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

Duration of the patient interval in breast cancer and factors associated with longer delays in low‐and middle‐income countries: A systematic review with meta‐analysis

Objective: Breast cancer survival is lower in low‐ and middle‐income countries (LMICs) partially due to many women being diagnosed with late‐stage disease. The patient interval refers to the time elapsed between the detection of symptoms and the first consultation with a healthcare provider and is considered one of the core indicators for early diagnosis and treatment. The goal of the current research was to conduct a meta‐analysis of the duration of the patient interval in LMICs and investigate the socio‐demographic and socio‐cultural factors related to longer delays in presentation. Methods: We conducted a systematic review with meta‐analysis (pre‐registered protocol CRD42020200752). We searched seven information sources (2009–2022) and included 50 articles reporting the duration of patient intervals for 18,014 breast cancer patients residing in LMICs. Results: The longest patient intervals were reported in studies from the Middle East (3–4 months), followed by South‐East Asia (2 months), Africa (1–2 months), Latin America (1 month), and Eastern Europe (1 month). Older age, not being married, lower socio‐economic status, illiteracy, low knowledge about cancer, disregarding symptoms or not attributing them to cancer, fear, negative beliefs about cancer, and low social support were related to longer delays across most regions. Longer delays were also related to use of alternative medicine in the Middle East, South‐East Asia, and Africa and distrust in the healthcare system in Eastern Europe. Conclusions: There is large variation in the duration of patient intervals across LMICs in different geographical regions. Patient intervals should be reduced and, for this purpose, it is important to explore their determinants taking into account the social, cultural, and economic context.Centro de Investigacion Biomedica en Red de Epidemiologia y Salud PublicaAgencia Estatal de InvestigacionFundacion Cientifica Asociacion Espanola Contra el Cance

The patient, diagnostic, and treatment intervals in adult patients with cancer from high- and lower-income countries: A systematic review and meta-analysis

Background: Longer time intervals to diagnosis and treatment are associated with worse survival for various types of cancer. The patient, diagnostic, and treatment intervals are considered core indicators for early diagnosis and treatment. This review estimated the median duration of these intervals for various types of cancer and compared it across high- and lower-income countries. Methods and findings: We conducted a systematic review with meta-analysis (prospectively registered protocol CRD42020200752). Three databases (MEDLINE, Embase, and Web of Science) and information sources including grey literature (Google Scholar, OpenGrey, EThOS, ProQuest Dissertations & Theses) were searched. Eligible articles were published during 2009 to 2022 and reported the duration of the following intervals in adult patients diagnosed with primary symptomatic cancer: patient interval (from the onset of symptoms to first presentation to a healthcare professional), diagnostic interval (from first presentation to diagnosis), and treatment interval (from diagnosis to treatment start). Interval duration was recorded in days and study medians were combined in a pooled estimate with 95% confidence intervals (CIs). The methodological quality of studies was assessed using the Aarhus checklist. A total of 410 articles representing 68 countries and reporting on 5,537,594 patients were included. The majority of articles reported data from high-income countries (n = 294, 72%), with 116 (28%) reporting data from lower-income countries. Pooled meta-analytic estimates were possible for 38 types of cancer. The majority of studies were conducted on patients with breast, lung, colorectal, and head and neck cancer. In studies from high-income countries, pooled median patient intervals generally did not exceed a month for most cancers. However, in studies from lower-income countries, patient intervals were consistently 1.5 to 4 times longer for almost all cancer sites. The majority of data on the diagnostic and treatment intervals came from high-income countries. Across both high- and lower-income countries, the longest diagnostic intervals were observed for hematological (71 days [95% CI 52 to 85], e.g., myelomas (83 days [47 to 145])), genitourinary (58 days [50 to 77], e.g., prostate (85 days [57 to 112])), and digestive/gastrointestinal (57 days [45 to 67], e.g., colorectal (63 days [48 to 78])) cancers. Similarly, the longest treatment intervals were observed for genitourinary (57 days [45 to 66], e.g., prostate (75 days [61 to 87])) and gynecological (46 days [38 to 54], e.g., cervical (69 days [45 to 108]) cancers. In studies from high-income countries, the implementation of cancer-directed policies was associated with shorter patient and diagnostic intervals for several cancers. This review included a large number of studies conducted worldwide but is limited by survivor bias and the inherent complexity and many possible biases in the measurement of time points and intervals in the cancer treatment pathway. In addition, the subintervals that compose the diagnostic interval (e.g., primary care interval, referral to diagnosis interval) were not considered. Conclusions: These results identify the cancers where diagnosis and treatment initiation may take the longest and reveal the extent of global disparities in early diagnosis and treatment. Efforts should be made to reduce help-seeking times for cancer symptoms in lower-income countries. Estimates for the diagnostic and treatment intervals came mostly from high-income countries that have powerful health information systems in place to record such information.This work was supported by the Spanish Association against Cancer (Asociación Española contra el Cáncer, PROYE20023SANC “High resolution study of social inequalities in cancer (HiReSIC)” to MJS), the Cancer Epidemiological Surveillance Subprogram of the CIBER of Epidemiology and Public Health and the Health Institute Carlos III (VICA to MJS), and the Health Institute Carlos III (PI18/01593 “Multilevel population-based study of socioeconomic inequalities in the geographical distribution of cancer incidence, mortality and net survival” to DP). DP is supported by a Juan de la Cierva Fellowship from the Ministry of Science and the National Research Agency of Spain (MCIN/AEI, JC2019-039691-I, http://doi.org/10.13039/501100011033, Accessed 4 October 2021). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.S

Evaluación de Tecnologías Sanitarias

Esta tesis está compuesta por tres capítulos, cada uno trata un tema de evaluación económica diferente, pero dirigido a disminuir la incertidumbre en la toma de decisiones en el sistema sanitario. Los dos primeros capítulos son estudios de coste-efectividad en el campo de medicina pública: evaluación de un programa de ejercicio físico en mujeres perimenopáusicas y la evaluación de diferentes programas de cribado para detectar el riesgo de tener una enfermedad cardiovascular. El tercer capítulo es una revisión y clasificación de las metodologías de costes para la evaluación económica. El primer capítulo estudia el coste-efectividad de un programa de ejercicio físico en una muestra de mujeres perimenopáusicas granadinas en edades comprendidas entre 45 y 64 años. Las 150 mujeres se asignaron de forma aleatoria al grupo de intervención (N=74) y o al grupo de control (N=76). El grupo de intervención estaba sujeto a un programa de ejercicio físico especialmente diseñado para las mujeres perimenopáusicas de 4 meses de duración. A partir del modelo de decisión y numerosos análisis de sensibilidad se pudo demostrar que el ejercicio físico mejora la calidad de vida y disminuye el coste, aunque de forma no significativa. El programa de ejercicio físico ha sido coste-efectivo. El segundo capítulo evalúa el coste-efectividad de diferentes programas de cribado para las enfermedades cardiovasculares en Inglaterra y en Andalucía. Los datos se han obtenido del estudio EPIC-CVD que reclutó a más de 500.000 personas en 10 países europeos y que tuvo un seguimiento de 15 años. El estudio identificó a más de 16.000 casos de enfermedades coronarias y 11.000 casos de ictus. Para estimar el riesgo de cada individuo se han considerado dos estrategias: la fórmula de riesgo Framingham, que estima el riesgo de tener un evento cardiovascular a los 10 años, y un enfoque novedoso basado en la fórmula Framingham ajustada por edad y sexo. Se han modelado los costes y beneficios de los métodos alternativos para identificar a los individuos de alto riesgo en atención primaria y tratarlos con estatinas para reducir su riesgo cardiovascular (modelo probabilístico de Markov). Tanto el modelo base como los análisis de sensibilidad muestran que el programa de cribado para predecir el riesgo de tener una enfermedad cardiovascular, basado en la fórmula Framingham ajustada por edad, es más coste-efectivo independientemente de sexo, edad y zona geográfica. El tercer capítulo ofrece una clasificación de los diferentes métodos de costes empleados en las evaluaciones económicas. Se propone un glosario de términos para una mejor aclaración de la terminología. Se ha realizado una revisión de alcance de la literatura. Se han incluido un total de 21 estudios que arrojaron 43 análisis de costes. El análisis más común fue el top-down micro-costing (49%), seguido por el top-down grosscosting (37%) y el bottom-up micro-costing (14%). Entre los hallazgos se encuentran las inconsistencias sustanciales en los métodos de costeo. La información relacionada con el cálculo del coste unitario falta frecuentemente. La convergencia de los métodos de bottom-up y top-down puede ser un tema importante en las próximas décadas.This thesis is composed of three substantial chapters, corresponding with three projects dealing with different topics on economic evaluation, but with one aspect in common, that is, the reduction of the uncertainty in healthcare decision making. Two are empirical cost-effectiveness studies in areas of public health: an evaluation of a physical exercise program in perimenopausal women, and an evaluation of options for a screening program for risk of cardiovascular disease. The third chapter is a review and classification of costing methods for economic evaluation. The first chapter studies the cost-effectiveness of an exercise intervention in perimenopausal women from Granada aged between about 45 and 64. The 150 women were randomly assigned to either an exercise intervention group (N = 74) or to control group (N = 76). The intervention group was subject to an exercise intervention program of 4 months of duration specially designed for perimenopausal women. Both decision model and numerous sensitivity analysis demonstrated that physical exercise improves the quality of life and decreases the costs, although the differences were not statistically significant. The exercise program was cost-effective. The second chapter assessed the cost-effectiveness of different screening strategies for cardiovascular disease in England and Andalusia. The data were obtained from the EPICCVD study that recruited more than 500,000 people in 10 European countries, giving up to 15 years follow-up. The study identified more than 16,000 cases of coronary heart disease and 11,000 cases of stroke. To estimate the risk of each individual, two strategies were considered: the Framingham risk score, which estimates the risk of having a cardiovascular event at 10 years, and a novel approach based on the Framingham risk score adjusted for age and sex. The costs and benefits of alternative methods of identifying high-risk individuals in primary care and treating them with statins to reduce their cardiovascular risk were modelled (probabilistic Markov model). Both the base case model and the sensitivity analysis show that the novel approach based on the age adjusted Framingham risk score is more cost-effective regardless of sex, age and geographic area. The third chapter offer a classification of different costing methods used in economic evaluations. For better clarification of terminology, a pragmatic glossary of terms is proposed. A scoping review was conducted. A total of 21 studies were included yielding 43 costing analysis. The most common analysis was top-down micro-costing (49%), followed by top-down gross-costing (37%) and bottom-up micro-costing (14%). In general, substantial inconsistencies in the costing methods were found. The information regarding unit cost calculation is lacking. The convergence of bottom-up and top-down methods might be a hot topic for discussion in next decades.Tesis Univ. Granada.Proyecto Fitness League Against MENopause COst (FLAMENCO) (15) financiado por la Consejería de Salud y Familias de la Junta de Andalucía, antes conocida como la Consejería de Salud y Bienestar Social (referencia: PI-0667-2013).The European Prospective Investigation into Cancer and Nutrition (EPIC), Individualised CVD risk assessment across Europe (EPIC-CVD). Este proyecto obtuvo financiación de la Unión Europea bajo el Programa Marco 7Proyecto Improved Methods and ACTionable tools for enhancing HTA (IMPACT-HTA) financiado por la Unión Europea dentro del programa Horizonte 2020 en virtud del acuerdo de subvención número 77931

Cost-utility of talazoparib monotherapy treatment for locally advanced or metastatic breast cancer in Spain

Breast cancer is one of the most frequent malignancies. The aim of the article is to analyse the cost-utility ratio and budgetary impact of talazoparib treatment for patients with locally advanced or metastatic gBRCA + breast cancer from the perspective of the Spanish National Health System. Analyses were based on the EMBRACA clinical trial and the model was constructed according to “partitioned survival analysis”. Two scenarios were considered in order to compare talazoparib with the alternatives of capecitabine, vinorelbine and eribulin: 1. Chemotherapy in patients pre-treated with anthracyclines/taxanes and, 2. A second- and subsequent-line treatment option. Treatment types following relapse were recorded in the mentioned clinical trial. The effectiveness measure used was quality-adjusted life years (QALY). The average health cost of patients treated at 43 months with talazoparib was 84,360.86€, whilst current treatment costs were 26,683.90€. The effectiveness of talazoparib was 1.93 years of survival (1.09 QALY) relative to 1.58 years (0.83 QALY) in the treatment group. The incremental cost-utility ratio was 252,420.04€/QALY. This represents the additional cost required to earn an additional QALY when changing from regular treatment to talazoparib. Regarding budgetary impact, the number of patients susceptible to receiving treatment with between 94 and 202 talazoparib was estimated, according to scenario and likelihood. The 3-year cost difference was between 6.9 and 9 million euros. The economic evaluation conducted shows an elevated incremental cost-utility ratio and budgetary impact. Taking these results into account, the price of talazoparib would have to be lower than that taken as a reference to reach the cost-utility thresholds

The cost-effectiveness of a uniform versus age-based threshold for one-off screening for prevention of cardiovascular disease.

The objective of this article was to assess the cost-effectiveness of screening strategies for cardiovascular diseases (CVD). A decision analytic model was constructed to estimate the costs and benefits of one-off screening strategies differentiated by screening age, sex and the threshold for initiating statin therapy ("uniform" or "age-adjusted") from the Spanish NHS perspective. The age-adjusted thresholds were configured so that the same number of people at high risk would be treated as under the uniform threshold. Health benefit was measured in quality-adjusted life years (QALY). Transition rates were estimated from the European Prospective Investigation into Cancer and Nutrition (EPIC-CVD), a large multicentre nested case-cohort study with 12 years of follow-up. Unit costs of primary care, hospitalizations and CVD care were taken from the Spanish health system. Univariate and probabilistic sensitivity analyses were employed. The comparator was no systematic screening program. The base case model showed that the most efficient one-off strategy is to screen both men and women at 40 years old using a uniform risk threshold for initiating statin treatment (Incremental Cost-Effectiveness Ratio of €3,274/QALY and €6,085/QALY for men and women, respectively). Re-allocating statin treatment towards younger individuals at high risk for their age and sex would not offset the benefit obtained using those same resources to treat older individuals. Results are sensitive to assumptions about CVD incidence rates. To conclude, one-off screening for CVD using a uniform risk threshold appears cost-effective compared with no systematic screening. These results should be evaluated in clinical studies

Cost-effectiveness of a primary care-based exercise intervention in perimenopausal women. The FLAMENCO Project

Adequate physical activity levels and a healthy lifestyle may prevent all kinds of non-communicable diseases, promote well-being and reduce health-care costs among perimenopausal women. This study assessed an exercise programme for perimenopausal women. Mean QALYs over 16 weeks were.228 in the control group and.230 in the intervention group (mean difference: .002; 95% confidence interval [95%CI]: −0.005 to 0.009). Improvements from baseline were greater in the intervention group in all dimensions of the EuroQol-5D-5L but not statistically significant. The total costs at the end of the intervention were 160.38 € in the control group and 167.80 € in the intervention group (mean difference: 7.42 € ; 95%CI: −47 to 62). The exercise programme had anincremental cost-effectiveness ratio of 4,686 € /QALY. The programme could be considered cost-effective, although the overall difference in health benefits and costs was very modest. Longer term follow-up is needed.The project received funds from Consejería de Economía, Innovación, Ciencia y Empleo, Junta de Andalucía (PI-0667-2013)