Donanemab-azbt (Kisunla) (CPB 1066, reviewed 2025-10-17)

Immediately: (1) Billing team must implement precertification requirement in billing system for all Kisunla requests—route all requests to prior auth department with phone number (866) 752-7021 or fax (888) 267-3277. (2) Clinical staff must verify patient meets ALL initial approval criteria before submission, including: age ≥50 (or documented early-onset AD), Clinical Stage 3-4 disease, baseline cognitive scores (CDR-GS 0.5-1, MMSE 21-30, or MoCA ≥16), positive amyloid PET or CSF biomarkers, MRI within 1 year, ApoE4 genotype status, and registry enrollment (ALZ-NET or equivalent). (3) Providers must confirm prescriber specialty (geriatrician, neurologist, psychiatrist, or neuropsychiatrist) on all requests. (4) Verify no contraindicated medications: anticoagulants are absolute contraindications; antiplatelet agents limited to monotherapy only. (5) Document all exclusion criteria have been ruled out (no neurodegenerative disease other than AD, microbleeds ≤4, no CNS pathology, no recent TIA/stroke/uncontrolled HTN/seizures, controlled bleeding disorder, no immunologic disorders requiring specific therapies). (6) For continuation therapy: ensure MRI assessments completed before 2nd, 3rd, 4th, and 7th doses; apply ARIA-E and ARIA-H management guidelines per appendices; after 19 months, require evidence of disease stabilization/slowing (CDR-GS stable, MMSE decline ≤3 points/year, or MoCA ≥16). (7) Claims will be denied without precertification or if criteria not met. Update encounter forms and billing workflow to include precertification checklist. Consequences: Failure to precertify results in claim denials; missing documentation or unmet criteria will trigger request denials.