OHS Formulary with restrictions:

• Indication: treatment of Alzheimer’s disease (AD)
• Service line: neurology, psychiatry, or neuropsychiatry involving in Ochsner Memory Program
• Formulary location: outpatient infusion
• Service location: outpatient infusion, home infusion
• Patient population: adults
  • 50 years of age or older
  •  If less than 50 years of age, patient with a genetic mutation in amyloid precursor protein (APP), presenilin-1 (PSEN1), or presenilin-2 (PSEN2), or other clinical documentation to support early onset AD
• Prior authorization required: yes
• Medicare Registry required: yes
• Restriction/criteria of use (all will apply unless specified):
  • Confirmed amyloid positive via amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) measurement of Aβ1–42
  • Confirmed diagnosis of mild cognitive impairment or mild dementia stage of disease
  • Testing for ApoE ε4 status performed prior to initiation of treatment to inform the risk of developing amyloid related imaging abnormalities (ARIA) (higher incidence of ARIA if ApoE ε4 homozygote)
  • Documentation of one of the following scores at baseline on any of the following assessment tools:
    • Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1; or
    • Mini-Mental Status Examination (MMSE) score of 21 - 30; or
    • Montreal Cognitive Assessment (MoCA) score of greater than or equal to 16
  • No significant pathological findings on pre‐treatment MRI (e.g., no contraindications for serial MRI brain scans, no prior history of brain surgery or implants, no evidence of intracranial hemorrhage or cerebral amyloid angiopathy)
  • No history of cerebrovascular abnormalities or bleeding disorder that would present a risk for ARIA‐related bleeding
  • Patients are NOT on therapeutic anticoagulation (e.g., enoxaparin, warfarin, apixaban, rivaroxaban, dabigatran, etc.)
  • Provider attestation that monitoring for ARIA will be conducted via MRI within one year prior to initiation and prior to the fifth, seventh, and fourteenth infusions of lecanemab, and periodically as appropriate in the setting of ARIA

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