CurrentHawaii Medical Service Association (HMSA)Policy N/A

Leqembi Prior Authorization Form

Prior authorization form used by CVS Caremark (for HMSA members) to collect clinical information to determine coverage for Leqembi (lecanemab). Governs initial and continuation authorization criteria, required diagnostic tests, baseline and follow-up assessments, and documentation submission instructions.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLeqembi Prior Authorization Form

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFax completed Leqembi prior authorization form and required attachments (baseline cognitive assessments, PET or CSF results, baseline MRI, follow-up MRIs) to CVS Caremark Specialty Programs at 1-866-237-5512; contact CVS Caremark for authorization questions at 1-808-254-4414.

POLICY UPDATE CHANGES

No material clinical/coverage changes

ManyRequired attachments/options (baseline PET/CSF/MRI/cognitive tests)

2Key exclusion lab thresholds (platelet, INR)

3Acceptable baseline cognitive tools (CDR-GS, MMSE, MoCA)

Coverage Summary

This is a prior authorization form used by CVS Caremark (for HMSA members) to collect clinical information to determine coverage for Leqembi (lecanemab). The form governs initial and continuation authorization criteria, required diagnostic tests, baseline and follow-up assessments, and documentation submission instructions and is currently in effect. Coverage stance: covered_with_criteria. The subject is Leqembi prior authorization criteria and continuation requirements and the status is CURRENT.

Required documentation/attachments enumerated on the form include baseline cognitive assessment(s) (one of CDR-GS, MMSE, or MoCA), confirmatory amyloid testing (baseline PET scan or CSF biomarker results), and a baseline brain MRI within one year to evaluate for pre-existing ARIA. For continuation requests, the form requires attaching MRIs corresponding to the 5th, 7th, and 14th doses as applicable and documentation of ARIA findings and symptoms.

The form highlights key safety thresholds and testing related to bleeding risk and ARIA risk: platelet count <50,000 and INR >1.5 are considered uncontrolled bleeding disorders (exclusions), and ApoE genotype testing is recommended prior to initiation to inform ARIA risk (with prescriber counseling required if testing not performed). Contact and submission instructions: fax the completed form and attachments to CVS Caremark Specialty Programs at 1-866-237-5512 and contact CVS Caremark for authorization questions at 1-808-254-4414.

Medical Necessity Criteria

General flow and eligibility screening

Form questions to establish diagnosis, contraindications, and prescriber specialty before assessing initial or continuation coverage criteria.

ALL of the following

Diagnosis: Alzheimer's disease OR Other (specify)
If Other, requester still continues through form
Therapy status
- Request for continuation of therapy with requested drug
  If yes go to continuation-specific questions
- Not a continuation (initial therapy)
  Proceed with initial therapy questions
Other neurodegenerative etiologies (e.g., FTLD, Lewy body) have been evaluated/ruled out
Form asks whether other etiologies have been ruled out
Concurrent antithrombotic therapy (aspirin, antiplatelets, anticoagulants) documented
Form asks and if present requires stability assessment
If on antithrombotic therapy: stable dose for at least 4 weeks prior to initiation
Yes/No asked
No history of TIA, stroke, or seizures within past 12 months
Form asks presence/absence
No uncontrolled bleeding disorder (including platelet count <50,000 or INR >1.5)
Form asks presence/absence
Not receiving combination therapy with other amyloid beta-directed antibodies (e.g., aducanumab)
Form asks whether used in combination
Medication prescribed by or in consultation with geriatrician, neurologist, psychiatrist, or neuropsychiatrist
Yes/No required
Age / early-onset pathway
- Patient is 50 years of age or older
  If yes proceed with standard pathway
- Patient under 50: requires genetic testing confirming APP, PSEN1, or PSEN2 mutation OR clinical documentation supporting early-onset Alzheimer's disease
  If under 50 attach documentation

Clinical status and baseline cognitive assessment (initial therapy)

Baseline objective evidence required for mild cognitive impairment due to AD or mild AD and baseline cognitive testing.

ALL of the following

Diagnosis of mild cognitive impairment due to AD or mild Alzheimer's disease (AD)
If yes, attach medical records/chart notes documenting diagnosis
Objective evidence of cognitive impairment at baseline
- Objective impairment in one or more cognitive domains (formal or bedside testing)
- Cognitive concern reflecting change reported by patient/informant/clinician
- Preservation of independence in functional abilities

Continuation / Reauthorization criteria

Questions to establish safety monitoring, ARIA evaluation, and evidence of clinical benefit at reauthorization intervals (6 months, 18+ months).

ALL of the following

Continuation interval pathway
- Completed 6 months of therapy (first reauthorization after initial 6-month period)
  Proceed to ARIA surveillance questions
- Completed 18 months of therapy or more
  Proceed to clinical response assessment
ANY of the following
- MRI to 5th dose: performed? (attach results if yes)

Provider Actions / Prior Authorization

Prior Authorization

Submit prior authorization form to CVS Caremark

Fax completed Leqembi prior authorization form and required attachments to CVS Caremark Specialty Programs. Fax: 1-866-237-5512. For authorization questions contact CVS Caremark at 1-808-254-4414. Submit the completed form and attachments to CVS Caremark Specialty Programs as instructed on the form.

Documentation Required

Attach required diagnostic and baseline documentation

Attach the following required diagnostic and baseline documentation with the prior authorization form: baseline cognitive assessment (CDR-GS, MMSE, or MoCA) with the baseline assessment tool attached if used; confirmatory amyloid testing results (positive amyloid PET scan or CSF lumbar puncture results meeting the listed biomarker criteria); baseline brain MRI performed within one year prior to initiating treatment (attach MRI); lumbar puncture/CSF results if used; and genetic testing results or clinical documentation supporting early-onset Alzheimer's disease for patients under age 50.

Baseline CDR-GS, MMSE, or MoCA (attach baseline assessment tool if used)
PET scan confirming amyloid pathology (attach results) or CSF lumbar puncture results meeting biomarker criteria (attach LP results)
Baseline brain MRI within one year prior to initiation (attach MRI)
Lumbar puncture (CSF) results if used (attach)
Genetic testing confirming APP/PSEN1/PSEN2 mutation or clinical documentation of early-onset AD for patients <50 (attach)

Documentation Required

ARIA monitoring imaging

For continuation requests, attach brain MRI results corresponding to dose-specific monitoring: MRI to the 5th dose, MRI to the 7th dose, and MRI to the 14th dose as applicable. The prescriber must document whether ARIA is present and, if so, specify type (ARIA-E or ARIA-H), radiographic severity, and patient symptom status.

Attach MRI results for evaluations to the 5th, 7th, and 14th doses if performed
Document presence or absence of ARIA
If ARIA present, document type (ARIA-E or ARIA-H), radiographic severity, and symptoms

Documentation Required

ApoE testing or patient counseling

Perform ApoE genotype testing prior to initiation to inform risk of developing ARIA when possible. If genotype testing has not been performed, the prescriber must document that they informed the patient that ApoE homozygosity cannot be determined and may confer higher ARIA risk.

ApoE genotype testing performed prior to initiation (preferred)
If not performed, document prescriber informed patient that ApoE homozygosity cannot be determined and may increase ARIA risk

Documentation Required

Demographic and administration site information

Complete patient demographic and administration/dispensing site information on the form. Include patient demographics, where the drug will be dispensed and administered, and prescriber specialty and NPI as requested on the prior authorization form.

Patient demographics (name, DOB, ID, weight/height as requested)
Dispensing site and administration site selection
Prescriber specialty and NPI

Coding

ICD-10 for diagnosis entryICD-10

No codes listed

Background

The form collects clinical and safety information aligned with lecanemab use, requiring documentation of a diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease and objective evidence of cognitive impairment at baseline (examples include impairment in one or more cognitive domains, cognitive concern reported by patient/informant/clinician, preservation of independence in function, and not demented).

Baseline cognitive testing is required: the form asks that one of Clinical Dementia Rating Global Score (CDR-GS), Mini-Mental Status Examination (MMSE), or Montreal Cognitive Assessment (MoCA) be completed and attached; acceptable score categories are captured as options (CDR-GS 0/0.5/1/2+, MMSE <21 or 21–30, MoCA ≥16 or ≤15). If none of these assessments were completed at baseline the form directs 'No Further Questions.'

Confirmatory amyloid pathology must be documented by either a positive PET scan (attach results) or cerebrospinal fluid (CSF) biomarkers meeting listed criteria (elevated P-tau and/or T-tau with reduced Aβ42, low Aβ42/Aβ40 ratio, or elevated P-Tau/Aβ42 or T-Tau/Aβ42 ratios; attach lumbar puncture results if used).

Safety evaluation for ARIA is required: a baseline MRI within one year prior to initiating treatment is requested to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA) and must be attached if performed. The form asks whether ApoE genotype testing for apolipoprotein E4 (ApoE) status was performed prior to initiation to inform ARIA risk; if testing was not performed, the prescriber must document that the patient was informed that ApoE homozygosity cannot be determined and may confer higher ARIA risk.

The form also captures concurrent medication and bleeding risk (concurrent antithrombotic therapy and stable dosing for at least 4 weeks prior to initiation), and asks about recent history of TIA, stroke, seizures, and uncontrolled bleeding disorders (including platelet count <50,000 or INR >1.5).

Key threshold criteria

ApoE genotype noteTesting recommended; ApoE homozygosity confers higher ARIA risk or prescriber must inform patient if testing not done

Platelet count<50,000 = uncontrolled bleeding disorder (exclusion)

INR>1.5 = uncontrolled bleeding disorder (exclusion)

MoCA baseline threshold>=16 considered acceptable baseline/continuation measure

MMSE categories<21 or 21-30 (documented as selectable categories)

Definitions

ARIA: Amyloid Related Imaging Abnormalities, encompassing ARIA-E (edema) and ARIA-H (hemorrhage/microhemorrhage), identified and classified on MRI with options for severity and symptom status captured on the form.

ApoE: Apolipoprotein E genotype testing is used to assess risk for ARIA; the form records ApoE status (homozygous, heterozygous, non-carrier, or unknown) and requires prescriber counseling if testing was not performed because homozygosity may confer higher ARIA risk.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLeqembi Prior Authorization Form

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

ALL of the following

Clinical Dementia Rating Global Score (CDR-GS) completed
Mini-Mental Status Examination (MMSE) completed
Montreal Cognitive Assessment (MoCA) completed

Acceptable baseline scores (captured as options)

CDR-GS: 0, 0.5, 1, 2 or more, or Unknown (must attach baseline CDR-GS if used)
MMSE: <21 or 21-30 or Unknown (attach baseline MMSE if used)
MoCA: >=16 or <=15 or Unknown (attach baseline MoCA if used)

ANY of the following

Positive amyloid PET scan (attach results)
CSF results meeting listed biomarker criteria (attach LP results)

Baseline brain MRI within one year prior to initiating treatment to evaluate for pre-existing ARIA (attach MRI)

Yes/No asked

ANY of the following

ApoE genotype: Homozygous
ApoE genotype: Heterozygous
ApoE genotype: Non-Carrier
Unknown
If not performed: prescriber informed patient that ApoE homozygosity cannot be determined
If not performed: prescriber informed patient that ApoE homozygosity cannot be determined

MRI to 7th dose: performed? (attach results if yes)

MRI to 14th dose: performed? (attach results if yes)

ALL of the following

If ARIA present
- ARIA severity / symptoms (selections)
  - Type of ARIA: ARIA-E or ARIA-H
  - Mild ARIA-E asymptomatic or mild symptoms
  - Mild ARIA-E with moderate or severe symptoms
  - Moderate ARIA-E (symptom status varied)
  - Severe ARIA-E (symptom status varied)
  - Mild ARIA-H asymptomatic
  - Mild ARIA-H symptomatic
  - Moderate ARIA-H asymptomatic or symptomatic
  - Severe ARIA-H asymptomatic or symptomatic

ALL of the following

CDR-GS most recent result (attach record): 0, 0.5, 1, 2 or more, Unknown
MMSE decline: decline >3 points per year OR decline ≤3 points per year OR Unknown (attach record)
MoCA most recent result: >=16 OR <=15 OR Unknown (attach record)

OpenPayer

Leqembi Prior Authorization Form

Coverage Summary

Medical Necessity Criteria

Provider Actions / Prior Authorization

Coding

Background

Definitions

Revision History