Abstract
INTRODUCTION: Respiratory syncytial virus (RSV) is a major cause of acute respiratory illness. A bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved in Japan to prevent RSV-related diseases in older adults in 2024. This study evaluated the cost-effectiveness of the RSVpreF vaccine compared with no vaccination in Japanese adults aged 60 years and older from the payer and societal perspectives. METHODS: A population-based, multi-cohort, Markov-type model was used to estimate the economic and health impact of vaccination against RSV over a lifetime horizon. Model inputs were derived from published Japanese and international sources. Vaccine effectiveness was derived from clinical trial data and assumed to wane over time. The base-case analysis was conducted assuming a vaccination rate of 50%. Scenario analyses, along with deterministic and probabilistic sensitivity analyses, were conducted to assess the uncertainty around model inputs. RESULTS: The RSVpreF vaccine was anticipated to reduce 204,145 cases of RSV hospitalization, 113,170 cases of RSV emergency department visits, 542,790 cases of RSV outpatient visits, and 27,764 RSV-related deaths versus no vaccination. These reductions in disease burden resulted in savings of Japanese yen (JPY) 176,121 million in medical expenses and JPY 161,307 million in productivity losses. There was an incremental gain of 290,312 quality-adjusted life-years (QALYs), with incremental cost-effectiveness ratios (ICERs) of JPY 1,458,898/QALY from the payer perspective and JPY 903,263/QALY from the societal perspective, which was below the cost-effectiveness threshold of JPY 5 million/QALY. The scenario and sensitivity analyses confirmed the robustness of the results. CONCLUSIONS: The RSVpreF vaccine is cost-effective compared to no vaccination for adults aged 60 years and older in Japan. It has the potential to provide significant public health benefits by reducing the burden of RSV-related diseases.