Original Title: Coste-efectividad de la vacunación sistemática frente a enfermedad meningocócica invasiva por serogrupo B en la infancia

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

Authors' results and conclusions: RESULTS: COST-EFFECTIVENESS AND BUDGETARY IMPACT ANALYSIS: The SR on cost-effectiveness revealed sixteen economic evaluations, eleven of which were included in a previous review and another five were published between 2019 and 2022. All the studies agree that vaccination against MenB reduces the number of cases and deaths from meningitis. All the studies, except one, also conclude that vaccination is not cost-effective, as all of them found very high incremental cost-effectiveness ratios. Several authors explain that this is due to the low incidence of the disease in their respective countries such as Canada, France, or the Netherlands and/or the high cost of the vaccine. The threshold price of the vaccine estimated in seven studies that would make the vaccination cost-effective varies between €1.45 and €10 according to the authors. The results of the modeling carried out show that both the 2+1 vaccination schedule and the 3+1 schedule prevent cases of IMD, both mild and severe, as well as deaths caused by the disease. The results of the cost-effectiveness analysis show that the mean average cost per individual for the strategy of not vaccinating, vaccinating with the 2+1 regimen, and vaccinating with the 3+1 regimen is €13.19, €229.40, and €303.23, respectively. The mean QALYs are slightly higher with the strategy of vaccinating with the 3+1 regimen than with the other strategies. However, this small difference in QALYs between alternatives means that the options to vaccinate (with any regimen) against MenB do not turn out to be cost-effective interventions from the NHS perspective (ICER > €25,000/QALY) considering the current incidence of the disease in Spain. The sensitivity analysis by scenarios shows that variations in the incidence of the disease and in the effectiveness of the vaccine have a significant effect on the cost-effectiveness results. The budget impact analysis shows that, given the current low incidence of the disease and the high price of the vaccine, the cost of MenB 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 MenB with the 2+1 regimen could mean an expense for the NHS that could reach forty-four million euros 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: Six 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. Only one study analyzed cases of children with severe serogroup B IMD, and it identified additional long-term sequelae such as bone damage and speech delay. The results showed different structural factors associated with non-compliance with the MenB 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 disperse, 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: • According to the reviewed scientific literature, routine childhood vaccination against MenB would not be justified from the point of view of cost-effectiveness. • 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 MenB 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 analysis by scenarios shows that considering a vaccine effectiveness of at least 80% and the current incidence, a systematic vaccination strategy against MenB with the 2+1 regimen would be a cost-effective alternative from the perspective of the NHS as long as the price per dose of the vaccine was €4.5. • The analysis of the budget impact estimates that the incorporation of a systematic vaccination strategy against MenB in the population under twelve months of age with a 2+1 vaccination schedule could mean an expense for the NHS of up to €44,240,831 in the fifth year of its introduction. • The analysis of the ethical, organizational, social, patient and environmental aspects related to vaccination against MenB in childhood and adolescence 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 MenB is noteworthy.

Authors' methods: COST-EFFECTIVENESS AND BUDGET IMPACT ANALYSIS: Firstly, a systematic review (SR) of the scientific evidence on the cost-effectiveness of vaccination against MenB in children and adolescents (up to 18 years of age) was carried out. Complete economic evaluations comparing a routine vaccination strategy against MenB versus no vaccination, or another strategy were included. The methodological quality was assessed using the criteria of Drummond et al. A complete de novo economic evaluation was conducted out in which the costs and health outcomes of routine vaccination against MenB in children under twelve months of age (2+1 regimen and 3+1 regimen) were evaluated versus not vaccinating from the perspective of the NHS. 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 MenB, as well as the consequences and/or sequelae of IMD associated with MenB (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 analysis 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 under 12 months of age) against MenB 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-sistematica-meningococica-b-infancia/

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