Modeling the costs and long-term health benefits of screening the general population for risks of cardiovascular disease: a review of methods used in the literature.

BACKGROUND: Strategies for screening and intervening to reduce the risk of cardiovascular disease (CVD) in primary care settings need to be assessed in terms of both their costs and long-term health effects. We undertook a literature review to investigate the methodologies used. METHODS: In a framework of developing a new health-economic model for evaluating different screening strategies for primary prevention of CVD in Europe (EPIC-CVD project), we identified seven key modeling issues and reviewed papers published between 2000 and 2013 to assess how they were addressed. RESULTS: We found 13 relevant health-economic modeling studies of screening to prevent CVD in primary care. The models varied in their degree of complexity, with between two and 33 health states. Programmes that screen the whole population by a fixed cut-off (e.g., predicted 10-year CVD risk >20 %) identify predominantly elderly people, who may not be those most likely to benefit from long-term treatment. Uncertainty and model validation were generally poorly addressed. Few studies considered the disutility of taking drugs in otherwise healthy individuals or the budget impact of the programme. CONCLUSIONS: Model validation, incorporation of parameter uncertainty, and sensitivity analyses for assumptions made are all important components of model building and reporting, and deserve more attention. Complex models may not necessarily give more accurate predictions. Availability of a large enough source dataset to reliably estimate all relevant input parameters is crucial for achieving credible results. Decision criteria should consider budget impact and the medicalization of the population as well as cost-effectiveness thresholds.This work was financially supported by the EPIC-CVD project. EPIC-CVD is a European Commision funded project under the Health theme of Seventh Framework Programme that builds on EPIC-Heart, which has been funded by the Medical Research Council, the British Heart Foundation and European Research Council Advanced Investigator Award.This is the author accepted manuscript. It is currently embargoed pending publication

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

Economic evaluation and budgetary burden of mepolizumab in severe refractory eosinophilic asthma

Objetivo: Mepolizumab está indicado como tratamiento adicional del asma eosinofílica refractaria grave. Las diferencias observadas en subgrupos poblacionales según recuento eosinofílico plasmático, existencia de pacientes con altos niveles de inmunoglobulina E candidatos a omalizumab y mepolizumab, e impacto económico de mepolizumab obligan a realizar estudios económicos para tomar decisiones clínicas eficientes. El objetivo fue realizar un análisis de coste/eficacia e impacto presupuestario de mepolizumab. Método: Se realizó la comparación de costes e impacto presupuestario del uso de mepolizumab desde la perspectiva del Sistema Nacional de Salud. Las alternativas valoradas fueron corticosteroides sistémicos inhalados + agonista β2 de larga duración y/o corticosteroides sistémicos orales en pacientes con asma alérgica grave no mediada por inmunoglobulina E, y este tratamiento junto a omalizumab en pacientes con asma eosinofílica alérgica mediada por inmunoglobulina E. La eficacia se evaluó mediante exacerbaciones clínicamente relevantes evitadas. Se valoraron los costes directos asociados a exacerbación. Resultados: El coste incremental medio de mepolizumab respecto a omalizumab es de 797 euros por paciente y año. Considerando precio alternativo con descuento de omalizumab, incluir mepolizumab para pa cientes con asma eosinofílica alérgica y mediada por inmunoglobulina E supondría incrementar el gasto público de 2,3 a 4,6 millones de euros. Teniendo en cuenta el precio notificado de omalizumab, la introducción gradual de mepolizumab en el Sistema Nacional de Salud supondría ahorrar 3,6 millones de euros en tres años. Para pacientes con asma grave no mediada por inmunoglobulina E, el coste/exacerbación evitada al añadir mepolizumab es de 15.085 euros, con un impacto presupuestario en tres años de 578,4 millones de euros, asumiendo una penetración progresiva de mepolizumab en el mercado. En los pacientes con ≥500 eosinófilos/µl, este coste disminuye a 7.767 euros por exacerbación evitada, con un impacto presupuestario de 183,2 millones de euros en tres años con penetración progresiva de mepolizumab. Conclusiones: La comparación de costes entre mepolizumab y omalizumab en pacientes con asma eosinofílica mediada por inmunoglobulina E señala como razonable utilizar el fármaco de menor coste, promoviendo competencia de precios. Asimismo, priorizar su uso en pacientes con asma eosinofílica refractaria grave no mediada por inmunoglobulina E y niveles plasmáticos ≥500 eosinófilos/µl permitiría mejorar la eficiencia y disminuir el impacto presupuestario.Objective: Mepolizumab is indicated as additional treatment of severe refractory eosinophilic asthma. Differences in subgroups according to plasmatic eosinophil count, existence of patients with high levels of immunoglobulin E candidates for omalizumab and mepolizumab, and budget impact of mepolizumab require economic studies for efficient clinical decisions. The objective was to perform a cost-efficacy and budget impact analysis of mepolizumab. Method: An analysis of comparison of costs and budgetary impact of use of mepolizumab has been performed from National Health System perspective. Evaluated alternatives were inhaled systemic corticosteroids + long-acting β2-agonist and/or oral systemic corticosteroids in patients with severe allergic asthma not mediated by immunoglobulin E, and the same treatment associated with omalizumab in patients with immunoglobulin E-mediated allergic eosinophilic asthma. Efficacy was assessed by clinically relevant exacerbations avoided. Direct costs associated with exacerbation were assessed Results: An average incremental cost of 797 euros/patient-year was estimated. Considering alternative price with discount for omalizumab, including mepolizumab for patients with immunoglobulin E-mediated allergic eosinophilic asthma would increase public spending from 2.3 to 4.6 million euros. According reported price for omalizumab, gradual introduction of mepolizumab into the National Health System would save 3.6 million euros in three years. For patients with immunoglobulin E-not mediated severe asthma, adding mepolizumab presented a cost/exacerbation avoided of 15,085 euros and a budgetary impact for three years of 578.4 million euros according a progressive penetration of mepolizumab in market. In patients with ≥ 500 eosinophils/μL, cost/exacerbation avoided is reduced to 7,767 euros and the budgetary impact is 183.2 million euros in three years according progressive penetration of mepolizumab. Conclusions: With analysis of cost comparison of mepolizumab vs. omalizumab in patients with eosinophilic immunoglobulin E-mediated asthma, it would be reasonable to prioritize the drug more economic to promote price competition. According this pharmacoeconomic study, prioritizing mepolizumab in patients with immunoglobulin E-not mediated severe refractory eosinophilic asthma and higher plasmatic eosinophil count (≥500 eosinophils/μL) would improve efficiency and decrease budgetary impac

Gender Differences in Social Support Received by Informal Caregivers: A Personal Network Analysis Approach

Social support is an important predictor of the health of a population. Few studies have analyzed the influence of caregivers? personal networks from a gender perspective. The aim of this study was to analyze the composition, structure, and function of informal caregiver support networks and to examine gender differences. It also aimed to explore the association between different network characteristics and self-perceived health among caregivers. We performed a social network analysis study using a convenience sample of 25 female and 25 male caregivers. A descriptive analysis of the caregivers and bivariate analyses for associations with self-perceived health were performed. The structural metrics analyzed were density; degree centrality mean; betweenness centrality mean; and number of cliques, components, and isolates. The variability observed in the structure of the networks was not explained by gender. Some significant differences between men and women were observed for network composition and function. Women received help mainly from women with a similar profile to them. Men?s networks were broader and more diverse and they had more help from outside family circles, although these outcomes were not statistically significant. Our results indicate the need to develop strategies that do not reinforce traditional gender roles, but rather encourage a greater sharing of responsibility among all parties.Funding: This project has received funding from Consejería de Salud (Junta de Andalucía) (PS-0280–2016) and from Instituto de Salud Carlos III and the European Regional Development Fund (PI16/00207

Optimal start in dialysis shows increased survival in patients with chronic kidney disease

Objective To compare the survival among patients with chronic kidney disease who had optimal starts of renal replacement therapy, dialysis or hemodialysis, with patients who had suboptimal starts. Methods A retrospective cohort consisting of >18 year-old patients who started renal replacement therapy, using peritoneal dialysis or hemodialysis, in any public hospital or associated center of the Andalusian Public Health System, between the 1st of January of 2006 and the 15th of March of 2017. The optimal start was defined when all the following criteria were met: a planned dialysis start, a minimum of six-month follow-up by a nephrologist, and a first dialysis method coinciding with the one registered at 90 days. The information was obtained from the registry of the Information System of the Transplant Autonomic Coordination of Andalusia. Results A total of 10,692 patients were studied. 4,377 (40.9%) of these patients died. A total of 4,937 patients (46.17%) achieved optimal starts of renal replacement therapy and showed higher survival rates (HR 0.669; 95% CI 0.628–0.712) in the multivariate analysis of Cox regression model

Determinants of Burden and Satisfaction in Informal Caregivers: Two Sides of the Same Coin? The CUIDAR-SE Study

The aim of this study conducted in Spain was to analyze and compare burden, severe burden, and satisfaction among informal caregivers in relation to health-related quality of life (HRQoL), type and duration of caregiving, perceived social support, and use of social and health care services. We performed multivariate analyses to identify variables associated with caregiver burden, severe burden, and satisfaction with caregiving, stratified by gender. The results showed that secondary or third-level education, performance of ungratifying tasks, negative coping with caregiving, and more years providing care were associated with greater burden. Variables with protective effect were better perceived health of the person being cared for, better caregiver HRQoL, and high perceived social support. Women were 75% more likely to experience severe burden compared with male caregivers. Burden was reduced by high perceived social support in the case of women and by high caregiver HRQoL in the case of men. The main determinant of caregiving satisfaction for both men and women was perceived social support (OR = 3.11 and OR = 6.64). This study shows the need for interventions that promote gender equality and social support as a means of relieving burden and severe burden and improving satisfaction in both male and female caregivers

Cost transferability problems in economic evaluation as a framework for an European health care and social costs database

This article presents part of the work within Work Package 3 (WP3) of Impact HTA (Improved methods and actionable tools for enhancing HTA), a H2020 EU-funded research project, intended to enhance and promote collaboration in HTA across EU MS. Amongst other objectives, and in close collaboration with WP4, WP3 addressed setting up a multi-country unit-cost database: the European health care and social costs database (EU HCSCD). The purpose of the database is to facilitate the transference of healthcare economic evaluation analyses across countries, jurisdictions and settings. WP3 concentrates on healthcare costs; WP4 on social costs. This paper discusses the state of the art on this topic, building an appropriate conceptual and theoretical framework for Database development. We conducted a broad, but not systematic, literature and gray-literature review (LR), identifying existing practices and problems, and their implications, described in the Results section. We discuss practical implications and draw important conclusions behind the construction, and future evolution, of this database.This study has received funding from the European Union’s Horizon 2020 research and innovation programme under Grant agreement no. 779312.Ye

A cost utility analysis alongside a cluster-randomised trial evaluating a minor ailment service compared to usual care in community pharmacy

This work was supported by a research grant from the Spanish Society of Community Pharmacy"and the Pharmaceutical Association of Valencia. Neither of these organisations influenced the study design, interpretation of data, writing of the manuscript, nor the decision to submit this manuscript for publication. The Pharmaceutical Association of Valencia assisted with initial selection of study locations and contacting community pharmacies.Background: Minor ailments are “self-limiting conditions which may be diagnosed and managed without a medical intervention”. A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC). Methods: The cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists’ training, practice change facilitators and patients’ educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals’ consultation time, medication costs, pharmacists’ training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences. Results: A total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness. Conclusions: Expanding community pharmacists’ scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP.Spanish Society of Community PharmacyPharmaceutical Association of Valenci