Lecanemab-irmb (Leqembi) (CPB 1026, reviewed 2026-01-27)
Summary
Aetna Clinical Policy Bulletin 1026 covers lecanemab-irmb (Leqembi) for commercial medical plans, and Medicare criteria are in a separate document. Aetna considers Leqembi medically necessary for Alzheimer's disease when the member is 50 or older, or younger with an APP, PSEN1 or PSEN2 genetic mutation or other clinical documentation to support early onset AD, and has Clinical Stage 3 or Clinical Stage 4 AD with objective cognitive impairment at baseline. Baseline scores must be taken within 12 months before treatment starts: CDR-Global Score of 0.5 or 1, MMSE of 21 to 30, or MoCA of 16 or greater. Amyloid pathology must be confirmed by PET or by a lumbar puncture CSF result, and a recent brain MRI within one year before starting is required. Members with a suspected non-AD neurodegenerative cause of cognitive impairment, more than 4 cerebral microbleeds, cortical superficial siderosis, a major vascular contribution confirmed by MRI, a cerebral contusion, encephalomalacia, brain aneurysm, CNS infection or brain tumor, a TIA, stroke, uncontrolled hypertension or seizure in the past 12 months, an uncontrolled bleeding disorder, or an immunologic disorder requiring immunoglobulins, monoclonal antibodies, immunosuppressants or plasmapheresis are excluded. Continuation is covered for 12 months after the initial 7-month approval period, and again for 12 months after the initial 19 months of therapy when the member shows a positive clinical response.
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