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    Kisunla™

    Drug - Kisunla™ (donanemab-azbt) [Eli Lilly and Company]

    March 2025

    Therapeutic Area - Alzheimer’s Agents

    Initial approval criteria

    • Patient is ≥ 18 years of age; AND
    • Patient has mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or has mild Alzheimer’s dementia (there is insufficient evidence in moderate or severe AD) as evidenced by ALL the following:
      • Clinical Dementia Rating (CDR)-Global Score of 0.5 to 1
      • Memory Box Score of ≥ 0.5
      • Objective evidence of cognitive impairment at screening
      • Mini-Mental State Examination (MMSE) score between 20 to 28, inclusive
      • Positron Emission Tomography (PET) scan or cerebrospinal fluid (CSF) assessment of amyloid ß (Aß 1-42) is positive for amyloid beta plaque; AND
    • Other conditions mimicking, but of non-Alzheimer’s dementia etiology, have been ruled out (e.g., vascular dementia, dementia with Lewy bodies [DLB], frontotemporal dementia [FTD], normal pressure hydrocephalus); AND
    • Must be prescribed by, or in consultation with, a specialist in neurology or gerontology.
    • Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., MMSE, Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog-13], Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment version [ADCS-ADL-MCI], Clinical Dementia Rating-Sum of Boxes [CDR-SB]); AND
      • Patient has been tested prior to treatment to assess apolipoprotein E ε4 (ApoE ε4) status (e.g., homozygote, heterozygote, or noncarrier), and the prescriber has informed the patient that those who are homozygotes have a higher incidence of developing amyloid related imaging abnormalities (ARIA); OR
      • Genotype testing has not been performed, and the prescriber has informed the patient that it cannot be determined if they are ApoE ε4 homozygotes and, therefore, it also cannot be determined whether they are at higher risk for developing ARIA; AND
    • Patient has received a baseline brain magnetic resonance imaging (MRI) prior to initiating treatment and periodically throughout therapy (see prescribing information for schedule of MRI scans); AND
    • Patient does NOT have a clinically significant and unstable psychiatric illness in the past 6 months; AND
    • Patient does NOT have a history of alcohol or substance abuse in the preceding year; AND
    • Will NOT be used concurrently with other anti-amyloid immunotherapies; AND
    • Prescriber attests that the patient and/or caregiver understands the risks and benefits of Kisunla therapy AND
    • Prescriber attests that the patient and/or caregiver understands and is committed to receiving scheduled doses and enhanced clinical vigilance during the first 24 weeks of treatment
    • The following documentation must be provided at time of requests:
      • Healthcare facility’s written processes and procedures to support enhanced clinical vigilance during the first 14 weeks of treatment; AND
      • Patient’s educational materials to empower patient and caregiver during the enhanced clinical vigilance period and thereafter including ways to contact prescriber and other relevant clinical staff
    • Initial approval is for 6 months

    Renewal criteria

    • Patient must continue to meet the above criteria; AND
    • Patient has responded to therapy compared to pretreatment baseline as evidenced by improvement, stability, or slowing in cognitive and/or functional impairment in ≥ 1 of the following (not all-inclusive): ADAS-Cog 13; ADCS-ADL-MCI; MMSE; CDR-SB; AND
    • Patient will discontinue treatment when reduction of amyloid plaques are reduced to minimal levels on amyloid PET imaging, defined as either of the following:
      • Level is < 11 Centiloids on a single PET scan; OR
      • Level is 11 to < 25 Centiloids on 2 consecutive PET scans; AND
    • Patient has NOT progressed to moderate or severe AD; AND
    • Patient has received a pre- 2nd, 3rd, 4th, AND 7th infusion MRI for monitoring of ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H) microhemorrhages; AND
    • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include ARIA-E and ARIA-H, intracerebral hemorrhage, and severe infusion-related reactions including anaphylaxis.
    • Renewal approval is for 12 months

    Quantity limits

    • 2 vials every 4 weeks for three doses followed by 4 vials every 4 weeks thereafter (700 mg every 4 weeks for the first three doses, followed by 1,400 mg every 4 weeks thereafter)

    Billing for Kisunla

    Kisunla must be billed as a medical claim.

    Questions

    Provider Call Center (844) 575-7887

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