OH Epic Formulary, available via therapy plan restricted to:

• 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
• 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 Beta-Amyloid Ratio (1- 42/1-40) or p-Tau/Abeta42
  • 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)
    • Clinical Dementia Rating-Global Score (CDR-GS) of 0.5 or 1; or
    • Mini-Mental Status Examination (MMSE) score of 22 – 30; or
    • Documentation of one of the following scores at baseline on any of the following assessment tools:
    • 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
  • No history of transient ischemic attacks (TIA), stroke, or seizures within 12 months of screening
  • Provider attestation that monitoring for ARIA will be conducted via MRI within one year prior to initiation and prior to the second, third, fourth and seventh infusions of donanemab (Kisunla), and periodically as appropriate in the setting of ARIA

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