Lecanemab Treatment Guidelines for Alzheimer's Disease
Monitoring and Patient Selection
- Mandatory MRI monitoring must be performed before the 5th, 7th, and 14th infusions to detect ARIA, according to Praxis Medical Insights 1, 2
- Baseline brain MRI is required before treatment initiation to assess for contraindications, as recommended by Praxis Medical Insights 1, 2
- Biomarker confirmation requires either amyloid PET, CSF testing, or blood-based biomarkers meeting appropriate performance standards, as stated by Nature Reviews Neurology 3, 4
- Patients must have objective cognitive impairment documented by comprehensive neuropsychological testing, according to Praxis Medical Insights 1, 2
Treatment Considerations
- Lecanemab is inappropriate for cognitively unimpaired individuals, even with positive biomarkers, as noted by Praxis Medical Insights 2
- Treatment requires multidisciplinary teams with specialized training in ARIA management, as recommended by Praxis Medical Insights 1, 2
- Hub-and-spoke care models are being developed to address specialist shortages and enable broader access to lecanemab therapy, according to Praxis Medical Insights 1
- Blood-based biomarkers, such as plasma p-tau217, are emerging as more accessible screening tools with AUCs of 0.92-0.98 for predicting amyloid status, as reported by Nature Reviews Neurology 4
- Enrollment in CMS registry is required for Medicare reimbursement, as noted by Praxis Medical Insights 2
Implementation Requirements for Lecanemab Therapy
Multidisciplinary Team and Registry Enrollment
- Initiation of lecanemab therapy requires a multidisciplinary care team with specialized training in ARIA management, and patients must be enrolled in a CMS‑approved registry to qualify for Medicare reimbursement. 5
Care Delivery Models
- Hub‑and‑spoke care models are being developed to mitigate specialist shortages and expand patient access to lecanemab treatment. 5
Patient Counseling Requirements
- Prior to starting therapy, comprehensive counseling covering anticipated benefits, potential risks, and the required monitoring schedule is essential for informed patient consent. 5