Viva Health Leqembi IV Coverage & Prior Auth

Coverage and Medical Necessity Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial eligibility: Patient is at least 18 years of age; physician has assessed baseline disease severity using at least one objective cognitive/functional tool (e.g., MMSE, ADAS‑Cog, ADCS‑ADL‑MCI, CDR‑SB, MoCA); patient does not have risk factors for intracerebral hemorrhage (prior cerebral hemorrhage >1 cm in greatest diameter, >4 microhemorrhages, superficial siderosis, vasogenic edema) or other lesions increasing hemorrhage risk (e.g., aneurysm, vascular malformation); patients on antithrombotic medication (antiplatelet or anticoagulant) have been on a stable dose for at least 4 weeks; and prescriber has either performed ApoE ε4 testing and informed the patient of increased ARIA risk for homozygotes OR has discussed that genotype testing was not performed and the patient may have unknown ApoE ε4 status.

Universal criteria; all items required.

Continuation / Renewal — Renewal of prior authorization may be granted when ALL of the following are met

Renewal of prior authorization may be granted when ALL of the following are met

Renewal eligibility: Patient continues to meet the universal and indication‑specific criteria from initial approval; there is absence of unacceptable toxicity (examples include ARIA‑E, ARIA‑H, intracerebral hemorrhage, hypersensitivity including angioedema/bronchospasm/anaphylaxis, or infusion‑related reactions); patient has demonstrated response to therapy compared with pretreatment baseline, evidenced by improvement, stability, or slowing of cognitive and/or functional decline on validated measures (e.g., ADAS‑Cog 13/14, ADCS‑ADL‑MCI, MMSE, CDR‑SB, MoCA); patient has not progressed to moderate or severe Alzheimer disease; and patient has received pre‑3rd, pre‑5th, pre‑7th, and pre‑14th infusion MRI monitoring for ARIA (ARIA‑E and ARIA‑H).

All items required for renewal.

ARIA Management — Management actions when ARIA identified

Management actions when ARIA identified

ARIA-E actions: If ARIA‑E: (1) asymptomatic or mildly symptomatic with mild radiographic severity on MRI — may continue dosing; OR (2) asymptomatic or mildly symptomatic with moderate to severe radiographic severity — suspend administration until MRI demonstrates radiographic resolution and symptoms (if present) resolve; OR (3) moderate to severe symptoms with any radiographic severity — suspend administration until MRI demonstrates radiographic resolution and symptoms resolve. Clinical judgment may be used to consider continuation or permanent discontinuation.

Decisions depend on combination of symptom severity and radiographic severity; suspend until resolution for specified severities.

ARIA-H actions: If ARIA‑H: (1) asymptomatic with mild radiographic severity on MRI — may continue dosing; OR (2) asymptomatic with moderate radiographic severity — suspend administration until MRI demonstrates radiographic stabilization and symptoms (if present) resolve; OR (3) symptomatic with mild to moderate radiographic severity — suspend administration until MRI demonstrates radiographic stabilization and symptoms resolve; OR (4) severe radiographic severity — suspend administration until MRI demonstrates radiographic stabilization and symptoms resolve. In patients with intracerebral hemorrhage >1 cm, suspend dosing until radiographic stabilization and symptoms resolve and consider follow‑up MRI 2–4 months after initial identification. Clinical judgment may guide continuation versus permanent discontinuation.

ARIA‑H management tied to radiographic severity and symptoms.

The policy does not support use of intravenous Leqembi outside the approved early-disease population. Specifically, treatment is limited to patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia; there is insufficient evidence to support use in moderate or severe Alzheimer’s disease. Requests for therapy that do not meet the indication and diagnostic confirmation requirements (positive amyloid PET or CSF) and the specified cognitive score thresholds will not meet coverage criteria. Additionally, Leqembi must not be used concurrently with other anti-amyloid immunotherapies (for example, donanemab or lecanemab SQ), except during the limited circumstances described for switch therapy with lecanemab SQ.

The coverage criteria and requirements in this policy apply to non‑Medicare members. For Medicare Part B claims, providers must follow Medicare rules: see the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15 §50 and any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Compliance with those CMS documents is required where applicable and may affect prior authorization or coverage decisions.

Treatment of patients with moderate or severe Alzheimer’s disease is not supported by this policy due to insufficient evidence. Coverage is restricted to patients who meet the diagnostic and cognitive severity criteria for MCI due to AD or mild AD dementia, with confirmed amyloid pathology by PET or CSF testing.

Billing Codes, Units, and Dose Information

HCPCS CodeHCPCSCovered

J0174

Injection, lecanemab-irmb, 1mg; 1 billable unit = 1 mg

NDCsNDC

62856-0212-xx	Leqembi 200 mg/2 mL (100 mg/mL) single-dose vial
62856-0215-xx	Leqembi 500 mg/5 mL (100 mg/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 of uncertain or unknown etiology

Medicare Part B Covered Diagnosis CodesICD-10

No codes listed

Dose frequency / units

Dose and billing unit1200 billable units (1200 mg) every 14 days

HCPCS unit definition1 billable unit = 1 mg (see HCPCS J0174)

Dosing intervalAdministered every 14 days (maximum dose per interval specified)

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approval is granted for 6 months and may be renewed every 12 months if renewal criteria are met.

Initial prior authorization validity: 6 months
Renewal prior authorization validity: may be renewed every 12 months if renewal criteria are met

Documentation Required

Required Documentation

Providers must submit documentation demonstrating patient eligibility and baseline assessments. Requests that lack required documentation are subject to denial.

Document patient age (≥ 18 years)
Document baseline objective cognitive assessment (e.g., MMSE, CDR‑SB, MoCA, ADAS‑Cog or other validated tool)
Document amyloid confirmation via PET scan or CSF (Aβ42/40 ratios, p‑tau/Aβ42, or t‑tau/Aβ42)

Drug Background and Context

Leqembi (lecanemab-irmb) is an anti-amyloid monoclonal antibody indicated for patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia with confirmed amyloid pathology. Therapy must be prescribed by or in consultation with a neurology or gerontology specialist and requires a baseline brain MRI prior to initiation and periodic MRIs during treatment for monitoring of amyloid‑related imaging abnormalities (ARIA). Dosing and billing use HCPCS code J0174 (1 mg = 1 billable unit); maximum dosing thresholds and infusion schedule are detailed elsewhere in the policy.

Key Terms and Abbreviations

ARIA-E / ARIA-H (amyloid‑related imaging abnormalities)

ARIA-E (edema) definitionRadiographic patterns of FLAIR hyperintensity on MRI ranging from focal cortical/subcortical involvement <5 cm (ARIA‑E 1) to >10 cm with gyral swelling and sulcal effacement (ARIA‑E 3); management depends on symptom and radiographic severity—may continue for asymptomatic/mild radiographic cases, or suspend administration until radiographic and symptom resolution for moderate-severe findings

ARIA-H (hemorrhage/hemosiderin) definitionIncludes new microhemorrhages (ARIA‑H microhemorrhage 1 = ≤4; 2 = 5–9; 3 = ≥10 new microhemorrhages) and superficial siderosis (1 = 1 focal area; 2 = 2 focal areas; 3 = >2 focal areas); management tied to radiographic severity and symptoms with suspension until stabilization/resolution for moderate–severe findings

Clinical management principleDecisions combine symptom severity and radiographic severity: asymptomatic/mild cases may continue; moderate/severe radiographic or symptomatic cases generally warrant temporary suspension until resolution

NCD / LCD / LCA (CMS coverage documents)

NCD/LCD/LCA purpose

OpenPayer

Leqembi® (lecanemab-irmb) (Intravenous) — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing Codes, Units, and Dose Information

Prior Authorization, Documentation, and Provider Responsibilities

Drug Background and Context

Key Terms and Abbreviations