Background
Respiratory syncytial virus (RSV) is associated with substantial morbidity in the United States, especially among infants. Nirsevimab, an investigational long-acting monoclonal antibody, was evaluated as an immunoprophylactic strategy for infants in their first RSV season and for its potential impact on RSV-associated, medically attended lower respiratory tract illness (RSV-MALRTI) and associated costs.
Methods
A static decision-analytic model of the US birth cohort during its first RSV season was developed to estimate nirsevimab’s impact on RSV-related health events and costs; model inputs included US-specific costs and epidemiological data. Modelled RSV-related outcomes included primary care and emergency room visits, hospitalizations including intensive care unit admission and mechanical ventilations, and RSV-related mortality.
Results
Under current standard of care, RSV caused 529 915 RSV-MALRTIs and 47 281 hospitalizations annually, representing $1.2 billion (2021 US dollars [USD]) in costs. Universal immunization of all infants with nirsevimab is expected to reduce 290 174 RSV-MALRTI, 24 986 hospitalizations, and expenditures of $612 million 2021 USD.
Conclusions
An all-infant immunization strategy with nirsevimab could substantially reduce the health and economic burden for US infants during their first RSV season. While this reduction is driven by term infants, all infants, including palivizumab-eligible and preterm infants, would benefit from this strategy.
A reviewer on this manuscript has disclosed that they serve as an Advisor to Pfizer and have served as a collaborating author on cost effective analyses for vedolizumab vs anti tnf therapies. Another of the reviewers is employed as a health economist with a pharmaceutical manufacturer and is currently leading health economic evaluation projects A c c e p t e d M a n u s c r i p t in the inflammatory bowel disease portfolio. The other peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.
reported data on UK patients. Five of them considered only emergency operations for the management of acute exacerbations. From the remaining four records, two publications reported data from large, population-based studies, with 15 and 20 years of patient follow-up. The evidence suggested a linear increase in the incidence after the first 5 years since diagnosis. The cumulative probability of colectomy ranged from 6.9% over 15 years in one study to 8.3% and 11.2% at 10 and 20 years since diagnosis in the second study. This cumulative risk was lower, but broadly within the range of colectomy incidence rates presented by other studies from Norway or a multi-country meta-analysis of population-based studies for surgery in inflammatory bowel diseases. The UK IBD reported complications among 32% and 35% of patients undergoing elective and non-elective surgery respectively, with wound infection being the most common event. The overall mortality was reported to be reduced by 19% between two consecutive versions of the audit: 0.92% (28/3049) in 2010-2012 and 0.75% (30/3987) in 2012-2014. Conclusions: Colectomy is still the last option for UC patients with an inadequate response to pharmacological treatments. The cumulative probability of colectomy, since diagnosis of UC, showed a steady increase but remained in comparable levels with other non-UK studies.
In comparison to double ballon enteroscopy, EC results in an incremental diagnostic yield of -0.04 and an incremental cost of BRL 2,451 (USD 612). As such, EC is a dominant therapy compared to double balloon enteroscopy. Sensitivity analysis indicated that the results were robust to variations in both cost and effectiveness variables. Cost of EC and push enteroscopy were the varibles with the greatest impact on results. Conclusions: The analysis indicates that enteroscopy with endoscopic capsule has lower costs and a better diagnostic yield when compared to double balloon enteroscopy, making it a dominant alternative. Compared to push enteroscopy, EC may be considered a cost-effectiveness therapy that considerably improves the diagnostic yield.
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