Description of day case costs and tariffs of cataract surgery from a sample of nine European countries

The project IMPACT-HTA has received funding from the European Union's Horizon 2020 research and innovation programme under Grant Agreement No. 779312.Background: The lack of transparency in the methodology of unit cost estimation and the usage of confidential or undisclosed information prevents cost comparisons and makes the transferability of the results across countries difficult. The objective of this article is to compare the methodologies used in the estimation of the cost of a day case cataract extirpation that are described in the official and publicly available sources and to study how these translate into different unit cost estimates. Methods: A literature review was conducted to identify the main sources of unit costs of cataract extirpation. A semistructured questionnaire to obtain information on national costing methodologies was developed and sent to consortium partners in nine European countries. Additionally, publicly available sources of unit cost of cataract surgery in those countries included in the European Healthcare and Social Cost Database (EU HCSCD) were analysed. Results: The findings showed a considerable diversity across countries on unit costs varying from 432.5€ in Poland (minor degree of severity) to 3411.96€ in Portugal (major degree of severity). In addition, differences were found in the year of cost publication and on the level of detail of different types of cataract surgery. The unit of activity were Diagnosis-Related Groups in all countries except Slovenia. All unit costs include direct costs and variable overheads (except Germany where nursing costs are financed separately). Differences were identified in the type of fixed overheads included in unit costs. Methodological documents explaining the identification, measurement and evaluation of resources included in the unit costs, as well as use of appropriate cost drivers are publicly available only in England, Portugal and Sweden. Conclusions: We can conclude that while unit costs of cataract extirpation are publicly available, the information on methodological aspects is scarce. This appears to pose a significant problem for cross-country comparisons of costs and transferability of results from one country to another.European Commission 77931

Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries

Introduction: Advanced Therapy Medicinal Products are a type of therapies that, in some cases, hold great potential for patients without an effective current therapeutic approach but they also present multiple challenges to payers. While there are many theoretical papers on pricing and reimbursement (P&R) options, original empirical research is very scarce. This paper aims to provide a comprehensive international review of regulatory and P&R decisions taken for all ATMPs with centralized European marketing authorization in March 2022. Methods: A survey was distributed in July 2022 to representatives of 46 countries. Results: Responses were received from 20 countries out of 46 (43.5%). 14 countries reimbursed at least one ATMP. Six countries in this survey reimbursed no ATMPs. Conclusion: Access to ATMPs is uneven across the countries included in this study. This arises from regulatory differences, commercial decisions by marketing authorization holders, and the divergent assessment processes and criteria applied by payers. Moving towards greater equality of access will require cooperation between countries and stakeholders, for example, through the WHO Regional Office for Europe’s Access to Novel Medicines Platform.Project PID 2019.105597RA.I00 financed by the Spanish Ministry of Science and Innovation/National Research Agency MCIN/AEI/10.13039/ 50110001103

Un año de pacientes nuevos en un Servicio de Salud Mental.

Muestra con 1.406 pacientes nuevos en el Servicio de Salud Mental de Aranjuez (2004), para realizar un perfil sociodemográfico de los pacientes nuevos vistos durante ese año, y conocer la distribución de las categorías diagnósticas totales y en función de las variables sexo y edad

Estudio descriptivo de los niños y adolescentes nuevos vistos en un servicio de salud mental en el periodo de un año.

En este trabajo se presenta un estudio descriptivo de los niños y adolescentes nuevos vistos en el Servicio de Salud Mental de Aranjuez (Área 11 de la Comunidad de Madrid) durante el año 2004. La muestra clínica consta de 314 pacientes nuevos. El propósito del estudio es doble: por un lado presentar algunas características sociodemográficas de los niños y adolescentes nuevos vistos y, por otro, mostrar los diagnósticos y las diferencias en función de la edad y el sexo. Se ha recurrido al programa informático de los Servicios de Salud Mental de distrito de la Comunidad de Madrid (Registro Acumulado de Casos: R. A. C.) para la obtención de los datos

Economic evaluation of the introduction of 4CMenB (Bexsero®) in the national vaccine schedule in Spain

Este estudio se realizó en el contexto de trabajo de fin de máster del XXXII Máster de Salud Pública y Gestión Sanitaria de la Escuela Andaluza de Salud Pública (EASP). Se agradece a la EASP y a su profesorado, en especial a D. Alberto Fernández, la formación recibida y los consejos para una mejor trayectoria tanto profesional como personal.Introducción: Bexsero® (4CMenB), vacuna contra el meningococo B, fue autorizada en Europa en 2013. En Espana, ˜ 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 Espana. ˜ Método: Se adaptó para Espana˜ 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 anos ˜ 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 D /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 D /AVAC (IC95%: 210.285-430.122). Conclusiones: Dada la incidencia actual de enfermedadmeningocócica invasiva enEspana˜ 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 D para la pauta 3+1 o de 3,37 D para la pauta 2+1 podría ser recomendada basándose en su eficiencia.Introduction: Bexsero® (4CMenB), meningococcal B vaccine, was licensed in Europe in 2013. In Spain, despite MenB being the mostfrequent 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: to 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 newborn 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 D /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 D /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 D for the 3+1 schedule or 3.37 D for the 2+1 schedule could it be recommended based on efficiency criteria.Los costes de publicación de este artículo han sido financiados por el Departamento de Ciencias Sociosanitarias, Radiología y Medicina Física de la Facultad de Medicina y Enfermería, Universidad de Córdoba, Córdoba (España)

Development of the European Healthcare and Social Cost Database (EU HCSCD) for use in economic evaluation of healthcare programs

This study has received funding from the European Union's Horizon 2020 research and innovation programme under Grant agreement no. 779312.Introduction: Costs are one of the critical factors for the transferability of the results in health technology assessment and economic evaluation. The objective is to develop a cost database at the European level to facilitate cross-border cost comparisons in different settings and explains the factors that lead to differences in healthcare costs in different countries, taking into account the differences between health systems and other factors. Methodology: The core of the database is compounded of three main categories (primary resources, composite goods and services, and complex processes and interventions) organized into 13 subcategories. A number of elements providing as detailed information of unit cost as possible were identified in order to mitigate the problem of comparability. Consortium partners validated both the database structure and selected costing items. Results: Twenty-seven costing items included in the EU HCSCD resulted in 1450 unit costs when taking into account all item subtypes and countries. Cross-country differences in costs are driven by the type of resources included in the costing items (e.g., overhead costs in case of complex processes and interventions) or by the variety of existing brands and/or models and the type of unit value in most of the primary resources. Conclusion: The EU HCSCD is the only public unit healthcare and social cost database at European level that gather data on unit costs and explains differences in costs across countries. Its maintenance and regular data updating will enable establishing specific systems for generating and recording information that will meet many of its current limitations.European Commission 77931

A multi-stakeholder multicriteria decision analysis for the reimbursement of orphan drugs (FinMHU-MCDA study)

Medicaments orfes; Reemborsament; EspanyaMedicamentos huérfanos; Reembolso; EspañaOrphan drugs; Reimbursement; SpainBackground Patient access to orphan medicinal products (OMPs) is limited and varies between countries, reimbursement decisions on OMPs are complex, and there is a need for more transparent processes to know which criteria should be considered to inform these decisions. This study aimed to determine the most relevant criteria for the reimbursement of OMPs in Spain, from a multi-stakeholder perspective, and using multicriteria decision analysis (MCDA). Methods An MCDA was developed in 3 phases and included 28 stakeholders closely related to the field of rare diseases (6 physicians, 5 hospital pharmacists, 7 health economists, 4 patient representatives and 6 members from national and regional health authorities). Initially [phase A], a bibliographic review was conducted to identify the potential reimbursement criteria. Then, a reduced advisory board (8 members) proposed, selected, and defined the final list of criteria that could be relevant for reimbursement. A discrete choice experiment (DCE) [phase B] was developed to determine the relevance and relative importance weight of such criteria according to the stakeholders’ preferences by choosing between pairs of hypothetical financing scenarios. A multinomial logit model was fitted to analyze the DCE responses. Finally [phase C], the advisory board review the results using a deliberative process. Results Thirteen criteria were selected, related to 4 dimensions: patient population, disease, treatment, and economic evaluation. Nine criteria were deemed relevant for decision-making and associated with a higher relative importance: Health-related quality of life (HRQL) (23.53%), treatment efficacy (14.64%), availability of treatment alternatives (13.51%), disease severity (12.62%), avoided costs (11.21%), age of target population (7.75%), safety (seriousness of adverse events) (4.72%), quality of evidence (3.82%) and size of target population (3.12%). The remaining criteria had a < 3% relative importance: economic burden of disease (2.50%), cost of treatment (1.73%), cost-effectiveness (0.83%) and safety (frequency of adverse events) (0.03%). Conclusion The reimbursement of OMPs in Spain should be determined by its effect on patient’s HRQL, the extent of its therapeutic benefit from efficacy and the availability of other therapeutic options. Furthermore, the severity of the rare disease should also influence the decision along with the potential of the treatment to avoid associated costs.This project was carried out with an unrestricted grant from AELMHU (Asociación Española de Laboratorios de Medicamentos Huérfanos y Ultrahuérfanos). AELMHU was not involved in the design of the study and collection, analysis, and interpretation of data and writing the manuscript

Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten‐free diet

Background Treatment for coeliac disease is a lifelong strict gluten‐free diet. Although guidelines recommend regular follow‐up with dietary interviews and coeliac serology, these methods may be inaccurate. Aim To evaluate the usefulness of faecal gluten immunogenic peptides to support the diagnosis and to determine the adherence to the gluten‐free diet in coeliac children. Methods Multicentre prospective observational study including 64 coeliac children. Faecal gluten peptides, and tissue transglutaminase and deamidated gliadin peptide antibodies were analyzed at diagnosis, and 6, 12 and 24 months thereafter. Gluten consumption was estimated from gluten peptide levels. Results Most children (97%) had detectable gluten peptides at diagnosis. On a gluten‐free diet, the rate of gluten peptides increased from 13% at 6 months to 25% at 24 months. Mean estimated gluten exposure dropped from 5543 mg/d at diagnosis to 144 mg/d at 6 months, then increased to 606 mg/d by 24 months. In contrast, deamidated gliadin peptide antibodies normalised and only 20% had elevated tissue transglutaminase antibody by 24 months. The elevation of tissue transglutaminase antibody was more prolonged in patients with detectable gluten peptides (P 0.1). Dietitian assessment was only moderately correlated with gluten peptide detection (κ = 0.5). Conclusions Faecal gluten peptides testing may guide treatment of coeliac disease prior to diagnosis and during the assessment diet adherence. Further studies could determine if early identification of gluten exposure reduces the need for expensive/invasive investigations for non‐responsive coeliac disease. ClinicalTrials.gov Number: NCT02711397.España, Ministerio de Ciencia e Innovación and FEDER funds DELIAC, IPT‐2011‐0952‐900000España, Corporación Tecnológica de Andalucía SINGLUCHECK, 1737/011