CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

Lecanemab (Leqembi€) and Donanemab (KisunlaTM) for Alzheimer's Disease Prior Authorization Request Form #949

Authorization form and checklist to request prior authorization for initiation and continuation (12-month approval) of Lecanemab (Leqembi) and Donanemab (Kisunla) for patients with MCI or mild dementia due to Alzheimer's disease; references Medical Policy MP 946 for detailed medical necessity criteria and FDA label. Provides documentation, registry participation, facility/provider identification, and ordering/billing code placeholders.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyLecanemab (Leqembi€) and Donanemab (KisunlaTM) for Alzheimer's Disease Prior Authorization Request Form #949

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit initial authorization requests using Authorization Manager (or fax OON requests to 888-973-0726) with supporting clinical documentation and completed form 949.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes to policy or form were reported.

2Drugs covered on form

12Initial approval length noted

1Registry requirement

Policy form purpose and scope

This authorization form accompanies Medical Policy MP 946 (Monoclonal Antibodies for Treatment of Alzheimer's Disease) and operationalizes prior authorization for two anti-amyloid monoclonal antibodies: Lecanemab (Leqembi) and Donanemab (Kisunla).

The form captures patient and facility identification, and requires clinical documentation supporting medical necessity consistent with MP 946; providers are instructed to submit requests via Authorization Manager (or fax for out-of-network) and to include required clinical documentation.

Providers and ordering clinicians must attest to specified clinical and facility-level requirements, including adherence to FDA labeling and MRI and anticoagulation safety requirements (e.g., platelet count <50,000 and INR >1.5 are exclusion thresholds, and anticoagulant therapy should be on a stable dose for 4 weeks prior to initiation).

The form includes MRI recency and findings criteria (MRI within the previous 12 months and must not show non‑AD dementia or significant pathological findings) and placeholders for ordering/billing codes and facility NPIs.

Approval length for initiation is specified as 12 months.

Form metadata

PolicyLecanemab and Donanemab Prior Authorization Request Form #949

PayerBlue Cross Blue Shield - Massachusetts

Effective date

StatusCURRENT

Scope summaryAuthorization form and checklist to request prior authorization for initiation and continuation (12-month approval) of Lecanemab (Leqembi) and Donanemab (Kisunla) for patients with MCI or mild dementia due to Alzheimer's disease; references Medical Policy MP 946 for detailed medical necessity criteria and FDA label. Provides documentation, registry participation, facility/provider identification, and ordering/billing code placeholders.

Approval length12 months

Medical necessity criteria for initiation and continuation

Initiation of Therapy (Approval Length 12 Months)

Patient must meet ALL of the following:

ALL of the following

Meets criteria for mild cognitive impairment (MCI) or mild dementia stage of Alzheimer disease (AD) (see policy guidelines in MP 946)
Presence of amyloid beta pathology (see policy guidelines in MP 946)
Access to an appropriate healthcare delivery model (see policy guidelines in MP 946)
MRI within previous 12 months
- MRI must NOT show: Evidence of a non-AD dementia
- MRI must NOT show: Evidence of significant pathological findings on brain MRI (see policy guidelines in MP 946)
Must not have any of the following
- Concurrent neurological condition(s), other than MCI or AD, contributing to cognitive impairment
- History of stroke, transient ischemic attacks or seizures within 12 months prior to initiating treatment with Lecanemab and Donanemab12 months
- Bleeding disorder that is not under adequate controlPlatelet <50,000; INR >1.5
  Per MP 946
Anticoagulation: If receiving anticoagulant therapy, anticoagulant status should be optimized and individual should be on a stable dose prior to initiating treatment with Lecanemab and DonanemabStable dose for 4 weeks prior to initiation
See MP 946
Anti-amyloid antibody exclusion: Not receiving another anti-amyloid monoclonal antibody (e.g., aducanumab)
FDA alignment: Is prescribed in accordance with the U.S. Food and Drug Administration (FDA) approved prescribing label (see policy guidelines in MP 946)

Continuation of Therapy / On-treatment Monitoring

Patient must meet ALL of the following during treatment:

ALL of the following

Disease progression: AD has not progressed to severe dementia
MRI monitoring: Has received MRI during treatment according to schedule recommended in FDA label to monitor for amyloid-related imaging abnormalities (ARIA) (see policy guidelines in MP 946)
See FDA label and MP 946 for schedule
MRI must NOT show
- ARIA of the severity that meets recommendations for dosing interruptions provided in the FDA label (see policy guidelines in MP 946)

Physician Requirements / Registry Participation

Providers must attest to ALL:

ALL of the following

CMS CED Registry participation: Physicians administering Lecanemab and Donanemab are required to be a participant in the CMS Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CED Study Registry (for Medicare patients) and must attest to participation
Providers must attest; registry requirement noted in form
Practice & data collection: The physician administering the drug practices in an appropriate setting with a structured data collection system that evaluates patient safety and harms, treatment benefits and efficacy, and overall improvement in patient health outcomes
Providers must attest to practice setting and structured data collection

Clinical safety thresholds

Platelet count< 50,000 — exclusion

INR> 1.5 — exclusion

Anticoagulant stabilityStable dose for 4 weeks prior to initiation

MRI recencyMRI completed within previous 12 months

Prior authorization, documentation, and registry requirements

Prior Authorization

Submit prior authorization via Authorization Manager

Submit initial prior authorization requests using Authorization Manager (preferred). For out-of-network providers, fax requests to 888-973-0726. Include clinical documentation supporting medical necessity and a completed Prior Authorization Request Form #949 with the submission.

Authorization Manager (preferred)
Fax for OON: 888-973-0726
Form: 949 (Prior Authorization Request Form)

Documentation Required

Clinical documentation requirement

Submit clinical documentation that supports the medical necessity criteria in MP 946. If the patient does not meet all listed criteria, submit a letter of medical necessity requesting a Clinical Exception (Individual Consideration) explaining why an exception is justified.

Documentation Required

Provider attestation and registry participation

Physicians administering Lecanemab and Donanemab must attest that they participate in the CMS Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CED Study Registry for Medicare patients and that they practice in an appropriate setting with a structured data collection system to evaluate safety, harms, benefits, efficacy, and overall patient outcomes.

Prior Authorization

Prior authorization for PET/MRI and ApoE testing

PET scans and MRIs require prior authorization from the Carelon High Technology Radiology Management Program. ApoE genotype testing requires prior authorization from the Carelon Genetic Testing Management Program.

Carelon High Technology Radiology Management: prior authorization for PET/MRI
Carelon Genetic Testing Management Program: prior authorization for ApoE genotype testing

Referenced policy and definitions

Definitions

MP 946Blue Cross Blue Shield Massachusetts Medical Policy 946: Monoclonal Antibodies for Treatment of Alzheimer's Disease (referenced for detailed criteria). Form operationalizes MP 946 and aligns with the FDA label.

The form requires physicians administering Lecanemab and Donanemab to attest participation in the CMS Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CED Study Registry as a Medicare Coverage with Evidence Development (CED) requirement for Medicare patients.

Providers must also attest that they practice in an appropriate setting with a structured data collection system to evaluate patient safety, harms, treatment benefits, efficacy, and overall patient health outcomes.

J0174	Injection, lecanemab-irmb, mg (eff 7/6/2023) [listed on form]
J0175	Code description incomplete on form; listed

OpenPayer

Lecanemab (Leqembi€) and Donanemab (KisunlaTM) for Alzheimer's Disease Prior Authorization Request Form #949

Policy form purpose and scope

Medical necessity criteria for initiation and continuation

Codes referenced on form and authorization notes

Prior authorization, documentation, and registry requirements

Referenced policy and definitions

Document changes