DraftAvMedPolicy N/A

Leqembi Iqlik (lecanemab-irmb) pharmacy prior authorization and step-edit

Pharmacy prior authorization and step-edit requirements for Leqembi Iqlik (lecanemab-irmb) maintenance dosing and reauthorization for AvMed members; applies to prescribers and specialty pharmacy processing requests.

Policy Summary

PayerAvMed

PolicyLeqembi Iqlik (lecanemab-irmb) pharmacy prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of biomarker positivity, baseline cognitive scales, recent MRI results, prescriber signature, and dates/doses of prior IV infusions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial auth duration

6 monthsreauthorization

50-90age range

18 monthsmin IV before maintenance

360 mg weeklymaintenance dose

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Leqembi Iqlik (lecanemab-irmb)

Initial Authorization Criteria

Covered when ALL of the following are met for initial authorization (6 months):

Age and prescriber: Prescribed by or in consultation with a neurologist; member age 50-90 years

Prior IV treatment for maintenance: Member has completed a minimum of 18 months of treatment with Leqembi IV meeting all initial approval criteria and documentation of first and last IV infusion dates and doses provided18 months

Any active Leqembi IV authorizations under the medical benefit will be discontinued

Diagnosis and cognitive assessment: Confirmed diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia based on: CDR-GS 0.5-1.0 AND CDR Memory Box >0.5 AND one of MMSE 22-28 or ADAS-Cog-13 >18 or ADCS-ADL-MCI or MoCA >=16; provider must submit baseline documentation

There is insufficient evidence in moderate or severe Alzheimer's disease

Differential diagnosis and documentation: Provider must submit chart notes supporting that other causes of cognitive impairment have been ruled out (e.g., DLB, FTD, vascular dementia, pseudodementia, B12 deficiency, encephalopathy)

Biomarker confirmation: Documentation of beta-amyloid protein deposition evidenced by positive amyloid PET OR positive CSF Aß(1-42)

ApoE ε4 counseling/testing: Provider must submit documentation meeting ONE: patient tested for ApoE ε4 with prescriber counseling about homozygote ARIA risk OR genotype not performed and prescriber informed patient that status is unknown; provider attests counseling on ARIA risks was provided

Include counseling about headache, dizziness, visual disturbances, nausea and vomiting

MRI and safety prerequisites: Recent (within last year) brain MRI showing: no brain hemorrhage >1 cm; no more than 4 brain microhemorrhages (<=10 mm); no localized superficial siderosis; no evidence of vasogenic edema; no stroke/TIA/unexplained loss of consciousness in past 12 months; stable antithrombotic therapy >=4 weeks if on antithrombotics; no impaired renal or liver function; no clinically significant unstable psychiatric illness in past 6 months<=4 microhemorrhages

Must submit MRI results

Concurrent therapy restriction: Leqembi Iqlik will NOT be used concurrently with other anti-amyloid immunotherapies (e.g., donanemab, Leqembi IV)

Reauthorization Criteria

Reauthorization (6 months): member must continue to meet initial criteria and specific MRI monitoring and stability rules

Continued clinical status: Member continues to meet all initial authorization criteria and has not progressed to moderate or severe dementia

Provider continues monitoring for other contributing conditions

MRI monitoring: Member has received follow-up MRIs approximately one week prior to the pre-3rd, pre-5th, pre-7th, and pre-14th infusions and MRI results meet stability criteria for ARIA-E, ARIA-H, and superficial siderosis as specified

Must submit MRI results

ARIA-E reauthorization conditions: For members with ARIA-E: one of the following — no new ARIA-E; mild ARIA-E that is asymptomatic; moderate or severe ARIA-E that is asymptomatic and stable; OR ARIA-E that was symptomatic (mild/moderate/severe) and is now stable

Clinical judgment used for continuation after stabilization

Dosing Interruption Recommendations

Dosing interruption rules for ARIA

Dosing with ARIA-E: Asymptomatic mild ARIA-E: may continue dosing; asymptomatic moderate or severe ARIA-E: suspend dosing; symptomatic ARIA-E (any severity): suspend dosing until radiographic stabilization and symptom resolution

Clinical judgment for restart after stabilization

Dosing with ARIA-H: Asymptomatic ARIA-H mild: may continue dosing; asymptomatic moderate or severe ARIA-H: suspend dosing; any symptomatic ARIA-H (any severity): suspend dosing until stabilization. Intracerebral hemorrhage >1 cm during treatment requires suspension until MRI demonstrates radiographic stabilization and symptoms resolve>1 cm for intracerebral hemorrhage

Consider follow-up MRI 2–4 months after identification

Leqembi Iqlik must not be used concurrently with other anti-amyloid immunotherapies. Examples include donanemab and Leqembi (lecanemab) IV. Concurrent administration with these agents is explicitly prohibited and will render a request non-compliant with coverage criteria.

Initial Therapy Requirements

Initial authorization requires biomarker confirmation, cognitive assessments, MRI safety, and risk counseling

Biomarker requirement: Positive amyloid PET OR positive CSF Aß(1-42)

Documentation required

Cognitive assessment: CDR-GS 0.5–1.0 AND CDR Memory Box >0.5 AND one qualifying scale: MMSE 22–28 OR ADAS-Cog-13 >18 OR ADCS-ADL-MCI OR MoCA >=16; baseline documentation required

Provider must submit baseline dementia rating scale results

MRI safety: MRI within the last year showing no hemorrhage >1 cm, no more than 4 microhemorrhages (<=10 mm), no localized superficial siderosis, and no evidence of vasogenic edema<=4 microhemorrhages

Must submit MRI results

Maintenance/Continuation Therapy

Maintenance dosing after 18 months of IV therapy and reauthorization rules

Maintenance dosing: Following 18 months of initial Leqembi IV dosing, administer 360 mg once weekly as maintenance; first maintenance dose given 2 weeks after last initial IV dose. Alternatives after 18 months include continuing 10 mg/kg every 2 weeks or transitioning to 10 mg/kg every 4 weeks or subcutaneous 360 mg once weekly

Clinical judgment may be used to continue or permanently discontinue after 18 months; suspend for intracerebral hemorrhage >1 cm until stabilization

Provider Submission & Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqembi Iqlik (lecanemab-irmb). Initial and reauthorization periods are each 6 months. Incomplete, incorrect, or illegible information on the prior authorization request may delay processing or result in denial.

Initial Authorization and Reauthorization: 6 months each
Prior authorization fax: 1-305-671-0200
Medication provided by Specialty Pharmacy - Proprium Rx

Documentation Required

Required Submission Elements

Provide a complete, legible, and signed prior authorization request. The prescribing physician must sign and clearly print their name (preprinted stamps are not valid). Missing or incomplete items may delay or cause denial.

Member and prescriber information: member name, AvMed ID number, DOB, prescriber name, prescriber signature, date, office contact name, phone, fax, NPI
Drug details: drug name/form/strength, dosing schedule, length of therapy, dates of administration (for prior IV Leqembi use include first and last infusion dates and doses)
Diagnosis and coding: diagnosis description and ICD code if applicable
Clinical data: weight (if applicable) and date weight obtained; dementia rating scale scores and baseline documentation; imaging and biomarker results (see MRI and biomarker callout)
Prescriber attestation: documentation that differential diagnoses have been considered/ruled out; counseling about ARIA and ApoE ε4 testing implications where applicable

Documentation Required

Biomarker and MRI Documentation

Documentation of beta-amyloid positivity and recent MRI results are required for initial and continued approval. MRI monitoring and safety-related documentation must be submitted as specified.

Beta-amyloid confirmation: positive amyloid PET scan OR cerebrospinal fluid (CSF) Aß(1-42) consistent with amyloid pathology
MRI: brain MRI within the last year required; must show no brain hemorrhage >1 cm, no more than 4 microhemorrhages (≤10 mm), no localized superficial siderosis, and no evidence of vasogenic edema
MRI monitoring: a brain MRI will be reviewed prior to the 3rd, 5th, 7th, and 14th infusions
Safety and exclusions: documentation that member has not had stroke/TIA/unexplained loss of consciousness in past 12 months, no relevant bleeding disorder or recent significant cardiovascular condition, stable dosing of antithrombotic agents for ≥4 weeks if applicable, and no impaired renal or liver function

Step Therapy

Samples and Step-Edit Verification

Use of samples to initiate therapy does not meet step-edit or prior authorization criteria and may lead to denial. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

Samples are not acceptable to satisfy step-edit or prior authorization requirements
Prior therapy verification: pharmacy paid claims or chart notes will be used to confirm previous treatments

Imaging / Findings Coding Notes

Microhemorrhages (thresholds)

Microhemorrhages thresholdNo more than 4 brain microhemorrhages (each defined as 10 mm or less at the greatest diameter)

Definition of lesion sizeMicrohemorrhages are defined as 10 mm or less at the greatest diameter

Contraindication related to countMore than 4 brain microhemorrhages prior to initiation is a contraindication to therapy

Key Definitions

ARIA (Amyloid‑related imaging abnormalities)

ARIA definitionARIA = amyloid-related imaging abnormalities including ARIA-E (edema/FLAIR hyperintensity) and ARIA-H (microhemorrhages and superficial siderosis)

ARIA-E descriptionARIA-E involves FLAIR hyperintensity (edema) with radiographic severity classified as mild/moderate/severe based on size and number of affected sites

ARIA-H descriptionARIA-H includes microhemorrhages and superficial siderosis with radiographic severity defined by incident microhemorrhage counts and number of superficial siderosis foci

Dementia rating scales (scores and interpretations)

CDR‑GS (Clinical Dementia Rating - Global Score)Scoring: 0 = normal; 0.5 = very mild dementia; 1 = mild dementia; 2 = moderate; 3 = severe

MMSE (Mini‑Mental State Exam)Score interpretation: 25–30 suggests normal cognition; 20–24 mild dementia; 13–20 moderate; <12 severe

ADAS‑Cog‑13Scale range 0–85 (higher scores indicate greater cognitive impairment)

ADCS‑ADL‑MCIRange 0–53 (lower scores indicate poorer functional performance)

Background

Leqembi (lecanemab) is an anti-amyloid monoclonal antibody indicated for early Alzheimer disease — specifically patients with mild cognitive impairment due to Alzheimer disease or mild Alzheimer dementia. Treatment requires confirmation of beta-amyloid pathology, baseline cognitive assessment using specified dementia rating scales, and MRI monitoring for amyloid-related imaging abnormalities (ARIA).

Step Therapy / Prior Treatments

Step	Requirement
1	Previous therapies will be verified via pharmacy paid claims or submitted chart notes; samples do not meet step-edit/preauthorization criteria.

Site of Care / Specialty Pharmacy

Billing Rule

Specialty pharmacy dispensing — Proprium Rx

Leqembi Iqlik will be dispensed through a specialty pharmacy (Proprium Rx); coordinate prescribing and fulfillment with the designated specialty pharmacy.

Medication provided by Specialty Pharmacy - Proprium Rx

Policy Summary

PayerAvMed

PolicyLeqembi Iqlik (lecanemab-irmb) pharmacy prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of biomarker positivity, baseline cognitive scales, recent MRI results, prescriber signature, and dates/doses of prior IV infusions.

SourceLink

On This Page

ARIA-H reauthorization conditions: For members with ARIA-H (microhemorrhage) or superficial siderosis: acceptable results include 1–4 new asymptomatic microhemorrhages; 5–9 new asymptomatic microhemorrhages if stabilized; 1–9 new symptomatic microhemorrhages if stabilized; for superficial siderosis allow no new areas, or 1 asymptomatic new area, or 2 asymptomatic new areas if stabilized, or 1–2 symptomatic new areas if stabilized

See MRI classification for severity thresholds

ApoE ε4 counseling/testing: Provider must document either ApoE ε4 testing with counseling about increased ARIA risk for homozygotes OR that genotype testing was not performed and the prescriber informed the patient that status is unknown; provider attests that counseling on ARIA risks was provided to patient/caregiver

Counsel to monitor for headache, dizziness, visual disturbances, nausea, vomiting