographic resolution and symptoms resolve. Consider follow-up MRI 2–4 months after identification. Resumption of dosing guided by clinical judgment; consider permanent discontinuation in severe cases (e.g., intracerebral hemorrhage >1 cm).

Radiographic severity defined by lesion size (see ARIA-E definitions) and symptom severity guides suspension/resumption

ARIA-H decision tree: Asymptomatic with mild radiographic severity: may continue dosing at current dose and schedule; Asymptomatic with moderate radiographic severity: suspend until MRI demonstrates radiographic stabilization and symptoms (if present) resolve; Asymptomatic with severe radiographic severity: suspend until stabilization and use clinical judgment regarding continuation or permanent discontinuation; Symptomatic with mild–moderate radiographic severity: suspend until radiographic stabilization and symptom resolution; Symptomatic severe radiographic severity: suspend until stabilization and use clinical judgment about continuation. Consider follow-up MRI 2–4 months after identification. In all cases, resumption of dosing should be guided by clinical judgment.

Severity thresholds use microhemorrhage counts and focal siderosis counts as defined

inv-04: General coverage criteria

Covered when ALL of the following are met:

Primary coverage conditions

Diagnosis: Member has one of the covered diagnoses listed (ICD-10: G30.0, G30.1, G30.8, G30.9, G31.84)
Medicare Part B covered diagnosis codes: N/A; where NCDs/LCDs exist they must be followed for Medicare members.

Concurrent administration with other anti-amyloid immunotherapies is prohibited. Per the universal eligibility criteria, the medication "will not be used concurrently with other anti-amyloid immunotherapies (i.e., Leqembi (lecanemab), etc.)". In addition, members must meet other universal exclusions such as no clinically significant unstable psychiatric illness in the past 6 months, no stroke/TIA or seizures in the prior 12 months, and no history of alcohol or substance abuse in the preceding year.

For Medicare members, existing CMS guidance governs coverage when a National Coverage Determination (NCD) or Local Coverage Determination (LCD) applies. Where NCDs/LCDs exist, those determinations must be followed; Local Coverage Articles (LCAs) may also apply for claims/payment clarification. The policy’s clinical criteria are intended for non‑Medicare determinations and may be applied to Medicare-Medicaid members only in the absence of an applicable NCD or LCD.

The evidence and FDA-approved indication support use in early symptomatic Alzheimer’s disease (mild cognitive impairment due to AD or mild Alzheimer’s dementia). Use in moderate or severe Alzheimer’s disease is not supported by the cited evidence and therefore is considered not medically necessary.

No specific Medicare Part B covered diagnosis codes are provided in this policy appendix. The document notes that Medicare Part B covered diagnosis codes are N/A here and directs users to CMS sources (NCD/LCD/LCA) for Medicare-specific coding and coverage determinations.

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J0175

Injection, donanemab-azbt, 2 mg

NDCNDCCovered

00002-9401-xx

Kisunla 350 mg/20 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

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

Medicare Part B Covered Diagnosis / MAC jurisdictionsmixed

No codes listed

Amyloid PET Centiloid thresholds for discontinuation

Discontinuation threshold (single PET)Stop treatment when amyloid PET level is <11 Centiloids on a single scan.

Discontinuation threshold (consecutive PETs)Stop treatment when amyloid PET level is 11 to <25 Centiloids on two consecutive scans.

Monitoring requirement tied to thresholdsAmyloid PET thresholds are applied as part of renewal decisions; continued therapy requires meeting other renewal criteria including absence of unacceptable toxicity and clinical response.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiation of Kisunla. Initial approvals are granted for 6 months and follow the dosing schedule of 700 mg IV every four weeks for the first three doses, then 1400 mg every four weeks thereafter. Prior authorization will be used to ensure use is consistent with FDA labeling and established clinical literature.

Initial approval duration: 6 months
Required dosing schedule: 700 mg IV q4w x3 then 1400 mg IV q4w
Prior authorization applied to ensure appropriate indication and safety monitoring

Denial Risk

Triggers for Denial

Requests lacking required baseline assessments or documentation may be denied. Missing or incomplete information that can trigger denial includes absence of baseline cognitive assessment, no baseline brain MRI, failure to document ApoE ε4 testing status or counseling, lack of specialist involvement, or requests inconsistent with FDA labeling or plan criteria.

Clinical Background and Rationale

Kisunla (donanemab-azbt) is an intravenous humanized IgG1 monoclonal antibody directed against N-truncated pyroglutamate amyloid‑beta plaques for the treatment of early symptomatic Alzheimer’s disease (mild cognitive impairment due to AD and mild Alzheimer’s dementia). Treatment eligibility requires biomarker confirmation of amyloid pathology and specialist involvement, with baseline and periodic brain MRI monitoring because amyloid‑related imaging abnormalities (ARIA‑E and ARIA‑H) are important safety concerns. The policy’s coverage stance is limited to patients meeting the specified cognitive severity ranges and other universal safety criteria.

Note

Policy rationale: P&T Committee review and adoption

Neighborhood's Pharmacy & Therapeutics Committee reviewed Kisunla and adopted the clinical coverage criteria to ensure use according to FDA labeling and relevant literature; criteria also aim to minimize adverse effects and promote cost‑effective options when appropriate.

P&T Committee review led to adoption of criteria
Criteria intended to align use with FDA labeling and clinical literature, reduce adverse effects, and consider cost‑effectiveness

Key Definitions

ARIA-E and ARIA-H definitions and radiographic severity

ARIA-E definitionAmyloid-related imaging abnormality—edema (ARIA-E): vasogenic edema/effusion seen as FLAIR hyperintensity on MRI; radiographic severity categorized by greatest lesion dimension and number of sites.

ARIA-E radiographic severity descriptorsMild: FLAIR hyperintensity confined to a sulcus and/or cortex/subcortical white matter in one location <5 cm. Moderate: FLAIR hyperintensity 5–10 cm in greatest dimension or >1 site each <10 cm. Severe: FLAIR hyperintensity >10 cm with gyral swelling and sulcal effacement; may involve multiple independent sites.

ARIA-H definitionAmyloid-related imaging abnormality—hemosiderin (ARIA-H): includes new microhemorrhages and superficial siderosis identified on MRI; severity defined by counts of new microhemorrhages or focal areas of siderosis.

ARIA-H radiographic severity descriptorsMicrohemorrhage: Mild = ≤4 new incident microhemorrhages; Moderate = 5–9 new incident microhemorrhages; Severe = ≥10 new incident microhemorrhages. Superficial siderosis: Mild = 1 focal area; Moderate = 2 focal areas; Severe = >2 focal areas.

Policy Revision History

01/01/2025effective_dateLatest

Policy became effective for Medicaid, Commercial, and Medicare-Medicaid Plan (MMP) populations.

11/13/2024review_date

Policy review completed prior to effective date (review notes recorded).

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