The criteria for stopping Donanemab-azbt (Kisunla) therapy are primarily based on amyloid plaque reduction and safety monitoring, as outlined in clinical guidelines and prescribing information:
Primary Stopping Criteria
Amyloid Plaque Reduction on PET Imaging:
Discontinue when amyloid plaques reach <11 Centiloids on a single PET scan or
11–<25 Centiloids on two consecutive PET scans (consistent with visually negative scans).
Clinical Progression:
Stop if the patient progresses to moderate or severe Alzheimer disease (loss of efficacy in later stages).
Safety Concerns:
Symptomatic ARIA-E (brain edema) or ARIA-H (microhemorrhages) requiring permanent discontinuation.
Intracerebral hemorrhage >1 cm (suspend and reassess).
Severe hypersensitivity reactions (e.g., anaphylaxis).
Additional Considerations
Clinical Judgment: Providers may stop therapy earlier if amyloid clearance is achieved and cognitive scores stabilize/improve[2][4].
Post-Cessation Monitoring: Amyloid levels may rebound after stopping; repeat PET imaging may guide retreatment decisions[2].
Documentation Requirements
Baseline and serial MRIs (before 2nd, 3rd, 4th, and 7th infusions) to monitor ARIA[1][3].
Cognitive/functional assessments (e.g., ADAS-Cog, CDR-SB) showing stability or slowed decline[1][4].
Donanemab is unique among anti-amyloid therapies for its finite treatment duration upon plaque clearance, reducing long-term costs and infusion burden[4][6].
Citations:
[1] http://mcgs.bcbsfl.com/MCG?mcgId=09-J4000-94&pv=false
[3] https://www.modahealth.com/-/media/modahealth/shared/medical-necessity-criteria/MODA_MPS_Kisunla.pdf
[4] https://hhs.iowa.gov/media/14833/download?inline
[5] https://www.fda.gov/media/180803/download
[7] https://medicalpolicy.bcbstx.com/content/dam/bcbs/medicalpolicy/pdf/rx/RX501.177_2025-03-15.pdf
[8] https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/kisunla.pdf
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