Evaluating respiratory syncytial virus immunization strategies for infants in Canada: A cost-utility analysis

Abstract

Background Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections and hospitalizations among infants in Canada. New long-acting monoclonal antibodies (mAbs) and vaccines administered during pregnancy have expanded prevention options, yet the most cost-effective immunization program remains uncertain. Methods We updated a Canadian cost-utility model to evaluate seven seasonal RSV prevention strategies over one year (with a lifetime horizon for mortality impacts), from health system and societal perspectives. Strategies included RSVpreF vaccination in late pregnancy; targeted or universal infant mAb programs using nirsevimab or clesrovimab; and combination programs in which infants could receive protection from either RSVpreF or mAbs. Sequential incremental cost-effectiveness ratios (ICERs) were estimated in 2024 Canadian dollars per quality-adjusted life year (QALY), using a $50,000/QALY threshold. The primary analysis used immunization product list prices. Findings The most cost-effective strategy was a seasonal combination program: RSVpreF vaccination for pregnancies due during the RSV season, with mAb for infants at high risk (<32 weeks’ gestation), including catch-up for infants at high risk born before the season. This strategy had an ICER of $35,408/QALY compared to seasonal mAb for infants at moderate risk (32 0/7 to 36 6/7 weeks’ gestation) or high-risk with catch-up. Expanding mAb to unimmunized non-high-risk infants born in-season increased the ICER to $132,131/QALY. Universal infant protection, with mAb alone or combined with RSVpreF in pregnancy, was not cost-effective across analyses. RSVpreF alone was dominated. Results were most sensitive to product prices, target populations, age at administration, and RSV burden. Conclusions A seasonal combination program with RSVpreF for in-season deliveries and mAb for infants at high risk of RSV offers the best value for money for protecting Canadian infants from RSV disease. Broader infant immunization programs may be cost-effective with substantial price reductions or in regions with higher disease burden and healthcare costs.