Availability and financing of CAR-T cell therapies: A cross-country comparative analysis.

Chimeric antigen receptor T-cell therapies (CAR-T therapies) are a type of advanced therapy medicinal product (ATMP) that belong to a new generation of personalised cancer immunotherapies. This paper compares the approval, availability and financing of CAR-T cell therapies in ten countries. It also examines the implementation of this type of ATMP within the health care system, describing the organizational elements of CAR-T therapy delivery and the challenges of ensuring equitable access to all those in need, taking a more systems-oriented view. It finds that the availability of CAR-T therapies varies across countries, reflecting the heterogeneity in the organization and financing of specialised care, particularly oncology care. Countries have been cautious in designing reimbursement models for CAR-T cell therapies, establishing limited managed entry arrangements under public payers, either based on outcomes or as an evidence development scheme to allow for the study of real-world therapeutic efficacy. The delivery model of CAR-T therapies is concentrated around existing experienced cancer centres and highlights the need for high networking and referral capacity. Some countries have transparent and systematic eligibility criteria to help ensure more equitable access to therapies. Overall, as with other pharmaceuticals, there is limited transparency in pricing, eligibility criteria and budgeting decisions in this therapeutic area.

Delayed treatment in breast cancer patients during the COVID-19 pandemic: a population health information research infrastructure (PHIRI) case study.

BACKGROUND: The indirect impact of the coronavirus disease 2019 pandemic on healthcare services was studied by assessing changes in the trend of the time to first treatment for women 18 or older who were diagnosed and treated for breast cancer between 2017 and 2021. METHODS: An observational retrospective longitudinal study based on aggregated data from four European Union (EU) countries/regions investigating the time it took to receive breast cancer treatment. We compiled outputs from a federated analysis to detect structural breakpoints, confirming the empirical breakpoints by differences between the trends observed and forecasted after March 2020. Finally, we built several segmented regressions to explore the association of contextual factors with the observed changes in treatment delays. RESULTS: We observed empirical structural breakpoints on the monthly median time to surgery trend in Aragon (ranging from 9.20 to 17.38 days), Marche (from 37.17 to 42.04 days) and Wales (from 28.67 to 35.08 days). On the contrary, no empirical structural breakpoints were observed in Belgium (ranging from 21.25 to 23.95 days) after the pandemic's beginning. Furthermore, we confirmed statistically significant differences between the observed trend and the forecasts for Aragon and Wales. Finally, we found the interaction between the region and the pandemic's start (before/after March 2020) significantly associated with the trend of delayed breast cancer treatment at the population level. CONCLUSIONS: Although they were not clinically relevant, only Aragon and Wales showed significant differences with expected delays after March 2020. However, experiences differed between countries/regions, pointing to structural factors other than the pandemic.

Has the COVID-19 pandemic changed existing patterns of non-COVID-19 health care utilization? A retrospective analysis of six regions in Europe.

BACKGROUND: Resilience of national health systems in Europe remains a major concern in times of multiple crises and as more evidence is emerging relating to the indirect effects of the COVID-19 pandemic on health care utilization (HCU), resulting from de-prioritization of regular, non-pandemic healthcare services. Most extant studies focus on regional, disease specific or early pandemic HCU creating difficulties in comparing across multiple countries. We provide a comparatively broad definition of HCU across multiple countries, with potential to expand across regions and timeframes. METHODS: Using a cross-country federated research infrastructure (FRI), we examined HCU for acute cardiovascular events, elective surgeries and serious trauma. Aggregated data were used in forecast modelling to identify changes from predicted European age-standardized counts via fitted regressions (2017-19), compared against post-pandemic data. RESULTS: We found that elective surgeries were most affected, universally falling below predicted levels in 2020. For cardiovascular HCU, we found lower-than-expected cases in every region for heart attacks and displayed large sex differences. Serious trauma was the least impacted by the COVID-19 pandemic. CONCLUSION: The strength of this study comes from the use of the European Population Health Information Research Infrastructure's (PHIRI) FRI, allowing for rapid analysis of regional differences to assess indirect impacts of events such as pandemics. There are marked differences in the capacity of services to return to normal in terms of elective surgery; additionally, we found considerable differences between men and women which requires further research on potential sex or gender patterns of HCU during crises.

Unravelling risk selection in Spanish general government employee mutual funds: evidence from cancer hospitalizations in the public health network.

Government employees in Spain are covered by public Mutual Funds that purchase a uniform basket of benefits, equal to the ones served to the general population, from private companies. Companies apply as private bidders for a fixed per capita premium hardly adjusted by age. Our hypothesis is that this premium does not cover risks, and companies have incentives for risk selection, which are more visible in high-cost patients. We focus on a particularly costly disease, cancer, whose prevalence is similar among government employees and the general population. We compare hospitalisations in the public hospitals of the government employees that have chosen public provision and the general population. We analysed a database of hospital discharges in the Valencian Community from 2010 to 2015 (3 million episodes). Using exact matching and logistic models, we find significant risk selection; thus, in hospitalised government employees, the likelihood for a solid metastatic carcinoma and non-metastatic cancer to appear in the registry is 31% higher than in the general population. Lymphoma shows the highest odds ratio of 2.64. We found quantitatively important effects. This research provides indirect evidence of risk selection within Spanish Mutual Funds for government employees, prompting action to reduce incentives for such a practice. More research is needed to figure out if what we have observed with cancer patients occurs in other conditions.

Exploring long-term breast cancer survivors' care trajectories using dynamic time warping-based unsupervised clustering.

OBJECTIVES: Long-term breast cancer survivors (BCS) constitute a complex group of patients, whose number is estimated to continue rising, such that, a dedicated long-term clinical follow-up is necessary. MATERIALS AND METHODS: A dynamic time warping-based unsupervised clustering methodology is presented in this article for the identification of temporal patterns in the care trajectories of 6214 female BCS of a large longitudinal retrospective cohort of Spain. The extracted care-transition patterns are graphically represented using directed network diagrams with aggregated patient and time information. A control group consisting of 12 412 females without breast cancer is also used for comparison. RESULTS: The use of radiology and hospital admission are explored as patterns of special interest. In the generated networks, a more intense and complex use of certain healthcare services (eg, radiology, outpatient care, hospital admission) is shown and quantified for the BCS. Higher mortality rates and numbers of comorbidities are observed in various transitions and compared with non-breast cancer. It is also demonstrated how a wealth of patient and time information can be revealed from individual service transitions. DISCUSSION: The presented methodology permits the identification and descriptive visualization of temporal patterns of the usage of healthcare services by the BCS, that otherwise would remain hidden in the trajectories. CONCLUSION: The results could provide the basis for better understanding the BCS' circulation through the health system, with a view to more efficiently predicting their forthcoming needs and thus designing more effective personalized survivorship care plans.

Why the US spends more treating high-need high-cost patients: a comparative study of pricing and utilization of care in six high-income countries.

One of the most pressing challenges facing most health care systems is rising costs. As the population ages and the demand for health care services grows, there is a growing need to understand the drivers of these costs across systems. This paper attempts to address this gap by examining utilization and spending of the course of a year for two specific high-need high-cost patient types: a frail older person with a hip fracture and an older person with congestive heart failure and diabetes. Data on utilization and expenditure is collected across five health care settings (hospital, post-acute rehabilitation, primary care, outpatient specialty and drugs), in six countries (Canada (Ontario), France, Germany, Spain (Aragon), Sweden and the United States (fee for service Medicare) and used to construct treatment episode Purchasing Power Parities (PPPs) that compare prices using baskets of goods from the different care settings. The treatment episode PPPs suggest other countries have more similar volumes of care to the US as compared to other standardization approaches, suggesting that US prices account for more of the differential in US health care expenditures. The US also differs with regards to the share of expenditures across care settings, with post-acute rehab and outpatient speciality expenditures accounting for a larger share of the total relative to comparators.

Revisiting systematic geographical variations in tonsils surgery in children in the Spanish National Health System: spatiotemporal ecological study on hospital administrative data.

OBJECTIVE: To provide new evidence on how tonsils surgery in children has geographically varied over time in the context of the Spanish National Health System. DESIGN: Observational ecological spatiotemporal study on geographical variations in medical practice, using linked administrative datasets, including virtually all surgeries performed from 2003 to 2015. SETTING: The Spanish National Health System, a quasi-federal structure with 17 autonomous communities (ACs), and 203 healthcare areas (HCAs). PARTICIPANTS: Patients aged 19 and younger residing in the HCAs and ACs. INTERVENTIONS: Tonsillectomy with adenoidectomy (T&A); and tonsillectomies alone (T). MAIN ENDPOINTS: (1) Evolution of T&A and T rates; (2) spatiotemporal variation in the risk of receiving T&A or T surgery at regional level (ACs) and HCAs; and (3) the fraction of the variation (FV) attributed to each of the components of variation-ACs, HCAs, year and interaction ACs year. RESULTS: T&A age-sex standardised rates increased over the period of analysis from 15.2 to 20.9 (5.7 points per 10 000 inhabitants). T alone remained relatively lower than T&A rates, evolving from 3.6 in 2003 to 3.9 in 2015 (0.3 points per 10 000 inhabitants). Most of the risk variation was captured at the HCAs level in both procedures (FV: 55.3% in T&A and 72.5% in T). The ACs level explained 27.6% of the FV in the risk in T&A versus 8% in T. The interaction ACs year was similar in both procedures (FV: 15.5% in T&A and 17.5% in T). The average trend hardly explained 1.46% and 1.83% of the variation, respectively. CONCLUSION: Our study showed wide persistent variations with a steady increase in rates and risk of T&A and a stagnation of T alone, where most of the variation risk was explained at HCA level.

Hepatitis of unknown aetiology in children - epidemiological overview of cases reported in Europe, 1 January to 16 June 2022.

Following the report of an excess in paediatric cases of severe acute hepatitis of unknown aetiology by the United Kingdom (UK) on 5 April 2022, 427 cases were reported from 20 countries in the World Health Organization European Region to the European Surveillance System TESSy from 1 January 2022 to 16 June 2022. Here, we analysed demographic, epidemiological, clinical and microbiological data available in TESSy. Of the reported cases, 77.3% were 5 years or younger and 53.5% had a positive test for adenovirus, 10.4% had a positive RT-PCR for SARS-CoV-2 and 10.3% were coinfected with both pathogens. Cases with adenovirus infections were significantly more likely to be admitted to intensive care or high-dependency units (OR = 2.11; 95% CI: 1.18-3.74) and transplanted (OR = 3.36; 95% CI: 1.19-9.55) than cases with a negative test result for adenovirus, but this was no longer observed when looking at this association separately between the UK and other countries. Aetiological studies are needed to ascertain if adenovirus plays a role in this possible emergence of hepatitis cases in children and, if confirmed, the mechanisms that could be involved.

Design and methodological characteristics of studies using observational routinely collected health data for investigating the link between cancer and neurodegenerative diseases: protocol for a meta-research study.

INTRODUCTION: Health services generate large amounts of routine health data (eg, administrative databases, disease registries and electronic health records), which have important secondary uses for research. Increases in the availability and the ability to access and analyse large amounts of data represent a major opportunity for conducting studies on the possible relationships between complex diseases. The objective of this study will be to evaluate the design, methods and reporting of studies conducted using observational routinely collected health data for investigating the link between cancer and neurodegenerative diseases. METHODS AND ANALYSIS: This is the protocol for a meta-research study. We registered the study protocol within the Open Science Framework: https://osf.io/h2qjg. We will evaluate observational studies (eg, cohort and case-control) conducted using routinely collected health data for investigating the associations between cancer and neurodegenerative diseases (such as Alzheimer's disease, amyotrophic lateral sclerosis/motor neuron disease, Huntington's disease, multiple sclerosis and Parkinson's disease). The following electronic databases will be searched (from their inception onwards): MEDLINE, Embase and Web of Science Core Collection. Screening and selection of articles will be conducted by at least two researchers. Potential discrepancies will be resolved via discussion. Design, methods and reporting characteristics in each article will be extracted using a standardised data extraction form. Information on general, methodological and transparency items will be reported. We will summarise our findings with tables and graphs (eg, bar charts, forest plots). ETHICS AND DISSEMINATION: Due to the nature of the proposed study, no ethical approval will be required. We plan to publish the full study in an open access peer-reviewed journal and disseminate the findings at scientific conferences and via social media. All data will be deposited in a cross-disciplinary public repository.

Differences in health outcomes for high-need high-cost patients across high-income countries.

OBJECTIVE: This study explores variations in outcomes of care for two types of patient personas-an older frail person recovering from a hip fracture and a multimorbid older patient with congestive heart failure (CHF) and diabetes. DATA SOURCES: We used individual-level patient data from 11 health systems. STUDY DESIGN: We compared inpatient mortality, mortality, and readmission rates at 30, 90, and 365 days. For the hip fracture persona, we also calculated time to surgery. Outcomes were standardized by age and sex. DATA COLLECTION/EXTRACTION METHODS: Data was compiled by the International Collaborative on Costs, Outcomes and Needs in Care across 11 countries for the years 2016-2017 (or nearest): Australia, Canada, England, France, Germany, the Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United States. PRINCIPAL FINDINGS: The hip sample across ranged from 1859 patients in Aragon, Spain, to 42,849 in France. Mean age ranged from 81.2 in Switzerland to 84.7 in Australia, and the majority of hip patients across countries were female. The congestive heart failure (CHF) sample ranged from 742 patients in England to 21,803 in the United States. Mean age ranged from 77.2 in the United States to 80.3 in Sweden, and the majority of CHF patients were males. Average in-hospital mortality across countries was 4.1%. for the hip persona and 6.3% for the CHF persona. At the year mark, the mean mortality across all countries was 25.3% for the hip persona and 32.7% for CHF persona. Across both patient types, England reported the highest mortality at 1 year followed by the United States. Readmission rates for all periods were higher for the CHF persona than the hip persona. At 30 days, the average readmission rate for the hip persona was 13.8% and 27.6% for the CHF persona. CONCLUSION: Across 11 countries, there are meaningful differences in health system outcomes for two types of patients.

Population-based organized screening by faecal immunochemical testing and colorectal cancer mortality: a natural experiment.

BACKGROUND: Population-based organized screening programmes for colorectal cancer (CRC) are underway worldwide, with many based on the faecal immunochemical test (FIT). No clinical trials assessing FIT compared with no screening are planned, and few studies have assessed the population impact of such programmes. METHODS: Before 2010, 11 out of 50 Spanish provinces initiated population-based organized screening programmes with FIT for an average-risk population aged 50-69 years. We used a quasi-experimental design across Spanish provinces between 1999 and 2016 to evaluate their impact on population age-standardized mortality and incidence rates due to CRC. Difference-in-differences and synthetic control analyses were performed to test for validation of statistical assumptions and to assess the dynamics of screening-associated changes in outcomes over time. RESULTS: No differences in outcome trends between exposed (n = 11) and control (n = 36) provinces were observed for up to 7 years preceding the implementation of screening. Relative to controls, exposed provinces experienced a mean increase in age-standardized incidence of 10.08% [95% confidence interval (CI) (5.09, 15.07)] 2 years after implementation, followed by a reduction in age-standardized mortality rates due to CRC of 8.82% [95% CI (3.77, 13.86)] after 7 years. Results were similar for both women and men. No associated changes were observed in adjacent age bands not targeted by screening, nor for 10 other major causes of death in the exposed provinces. CONCLUSIONS: FIT-based organized screening in Spain was associated with reductions in population colorectal cancer mortality. Further research is warranted in order to assess the replicability and external validity of our findings, and on gender-specific use of FIT in organized screening.

Evolution of public hospitals expenditure by healthcare area in the Spanish National Health System: the determinants to pay attention to.

BACKGROUND: In Spain, hospital expenditure represents the biggest share of overall public healthcare expenditure, the most important welfare system directly run by the Autonomous Communities (ACs). Since 2001, public healthcare expenditure has increased well above the GDP growth, and public hospital expenditure increased at an even faster rate. This paper aims at assessing the evolution of need-adjusted public hospital expenditure at healthcare area level (HCA) and its association with utilisation and 'price' factors, identifying the relative contribution of ACs, as the main locus of health policy decisions. METHODS: Ecological study on public hospital expenditure incurred in 198 (HCAs) in 16 Spanish ACs, between 2003 and 2015. Aggregated and annual log-log multilevel models, considering ACs as a cluster, were modelled using administrative data. HCA expenditure was analysed according to differences in population need, utilization and price factors. Standardised coefficients were also estimated, as well as the variance partition coefficients. RESULTS: Between 2003 and 2015, over 59 million hospital episodes were produced in Spain for an overall expenditure of €384,200 million. Need-adjusted public hospital expenditure, at HCA level, was mainly associated to medical and surgical hospitalizations (standardized coefficients 0.32 and 0.28, respectively). The ACs explained 42% of the variance not explained by HCA utilization and 'price' factors. CONCLUSIONS: Utilization, rather than 'price' factors, may be explaining the difference in need-adjusted public hospital expenditure at HCA level in Spain. ACs, third-payers in the fully devolved Spanish National Health System, are responsible for a great deal of the variation in hospital expenditure.

Applying spatio-temporal models to assess variations across health care areas and regions: Lessons from the decentralized Spanish National Health System.

OBJECTIVE: To illustrate the ability of hierarchical Bayesian spatio-temporal models in capturing different geo-temporal structures in order to explain hospital risk variations using three different conditions: Percutaneous Coronary Intervention (PCI), Colectomy in Colorectal Cancer (CCC) and Chronic Obstructive Pulmonary Disease (COPD). RESEARCH DESIGN: This is an observational population-based spatio-temporal study, from 2002 to 2013, with a two-level geographical structure, Autonomous Communities (AC) and Health Care Areas (HA). SETTING: The Spanish National Health System, a quasi-federal structure with 17 regional governments (AC) with full responsibility in planning and financing, and 203 HA providing hospital and primary care to a defined population. METHODS: A poisson-log normal mixed model in the Bayesian framework was fitted using the INLA efficient estimation procedure. MEASURES: The spatio-temporal hospitalization relative risks, the evolution of their variation, and the relative contribution (fraction of variation) of each of the model components (AC, HA, year and interaction AC-year). RESULTS: Following PCI-CCC-CODP order, the three conditions show differences in the initial hospitalization rates (from 4 to 21 per 10,000 person-years) and in their trends (upward, inverted V shape, downward). Most of the risk variation is captured by phenomena occurring at the HA level (fraction variance: 51.6, 54.7 and 56.9%). At AC level, the risk of PCI hospitalization follow a heterogeneous ascending dynamic (interaction AC-year: 17.7%), whereas in COPD the AC role is more homogenous and important (37%). CONCLUSIONS: In a system where the decisions loci are differentiated, the spatio-temporal modeling allows to assess the dynamic relative role of different levels of decision and their influence on health outcomes.

Hospital Surgical Volumes and Mortality after Coronary Artery Bypass Grafting: Using International Comparisons to Determine a Safe Threshold.

OBJECTIVE: To estimate a safe minimum hospital volume for hospitals performing coronary artery bypass graft (CABG) surgery. DATA SOURCE: Hospital data on all publicly funded CABG in five European countries, 2007-2009 (106,149 patients). DESIGN: Hierarchical logistic regression models to estimate the relationship between hospital volume and mortality, allowing for case mix. Segmented regression analysis to estimate a threshold. FINDINGS: The 30-day in-hospital mortality rate was 3.0 percent overall, 5.2 percent (95 percent CI: 4.0-6.4) in low-volume hospitals, and 2.1 percent (95 percent CI: 1.8-2.3) in high-volume hospitals. There is a significant curvilinear relationship between volume and mortality, flatter above 415 cases per hospital per year. CONCLUSIONS: There is a clear relationship between hospital CABG volume and mortality in Europe, implying a "safe" threshold volume of 415 cases per year.

Neurofibroma del mesenterio en un paciente sin enfermedad de Von Recklinghausen / Mesenteric neurofibroma seen in a patient without Von Recklinghausen´disease

Los neurofibromas son tumores benignos del sistema nervioso que pueden ser solitarios o múltiples: la neurofibromatosis o enfermedad de Von Recklinghausen. Estos tumores en general son de consistencia blanda, frecuentes a nivel de partes blandas, su localización en el aparato digestivo es infrecuente y no son encapsulados. El objetivo del presente trabajo fue presentar el caso de una paciente con neurofibroma mesentérico sin enfermedad de Von Recklinghausen. Se presenta el caso de una paciente de 41 años que fue ingresada por dolor abdominal y una tumoración palpable en la región entre flanco e hipocondrio izquierdo. En los estudios imaginológicos realizados se informó como quiste del mesenterio, lo que fue confirmado en el acto quirúrgico. Se realizó exéresis de la tumoración informada por Anatomía Patológica como neurofibroma secundariamente enquistado benigno. El neurofibroma mesentérico es una tumoración que puede verse en pacientes sin enfermedad de Von Recklinghausen.

Neurofibromas are benign tumors of the nervous system that can be solitary or multiple, the neurofibromatosis or Recklinghausen's disease. In general, these tumors are soft, non-encapsulated, more frequent in soft parts of the body and infrequent in the digestive system. The objective of the present paper was to present a female patient with mesenteric neurofibroma and without Von Recklinghausen disease. Here is a 41 years-old female patient who was admitted to the hospital because she suffered abdominal pain and a palpable tumor at the region between left flank and hypochondrium. The imaging studies revealed a mesenteric cyst, which was confirmed in surgery. The tumor was classified as a benign cyst neurofibroma by pathological anatomy and finally removed. The mesenteric neurofibroma is a tumor that can be found in patients without Von Recklinghausen disease.

Eficacia de sutura y epiploplastia con tratamiento médico posterior en la úlcera perforada / Epiploplasty and Suture Efficiency Using Further Medical Treatment in Perforated Ulcer

Introducción: la sutura y epiploplastia de la úlcera perforada con tratamiento médico posterior para erradicar el Helicobacter pylori, ha disminuido la recurrencia de la úlcera péptica, lo cual renueva el interés en este proceder ante las técnicas definitivas. Objetivos: determinar la eficacia a mediano plazo de este proceder en pacientes operados de úlcera péptica perforada. Métodos: se realizó un estudio observacional analítico en el Hospital Universitario "Manuel Ascunce Domenech" de Camagüey, desde enero de 2010 hasta diciembre de 2013. El estudio estuvo conformado por los pacientes operados de úlcera perforada con más de un año de evolución (45 casos). Los datos obtenidos se procesaron mediante el paquete estadístico SPSS para Windows versión 15.0, con técnica estadística de comparación de la prueba de hipótesis de proporciones en una computadora Pentium IV. Resultados: el sexo más afectado fue el masculino y predominó en la cuarta y quinta décadas de la vida. La localización más frecuente de la perforación fue duodenal y la mayoría, menores de 1 cm. Las complicaciones posoperatorias más frecuentes fueron las infecciones respiratorias. El tabaquismo y la ingestión de café fueron los factores de riesgo actuales más frecuentes. La mayoría de los pacientes recibieron tratamiento médico completo en el posoperatorio, con buenos resultados de acuerdo a la clasificación de Visick y en la endoscopia realizada, donde solo una paciente presentó enfermedad ulcerosa. Conclusiones: se comprobó que la sutura y epiploplastia de la úlcera perforada con tratamiento médico posterior completo es eficaz a mediano plazo(AU)

Introduction: suture and epiploplasty of perforated ulcer using further medical treatment for helicobacter pylori eradication has decreased recurrence of peptic ulcer, renewing interest in this proceeding in contrast to final techniques. Objective: determine the medium term efficacy of this procedure in patients undergoing surgery for perforated peptic ulcer. Methods: an observational study was conducted at Manuel Ascunce Domenech University Hospital in Camagüey, from January 2010 to December 2013. The study consisted of patients operated on for perforated ulcer over a year (45 cases). The obtained data were processed using SPSS for Windows version 15.0, with statistical technique of comparing the proportions hypothesis test on a Pentium IV computer. Results: the most affected patients were male aging forty and fifty. The most frequent location was duodenal perforation and most of them less than 1 cm. The most frequent postoperative complications were respiratory infections. Smoking habits and coffee intake were the most common risk factors. Most patients received full medical treatment in the postoperative period, with good results according to Visick classification and the endoscopy, where only one patient had ulcer disease. Conclusions: suture and perforated ulcer epiploplasty with subsequent full medical treatment, definitively, cure patients(AU)

The merry-go-round of approval, pricing and reimbursement of drugs against the Hepatitis C virus infection in Spain.

Given that drug innovation has been largely away from breakthroughs, arguing that a new drug recently approved and reaching the market is downright effective, safe and affordable is actually parlous. The soaring costs of an increasing number of new drugs (specially for cancer and rare diseases) threaten to supersede societal absorbing capacity, competing with other health and outside health sector resources. Some health systems are not making headways towards solving the current conundrum of keeping path with the state of the art regulatory mechanisms in delivering cost-effective, equitable and affordable treatments. The way pricing and reimbursement decisions have been made in Spain regarding the recent wave of new drugs against the hepatitis C virus could be one case in point. This paper analyses the path of decision-making and the positioning of the relevant actors in this case, that has set a cumbersome precedent (earmarked fund) for the Spanish National Health Service. It also stresses the need for current decision-making mechanisms on approval, pricing, coverage and reimbursement in Spain to move to a transparent regulatory system, avoiding improvisation and incorporating the highest regulatory standards that other countries have in place.

[Trend in potentially avoidable hospitalisations for chronic conditions in Spain]. / Evolución de las hospitalizaciones potencialmente evitables por condiciones crónicas en España.

OBJECTIVE: To analyse the trend in potentially avoidable hospitalisations (PAH) in frail patients or those with chronic conditions in Spain during the period 2002-2013. METHODS: An observational, ecological study was conducted to analyse the trend in age-sex standardised rates of PAH affecting six clinical conditions, and their variation, in the 203 health care areas composing the publicly-funded health system in Spain. RESULTS: During the period 2002-2013, overall PAH standardised rates decreased by 35%, but systematic variation remained moderately high, around 13% above that expected by chance. Angina admissions showed the largest reduction, followed by those for asthma and chronic obstructive pulmonary disease. In contrast, the prevalence of admissions for dehydration doubled. CONCLUSIONS: Despite the decrease in PAH rates, systematic variation among areas remains, indicating differences in chronic care management that lead to distinct healthcare outcomes.

Comparing variation across European countries: building geographical areas to provide sounder estimates.

BACKGROUND: In geographical studies, population distribution is a key issue. An unequal distribution across units of analysis might entail extra-variation and produce misleading conclusions on healthcare performance variations. This article aims at assessing the impact of building more homogeneous units of analysis in the estimation of systematic variation in three countries. METHODS: Hospital discharges for six conditions (congestive heart failure, short-term complications of diabetes, hip fracture, knee replacement, prostatectomy in prostate cancer and percutaneous coronary intervention) produced in Denmark, England and Portugal in 2008 and 2009 were allocated to both original geographical units and new ad hoc areas. New areas were built using Ward's minimum variance methods. The impact of the new areas on variability was assessed using Kernel distribution curves and different statistic of variation such as Extremal Quotient, Interquartile Interval ratio, Systematic Component of Variation and Empirical Bayes statistic. RESULTS: Ward's method reduced the number of areas, allowing a more homogeneous population distribution, yet 20% of the areas in Portugal exhibited less than 100 000 inhabitants vs. 7% in Denmark and 5% in England. Point estimates for Extremal Quotient and Interquartile Interval Ratio were lower in the three countries, particularly in less prevalent conditions. In turn, the Systematic Component of Variation and Empirical Bayes statistic were slightly lower in more prevalent conditions. CONCLUSIONS: Building new geographical areas produced a reduction of the variation in hospitalization rates in several prevalent conditions mitigating random noise, particularly in the smallest areas and allowing a sounder interpretation of the variation across countries.

Comparing hospital performance within and across countries: an illustrative study of coronary artery bypass graft surgery in England and Spain.

OBJECTIVE: To assess the feasibility, strengths and weaknesses of using administrative data to compare hospital performance across countries, using mortality after coronary artery bypass graft (CABG) surgery as an illustrative example. METHODS: Country specific and pooled models using individual-level data and logistic regression methods assess individual hospital performance using funnel plots accounting for multiple testing. Outcomes are adjusted for age, sex, comorbidities and indicators of patient severity. Data includes patients from all publicly funded hospitals delivering CABG surgery in England and Spain. Inpatient hospital-level standardized mortality rates within 30 days of CABG surgery are calculated for 83 999 CABG patients between 2007 and 2009. RESULTS: Unadjusted national mortality rates are 5% in Spain and 2.3% in England. Country-specific models identified similar patterns of excess mortality 'alerts' and 'alarms' in hospitals in Spain or England. Pooling data from both countries identifies larger numbers of alerts and alarms in Spanish hospitals, and risk-adjustment increased the already large national mortality difference. This was reduced but not eliminated by accounting for lower volume in Spanish hospitals. CONCLUSION: Cross-national comparisons potentially add value by providing international performance benchmarks. Hospital-level analysis across countries can illuminate differences in hospital performance, which might not be identified using country-specific data or incomplete registry data, and can test hypotheses that may explain national differences. Difficulties of making data comparable between countries, however, compound the usual within-country measurement problems.