ModifiedBlue Cross Blue Shield - MassachusettsPolicy 946

Lecanemab and Donanemab for Alzheimer's disease (Coverage Criteria)

Medical necessity, prior authorization, and coverage criteria for initiation and continuation of lecanemab (Leqembi) and donanemab (Kisunla) for commercial members of Blue Cross Blue Shield Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyLecanemab and Donanemab for Alzheimer's disease (Coverage Criteria)

Policy CodePolicy 946

Change TypeMaterial clinical update (lecanemab added)clarifications to donanemab MRI/dosingadministrative code removal

Effective Date6/1/2024

Next Review Date

Key ActionSubmit prior authorization via Authorization Manager and include required diagnostic documentation confirming amyloid pathology and trial-like eligibility.

SourceLink

POLICY UPDATE CHANGES

Policy revised to include medically necessary and investigational indications for Leqembi (lecanemab).

Policy clarified to include that per label, Donanemab is administered every four weeks as an intravenous infusion over approximately 30 minutes and recommends obtaining MRIs prior to several infusions.

Policy removed Aducanumab (Aduhelm) from the policy as the drug has been discontinued and code J0172 transferred.

12 monthsinitial approval length

6 monthscontinuation reauthorization

More than 4microhemorrhages exclusion

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69%donanemab PET switch eligible

J0174,J0175HCPCS codes

Coverage Criteria for Lecanemab and Donanemab

inv-01: Initiation of Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Diagnosis and Stage: Meets criteria for mild cognitive impairment (MCI) or mild dementia stage of Alzheimer disease as defined by NIA-AA core clinical criteria

See policy initiation criteria and trial entry criteria

Amyloid confirmation: Presence of amyloid beta pathology confirmed by PET imaging within 12 months OR cerebrospinal fluid (CSF) assessment of t-tau/Aβ42 or p-tau/Aβ42

See PET or CSF requirements

MRI and imaging exclusions: Baseline brain MRI within the previous 12 months without exclusionary pathological findings (for example: more than 4 microhemorrhages ≤10 mm, superficial siderosis, a single macrohemorrhage >10 mm, vasogenic edema, multiple lacunar infarcts or major territory stroke, space-occupying lesions, most brain tumors)

Specific MRI exclusionary findings listed in policy

Healthcare delivery model: Care delivered within an appropriate healthcare model with access to trained specialists (neurology/geriatric psychiatry/geriatricians), trained radiologists for amyloid PET and MRI interpretation, an informant/care partner involved in treatment planning, and a protocol for ARIA management

Multidisciplinary care and ARIA management capability required

Bleeding and anticoagulation: No inadequately controlled bleeding disorder (including platelet count <50,000 or INR >1.5). If on anticoagulant therapy, dose must be stable for at least 4 weeks prior to initiation

Optimize anticoagulation status before starting therapy

Concomitant therapy and prescribing: Not currently receiving another anti-amyloid monoclonal antibody and prescribed in accordance with the FDA-approved product labeling (dose and administration per label)

See FDA label dosing guidance

inv-02: Continuation/Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Disease stage: Alzheimer disease has not progressed to severe dementia (patient remains in MCI or mild dementia stage)

Continuation only for non-severe AD

Monitoring MRIs: Has received MRI during treatment according to the schedule recommended in the FDA label to monitor for amyloid-related imaging abnormalities (ARIA)

Baseline MRI and follow-up MRIs per label (including prior to specified infusions)

ARIA and other brain disease: No ARIA of severity that meets the FDA label recommendations for dosing interruption OR no development of additional brain disease likely to account for greater cognitive decline than Alzheimer disease

Continuation may be denied if severe ARIA or new brain disease is present

inv-03: Initial coverage criteria — Covered when ALL of the following are met for Commercial Members

Covered when ALL of the following are met for Commercial Members:

Population: Diagnosis of early Alzheimer disease (MCI due to AD or mild AD dementia) with confirmed brain amyloid pathology by PET visual read or CSF Aβ42 assessment

Reflects trial inclusion and policy requirements

Functional stage and cognitive criteria: Clinical Dementia Rating (CDR) global score of 0.5 or 1.0; Memory Box score ≥0.5; MMSE within trial-specified ranges and objective episodic memory impairment per trial entry requirements

Matches pivotal trial entry criteria

Prior authorization submitted via Authorization Manager and request meets medical policy guidelines for Commercial Members

Administrative requirement for outpatient administration

inv-04: Evidence and safety considerations — Evidence summary for lecanemab

Evidence summary for lecanemab:

Efficacy: Randomized trials (including Clarity AD, n=1795) demonstrated approximately 27% slower clinical decline on primary cognitive/functional outcomes for lecanemab versus placebo

Benefit observed across primary and key secondary outcomes

Safety: ARIA occurred in 21% of treated patients (3% symptomatic); ARIA incidence higher in ApoE e4 homozygotes; infusion-related reactions and rare serious ARIA events occurred

Important safety considerations for counseling and monitoring

inv-05: Initial therapy coverage criteria — Covered when ALL of the following are met (per trials/label guidance)

Covered when ALL of the following are met (per trials/label guidance):

Population and diagnostic confirmation: Age within trial range (50–90 years); diagnosis of MCI due to AD or mild AD dementia; confirmed brain amyloid pathology by PET visual read or CSF Aβ42; baseline CDR global 0.5 or 1.0, Memory Box score ≥0.5, and objective episodic memory impairment per trial entry requirements

Criteria based on lecanemab and donanemab pivotal trial inclusion

Dosing and monitoring plan: Treatment and monitoring consistent with product label/trials: lecanemab dosing per label (10 mg/kg IV every two weeks as used in trials) and donanemab dosing per label (initial 700 mg then 1400 mg every 4 weeks) with PET-guided discontinuation thresholds; obtain baseline and on-treatment MRIs per label timing to monitor for ARIA and adjust/stop dosing for ARIA or PET criteria

Donanemab PET-guided discontinuation: switch to placebo possible when amyloid reduced to minimal levels; obtain MRIs per label

Risk counseling and genotype consideration: Document counseling regarding risk of ARIA and consider ApoE e4 testing to inform risk assessment prior to initiation, as ARIA incidence and severity are higher in ApoE e4 homozygotes

Patients with the following significant pathological findings on brain MRI are excluded from coverage: more than 4 microhemorrhages (each ≤10 mm at greatest diameter), an area of superficial siderosis, a single macrohemorrhage >10 mm at greatest diameter, evidence of vasogenic edema, evidence of multiple lacunar infarcts or a stroke involving a major vascular territory or severe small vessel/white matter disease, cerebral contusion/encephalomalacia/aneurysm/vascular malformation/infective lesion, space-occupying lesions, and most brain tumors (with limited exceptions for small asymptomatic meningiomas or arachnoid cysts as noted in the MRI findings guidance).

Inclusion or exclusion of a procedure or billing code in this policy is for informational purposes only and does not guarantee coverage or payment. Coverage for an individual member is determined by that member’s contract benefits in effect at the time of service.

Aducanumab (Aduhelm) has been removed from this policy because the product was discontinued; the related HCPCS code (J0172) was transferred per policy history and Aducanumab is not covered under this policy.

Use of lecanemab and donanemab for indications other than those explicitly described in this policy (including situations that do not meet the stated medical necessity criteria and MRI/diagnostic requirements) is considered investigational and not medically necessary.

HCPCS and other codes listed in this policy are provided for informational purposes only. The applicable medical necessity criteria described in this policy must be met for the listed codes to be eligible for coverage for Commercial Members.

Treatment with discontinued agents (for example, aducanumab) or use of anti-amyloid monoclonal antibodies outside the described early Alzheimer disease population and without biomarker-confirmed amyloid pathology is not covered under this policy.

Coding and Billing Codes

HCPCS CodesHCPCS

J0174	Injection, lecanemab-irmb, mg (eff 7/6/2023)
J0175	Injection, donanemab-azbt; 2 mg

Removed/Transferred CodesHCPCS

J0172

Injection, aducanumab-avwa, 2 mg (code removed/transferred per policy history)

Microhemorrhages

ThresholdMore than 4 cerebral microhemorrhages (each ≤10 mm greatest diameter) excludes treatment

Definition detailMicrohemorrhages defined as 10 mm or less at greatest diameter

ContextListed as an exclusionary pathological finding on brain MRI required to be absent within prior 12 months

Age range in trials

Trial age range50 to 90 years

Median age reportedMedian age 72 years (range 50 to 90)

Applicability

Provider Requirements, Prior Authorization, and Submission

Prior Authorization

Prior Authorization Required

Prior authorization is required for outpatient administration of Lecanemab (Leqembi) and Donanemab (Kisunla) for Commercial Members. Submit initial authorization requests via Authorization Manager; out-of-network providers may fax requests to 888-973-0726.

Prior authorization required for outpatient administration; use Authorization Manager
Prior authorization required via Authorization Manager for J0174 and J0175; requests must meet medical policy guidance

Prior Authorization

Submitting Prior Authorization

Providers must use Authorization Manager to submit initial authorization requests for anti-amyloid monoclonal antibody therapy. Authorization Manager is available 24/7 and is the preferred method to review requirements, submit clinical documentation, check case status, and obtain decision letters.

Submit initial authorization requests using Authorization Manager (quickest method)
For out-of-network providers: fax to 888-973-0726
Enter servicing provider NPI (surgeon/provider) and facility NPI for where services are performed

Background and Clinical Context

Lecanemab and donanemab are human monoclonal antibodies evaluated in pivotal randomized controlled trials for early Alzheimer disease (mild cognitive impairment due to AD or mild AD dementia). Lecanemab’s efficacy was assessed in the Phase 3 Clarity AD program (Study 301, n≈1795) and related trials, and donanemab was evaluated in the Trailblazer-ALZ program; both agents have demonstrated effects on amyloid pathology but carry risks of amyloid-related imaging abnormalities (ARIA) and other adverse events that inform the coverage and monitoring requirements in this policy.

Definitions and Outcome Measures

MCI due to AD - intermediate likelihood

DefinitionMeets NIA-AA core clinical criteria for MCI due to Alzheimer disease - intermediate likelihood

Functional statusDocumentation that the patient is independent in all basic activities of daily living

CorroborationHistory of gradual subjective memory decline over the last year corroborated by an informant

Mild AD dementia

DefinitionMeets NIA-AA core clinical criteria for probable AD dementia

Functional statusDocumentation that the patient is independent with all basic activities of daily living

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyLecanemab and Donanemab for Alzheimer's disease (Coverage Criteria)

Policy CodePolicy 946

Change TypeMaterial clinical update (lecanemab added)clarifications to donanemab MRI/dosingadministrative code removal

Effective Date6/1/2024

Next Review Date

Key ActionSubmit prior authorization via Authorization Manager and include required diagnostic documentation confirming amyloid pathology and trial-like eligibility.

SourceLink

On This Page

Genotype influences ARIA risk and monitoring intensity

Age 50–90 used as inclusion criteria in pivotal lecanemab trials (Study 201 and Clarity AD)

Donanemab amyloid PET switch thresholds

Switch/discontinuation ruleDonanemab dosing may be stopped (switched to placebo per trial rules) if amyloid PET Centiloids <11 on a single PET or 11–<25 on two consecutive PETs

Timing evidencePercent eligible to switch to placebo rose to 69% by Week 76 based on PET thresholds

Note on PET valuesAmyloid PET values may increase after stopping donanemab and there are no data beyond 76 weeks to guide further dosing

Note

References Informing Prior Authorization

Prior authorization requests must include documentation demonstrating that the patient meets the medical necessity criteria in this policy (including clinical staging and confirmation of amyloid pathology). References that may inform prior authorization decisions include FDA summary reviews, prescribing labels, advisory committee briefing documents, and key clinical trial publications.

References include FDA summary reviews, prescribing labels, and advisory committee briefing documents that may inform coverage decisions
Clinical trial publications and evidence reports (e.g., NEJM lecanemab trial, TRAILBLAZER-ALZ donanemab trial, ICER report) may be used to support PA review
None specified in this references section regarding additional PA procedural steps

Denial Risk

Investigational Designation and Individual Consideration

Lecanemab and Donanemab are considered investigational for indications and situations outside the specified policy criteria. Failure to meet the medical necessity criteria may result in denial for Commercial Members. Providers may request individual consideration by submitting relevant clinical information to Pharmacy Operations.

Lecanemab and Donanemab considered INVESTIGATIONAL for all other indications and when the policy criteria are not met
Denial risk: failure to meet medical necessity criteria may trigger denial for Commercial Members
Individual consideration pathway: submit clinical information to Blue Cross Blue Shield of Massachusetts Pharmacy Operations (Tel: 1-800-366-7778; Fax: 1-800-583-6289)

Step Therapy

Imaging-Guided Dosing/Step

Donanemab dosing in clinical trials included imaging-guided rules: dosing was continued or stopped based on amyloid PET thresholds, with scheduled assessments at Week 24, Week 52, and Week 76 determining eligibility for continuation versus switch to placebo. Imaging-guided dosing and stopping rules should be considered when documenting treatment plans and prior authorization requests.

Imaging-guided dosing/step: Donanemab dosing may be adjusted or stopped based on amyloid PET thresholds per trial protocol (eligibility for switch at Weeks 24, 52, 76)
Amyloid PET levels may increase after stopping donanemab; no long-term data beyond 76 weeks to guide re-dosing

Applied to identify mild AD dementia stage for eligibility for therapy per policy

MCI

Core definitionObjective cognitive impairment without loss of independence in daily activities

Risk implicationIndividuals with MCI are at increased risk of progression to dementia

Functional detailMay have mild functional impact on complex activities but remain independent in basic ADLs

NIA-AA staging

SchemeNIA-AA numeric clinical staging (stages 1–6) for the Alzheimer continuum based on biomarkers and clinical progression

Intended useDeveloped for interventional trials rather than routine clinical staging

Biomarker groupsStages applicable to biomarker groups (eg, A+T+N+, A+T-N-, etc.)

iADRS

What it measuresIntegrated Alzheimer's Disease Rating Scale (iADRS) combines ADAS-Cog13 and ADCS-iADL

Scoring implicationLower scores indicate worse cognitive and functional performance

Use in trialsPrimary efficacy endpoint for donanemab (change from baseline to 76 weeks)

ADCOMS

MeasureAlzheimer's Disease Composite Score (ADCOMS)

Trial roleUsed as a primary clinical endpoint in lecanemab dose-finding and pivotal studies

CompositionComposite outcome combining elements sensitive to early cognitive change

CDR-SB

MeasureClinical Dementia Rating Sum of Boxes (CDR-SB)

Trial useReferenced as a primary outcome measure and reported for donanemab and other AD trials

Supporting rationaleCited rationale for use in trials (Cedarbaum et al.)

MMSE

MeasureMini-Mental State Examination (MMSE)

RoleReferenced regarding trial entry ranges and psychometric limitations (ceiling/floor and practice effects)

Trial detailMMSE used among baseline cognitive measures with ranges specified in trial inclusion criteria