ModifiedBlue Cross Blue Shield - MassachusettsPolicy 946

Anti‑amyloid monoclonal antibodies for Alzheimer disease (lecanemab, donanemab) — Coverage Criteria

Policy governing prior authorization, medical necessity criteria, monitoring, and coverage for lecanemab (Leqembi IV and Leqembi IQLIK) and donanemab (Kisunla) for treatment of mild cognitive impairment or mild dementia due to Alzheimer disease for BCBSMA commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyAnti‑amyloid monoclonal antibodies for Alzheimer disease (lecanemab, donanemab) — Coverage Criteria

Policy CodePolicy 946

Change TypeMaterial updates to coverage criteria and monitoringadded subcutaneous formulation and updated donanemab titration

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation confirming amyloid positivity (PET within 12 months or CSF results), MRI within 12 months, and prescriber participation in the CMS CED registry.

SourceLink

POLICY UPDATE CHANGES

Leqembi IQLIK (subcutaneous formulation) included with specific maintenance dosing criteria after 18 months of IV treatment.

Updated coverage criteria requiring prescriber participation in the CMS CED Study Registry and specific imaging and CSF documentation for initiation.

Explicit exclusionary MRI findings and limits on microhemorrhages and macrohemorrhages for patient selection.

Added Leqembi IQLIK.

Added updated titration for Kisunla based on TRAILBLAZER-ALZ 6 study.

Updated renewal from 12 to 6 months.

Policy clarified to include that per label, Donanemab is administered every four weeks as an intravenous infusion over approximately 30 minutes and MRI monitoring recommended prior to specific infusions.

Policy clarified to add medically necessary and investigational indications for Donanemab (KISUNLA) and removed aducanumab (Aduhelm).

12 monthsinitial approval length of authorization

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6 monthscontinuation and maintenance approval length

J0174, J0175HCPCS codes listed

Baseline MRI ≤1 yrrequired baseline imaging for ARIA risk

27% slowerapproximate reduction in decline

Coverage Criteria and Medical Necessity

Initial Approval Criteria

Initial Approval — Leqembi IV or Donanemab

Length of approval: 6 months

Leqembi IQLIK (subcutaneous) — Maintenance Dosing

Clinical Guideline Coverage Criteria: Leqembi IQLIK

Length of approval: 6 months

Continuation of Therapy

Operational note: Continue monitoring per FDA label and study-derived guidance (periodic MRI monitoring, assessment for infusion-related reactions, and consideration of ApoE ε4 testing to inform ARIA risk).

Coverage Context and Evidence

Coverage for lecanemab

Operational note: Use of lecanemab outside early AD (e.g., moderate-to-severe AD, preclinical AD without symptoms) is not supported by the coverage criteria and is investigational.

Provider Action Summary and Monitoring

Extracted coverage-relevant criteria and monitoring points

Operational note: Provider should include ApoE ε4 status when available to inform ARIA risk management; consider MRI monitoring per product labeling (prior to specified infusions) and after symptomatic events.

Denial Risk

Provider Notice — Documentation & Denial Risk

Exclusionary imaging and clinical conditions — denial-risk / exclusion flags

Prior authorization denial-risk is high when MRI shows exclusionary pathological findings (see MRI exclusionary list).
Providers must attest absence of exclusionary findings and submit MRI reports; failure to provide imaging or documentation of exclusionary conditions may result in denial.
Prior authorization must include documentation of specialty pharmacy routing if the plan requires dispensation via an in-network specialty pharmacy.

Coding and Code Tables

HCPCS CodesHCPCS

J0174	Injection, lecanemab-irmb, 1 mg (eff 7/6/2023)
J0175	Injection, donanemab-azbt, 2 mg

Amyloid PET tracersmixed

18F-florbetapir	Approved amyloid PET tracer (example)
18F-flutemetamol	Approved amyloid PET tracer (example)
18F-florbetaben	Approved amyloid PET tracer (example)

inv-16: Microhemorrhages — exclusion threshold

Exclusion thresholdMore than 4 cerebral microhemorrhages (each ≤10 mm in greatest diameter) is exclusionary.

Definition usedMicrohemorrhage defined as 10 mm or less at the greatest diameter.

Documentation requiredSubmit MRI report within previous 12 months confirming count of microhemorrhages.

inv-17: Macrohemorrhage — exclusion threshold

Exclusion thresholdA single macrohemorrhage greater than 10 mm at greatest diameter is exclusionary.

Imaging requirementSubmit MRI report within previous 12 months documenting absence of macrohemorrhage >10 mm.

Prior Authorization, Documentation, and Submission Instructions

Prior Authorization

Prior authorization required for Leqembi and Kisunla

Prior authorization is required for Leqembi (lecanemab) IV, Leqembi IQLIK (subcutaneous), and Kisunla (donanemab); submit the Massachusetts standard medication prior authorization form or eForm and provide required clinical documentation.

Leqembi (lecanemab) IV: Medical, PA (HCPCS J0174).
Leqembi IQLIK (subcutaneous): PA.
Kisunla (donanemab): Medical, PA (HCPCS J0175).

Prior Authorization

Document amyloid positivity and trial‑based staging for PA

PA requests must include confirmation of amyloid pathology (amyloid PET visual read within 12 months or CSF ttau/Aβ42 or ptau/Aβ42) and documentation that the patient meets early AD trial‑based staging (MCI due to AD or mild dementia with CDR global 0.5 or 1.0, Memory Box ≥0.5, objective episodic memory impairment, and MMSE within trial range).

Amyloid PET results within the last 12 months OR CSF assessment (ttau/Aβ42 or ptau/Aβ42).

Clinical Background and Rationale

Alzheimer disease is a progressive neurodegenerative disorder characterized by accumulation of amyloid beta plaques and tau tangles leading to progressive cognitive and functional decline. Anti‑amyloid monoclonal antibodies such as lecanemab and donanemab target amyloid pathology and were evaluated in randomized trials enrolling patients with mild cognitive impairment due to AD or mild AD dementia (for example, Study 201 and Clarity AD for lecanemab). Baseline and interval MRI monitoring is required because of the risk of amyloid‑related imaging abnormalities (ARIA) associated with these agents.

Definitions and Scales

inv-37: Alzheimer disease (AD) definition

DefinitionAlzheimer disease (AD) is a progressive neurodegenerative disorder causing progressive loss of memory, language, and thinking leading to impairment in daily social and functional activities.

Pathologic hallmarksAssociated with extracellular amyloid beta plaques and intracellular hyperphosphorylated tau neurofibrillary tangles.

Clinical courseProgressive continuum from preclinical biomarker changes to MCI and dementia; survival after dementia diagnosis typically ranges 4–8 years but varies with comorbidities.

inv-38: ARIA definition

DefinitionAmyloid‑related imaging abnormalities (ARIA) include ARIA‑E (edema/effusion) and ARIA‑H (hemorrhage) associated with anti‑amyloid antibody treatment.

Risk factors

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyAnti‑amyloid monoclonal antibodies for Alzheimer disease (lecanemab, donanemab) — Coverage Criteria

Policy CodePolicy 946

Change TypeMaterial updates to coverage criteria and monitoringadded subcutaneous formulation and updated donanemab titration

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Related exclusionsMacrohemorrhage is listed among other exclusionary pathological MRI findings (eg superficial siderosis, vasogenic edema).

inv-18: MMSE — trial entry threshold

Trial entry thresholdMMSE score ≥22 (and ≤30) as used for Clarity AD (Study 301) trial inclusion.

ContextMMSE requirement applies to trial-based eligibility for early AD (MCI due to AD or mild AD dementia).

DocumentationDocument MMSE score in prior authorization submission to confirm eligibility range.

inv-19: Age — trial entry range

Trial entry age range50 to 90 years (Clarity AD / Study 301 enrollment range).

Median/typicalMedian age in Clarity AD was 72 years (range 50–90).

DocumentationInclude patient age in prior authorization to confirm within trial range.

Clinical staging consistent with trial criteria: MCI or mild dementia, CDR 0.5 or 1.0, Memory Box ≥0.5, objective episodic memory impairment, MMSE ≥22 (within trial range).

Prior Authorization

Use MA standard PA form and network specialty pharmacy when applicable

Submit PA using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm or faxed form); when covered under the Pharmacy benefit, specialty medications must be obtained from a network specialty pharmacy.

eForm link and printable form available per Appendix instructions.
Specialty medications under the Pharmacy benefit must be filled at a network specialty pharmacy.

Note

How to submit an exception request to Pharmacy Operations

To request an exception (individual consideration), providers may call, fax, or mail clinical information and supporting documentation to BCBSMA Pharmacy Operations using the contact details in the Appendix.

Phone: 1-800-366-7778; Fax: 1-800-583-6289; Mail: Pharmacy Operations, 25 Technology Place, Hingham, MA 02043.
Include clinical rationale and supporting documentation as described in Appendix.

Step Therapy

Document step therapy trials or clinical rationale

Step therapy applies: the provider must document trials and failures of formulary alternatives or a clinical rationale preventing switching to formulary alternatives when requesting coverage for non‑formulary/non‑covered medications.

Documentation must include name, strength, and dates of alternatives tried and specifics of treatment failure when available.
Prescription claims may be used to establish prior use of formulary alternatives.

Note

Document symptomatic AD therapies when relevant

Document prior or concurrent use of standard symptomatic AD therapies (e.g., cholinesterase inhibitors, memantine) as contextual information when relevant to the PA or exception request.

Cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine are acknowledged as standard symptomatic therapies.
Include prior treatment history if it informs the request.

Step Therapy

Meet formulary step requirements or request exception

For requests involving non‑covered medications, the member must have had previous treatment failure with, or contraindication to, at least two covered formulary alternatives when available; exceptions may be considered via individual consideration.

Member may require documentation of failure or contraindication to two covered formulary alternatives.
Individual consideration process is available for atypical patients.

Documentation Required

Document prior formulary trials with specifics

If formulary alternatives were tried, include the name and strength of each alternative and specifics regarding the treatment failure (dates and reason) with the exception or PA submission.

Provide dates of trial and detailed description of treatment failure or adverse effects.
If prescription claims are insufficient, include chart documentation.

Documentation Required

Required documentation to support prior authorization

Providers must document prior use/failure of formulary alternatives if applicable, prescriber participation in the CMS CED registry, attestation of amyloid pathology with PET within 12 months or CSF ttau/Aβ42 or ptau/Aβ42, and MRI report within 12 months confirming absence of exclusionary findings.

Prescriber participation in CMS Monoclonal Antibodies Directed Against Amyloid CED Study Registry is required.
Amyloid PET within 12 months OR CSF ttau/Aβ42 or ptau/Aβ42 results must be submitted.
MRI report within the previous 12 months attesting absence of exclusionary pathological findings must be submitted.

Documentation Required

Provide clinical and biomarker documentation matching trial criteria

Include evidence of amyloid pathology (amyloid PET visual read or CSF Aβ1‑42 assessment) and clinical staging consistent with trial entry (MCI or mild dementia; CDR global 0.5 or 1.0; Memory Box ≥0.5; objective episodic memory impairment; MMSE ≥22 and within trial range).

Amyloid PET visual read or CSF Aβ1‑42 results.
Clinical measures: CDR global 0.5 or 1.0; Memory Box ≥0.5; objective episodic memory impairment; MMSE ≥22.

Documentation Required

Submit supporting clinical documentation with PA/exception requests

Submit supporting documentation such as chart notes, lab results, and other clinical information to show the member meets all approval criteria; for exception requests include prior treatments tried/failed and clinical rationale.

Chart notes, lab/imaging results, and relevant clinical statements are expected.
For exceptions, include clinical literature, compendia references, and guideline citations when helpful.

Documentation Required

Attach detailed supporting documentation to exception requests

Providers should include clinical notes, supporting statements, names and strengths of formulary alternatives tried and specifics regarding treatment failure, relevant literature, and compendia or guideline references to facilitate exception review.

Clinical notes or supporting clinical statements.
Names and strengths of alternatives tried, with specifics of failure.
Peer‑reviewed literature or references from recognized drug compendia or guidelines.

Documentation Required

Document diagnostic and staging criteria (amyloid confirmation + cognitive testing)

Document diagnostic testing and staging evidence: amyloid PET visual read or CSF Aβ measures to confirm amyloid positivity, and objective cognitive testing showing MCI due to AD or mild AD dementia consistent with trial criteria.

Amyloid PET visual read OR CSF Aβ1‑42/ttau or ptau ratios.
Objective episodic memory impairment and CDR/MMSE scores per trial entry criteria.

Denial Risk

Incomplete documentation increases denial risk

Failure to provide required documentation (amyloid confirmation, MRI report, clinical staging, prior therapy trials, prescriber registry participation) increases the risk of denial or non‑coverage.

Requests based solely on samples will not meet coverage criteria.
Lack of chart notes, lab/imaging results, or required attestations risks denial.

Denial Risk

Sample‑only requests are not acceptable for exceptions

Requests based exclusively on the use of samples will not meet coverage criteria for exception; additional clinical information demonstrating medical necessity must be submitted by the prescriber.

Samples alone are insufficient for approval of an exception.
Provide clinical notes, test results, and rationale to support medical necessity.

ApoE ε4 homozygotes have a higher incidence of ARIA; consider testing ApoE ε4 status prior to initiation to inform ARIA risk.

Monitoring implicationBaseline and interval MRI monitoring is required because ARIA is a recognized safety risk.

inv-39: Mild cognitive impairment (MCI)

DefinitionMild cognitive impairment (MCI) is a syndrome of memory loss or other cognitive deficits greater than expected for age but without impairment of day‑to‑day functioning.

Clinical significanceIndividuals with MCI are at increased risk of progression to dementia but many do not progress and some improve.

Trial contextMCI due to AD was an enrolment category in pivotal trials (Clarity AD, TRAILBLAZER‑ALZ 2) for these therapies.

inv-40: NIA-AA numeric clinical staging

DefinitionThe NIA‑AA numeric clinical staging is a research-oriented 1–6 staging scheme reflecting progression from biomarker abnormalities in asymptomatic individuals to severe dementia.

Use caseDesigned for interventional trials and research rather than routine clinical labeling.

FeaturesStages incorporate biomarker status (A/T/N) and cognitive performance comparisons to normative data; later stages include neurobehavioral changes and functional impairment.

inv-41: Amyloid positivity — definition and acceptable tests

Definition of amyloid positivityPresence of brain amyloid pathology confirmed by amyloid PET visual read or CSF Aβ measures (eg ttau/Aβ42 or ptau/Aβ42) as used for trial enrollment.

Acceptable testsAmyloid PET using approved tracers (eg 18F‑florbetapir, 18F‑flutemetamol, 18F‑florbetaben) or CSF assays reporting Aβ42 or Aβ42 ratios; PET results may also be expressed on the Centiloid scale.

DocumentationPrescriber attestation and supporting PET within 12 months or CSF results must be submitted for prior authorization.

inv-42: iADRS scale description

Scale descriptionThe integrated Alzheimer's Disease Rating Scale (iADRS) combines cognitive (ADAS‑Cog13) and functional (ADCS‑iADL) components to assess overall clinical status; lower scores reflect worse cognitive‑functional performance.

Use in trialsiADRS was the primary efficacy endpoint for donanemab (KISUNLA) Study 1, assessing change from baseline to 76 weeks.

InterpretationUsed to quantify clinical decline and treatment effect in pivotal donanemab studies (eg significant reduction in decline on iADRS reported at Week 76).

inv-43: Centiloid — amyloid PET quantification

DefinitionCentiloid is a standardized scale for quantifying amyloid PET signal to express amyloid plaque levels across different tracers and scans.

Use in donanemab trialsDonanemab Study 1 used centiloid thresholds to determine treatment discontinuation (eg <11 Centiloids on single PET or 11–<25 on two consecutive PETs allowed switching to placebo).

Relation to SUVRAmyloid PET results were quantified by SUVR methods and also expressed on the Centiloid scale to facilitate cross‑study comparison and treatment decisions.