What infrastructure and staffing changes do infusion centers need to safely deliver and monitor anti‑amyloid antibody treatments?
Executive summary
Infusion centers that plan to deliver anti‑amyloid monoclonal antibodies must expand beyond routine infusion capacity: they need protocols and physical space for repeated IV infusions, rapid access to MRI and laboratory testing for ARIA surveillance, trained multidisciplinary staffing including neurology and radiology expertise, and systems for registry reporting and informed‑consent counseling [1] [2] [3]. The operational change is as much about ongoing monitoring and risk mitigation — frequent MRIs, APOE genotyping, graded reaction protocols, and neurologic assessment — as it is about chair time and drug handling [4] [5] [6].
1. Clinical protocols and risk pathways must be standardized and embedded in workflows
Anti‑amyloid infusions require explicit, codified protocols for eligibility screening, infusion reaction grading, ARIA surveillance and dose‑holding or discontinuation decisions; these protocols mirror clinical‑trial workflows and have been recommended in institutional playbooks and appropriate‑use frameworks [7] [3] [4]. Centers must incorporate pre‑infusion checks (confirmation of amyloid pathology, APOE genotyping recommendations, baseline MRI) and a schedule of surveillance MRIs tied to specific infusion numbers (for example, before the 2nd, 3rd, 4th and 7th infusions with additional scans for higher‑risk patients) as described in AURs for donanemab and for lecanemab guidance [4] [5].
2. Imaging capacity and rapid radiology read‑outs are a bottleneck that must be solved
ARIA (amyloid‑related imaging abnormalities) — edema, microhemorrhages, superficial siderosis — drive the need for repeated, sometimes urgent MRIs and expert neuroradiology interpretation; centers therefore need guaranteed MRI access and radiologists trained to report ARIA promptly so infusion and management decisions can be made the same day [2] [4]. Real‑world implementation documents and advisory statements emphasize MRI availability as a core resource, and many centers have centralized initial infusions at hospital sites to ensure imaging and escalation pathways are immediately available [5] [8].
3. Nursing, neurology, and pharmacy staffing require new competencies and expanded headcount
Nurses will need education in grading infusion reactions (mild to severe), administering premedication when indicated, and recognizing neurologic or systemic signs that warrant MRI or hospitalization; reports note nursing unfamiliarity with these specific mAbs and high infusion‑reaction rates in trials (~26% in CLARITY‑AD for lecanemab), prompting formal reaction protocols and possible increased observation time post‑infusion [3] [6]. Neurologists or memory‑clinic physicians must be available for baseline cognitive assessment, shared decision‑making, and same‑day consults if ARIA or concerning events occur, while pharmacy teams need validated preparation, dilution and administration procedures and secure cold‑chain handling [7] [9].
4. Administrative systems: registries, consent, and payer/documentation burdens
Centers must document therapy in health records clearly, enroll patients in CMS or FDA registries when required for reimbursement and post‑market surveillance, capture NPIs and MBIs, and build processes for tracking imaging and adverse events for quality reporting — administrative work that will require dedicated coordinator time and training [3] [7]. Informed‑consent conversations are more substantive than many routine infusions: clinicians must cover modest efficacy, ARIA risks, APOE genotype implications, blood‑thinning exclusions, and long‑term uncertainty, tasks often supported by social workers or specialized clinic navigators [10] [11].
5. Physical infrastructure, patient flow and contingency planning
Infusion centers should plan for recurring visits every 2–4 weeks over many months, needing more infusion chairs/rooms, longer turnaround times per patient, and pathways for urgent transfer to emergency or inpatient care when severe ARIA or allergic reactions occur; several centers route initial infusions to hospital infusion suites for this reason [1] [8]. Where subcutaneous formulations remain investigational, current reality is IV delivery with attendant resource intensity; if SC options succeed, some pressures on infusion capacity may ease, but that is not yet standard practice [9].
Limitations and contested issues: long‑term benefits versus costs and the natural history of ARIA remain debated, and some centers differ on eligibility thresholds and monitoring cadence; the sources outline consensus recommendations but acknowledge evolving evidence and local adaptation will be necessary [12] [2].