The results of a study on the cost-effectiveness of Sanofi’s RSV preventive antibody injection for infants, Beyfortus (nirsevimab), have been published, sparking debate around including Beyfortus in Korea’s National Immunization Program (NIP).

A research team led by Professor Hae-Sun Suh from Kyung Hee University College of Pharmacy recently published Beyfortus’s cost-effectiveness when introducing it to Korea.

This study is the first in Korea to analyze the cost-effectiveness of Beyfortus and was published in the international journal ‘Human Vaccines & Immunotherapeutics’.

The study compared two strategies: administering Beyfortus to all infants under 12 months and to high-risk children under 24 months, versus the current strategy of administering a preventive antibody injection (palivizumab) only to high-risk infants.

Using claims data from the Health Insurance Review and Assessment Service (HIRA), the team conducted a cost-utility analysis (CUA) from a societal perspective. This included outpatient and inpatient treatment, management of complications, caregiver productivity loss, and socioeconomic costs from premature death.

Results showed that using the Beyfortus strategy on all infants under 1 year of age and high-risk groups under 2 years of age reduces unnecessary medical costs associated with RSV infection and alleviates the burden of productivity loss for caregivers.

In particular, it was confirmed that over 90% of the overall health improvement effect originated from the group of full-term infants under one year of age, supporting the validity of a universal RSV prevention strategy for all infants.

Furthermore, the incremental cost-effectiveness ratio (ICER) for introducing the Beyfortus prevention strategy compared to the existing strategy was USD 33,071 per QALY (approximately KRW 43 million per QALY), demonstrating its cost-effectiveness.

QALY, the cost-effectiveness indicator used in this study, is a health outcome measure that reflects health-related quality of life by applying a weight. It quantifies ‘how long and how healthily one can live’ through treatment and prevention.

Although a cost-effectiveness threshold is not explicitly defined in Korea, analysis using commonly accepted standards—ranging from approximately USD 35,000 (per capita GDP) to USD 50,000 (1.5 times per capita GDP)—showed this study demonstrated cost-effectiveness within that range.

Professor Suh said, “This study confirmed that a prevention strategy utilizing Beyfortus is not only effective for preventing RSV in infants and young children in Korea, but also provides a valid basis for its inclusion in a nationwide universal vaccination program. We hope these results will serve as key policy data for the future introduction of Beyfortus into the National Immunization Program, thereby contributing to protecting infant and young child health and reducing the social burden.”

Beyfortus demonstrates cost-effectiveness …Will it synergize with the revised legislation?


The published research on Beyfortus is expected to bolster future discussions regarding the National Immunization Program (NIP).

Given the NIP's inherent goal of maximizing the vaccination effect through universal immunization, cost-effectiveness remains a critical consideration alongside efficacy.

This aspect is included in the ‘Bill for the Partial Amendment to the Infectious Disease Prevention and Management Act’ proposed by Representative Yong-ki Jeon of the Democratic Party of Korea last August, which addresses RSV's inclusion in the NIP.

While the legislative intent stated that it aims to contribute to public health improvement through infectious disease prevention by mandating essential vaccinations for acute respiratory infections, the inclusion of provisions regarding the submission of cost estimation requests implies that future submission of vaccine cost-effectiveness evaluation data is a prerequisite.

Particularly, it is analyzed that the fact that the Korea Disease Control and Prevention Agency (KDCA) has not established clear guidelines for the preventive antibody Beyfortus within the NIP program, which has primarily focused on vaccines, could positively influence its potential inclusion in the universal vaccination program.

Hee-kyung Park, Head of Sanofi’s Vaccine Division, said, “While 90% of infants under 2 years old are infected with RSV, there are no available treatments for RSV, making prevention crucial. Hospitalizations due to infant RSV infection place a significant burden on parents and families raising children. Therefore, establishing an effective prevention strategy accessible to all infants is paramount.”

Park added, “Sanofi will continue to protect infant health and reduce the medical and economic burdens faced by families and society through innovative preventive solutions.”