Development of a Multidimensional HTA Evaluation for the Introduction of Clesrovimab in Pediatric RSV Prevention: An Integrated Methodological Approach
Author(s)
Filippo Rumi, MA, MSc1, Michele Basile, Sr., Msc2, Eugenio Di Brino, Msc3, Giovanna Elisa Calabrò, PhD4.
1Co-Founder & Partner, Altems Advisory, Università Cattolica del Sacro Cuore, Roma, Italy, 2Altems Advisory, Università Cattolica del Sacro Cuore, Rome, Italy, 3Altems Advisory, Università Cattolica del Sacro Cuore, Roma, Italy, 4Università degli Studi di Cassino e del Lazio Meridionale, Cassino, Italy.
1Co-Founder & Partner, Altems Advisory, Università Cattolica del Sacro Cuore, Roma, Italy, 2Altems Advisory, Università Cattolica del Sacro Cuore, Rome, Italy, 3Altems Advisory, Università Cattolica del Sacro Cuore, Roma, Italy, 4Università degli Studi di Cassino e del Lazio Meridionale, Cassino, Italy.
OBJECTIVES: Respiratory Syncytial Virus (RSV) infection is one of the leading causes of hospitalization in newborns and infants during the first months of life. The introduction of clesrovimab, a long-acting monoclonal antibody developed for seasonal RSV prophylaxis in the pediatric population, opens new perspectives for universal prevention. This study outlines the methodological approach used to structure a multidimensional Health Technology Assessment (HTA) aimed at supporting evidence-informed decision-making regarding the national adoption of the technology.
METHODS: The project is based on the EUnetHTA Core Model framework, which integrates nine domains of evaluation, from clinical aspects to ethical and organizational dimensions. The methodology included: a systematic review of the scientific literature on disease burden, efficacy, and safety of clesrovimab; adaptation of a cost-effectiveness model (CEM) and a budget impact model (BIM) to the Italian National Health Service (NHS) context; two multi-stakeholder focus groups involving clinicians, institutional representatives, and patient associations to validate model assumptions and select relevant outcomes.
The analysis is conducted from the NHS perspective and a seasonal time horizon, considering direct healthcare costs, QALYs gained, and service organization aspects related to administration.
RESULTS: The cost-effectiveness model will estimate the ICER of clesrovimab compared to the absence of systematic prophylaxis, assessing its impact on severe RSV incidence and pediatric hospitalizations. Efficacy data suggest a significant protective effect in the early months of life, consistent with regulatory evidence. Safety assessment shows a favorable profile, with mild and self-limiting adverse events. The organizational impact will be analyzed in relation to the integration of seasonal administration into existing vaccination pathways, while the ethical-social domain will explore the relevance of prophylaxis in reducing inequalities and improving equitable access to care.
CONCLUSIONS: Clesrovimab appears to be a cost-effective option for RSV prevention. The HTA approach supports informed decisions and may promote equitable access and improved outcomes in the neonatal population.
METHODS: The project is based on the EUnetHTA Core Model framework, which integrates nine domains of evaluation, from clinical aspects to ethical and organizational dimensions. The methodology included: a systematic review of the scientific literature on disease burden, efficacy, and safety of clesrovimab; adaptation of a cost-effectiveness model (CEM) and a budget impact model (BIM) to the Italian National Health Service (NHS) context; two multi-stakeholder focus groups involving clinicians, institutional representatives, and patient associations to validate model assumptions and select relevant outcomes.
The analysis is conducted from the NHS perspective and a seasonal time horizon, considering direct healthcare costs, QALYs gained, and service organization aspects related to administration.
RESULTS: The cost-effectiveness model will estimate the ICER of clesrovimab compared to the absence of systematic prophylaxis, assessing its impact on severe RSV incidence and pediatric hospitalizations. Efficacy data suggest a significant protective effect in the early months of life, consistent with regulatory evidence. Safety assessment shows a favorable profile, with mild and self-limiting adverse events. The organizational impact will be analyzed in relation to the integration of seasonal administration into existing vaccination pathways, while the ethical-social domain will explore the relevance of prophylaxis in reducing inequalities and improving equitable access to care.
CONCLUSIONS: Clesrovimab appears to be a cost-effective option for RSV prevention. The HTA approach supports informed decisions and may promote equitable access and improved outcomes in the neonatal population.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA108
Topic
Economic Evaluation, Epidemiology & Public Health, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Infectious Disease (non-vaccine)