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A physician fax prior authorization form (CVS Caremark/HMSA) to support coverage determinations for an amyloid beta-directed antibody (Leqembi) for patients with Alzheimer's disease; collects clinical criteria, baseline testing, safety monitoring (ARIA), and continuation/reauthorization data required for approval.
No material changes to clinical criteria or coverage in this update.
Coverage Summary
This is a CVS Caremark prior authorization fax form used by HMSA to support coverage determinations for lecanemab (Leqembi) with a covered_with_criteria stance. The form requires a documented diagnosis of Alzheimer’s disease (or specification of other diagnosis), objective cognitive testing at baseline (CDR‑GS, MMSE, or MoCA), and biomarker confirmation of amyloid pathology (positive amyloid PET or qualifying CSF results). It also requires baseline and scheduled MRI monitoring for ARIA and documentation of ApoE genotype or evidence that the prescriber counseled the patient about ApoE status and ARIA risk.
Key facts: - Drug referenced: Leqembi (lecanemab). - Required baseline/monitoring tests: Multiple (PET or CSF amyloid, baseline MRI within 1 year, baseline cognitive assessments, scheduled MRIs prior to specified doses). - Key cognitive assessments listed: 3 (CDR‑GS, MMSE, MoCA).
Medical‑Necessity Criteria
Initial and Continuation Therapy Criteria
Covered when ALL of the following (as applicable for initial or continuation requests) are met:
Not Covered / Experimental
Excluded uses and safety contraindications include use in combination with any other amyloid beta‑directed antibodies (the form asks if the drug will be used with another amyloid antibody) and patients with recent (<12 months) TIA, stroke, or seizures or with bleeding disorders that are not adequately controlled (including platelet count <50,000 or INR >1.5). The brief does not list additional experimental interventions beyond these explicit exclusion statements on the form.
Coding and Identifiers Collected
| Form requests the ICD-10 code to be entered by provider (blank on form) |
| Leqembi | Leqembi (lecanemab) referenced in footer; form is for prior authorization of this amyloid beta-directed antibody |
Provider Actions & Submission Requirements
Submit prior authorization via fax to CVS Caremark
Fax the completed prior authorization form and all required attachments to CVS Caremark at 1-866-237-5512 for HMSA patients.
Attach required baseline and monitoring assessments
Attach the following assessments and results with the request:
- Baseline Clinical Dementia Rating Global Score (CDR-GS) or MMSE or MoCA (attach baseline assessment tool)
- Baseline PET scan results OR lumbar puncture (CSF) results confirming amyloid (attach results)
- Baseline brain MRI within one year prior to initiating treatment (attach MRI)
- Subsequent MRIs as required prior to the 5th, 7th, and/or 14th doses (attach each applicable MRI)
- Most recent clinical assessment (CDR‑GS, MMSE, or MoCA) within 1 month prior to a continuation request (attach results)
Provide ApoE testing or counseling documentation
If ApoE genotype testing was not performed, document that the prescriber informed the patient that ApoE homozygosity cannot be determined and that they may be at higher risk for ARIA.
Provider attestation signature required
The prescriber or an authorized signer must sign and date the form to attest that the information is accurate and that supporting documentation is available for review.
Risk of denial if missing required tests or documentation
Requests may be denied or not approved if required documentation is missing. Denial risk applies when baseline biomarker confirmation of amyloid (PET or CSF), baseline cognitive assessments (CDR‑GS, MMSE, or MoCA), required MRIs (baseline within 1 year or monitoring MRIs prior to specified doses), or documentation of clinical response for continuation (recent CDR‑GS/MMSE/MoCA) are not attached as indicated on the form.
Background
Background: This fax prior authorization form administered by CVS Caremark for HMSA collects the clinical documentation necessary to determine coverage for lecanemab (Leqembi). It requests the patient’s diagnosis (Alzheimer’s disease or other), baseline cognitive assessments (CDR‑GS, MMSE, or MoCA) and their results, biomarker confirmation of amyloid pathology via amyloid PET or CSF assay, a recent baseline brain MRI within one year to assess for pre‑existing ARIA, and documentation of ApoE genotype testing or that the prescriber informed the patient about ApoE homozygosity risk prior to initiation.
Definition: ARIA refers to Amyloid Related Imaging Abnormalities (including ARIA‑E and ARIA‑H), which are to be assessed by MRI and characterized by severity and symptom status.
Revision History
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