Leqembi Iqlik (lecanemab-irmb) — Highmark
Alzheimer’s disease (ICD-10: G30)
Initial criteria
- Diagnosis of Alzheimer’s disease (ICD-10: G30)
- Disease classified as mild cognitive impairment OR mild dementia
- Completed 18 months of IV infusions of Leqembi 10 mg/kg every two weeks
- Prior to initiation of Leqembi IV, confirmed presence of amyloid beta pathology via PET imaging
- Prior to initiation of Leqembi IV, documentation of baseline functional and/or cognitive status INCLUDING Clinical Dementia Rating (CDR)-Global score AND Mini-Mental State Examination (MMSE) score ≥ 19
- Prior to initiation of Leqembi IV, brain MRI obtained within the past year
- Prior to initiation of Leqembi IV, no history within previous year of localized superficial siderosis, ≥ 10 brain microhemorrhages, OR brain hemorrhage > 1 cm
- Not taking anticoagulant or antiplatelet agents except aspirin for prevention of cardiovascular or thromboembolic events
- Prescriber has ruled out other possible causes of cognitive impairment or dementia (e.g., substance abuse, schizophrenia, vascular dementia, Parkinson’s disease dementia, Huntington’s disease)
- Prior to initiation of Leqembi IV, ApoE ε4 genetic testing performed
Reauthorization criteria
- Documentation that disease is stable or improved
- No progression to moderate or severe disease as indicated by BOTH MMSE score ≥ 19 AND CDR-Global score ≤ 1.0 OR CDR-Sum of Boxes ≤ 9
Approval duration
12 months