Original Title: Coste-efectividad de la vacunación sistemática frente a enfermedad meningocócica invasiva por serogrupos A, C, W e Y en nińos y niñas de 12 meses

Authors' objectives: To assess cost-effectiveness, ethical, patient, social, legal, and organizational considerations, as well as to describe the research needs for routine MenACWY vaccination of children up to twelve months of age.

Authors' results and conclusions: RESULTS: COST-EFFECTIVENESS AND BUDGETARY IMPACT ANALYSIS: The SR on cost-effectiveness revealed four economic evaluations published between 2005 and 2017 in the USA, Canada, and the Netherlands. All the studies agree that vaccination against MenACWY reduces the number of cases and deaths from meningitis. Only one study compares vaccination strategies against MenACWY in different population groups versus non-vaccination, concluding that vaccination is not a cost-effective alternative from a societal perspective. The rest of the studies compare MenACWY vaccination strategies versus MenC vaccination strategies in different population groups, obtaining in two of them that vaccination against MenACWY is cost-saving with respect to vaccination against MenC in childhood. The results of the cost-effectiveness analysis carried out show that the mean average cost per individual for the strategy of vaccinating against MenACWY and vaccinating against MenC is €77.92 and €43.76, respectively, from the NHS perspective. The mean QALYs are slightly higher with the strategy of vaccinating against MenC. However, this small difference in QALYs between alternatives means that vaccinating against MenACWY does not turn out to be a cost-effective intervention from the NHS perspective (ICER > €25,000/QALY). These conclusions hold when considering the societal perspective. The sensitivity analysis by scenarios shows that variations in the incidence of the disease and in the price of the vaccine have a significant effect on the cost-effectiveness results. It should be noted that, taking into account the current incidence of IMD by any serogroup in our country, MenACWY vaccination would be a cost-effective alternative compared to vaccination against MenC if the price of MenACWY vaccine was €15.20/dose (ICER: €23,816.31/QALY). The budget impact analysis shows that, given the current low incidence of the disease and the high price of the vaccine, the cost of MenACWY, cases averted by the vaccine, both mild and severe, does not exceed that of routine vaccination throughout Spain for the target child population. Therefore, the implementation of a systematic vaccination strategy against MenACWY with two doses instead of vaccination against MenC could mean an expense for the NHS of €11,767,217 in the fifth year of its introduction across Spain. This estimated expense assumes that there is no extra cost for the administration of the childhood vaccine, since it would be applied as part of routine pediatric health check-ups. ORGANIZATIONAL, ETHICAL, SOCIAL AND/OR LEGAL ISSUES: Five studies that addressed these issues were included. The included studies described the physical, neurological, and psychosocial sequelae of IMD that increase the health and socio-familial burden associated with the disease and have a negative impact on the long-term quality of life of those infected and their families. The results showed different structural factors associated with non-compliance with the MenACWY vaccination schedule, which are related to social determinants such as school absenteeism, geographic residence, race/ethnicity, family income, and gender. Overall, the findings were of little relevance, since the outcome measures used were dispersed, the follow-up period was highly variable, and they presented conflicts of interest. In addition, they had differing methodological designs. No study with qualitative methodology was found that could provide greater clarity about the phenomenon studied, and the research came from high-income countries, but none were conducted in the Spanish context. CONCLUSIONS: • There is insufficient scientific evidence to ensure that routine childhood vaccination against MenACWY is a cost-effective option compared to vaccination against MenC. • The de novo cost-effectiveness analysis conducted in this report with data from Spain concludes that the incorporation of a systematic childhood vaccination strategy against MenACWY instead of vaccination against MenC would not be a cost-effective option from the perspective of the NHS, taking into account the incidence of the disease and the price of the currently available vaccine. • The de novo cost-effectiveness analysis conducted in this report with data from Spain concludes that the incorporation of a systematic childhood vaccination strategy against MenACWY instead of vaccination against MenC would be a cost-effective option from the perspective of the NHS as long as the price of the vaccine against MenACWY does not exceed €15.20 per dose. • The analysis of the budget impact estimates that the incorporation of a systematic vaccination strategy against MenACWY in the population up to twelve months of age could mean an expense for the NHS of up to €11 767 217 in the fifth year of its introduction. • The analysis of the ethical, organizational, social, patient and environmental aspects related to vaccination against MenACWY in childhood shows that there are few studies and their results are inconclusive, particularly those studies referring to the burden of the disease, quality of life and the modification of the vaccination schedule and its repercussions. • The absence of studies with qualitative or mixed methodology that could contribute a deeper analysis of the burden of the disease, the long-term quality of life and the reasons influencing non-compliance with the vaccination scheme against MenACWY is noteworthy. • The variations observed in the access to vaccination against MenACWY between the different Autonomous Communities, highlights the existing geographical inequity within the NHS.

Authors' methods: COST-EFFECTIVENESS AND BUDGET IMPACT ANALYSIS: Firstly, a systematic review (SR) of the scientific evidence on the cost-effectiveness of vaccination against MenACWY in children was carried out. Complete economic evaluations comparing a routine vaccination strategy against MenACWY versus no vaccination, or another strategy were included. The methodological quality was assessed using the criteria of Drummond et al. A complete economic evaluation was conducted out in which the costs and health outcomes of routine vaccination against MenACWY in children up to twelve months of age were evaluated versus routine vaccination against MenC from the NHS and societal perspective. The analysis was based on a decision model that synthesizes the information obtained in the literature on the incidence of the disease, the efficacy of the vaccine against MenACWY, as well as the consequences and/or sequelae of IMD associated with MenACWY (in terms of both cost and QALY) that are avoided by the introduction of a routine vaccination programme. In order to do this, a mathematical model was built that combines a decision tree and a Markov type model with annual cycles. The time horizon was patient lifetime and a discount of 3% is applied to both costs and effects. In addition, probabilistic and deterministic sensitivity analyzes by scenarios were carried out. Finally, a five-year budget impact analysis (from 2022 to 2026) was performed to inform about the cost of implementing a systematic childhood vaccination strategy (in children up to 12 months of age) against MenACWY in Spain. ORGANIZATIONAL, ETHICAL, SOCIAL AND/OR LEGAL ISSUES: An SR of the literature was performed, starting from the same population, intervention, and comparison mentioned in the cost-effectiveness section. The review focused on two of the Evaluation Criteria to Support Modifications in the Vaccination Program in Spain (2011): the burden of the disease and the modification of the vaccination schedule and its repercussions.

Project Status: Completed

Year Published: 2023

URL for published report: https://sescs.es/coste-efectividad-vacunacion-meningococica-invasiva-ninos-ninas-12-meses/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es