Letermovir Prophylaxis in Pediatric Allogeneic Hematopoietic Stem Cell Transplantation: Clinical Effectiveness and Economic Implications

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Abstract
Background: Cytomegalovirus (CMV) reactivation is a major infectious complication following pediatric allogeneic hematopoietic stem cell transplantation (HSCT), particularly in low‐ and middle‐income countries (LMICs) with high CMV seroprevalence. Data on the clinical and economic impact of letermovir prophylaxis in pediatric HSCT recipients from resource‐constrained settings remain limited. Methods: We conducted a retrospective cost‐effectiveness analysis of pediatric allogeneic HSCT recipients at a university‐affiliated tertiary‐care transplant center in India. Clinical outcomes and direct medical costs were compared between patients who received letermovir prophylaxis and those managed with a standard pre‐emptive CMV strategy. The primary outcome was CMV reactivation by Day +100 post‐transplant. Cost‐effectiveness was evaluated using the incremental cost‐effectiveness ratio (ICER). Results: Fifty patients were included, of whom 15 received letermovir prophylaxis and 35 received standard pre‐emptive management. By Day +100 post‐transplant, CMV reactivation occurred in 26.7% of patients receiving letermovir compared with 91.4% in the non‐letermovir group ( p < 0.001). Median time to CMV reactivation was longer in the letermovir group at 28.5 days versus 18.0 days. No patient in the letermovir group required additional CMV‐related hospitalization, whereas 50% of patients in the non‐letermovir group required prolonged hospitalization. Mean total treatment costs were higher in the letermovir group at $1868.5 compared with $1698.6 in the non‐letermovir group; however, the incremental cost‐effectiveness ratio was $262.6 per additional patient without CMV reactivation. Conclusions: Despite higher upfront costs, letermovir demonstrated favorable cost‐effectiveness in pediatric allogeneic HSCT recipients in resource‐limited settings, while providing significant clinical benefits through reduced CMV reactivation, delayed breakthrough infection, and decreased CMV‐related hospitalization.

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