[Future National Public Health Agency: an opportunity for the public health system in Spain]. / La Agencia Estatal de Salud Pública: una oportunidad para el sistema de Salud Pública en España.

The creation of a national centre for public health, with adequate resources, will make it possible to face the public health challenges of the present and the future in our country. To this end, the proposed state agency, should hold functions based on advanced public health organizational schemes, while linking with the sustainable development goals. The coordination of a national public health strategy built on a collaborative network of networks would also be essential, as developing an innovative, benchmarked and prioritised public health communication strategy, among other tasks. The lack of resources, the current relative disconnection of essential public health functions at the state level, and the inequity in their development of these functions at the regional and municipal levels, favour the development of the agency project as a network of networks. In this paper we give ideas for a process that seems decisive for Spanish public health in the 21st century.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making.

The Monitoring Studies (MS) program, the approach developed by RedETS to generate postlaunch real-world evidence (RWE), is intended to complement and enhance the conventional health technology assessment process to support health policy decision making in Spain, besides informing other interested stakeholders, including clinicians and patients. The MS program is focused on specific uncertainties about the real effect, safety, costs, and routine use of new and insufficiently assessed relevant medical devices carefully selected to ensure the value of the additional research needed, by means of structured, controlled, participative, and transparent procedures. However, despite a clear political commitment and economic support from national and regional health authorities, several difficulties were identified along the development and implementation of the first wave of MS, delaying its execution and final reporting. Resolution of these difficulties at the regional and national levels and a greater collaborative impulse in the European Union, given the availability of an appropriate methodological framework already provided by EUnetHTA, might provide a faster and more efficient comparative RWE of improved quality and reliability at the national and international levels.

The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

Spain: Health System Review.

This analysis of the Spanish health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Overall health status continues to improve in Spain, and life expectancy is the highest in the European Union. Inequalities in self-reported health have also declined in the last decade, although long-standing disability and chronic conditions are increasing due to an ageing population. The macroeconomic context in the last decade in the country has been characterized by the global economic recession, which resulted in the implementation of health system-specific measures addressed to maintain the sustainability of the system. New legislation was issued to regulate coverage conditions, the benefits package and the participation of patients in the National Health System funding. Despite the budget constraints linked to the economic downturn, the health system remains almost universal, covering 99.1% of the population. Public expenditure in health prevails, with public sources accounting for over 71.1% of total health financing. General taxes are the main source of public funds, with regions (known as Autonomous Communities) managing most of those public health resources. Private spending, mainly related to out-of-pocket payments, has increased over time, and it is now above the EU average. Health care provision continues to be characterized by the strength of primary care, which is the core element of the health system; however, the increasing financing gap as compared with secondary care may challenge primary care in the long-term. Public health efforts over the last decade have focused on increasing health system coordination and providing guidance on addressing chronic conditions and lifestyle factors such as obesity. The underlying principles and goals of the national health system continue to focus on universality, free access, equity and fairness of financing. The evolution of performance measures over the last decade shows the resilience of the health system in the aftermath of the economic crisis, although some structural reforms may be required to improve chronic care management and the reallocation of resources to high-value interventions.

Spain: health system review

This analysis of the Spanish health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Overall health status continues to improve in Spain, and life expectancy is the highest in the European Union. Inequalities in self-reported health have also declined in the last decade, although long-standing disability and chronic conditions are increasing due to an ageing population. The macroeconomic context in the last decade in the country has been characterized by the global economic recession, which resulted in the implementation of health system-specific measures addressed to maintain the sustainability of the system. New legislation was issued to regulate coverage conditions, the benefits package and the participation of patients in the National Health System funding. Despite the budget constraints linked to the economic downturn, the health system remains almost universal, covering 99.1% of the population. Public expenditure in health prevails, with public sources accounting for over 71.1% of total health financing. General taxes are the main source of public funds, with regions (known as Autonomous Communities) managing most of those public health resources. Private spending, mainly related toout-of-pocket payments, has increased over time, and it is now above the EU average. Health care provision continues to be characterized by the strength of primary care, which is the core element of the health system; however, the increasing financing gap as compared with secondary care may challenge primary care in the long term. Public health efforts over the last decade have focused on increasing health system coordination and providing guidance on addressing chronic conditions and life style factors such as obesity. The underlying principles and goals of the national health system continue to focus on universality, free access, equity and fairness of financing. The evolution of performance measures over the last decade shows the resilience of the health system in the aftermath of the economic crisis, although some structural reforms may be required to improve chronic care management and the reallocation of resources to high-value interventions.

Drivers of poor medical care.

The global ubiquity of overuse and underuse of health-care resources and the gravity of resulting harms necessitate an investigation of drivers to inform potential solutions. We describe the network of influences that contribute to poor care and suggest that it is driven by factors that fall into three domains: money and finance; knowledge, bias, and uncertainty; and power and human relationships. In each domain the drivers operate at the global, national, regional, and individual level, and are modulated by the specific contexts within which they act. We discuss in detail drivers of poor care in each domain.

[Health reports as the centrepiece of public health services]. / Los informes de salud como eje de los servicios de salud pública.

The main objective of health reports is to contribute to the health improvement of a specific population. They are an essential support tool for the design and planning of health policies and can also be used for accountability and evaluation. This study assesses various types of health report, including that used by the City of Barcelona (Spain), with a focus on social determinants, as well as an international health report more centred on the impact of health services. Some suggestions are proposed about the appropriateness and best use of these documents, including: the need for effective communication between technical professionals and politicians through meetings and dialogue; commitment to transparency, both authors (by means of the declaration of interests) and in terms of the information reported and with the maximum level of participation; to promote the use of a conceptual framework of social determinants of health; a focus on health inequalities; the inclusion of information relevant to policy action; the organisation of information in such a way that it allows comparison or benchmarking with similar areas and prospectively; presenting the information in an attractive way using elements such as rankings, maps or other tools; and the design of communication strategies adapted to key stakeholders.

The Spanish long-term care system in transition: Ten years since the 2006 Dependency Act.

At the end of 2006, a new System for Promotion of Personal Autonomy and Assistance for Persons in a Situation of Dependency (SAAD) was established in Spain through the approval of the Act 39/2006 of 14th December (the Dependency Act, DA). The DA acknowledged the universal entitlement of Spanish citizens to social services. The recent economic crisis added degrees of uncertainty to several dimensions of the SAAD implementation process. Firstly, the political consensus on which its foundation rested upon has weakened. Secondly, implementation of the SAAD was hampered by several challenges that emerged in the context of the economic crisis. Thirdly, the so-called "dependency limbo" (i.e. the existence of a large number of people eligible for benefits but who do not receive them) has become a structural feature of the system. Finally, contrary to the spirit of the DA, monetary benefits have become the norm rather than a last resort. High heterogeneity across regions regarding the number of beneficiaries covered and services provided reveal the existence of regional inequity in access to long-term care services in the country. Broadly, the current evidence on the state of the SAAD suggests the need to improve the quality of governance, to enhance coordination between health and social systems, to increase the system's transparency, to foster citizens' participation in decision-making and to implement a systematic monitoring of the system.

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.

Socioeconomic inequality in hip replacement in four European countries from 2002 to 2009--area-level analysis of hospital data.

BACKGROUND: Cross-country comparisons of socioeconomic equity in health care typically use sample survey data on general services such as physician visits. This study uses comprehensive administrative data on a specific service: hip replacement. METHODS: We analyse 651 652 publicly funded hip replacements, excluding fractures and accidents, in adults over 35 in Denmark, England, Portugal and Spain from 2002 to 2009. Sub-national administrative areas are split into socioeconomic quintile groups comprising approximately one-fifth of the national population. Area-level Poisson regression with Huber-White standard errors is used to calculate age-sex standardised hip replacement rates by quintile group, together with gaps and ratios between richest and poorest groups (Q5 and Q1) and the middle group (Q3). RESULTS: We find pro-rich-area inequality in England (2009 Q5/Q1 ratio 1.35 [CI 1.25-1.45]) and Spain (2009 Q5/Q1 ratio 1.43 [CI 1.17-1.70]), pro-poor-area inequality in Portugal (2009 Q5/Q1 ratio 0.67 [CI 0.50-0.83]) and no significant inequality in Denmark. Pro-rich-area inequality increased over time in England and Spain but not significantly. Within-country differences between socioeconomic quintile groups are smaller than between-country differences in general population averages: hip replacement rates are substantially lower in Portugal and Spain (8.6 and 7.4 per 10 000 in 2009) than England and Denmark (20.2 and 27.8 per 10 000 in 2009). CONCLUSION: Despite limitations regarding individual-level inequality and area heterogeneity, analysis of area-level data on publicly funded hospital activity can provide useful cross-country comparisons and longitudinal monitoring of socioeconomic inequality in specific health services. Although this kind of analysis cannot provide definitive answers, it can raise important questions for decision makers.

Potentially avoidable hospitalizations in five European countries in 2009 and time trends from 2002 to 2009 based on administrative data.

INTRODUCTION: Potentially avoidable hospitalizations in chronic conditions are used to evaluate health-care performance. However, evidence comparing different countries at small geographical areas is still scarce. The aim of the present study is to describe and discuss differences in rates and time-trends across health-care areas from five European countries. METHODS: Observational, ecological study, on virtually all discharges produced in five European countries between 2002 and 2009. Potentially avoidable hospitalizations were operationally defined as a joint indicator composed of six chronic conditions. Episodes flagged as potentially avoidable were allocated to 913 geographical health-care areas. Age-sex standardized rates and standardized hospitalization ratios, as well as several statistics of variation, were estimated. RESULTS: Four hundred sixty-two thousand seven hundred and ninety-two episodes were flagged as potentially avoidable. Variation in rates across countries was notable, from 93.7 cases per 10,000 inhabitants in Denmark to 34.8 cases per 10,000 inhabitants in Portugal. Within-country variation was also noteworthy, from 3.12 times among extreme areas in Spain to a 1.46-fold difference in Denmark. The highest systematic variation was found in Denmark (empirical Bayes 0.45) and the lowest in England (empirical Bayes 0.08). Rates and systematic variation remained fairly stable over time, with Denmark and England experiencing a statistically significant decrease (20% and 10%, respectively). Income and educational level, hospital utilization propensity, and region of residence were found to be associated with avoidable admissions. CONCLUSION: The dramatic variation across countries, beyond age and sex differences, and its consistency over time, implies systemic, although differential, behaviour of the five health-care systems with regard to chronic care.

Potential of geographical variation analysis for realigning providers to value-based care. ECHO case study on lower-value indications of C-section in five European countries.

BACKGROUND: Although C-section is a highly effective procedure, literature abounds with evidence of overuse and particularly misuse, in lower-value indications such as low-risk deliveries. This study aims to quantify utilization of C-section in low-risk cases, mapping out areas showing excess-usage in each country and to estimate excess-expenditure as a proxy of the opportunity cost borne by healthcare systems. METHODS: Observational, ecologic study on deliveries in 913 sub-national administrative areas of five European countries (Denmark, England, Portugal, Slovenia and Spain) from 2002 to 2009. The study includes a cross-section analysis with 2009 data and a time-trend analysis for the whole period. Main endpoints: age-standardized utilization rates of C-section in low-risk pregnancies and deliveries per 100 deliveries. Secondary endpoints: Estimated excess-cases per geographical unit of analysis in two scenarios of minimized utilization. RESULTS: C-section is widely used in all examined countries (ranging from 19% of Slovenian deliveries to 33% of deliveries in Portugal). With the exception of Portugal, there are no systematic variations in intensity of use across areas in the same country. Cross-country comparison of lower-value C-section leaves Denmark with 10% and Portugal with 2%, the highest and lowest. Such behaviour was stable over the period of analysis. Within each country, the scattered geographical patterns of use intensity speak for local drivers playing a major role within the national trend. CONCLUSION: The analysis conducted suggests plenty of room for enhancing value in obstetric care and equity in women's access to such within the countries studied. The analysis of geographical variations in lower-value care can constitute a powerful screening tool.

[Health services supply and the economic crisis: either we fund goods and services according to their value or we become bankrupt. SESPAS report 2014]. / Oferta sanitaria y crisis: financiamos los bienes y servicios según su valor o caemos en la insolvencia. Informe SESPAS 2014.

Health policy has reacted to the financial crisis by overemphasising measures targeted at reducing unit costs, increasing barriers to access (waiting lists) or closing premises. It is too soon for scientific assessment of the impact of this reshaping of supply on equity, quality and safety, and on individual and population health. Nevertheless, the emergency measures taken to achieve fiscal stabilization have shifted the focus to resolving budget problems at the expenses of sounder and deeper initiatives aimed at deciding what must be funded and how. This article advocates a policy based on selective funding of services and benefits on the basis of their value. Other countries' experiences can serve as a useful guide, including robust methods to identify technologies (or their uses) of questionable value, prioritization criteria, and careful consideration of limitations associated with the elimination of a certain benefit, especially if it affects the founding values of the system. The necessary tools are available to the Spanish health system: the regulatory framework and technical bodies able to identify lower value care, support for decision-making, and timely evaluation of such decisions. Despite the numerous hurdles, maintaining the status quo is too expensive a choice, given the opportunity costs of effectiveness and safety losses, measured in terms of equity and the economic efficiency of the Spanish health system, which may ultimately translate into worsening of the population's health status.

[Variability and opportunity costs among the surgical alternatives for breast cancer]. / Variabilidad y coste de oportunidad de las alternativas quirúrgicas en cáncer de mama.

OBJECTIVE: To analyze medical practice variation in breast cancer surgery (either inpatient-based or day-case surgery), by comparing conservative surgery (CS) plus radiotherapy vs. non-conservative surgery (NCS). We also analyzed the opportunity costs associated with CS and NCS. METHODS: We performed an observational study of age- and sex-standardized rates of CS and NCS, performed in 199 Spanish healthcare areas in 2008-2009. Costs were calculated by using two techniques: indirectly, by using All-Patients Diagnosis Related Groups (AP-DRG) based on hospital admissions, and directly by using full costing from the Spanish Network of Hospital Costs (SNHC) data. RESULTS: Standardized surgery rates for CS and NCS were 6.84 and 4.35 per 10,000 women, with variation across areas ranging from 2.95 to 3.11 per 10,000 inhabitants. In 2009, 9% of CS was performed as day-case surgery, although a third of the health care areas did not perform this type of surgery. Taking the SNHC as a reference, the cost of CS was estimated at 7,078 € and that of NCS was 6,161 €. Using AP-DRG, costs amounted to 9,036 € and 8,526 €, respectively. However, CS had lower opportunity costs than NCS when day-case surgery was performed frequently-more than 46% of cases (following SNHC estimates) or 23% of cases (following AP-DRG estimates). CONCLUSIONS: Day-case CS for breast cancer was found to be the best option in terms of opportunity-costs beyond a specific threshold, when both CS and NCS are elective.

Atlas of Variations in Medical Practice in Spain: the Spanish National Health Service under scrutiny.

Early in the 2000s, a countrywide health services research initiative was launched under the acronym of Atlas VPM: Atlas of Variations in Medical Practice in the Spanish National Health System. This initiative aimed at describing systematic and unwarranted variations in medical practice at geographic level-building upon the seminal experience of the Dartmouth Atlas of Health Care. The paper aims at explaining the Spanish Atlas experience, built upon the pioneer Dartmouth inspiration. A few selected examples will be used along the following sections to illustrate the outlined conceptual framework, the different factors that may affect variation, and some methodological challenges.

Disinvestment in the age of cost-cutting sound and fury. Tools for the Spanish National Health System.

This paper proposes the framing of disinvestment strategies as the "value for money" approach suitable for the current situation of acute budget restrictions. Building on the experiences from other countries, it first reviews the instruments already available for implementing this approach within the Spanish National Health Service (SNS) named (A) The mandate to do it: regulatory framework.(B) The capacity to identify "low value" interventions and produce guidance on best practice.(C) The capacity to monitor compliance to and effects of "enforced" guidance.These three elements have been in place in the SNS for some years now. However their effective alignment in supporting a disinvestment strategy has met with several hurdles. Components of organisational incentives as well as the "technological fascination" affecting professionals' and public perceptions have played a role in Spain as elsewhere. In addition, some idiosyncratic political factors lead to weak mechanisms for the channelling of available evidence into decision-making and the existing SNS technical bodies capped to issue only non-binding recommendations. Sadly, the "cuts across the board" strategy adopted in facing the financial crisis might have finally triggered the required political clime to overcome these obstacles to disinvestment. In the current context, the SNS stakeholders (professionals and the public) may regard the disinvestment proposal of informed local decisions about how best to spend the shrinking amount of resources, getting rid of low value care, as a shielding rationale, rather than a thread.

[Are studies of geographical variation in medical practice useful in guiding decisions on disinvestment? Some pros and cons]. / ¿Sirven los estudios de variabilidad geográfica de la práctica para informar la desinversión? Varias cautelas y algunas reflexiones.

OBJECTIVE: Disinvestment has been defined as the explicit process of cutting funding, either totally or partially, from health technologies deemed of low-value. Studies of geographic variation in medical practice have been suggested to be useful in guiding decisions on disinvestment, as they may identify unwarranted variations in procedure-rates at the population level. This study aimed to determine the utility of these studies. METHODS: We performed an ecologic study of variations in standardized rates in four «low-value¼ interventions: proctologic surgery, arthroplasty revision, incisional hernia repair and tonsillectomy. Variation across 199 healthcare areas within the Spanish national health system between 2002 and 2007 was studied by using the extremal quotient (EQ), the empirical Bayes statistic (EB) and the standardized utilization ratio (SUR). RESULTS: A total of 168,363 proctologic interventions, 41,066 arthroplasty revisions, 222,427 incisional hernia repairs, and 72,724 tonsillectomies were studied. The EQ ranged from a 3-fold variation in proctologic surgery to a 6.5-fold variation in tonsillectomy. The EB figures varied from moderate to high systematic variation: 0.12 in hernia repair and proctology, 0.20 in arthroplasty revision, and 0.30 in tonsillectomy. Twenty-five percent of the healthcare areas showed SUR figures above 1.24 in proctologic interventions, 1.25 in arthroplasty revision, 1.32 in hernia repair and 1.35 in tonsillectomy. CONCLUSIONS: The interventions studied showed moderate to high systematic variation, supporting the usefulness of variation studies in guiding disinvestment policies. Nevertheless, caution should be exercised when evaluating interventions with an uncertain risk-benefit ratio.

Spanish health care cuts: penny wise and pound foolish?

The purpose of this paper is to convey the specific health care actions and policies undertaken by the Spanish government, as well as by regional governments, as a result of the economic crisis. Throughout the last two years we have witnessed a number of actions in areas such as human capital, activity and processes, outsourcing and investment that, poorly coordinated, have shaped the nature of financial cuts on public services. This paper discloses the size and magnitude of these actions, the main actors involved and the major consequences for the health sector, citizens and patients. We further argue that there are a number of factors which have been neglected in the discourse and in the actions undertaken. First, the crisis situation is not being used as an opportunity for major reforms in the health care system. Further, the lay public and professionals have remained as observers in the process, with little to no participation at any point. Moreover, there is a general perception that the solution to the Spanish situation is either the proposed health care cuts or an increase in cost sharing for services which neglects alternative and/or complementary measures. Finally, there is a complete absence of any scientific component in the discourse and in the policies proposed.

[Indicators in primary care: reality or desire. SESPAS report 2012]. / Indicadores en atención primaria: la realidad o el deseo. Informe SESPAS 2012.

The aim of this article is two-fold: firstly, to illustrate international experiences of assessing primary care performance by using examples of both cross-country comparisons and national assessment efforts and, secondly, to describe the progress achieved to date in the articulation of the Spanish Primary Care Information System. The central role assigned to primary care in conceptual frameworks clashes with the severe limitations in the quality and availability of the data required to construct the indicators. The lack of systematic and standardized databases covering diagnosis, procedures and intermediate results in individual patients is endemic across countries. Filling this gap has become a priority in most countries, especially during the last decade. In Spain, the concept of the Primary Care Information System appeared in 2003 and the first data/results were published in 2006. Since then, distinct elements have been progressively incorporated with the involvement of the various autonomous regions in Spain. Currently, the system includes various aspects such as the population assigned, the available resources, a national catalogue of primary care centers, and activity. The next challenge in this work in progress is to build a database of clinical information.

Income level and regional policies, underlying factors associated with unwarranted variations in conservative breast cancer surgery in Spain.

BACKGROUND: Geographical variations in medical practice are expected to be small when the evidence about the effectiveness and safety of a particular technology is abundant. This would be the case of the prescription of conservative surgery in breast cancer patients. In these cases, when variation is larger than expected by need, socioeconomic factors have been argued as an explanation. OBJECTIVES: Using an ecologic design, our study aims at describing the variability in the use of surgical conservative versus non-conservative treatment. Additionally, it seeks to establish whether the socioeconomic status of the healthcare area influences the use of one or the other technique. METHODS: 81,868 mastectomies performed between 2002 and 2006 in 180 healthcare areas were studied. Standardized utilization rates of breast cancer conservative (CS) and non-conservative (NCS) procedures were estimated as well as the variation among areas, using small area statistics. Concentration curves and dominance tests were estimated to determine the impact of income and instruction levels in the healthcare area on surgery rates. Multilevel analyses were performed to determine the influence of regional policies. RESULTS: Variation in the use of CS was massive (4-fold factor between the highest and the lowest rate) and larger than in the case of NCS (2-fold), whichever the age group. Healthcare areas with higher economic and instruction levels showed highest rates of CS, regardless of the age group, while areas with lower economic and educational levels yielded higher rates of NCS interventions. Living in a particular Autonomous Community (AC), explained a substantial part of the CS residual variance (up to a 60.5% in women 50 to 70). CONCLUSION: The place where a woman lives -income level and regional policies- explain the unexpectedly high variation found in utilization rates of conservative breast cancer surgery.