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21 December 2023 | Country Update
Assessment of the performance of the SNS in the COVID-19 pandemic -
05 December 2019 | Country Update
Is this drug financed by the National Health System? -
28 October 2019 | Country Update
A new information system to assess the therapeutic value of drugs in real practice
7.1. Monitoring health system performance
Despite the vast impact of the financial and economic crisis on Spanish society, and the austerity measures imposed by the Stability Programme for the Kingdom of Spain, the underlying principles and goals of the SNS (universal coverage, equitable access to a comprehensive package of benefits, easy access to primary care and gatekeeping, taxation as the basis for financing with limited patient cost-sharing and low risks of financial hardship) remain in place. On the other hand, the SNS response in the form of budgetary cutbacks and new regulations on the scope, breadth and depth of coverage did apparently not have any substantial immediate impact on health outcomes, although discontent is observed to be growing among the population and professionals.
In September 2021, the Interterritorial Council of the National Health System (CISNS) mandated the elaboration of a report assessing the response of the Spanish National Health System (SNS) to the COVID-19 pandemic. The report was presented on December 2023.
The report revealed some gaps in preparedness, such as lack of strategic stock of material as well as weak information and early warning systems. In addition, it states that some errors in the response to the COVID-19 pandemic were due to already existing problems in the SNS, including deficiencies in epidemiological surveillance systems, structurally undersized human resources, the absence of comprehensive information systems at national level and lack of protocols in nursing homes. Likewise, although there was continuous communication between the central government and the Autonomous Communities, the CISNS was not as effective as it could have been to enhance the homogeneity of decisions across the territory.
The report also highlights actions that had a positive impact to tackle the COVID-19 pandemic, such as the setting-up of a single command at the beginning of the pandemic based in the Ministry of Health that centralized the response, the active involvement of the Military and Security Forces, the introduction of comprehensive social protection measures, the outstanding response of health and social care professionals, and the excellent deployment of the vaccination campaign.
More information (in Spanish), here: Evaluación del desempeño del Sistema Nacional de Salud español frente a la pandemia de COVID-19 [Assessment of the performance of the Spanish National Health System in the face of the COVID-19 pandemic] https://www.sanidad.gob.es/areas/alertasEmergenciasSanitarias/alertasActuales/nCov/documentos/EVALUACION_DEL_DESEMPENO_DEL_SNS_ESPANOL_FRENTE_A_LA_PANDEMIA_DE_COVID-19.pdf
The Ministry of Health has launched BIFIMED, a new interactive tool that provides detailed information about whether a drug previously authorised by the National Health System is financed by the public system, and for what indications. This tool is accessible to any interested public, including insurees, and it is updated on a monthly basis.
A quick glance at the existing information within BIFIMED reveals that, for example, 4,975 authorised drugs (out of 32,179) were not publicly financed, corresponding 62% (out of 17029 applications) to generic drugs, 6% (out of 1632 applications) to biological drugs and 1% to orphan drugs (out of 193 applications).
Furthermore, the number of funding refusals has increased steadily since 2005. For example, up to now in 2019 there has been 675 negative resolutions, a 33% of the funding applications this year, compared to the 121 refusals (16% of the total) issued in 2005.
More information (in Spanish):
The Spanish Health Minister presented Valtermed, a new shared information system implemented within the Spanish National Health System to assess the real therapeutic value of drugs. Valtermed will allow to measure health outcomes for new generation drugs to increase effectiveness and safety of patients’ treatments and improve value-based reimbursement agreements with pharma companies or resource allocation.
In practice, physicians will voluntarily register patients’ health outcomes specific to each evaluated drug, out of the information collected in accordance with the pharmaceutical and clinical protocols previously loaded in the system.
At a first stage, Valtermed will assess seven drugs: Orkambi, Symkevi and Kalydeco for cystic fibrosis; Kymriah for B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma; Yescarta for diffuse large B-cell lymphoma; Besponsa, for acute lymphoblastic leukemia; and Alofisel for fistulas in Crohn’s disease. At a second stage, Valtermed is expected to include patient reported outcomes.
More information (in Spanish):
http://www.mscbs.gob.es/profesionales/farmacia/valtermed/home.htm
7.1.1. SNS information system
This section describes the nationwide initiatives approved by the ACs in the context of the Interterritorial Council. Individual ACs may have developed these initiatives further; for example, projects aiming to reuse and link electronic health data sources to develop smart health systems – notably, in Aragon, Basque Country or Catalonia.
The MSSSI, as well as the Health Departments of the 17 ACs, have responsibility for the design, collection and maintenance of data sources that allow monitoring of health, health determinants and health system performance. Traditionally, these information systems have operated as a collection of data repositories that provided partial information on a specific topic, frequently aimed at responding to the data requirements of the National Plan of Statistics. In the last years, the MSSSI and the ACs have been looking for a more integrated approach with a view to providing more complete, meaningful and actionable information. As a consequence of the 2003 Law for the Cohesion and Quality of the SNS, the MSSSI set up the so-called Information System for the SNS (IS-SNS) (MSSSI, 2014f).
The IS-SNS, whose main users are the health authorities, professionals, citizens and civil organizations, is run by the MSSSI under the mandate of the Interterritorial Council. Since its inception, the IS-SNS has been working on the development of the Statistical Portal of the SNS (MSSSI, 2017s), the SNS Data-Bank (MSSSI, 2017t), the reporting of the SNS Key Indicators (MSSSI, 2017b), the Model of Indicators for the analysis of hospitalization (iCMBD) (http://icmbd.es/) and several technological background projects, such as the “Insurance ID card” project, the EMR project (more information on the EMR project can be found at MSSSI, 2017k) and the “Interoperable Electronic Prescription” project (see section 4.1.4 Information technology and e-health).
Other initiatives within the scope of the IS-SNS are the new regulation on Specialized Care Activity registration (RAE-CMBD), two initiatives on primary health care (BDCAP and BIFAP) and the accreditation of scientific data collections as utility registries for the SNS.
A new regulation was enacted in 2015 (RD 69/2015) aimed at the registration of all the activity developed in specialized care. This registry enhances the information currently collected on hospitalizations (consolidated since the mid-1990s), and increases its scope to emergency care provided in hospital premises, and outpatient specialized care, in particular, day-case care, day-case surgery and at-home hospitalizations.
The primary care data set (BDCAP) collects clinical data from a random sample of primary health care (including all the registered population and their episodes). It includes information on active health problems, interventions and some intermediate health outcomes. BDCAP aims to facilitate the study of the effectiveness, quality and cost of primary care. Designed, curated and maintained by the MSSSI, it has been operational since 2011 and currently manages 4.68 million electronic health records covering 16 of the 17 ACs.
The primary care drugs prescription data set (BIFAP) aims to facilitate pharmaco-epidemiological research evaluating the benefits or risks of drugs as used in real-life outpatient settings. The information is voluntarily collected by GPs and paediatricians working in seven ACs. BIFAP includes clinical and prescription data from around 4.8 million patients. BIFAP is maintained by the Spanish Agency of Medical Products and Devices, a public agency of the MSSSI.
In turn, the utility registries are a compilation of data sources, a by-product of different research or monitoring projects, endorsed by the MSSSI after an accreditation process. The information collected in those “registries” is deemed of interest to inform SNS policies. The data sources currently certified are: (a) RECALCAR (a registry on health care quality in the departments of cardiology); (b) REDECAN (a joint data set by the Spanish network of cancer registries); (c) ENVIN-UCI (a Spanish registry on nosocomial infections in intensive care units); (d) a joint data set of the Spanish Network on Hospital Costs Measurement; (e) ARIAM (a registry for the analysis of the delay in therapeutic interventions in acute myocardial infarction); (f) the Spanish Fertility Registry; and (g) the Atlas VPM (Atlas de Variación de la Práctica Médica en el Sistema Nacional de Salud Español, Atlas of Variations in Medical Practice in the National Health System) data infrastructure for the assessment of unwarranted variations in health care performance.
7.1.2. Monitoring initiatives
Given the richness of the data available (the SNS occupies a remarkable position in the meaningful adoption of information technologies), EMRs are not being used systematically to monitor the effect of interventions and policies.
It is worth highlighting three nationwide monitoring initiatives, Key Indicators for the SNS (Indicadores Clave del Sistema Nacional de Salud, INCLASNS), the model of indicators for the analysis of hospitalization (iCMBD) and the Atlas VPM project, namely the atlas of variations in health care performance in the SNS.
INCLASNS compiles data from the different administrative data repertoires. Conceptually, INCLASNS is an adaptation of the framework developed by the European Core Health Indicators initiative and contains 247 indicators, with a short list of 50 indicators, covering a number of areas: health outcomes, determinants of health, health care resources, utilization and adequacy, accessibility, effectiveness and safety, expenditure and population satisfaction. The main goal is the overall assessment of the health system and the comparison of performance across ACs. INCLASNS is run by the MSSSI on behalf of the Interterritorial Council (MSSSI, 2017b).
Furthermore, since 2007, the iCMBD – the model of indicators for the analysis of hospitalization – has monitored the outcomes of a series of indicators of performance and results of the hospital network of the SNS, including indicators for the evaluation of certain strategies in the SNS and the safety of the patient (see http://icmbd.es/).
Since 2002, Atlas VPM has linked a number of administrative data sets consolidated by the 17 ACs, the MSSSI and the National Statistics Office. So far, Atlas VPM has analysed unwarranted differences in the effectiveness, efficiency, quality and safety of hospital providers at geographical level. Hence, Atlas VPM[27] has found unwarranted variability in orthopaedic procedures, cardiovascular care, cancer surgery, mental health admissions, and potentially avoidable hospitalizations in chronic conditions, ischaemic stroke and low-value procedures.
- 27. Atlas VPM is curated and exploited by the Institute for Health Sciences (IACS) in Aragon, a public institution of the SNS at regional level. All the research outputs are open access at www.atlasvpm.org. ↰