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      Evaluación económica de la inclusión en el calendario vacunal de 4CMenB (Bexsero®) en España Translated title: Economic evaluation of the introduction of 4CMenB (Bexsero®) in the national vaccine schedule in Spain

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          Abstract

          Resumen Introducción Bexsero® (4CMenB), vacuna contra el meningococo B, fue autorizada en Europa en 2013. En España, a pesar de que el meningococo B es la principal causa de enfermedad meningocócica invasiva (EMI), Bexsero® está recomendada y financiada para pacientes con alto riesgo de EMI pero no de forma sistemática en el calendario vacunal del SNS. Objetivo Evaluar el coste-utilidad, el impacto epidemiológico y los costes totales de la introducción de 4CMenB para una política vacunal informada en España. Método Se adaptó para España un análisis de coste-utilidad, árbol de decisión probabilístico. Una cohorte de recién nacidos en 2015 fue modelizada con dos posologías mediante dos estrategias: vacunación sistemática con 4CMenB o no vacunación. Los costes se midieron desde la perspectiva del pagador y los beneficios se calcularon en años de vida ajustados por calidad (AVAC). Se realizó un análisis de Monte Carlo y se consideraron 32 escenarios para valorar la robustez y la incertidumbre de los resultados. Resultados Con la pauta 3+1, la vacunación sistemática previno el 54% de los casos y de las muertes, y se estimó una razón de coste-utilidad incremental (RCUI) de 351.389 €/AVAC (intervalo de confianza del 95% [IC95%]: 265.193-538.428). La pauta 2+1 previno el 50% de los casos y de las muertes, con una RCUI de 278.556 €/AVAC (IC95%: 210.285-430.122). Conclusiones Dada la incidencia actual de enfermedad meningocócica invasiva en España y la información disponible sobre 4CMenB, nuestro modelo indica que la vacunación sistemática no es coste-efectiva con el actual precio. Solo con un precio de 1,45 € para la pauta 3+1 o de 3,37 € para la pauta 2+1 podría ser recomendada basándose en su eficiencia.

          Translated abstract

          Abstract Introduction Bexsero® (4CMenB), meningococcal B vaccine, was licensed in Europe in 2013. In Spain, despite MenB being the most frequent cause of invasive meningococcal disease (IMD), Bexsero® is recommended and financed for patients at increased risk of IMD but is not financed by the NHS in the routine vaccination schedule. Objective Evaluate the cost-utility, epidemiological impact, and total costs of the introduction of 4CMenB into the vaccination schedule to help inform vaccine policy in Spain. Method We adapted a cost-utility analysis, a probabilistic decision-tree, to Spain. A cohort of new-born infants in 2015 was modelled with two dosages, using two different strategies: routine vaccination schedule with 4CMenB and non-vaccination. Costs were measured from a payer perspective and benefits were calculated in quality-adjusted life years (QALYs). A Monte Carlo analysis and 32 scenarios were performed to assess the robustness and the uncertainty of our results. Results With the 3+1 dosage, routine vaccination prevented 54% of cases and deaths and an incremental cost-utility ratio (ICUR) of 351.389 €/QALY (95% confidence interval [95%CI]: 265,193-538,428) was estimated. The 2+1 dosage prevented 50% of cases and deaths, with an ICUR of 278.556 €/QALY (95%CI: 210,285-430,122). Conclusions Given the current incidence of invasive meningococcal disease in Spain and the information available from 4CMenB, our model shows that routine vaccination is not cost-effective at the current price. Only with a vaccine price of 1.45 € for the 3+1 schedule or 3.37 € for the 2+1 schedule could it be recommended based on efficiency criteria.

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          Meningococcal disease.

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            Global epidemiology of meningococcal disease.

            As reviewed in this paper, meningococcal disease epidemiology varies substantially by geographic area and time. The disease can occur as sporadic cases, outbreaks, and large epidemics. Surveillance is crucial for understanding meningococcal disease epidemiology, as well as the need for and impact of vaccination. Despite limited data from some regions of the world and constant change, current meningococcal disease epidemiology can be summarized by region. By far the highest incidence of meningococcal disease occurs in the meningitis belt of sub-Saharan Africa. During epidemics, the incidence can approach 1000 per 100,000, or 1% of the population. Serogroup A has been the most important serogroup in this region. However, serogroup C disease has also occurred, as has serogroup X disease and, most recently, serogroup W-135 disease. In the Americas, the reported incidence of disease, in the range of 0.3-4 cases per 100,000 population, is much lower than in the meningitis belt. In addition, in some countries such as the United States, the incidence is at an historical low. The bulk of the disease in the Americas is caused by serogroups C and B, although serogroup Y causes a substantial proportion of infections in some countries and W-135 is becoming increasingly problematic as well. The majority of meningococcal disease in European countries, which ranges in incidence from 0.2 to 14 cases per 100,000, is caused by serogroup B strains, particularly in countries that have introduced serogroup C meningococcal conjugate vaccines. Serogroup B also predominates in Australia and New Zealand, in Australia because of the control of serogroup C disease through vaccination and in New Zealand because of a serogroup B epidemic. Based on limited data, most disease in Asia is caused by serogroup A and C strains. Although this review summarizes the current status of meningococcal disease epidemiology, the dynamic nature of this disease requires ongoing surveillance both to provide data for vaccine formulation and vaccine policy and to monitor the impact of vaccines following introduction.
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              Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: a national observational cohort study.

              In September, 2015, the UK became the first country to introduce the multicomponent group B meningococcal (MenB) vaccine (4CMenB, Bexsero) into a publicly funded national immunisation programme. A reduced two-dose priming schedule was offered to infants at 2 months and 4 months, alongside an opportunistic catch-up for 3 month and 4 month olds. 4CMenB was predicted to protect against 73-88% of MenB strains. We aimed to assess the effectiveness and impact of 4CMenB in vaccine-eligible infants in England.
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                Author and article information

                Journal
                gs
                Gaceta Sanitaria
                Gac Sanit
                Ediciones Doyma, S.L. (Barcelona, Barcelona, Spain )
                0213-9111
                August 2020
                : 34
                : 4
                : 318-325
                Affiliations
                [4] Granada Andalucía orgnameUniversidad de Granada orgdiv1Facultad de Ciencias Económicas y Empresariales Spain
                [7] orgnameCIBER de Epidemiología y Salud Pública (CIBERESP) España
                [6] Granada orgnameInstituto de Investigación Biosanitaria (IBS Granada) España
                [1] Córdoba orgnameHospital Universitario Reina Sofía orgdiv1Unidad de Gestión Clínica Interniveles de Prevención, Promoción y Vigilancia de la Salud España
                [5] Granada orgnameEscuela Andaluza de Salud Pública España
                [2] Córdoba orgnameInstituto Maimónides de Investigación Biomédica de Córdoba (Imibic) España
                [3] Córdoba Andalucía orgnameUniversidad de Córdoba orgdiv1Facultad de Medicina y Enfermería Spain
                Article
                S0213-91112020000400003 S0213-9111(20)03400400003
                10.1016/j.gaceta.2019.08.007
                31776044
                1e02ffc5-31e8-4407-876b-19dcb4128bea

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 13 August 2019
                : 11 March 2019
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 29, Pages: 8
                Product

                SciELO Spain

                Categories
                Originales

                Neisseria meningitidis serogrupo B,Mass vaccination,Preschool,Análisis de costo-beneficio,España,Child,Lactantes,Vacunas meningocócicas,Meningococcal vaccines,Preescolares,Infant,Vacunación masiva,Spain,Cost-benefit analysis,Neisseria meningitidis serogroup B

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