[Health policy priorities. SESPAS meeting at the XXXIII School of Public Health of Menorca]. / Prioridades de políticas de salud. Encuentro SESPAS en la XXXIII Escuela de Salud Pública de Menorca.

OBJECTIVE: In September 2022, the Sociedad Española de Salud Pública y Administración Sanitaria (SESPAS) brought together a panel of experts with the aim of defining and prioritizing health policy proposals, from the perspective of the Spanish State as a whole, to adapt the National Health System (NHS) to current risks and to contemporary/present-day society. METHOD: Expert meeting structured using a mix of procedures adapted from brainstorming, nominal group and Rand consensus method techniques. Relevance and feasibility of proposals identified were assessed individually by each panelist. Proposals were then ordered thematically and ranked according to the median and quartile deviation of relevance scores. RESULTS: Panelists identified and prioritized several proposals in different areas: governance and funding of the NHS, reform of the portfolio of services and benefits and of the NHS human resources, public health and health policy, actions against inequality and poverty, and healthcare delivery reform, including socio-sanitary, primary and end-of-life care. CONCLUSIONS: The results of the meeting show the urgent need to address in-depth changes in many state-wide health policies, including a major reconfiguration of governance, public health, and health care structures. They also point out potential areas of improvement, constituting a tentative guide of prioritized issues to be addressed.

Analysis of Healthcare Costs Incurred in Regional Hospitals in Andalusia (Spain) during the COVID-19 Pandemic.

(1) Background: The global health crisis caused by the coronavirus disease (COVID-19) pandemic has led to extreme overloading of different public healthcare systems worldwide. The Spanish Public Healthcare System is one of them. This study aimed to conduct a comparative cost analysis to assess the impact of the COVID-19 pandemic on small- and medium-sized regional hospitals in Andalusia (Spain). (2) Methods: This comparative, multicentre, observational, and retrospective study was designed to perform a comparative cost analysis between the Alto Guadalquivir Health Agency (AGHA) and Poniente University Hospital (PUH), both of which belong to the Spanish Public Health System (PHS). The data included in this study corresponds to the total costs by area and year incurred by the 61,335 patients from both healthcare institutions (AGHA = 36,110; PUH = 25,225) in the areas of hospital emergency service (HES), hospitalisation, and intensive care unit (ICU), during the 24 months of the study period (from 1 January 2019 to 31 December 2020). (3) Results: The analysis results showed a significant increase in costs incurred in 2020 for HES relative to those incurred in 2019 for both AGHA (+14%; p < 0.003) and PUH (+36%; p = 0.002). Additionally, costs incurred for ICU increased significantly in 2020 relative to those incurred in 2019 for both AGHA (+30%; p = 0.003) and PUH (+46%; p = 0.002). Hospitalisation costs for AGHA also increased significantly (+9%; p < 0.012) in 2020 versus those obtained in 2019; however, no significant differences were found for PUH (+6%; p = 1) in the same period analysed. However, the number of patients treated in the areas of HES, hospitalisation, and ICU was significantly reduced throughout 2020 compared to 2019. (4) Conclusions: Our findings show that the costs incurred during 2020 in the regional hospitals of Andalusia (Spain) increased significantly in most of the parameters analysed relative to those incurred in the year before the pandemic (i.e., 2019).

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.

Teledermatology versus Face-to-Face Dermatology: An Analysis of Cost-Effectiveness from Eight Studies from Europe and the United States.

(1) Background: The aim of this systematic review was to compare the cost-effectiveness of two follow-up methods (face-to-face and telemedicine) used in dermatology in the last ten years. (2) Methods: A search for articles that included economic analyses was conducted in August 2021 in the databases PubMed, Medline, Scielo and Scopus using the following keywords: "Cost-Benefit Analysis", "Dermatology", "Telemedicine", "Primary Health Care", as well as other search terms and following the PICOS eligibility criteria. (3) Results: Three clinical trials and five observational studies were analyzed, providing information for approximately 16,539 patients (including four cost-minimization or saving analyses, three cost-effectiveness analyses, and one cost-utility analysis) in Europe and the United States. They describe the follow-up procedures in each of the cases and measure and analyze the direct and indirect costs and effectiveness. All the articles indicate that teledermatology lowers costs and proves satisfactory to both patients and professionals. (4) Conclusions: Although it has been found that follow-up via teledermatology can be more efficient than traditional hospital follow-up, more work is needed to establish evaluation protocols and procedures that measure key variables more equally and demonstrate the quality of the evidence of said studies.

Economic impact and cost savings of teledermatology units compared to conventional monitoring at hospitals in southern Spain.

INTRODUCTION: Asynchronous teledermatology (TD) has undergone exponential growth in the past decade, allowing better diagnosis. Moreover, it saves both cost and time and reduces the number of visits involving travel and opportunity cost of time spent on visits to the hospital. The present study performed a cost-saving analysis of TD units and assessed whether they offered a cheaper alternative to conventional monitoring (CM) in hospitals from the perspective of public health-care systems (PHS) and patients. METHODS: This study was a retrospective assessment of 7030 patients. A cost-saving analysis comparing TD units to CM for patients at the Hospital de Poniente was performed over a period of one year. The TD network covered the Hospital de Poniente reference area (Spain) linked to 37 primary care (PC) centres that belonged to the Poniente Health District of Almeria. RESULTS: We observed a significant cost saving for TD units compared to participants in the conventional follow-up group. From the perspective of a PHS, there was a cost saving of 31.68% in the TD group (€18.59 TD vs. €27.20 CM) during the follow-up period. The number of CM visits to the hospital reduced by 38.14%. From the patients' perspective, the costs were lower, and the cost saving was 73.53% (€5.45 TD vs. €20.58 CM). DISCUSSION: The cost-saving analysis showed that the TD units appeared to be significantly cheaper compared to CM.

Cost-Sharing Increase, Medication Adherence, and Hospitalizations in Schizophrenia Patients: A Natural Experiment.

Increases in medication cost-sharing rates remain a controversial system-wide cost-containment measure for chronic mental health patients. The objective was to investigate the effects of cost-sharing increases on adherence to prescribed antipsychotic medication and psychiatric hospitalizations among patients with schizophrenia. In July 2012, a Spanish National Law raised the cost-sharing rate from 0 to 10% for pensioner outpatient medication while cost-sharing remained at 0% for other socioeconomic groups. To estimate the effects of the reform, we analyzed the prevalent adult schizophrenic population of Valencia, Spain, followed up 1 year before and after the Law took effect. We used a quasi-experimental design with a patient fixed-effects difference-in-differences regression to evaluate the reform effects on antipsychotic medication adherence, prescription, and hospitalization rates. A total of 5,672 included patients were exposed to the reform, whereas 5,545 were not. There were no differences in adherence, prescription, or hospitalization rates between exposed and nonexposed patients prior to its implementation. The odds ratio of exposed patients remaining adherent to issued prescriptions after the reform took effect were 0.70 99% confidence interval (CI 0.66-0.75), in relation to the nonexposed group. Additionally, the reform was associated with a reduction in exposure to antipsychotic medication (odds ratio (OR) 0.85, 99%CI 0.83-0.88) and an increase in hospitalization risk (OR 1.13, 99% CI 1.05-1.23) during the first year after implementation. Policies raising the cost-sharing rate of medication for patients with schizophrenia are simultaneously associated with unintended effects. We report decreases in antipsychotic exposure and increases in hospitalization rates that lasted for 1 year after follow-up.

Long-term cost-utility analysis of remote monitoring of older patients with pacemakers: the PONIENTE study.

BACKGROUND: Cost-effectiveness studies on pacemakers have increased in the last years. However the number of long-term cost-utility studies is limited. The objective of this study was to perform a cost-utility analysis comparing remote monitoring (RM) versus conventional monitoring (CM) in hospital of older patients with pacemakers, 5 years after implant. METHODS: Under a controlled, not randomized, nor masked clinical trial, 83 patients with pacemakers were initially selected. After five years of follow-up, a total of 55 patients (CM = 34; RM = 21) completed the study. A cost-utility analysis of RM in terms of costs per gained quality-adjusted life years (QALYs) was conducted. The costs from the Public Health System (PHS) as well as patients and their relatives were taken into account for the study. The robustness of the results was verified by the probabilistic analyses through Monte-Carlo simulations. RESULTS: After a five-year follow-up period, total costs were lower in the RM group by 23.02% than in the CM group (€274.52 versus €356.62; p = 0.033) because of a cost saving from patients' perspective (€59.05 versus €102.98; p = 0.002). However, the reduction of in-hospital visits derived from RM exhibited insignificant impact on the costs from the PHS perspective, with a cost saving of 15.04% (€215.48 vs. €253.64; p = 0.144). Costs/QALYs obtained by the RM group were higher as compared to the CM group, although there were no significant differences. The incremental cost-effectiveness ratio of CM in comparison to RM became positive (€301.16). CONCLUSIONS: This study confirms RM of older patients with pacemakers appears still as a cost-utility alternative to CM in hospital after 5 years of follow-up. TRIAL REGISTRATION: ClinicalTrials.gov: (Identifier: NCT02234245 ). Registered 09 September 2014 - Prospectively registered.

Cost-utility analysis of telemonitoring versus conventional hospital-based follow-up of patients with pacemakers. The NORDLAND randomized clinical trial.

INTRODUCTION: The aim of our study was to perform an economic assessment in order to check whether or not telemonitoring of users with pacemakers offers a cost-effective alternative to traditional follow-up in outpatient clinics. METHODS: We used effectiveness and cost data from the NORDLAND trial, which is a controlled, randomized, non-masked clinical trial. Fifty patients were assigned to receive either telemonitoring (TM; n = 25) or conventional monitoring (CM; n = 25) and were followed up for 12 months after the implantation. A cost-utility analysis was performed in terms of additional costs per additional Quality-Adjusted Life Year (QALY) attained from the perspectives of the Norwegian National Healthcare System and patients and their caregivers. RESULTS: Effectiveness was similar between alternatives (TM: 0.7804 [CI: 0.6864 to 0.8745] vs. CM: 0.7465 [CI: 0.6543 to 0.8387]), while cost per patient was higher in the RM group, both from the Norwegian NHS perspective (TM: €2,079.84 [CI: 0.00 to 4,610.58] vs. €271.97 [CI: 158.18 to 385.76]; p = 0.147) and including the patient/family perspective (TM: €2,295.91 [CI: 0.00 to 4,843.28] vs. CM: €430.39 [CI: 0.00 to 4,841.48]), although these large differences-mainly due to a few patients being hospitalized in the TM group, as opposed to none in the CM group-did not reach statistical significance. The Incremental Cost-Effectiveness Ratio (ICER) from the Norwegian NHS perspective (€53,345.27/QALY) and including the patient/caregiver perspective (€55,046.40/QALY), as well as the Incremental Net Benefit (INB), favors the CM alternative, albeit with very broad 95%CIs. The probabilistic analysis confirmed inconclusive results due to the wide CIs even suggesting that TM was not cost-effective in this study. Supplemental analysis excluding the hospitalization costs shows positive INBs, whereby suggesting a discrete superiority of the RM alternative if hospitalization costs were not considered, albeit also with broad CIs. CONCLUSIONS: Cost-utility analysis of TM vs. CM shows inconclusive results because of broad confidence intervals with ICER and INB figures ranging from potential savings to high costs for an additional QALY, with the majority of ICERs being above the usual NHS thresholds for coverage decisions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02237404.

Impact of Drug Safety Warnings and Cost-Sharing Policies on Osteoporosis Drug Utilization in Spain: A Major Reduction But With the Persistence of Over and Underuse. Data From the ESOSVAL Cohort From 2009 to 2015.

Background: Recent studies in several countries show a significant decrease in the consumption of osteoporosis drugs from a peak around 2009, mainly attributed to bisphosphonate safety warnings issued by regulatory agencies on jaw osteonecrosis, atypical fractures, and esophageal cancer, but no studies have assessed the impact of these warnings by risk of fracture strata. Aim: The aim of this work is to assess changes in the utilization of osteoporosis drugs in the region of Valencia (Spain) after safety warnings from regulatory agencies and cost-sharing changes, according to patient socio-demographic and risk of fracture characteristics. Patients and Methods: We constructed a monthly series of osteoporosis drug consumption for 2009-2015 from the ESOSVAL cohort (n = 11,035; women: 48%; mean age: 65 years old) and used interrupted time series and segmented linear regression models to assess changes in osteoporosis drug utilization while controlling for previous levels and trends after three natural intervention dates: the issue of the Spanish Agency for Drugs and Medical Products (AEMPS) Osteonecrosis Jaw Warning (Sept 2009), the AEMPS Atypical femur Fracture Warning (Apr 2011), and the modification of the cost-sharing scheme (Jul 2012). Results: The AEMPS Osteonecrosis Jaw Warning was not associated with a decline in the consumption of osteoporosis drugs, while the warning on atypical fracture (a downward trend of 0.11% fewer people treated each month) and the increase in the cost-sharing scheme (immediate change level of -1.07% in the proportion of people treated) were associated with a strong decline in the proportion of patients treated, so that by the end of 2015 osteoporosis drug consumption was around half that of 2009. The relative decline was similar in people with both a high and low risk of fracture. Conclusion: The AEMPS Atypical femur Fracture Warning of Apr 2010 was associated with a significant decrease in the number of people treated, reinforced by the increase in the pharmaceutical cost-sharing in 2012. Decreases in treatment affected patients both at a low and higher risk of fracture.

Cost-utility analysis on telemonitoring of users with pacemakers: The PONIENTE study.

INTRODUCTION: Few studies have confirmed the cost-saving of telemonitoring of users with pacemakers (PMs). The purpose of this controlled, non-randomised, non-masked clinical trial was to perform an economic assessment of telemonitoring (TM) of users with PMs and check whether TM offers a cost-utility alternative to conventional follow-up in hospital. METHODS: Eighty-two patients implanted with an internet-based transmission PM were selected to receive either conventional follow-up in hospital ( n = 52) or TM ( n = 30) from their homes. The data were collected during 12 months while patients were being monitored. The economic assessment of the PONIENTE study was performed as per the perspectives of National Health Service (NHS) and patients. A cost-utility analysis was conducted to measure whether the TM of patients with PMs is cost-effective in terms of costs per gained quality-adjusted life years (QALYs). RESULTS: There was a significant cost-saving for participants in the TM group in comparison with the participants in the conventional follow-up group. From the NHS's perspective, the patients in the TM group gained 0.09 QALYs more than the patients in the conventional follow-up group over 12 months, with a cost saving of 57.64% (€46.51 versus €109.79, respectively; p < 0.001) per participant per year. In-office visits were reduced by 52.49% in the TM group. The costs related to the patient perspective were lower in the TM group than in the conventional follow-up group (€31.82 versus €73.48, respectively; p < 0.005). The costs per QALY were 61.68% higher in the in-office monitoring group. DISCUSSION: The cost-utility analysis performed in the PONIENTE study showed that the TM of users with PMs appears to be a significant cost-effective alternative to conventional follow-up in hospital.

Pinocchio testing in the forensic analysis of waiting lists: using public waiting list data from Finland and Spain for testing Newcomb-Benford's Law.

OBJECTIVE: Newcomb-Benford's Law (NBL) proposes a regular distribution for first digits, second digits and digit combinations applicable to many different naturally occurring sources of data. Testing deviations from NBL is used in many datasets as a screening tool for identifying data trustworthiness problems. This study aims to compare public available waiting lists (WL) data from Finland and Spain for testing NBL as an instrument to flag up potential manipulation in WLs. DESIGN: Analysis of the frequency of Finnish and Spanish WLs first digits to determine if their distribution is similar to the pattern documented by NBL. Deviations from the expected first digit frequency were analysed using Pearson's χ2, mean absolute deviation and Kuiper tests. SETTING/PARTICIPANTS: Publicly available WL data from Finland and Spain, two countries with universal health insurance and National Health Systems but characterised by different levels of transparency and good governance standards. MAIN OUTCOME MEASURES: Adjustment of the observed distribution of the numbers reported in Finnish and Spanish WL data to the expected distribution according to NBL. RESULTS: WL data reported by the Finnish health system fits first digit NBL according to all statistical tests used (p=0.6519 in χ2 test). For Spanish data, this hypothesis was rejected in all tests (p<0.0001 in χ2 test). CONCLUSIONS: Testing deviations from NBL distribution can be a useful tool to identify problems with WL data trustworthiness and signalling the need for further testing.

Primary Nonadherence to Oral Anticoagulants in Patients with Atrial Fibrillation: Real-World Data from a Population-Based Cohort.

BACKGROUND: Primary nonadherence (not filling a first prescription) is an important yet unstudied aspect of adherence to oral anticoagulant (OAC) therapy. OBJECTIVE: To estimate the rates of primary nonadherence to OACs and determine associated factors in real-world practice. METHODS: This population-based retrospective cohort study set in the Valencia region of Spain (about 5 million inhabitants) included all patients with atrial fibrillation who were newly prescribed OACs during 2011-2014 (N = 18,715). Primary nonadherence was obtained by linking electronic prescription and dispensing data and assessed by type of OAC-vitamin K antagonists (VKAs) or non-VKA oral anticoagulants (NOACs). Covariates were obtained from diverse databases, including electronic medical records. Multivariate logistic regression models were used to assess characteristics associated with primary nonadherence, adjusting for a propensity score to minimize confounding by indication. RESULTS: Primary nonadherence to OACs was 5.62% (VKA 4.29% vs. NOAC 10.81%; P < 0.001), with varying rates among specific drugs (acenocoumarol 4.2%, warfarin 10.9%, apixaban 5.0%, dabigatran 7.9%, and rivaroxaban 15.5%). After adjusting for potential confounders, the likelihood of not filling the first prescription was higher for NOAC patients than for VKA patients (OR = 2.76, 95% CI = 2.41-3.15). High coinsurance in the older groups (OR = 2.63, 95% CI = 1.47-4.69 for patients aged 66-75 years and OR = 3.02, 95% CI = 1.58-5.76 for patients aged > 75 years); being a non-Spanish European (OR = 1.49, 95% CI = 1.12-1.99); and having dementia (OR = 1.72, 95% CI = 1.37-2.16) were positively associated with primary nonadherence. Electronic transmission of prescriptions (OR = 0.85, 95% CI = 0.74-0.96); liver disease (OR = 0.73, 95% CI = 0.54-0.99); and polypharmacy (OR = 0.59, 95% CI = 0.50-0.70) were inversely associated with primary nonadherence. CONCLUSIONS: Overall, primary nonadherence to OACs was relatively low (5%). However, important differences were found between VKAs and NOACs. After adjustment, patients prescribed NOACs nearly tripled the likelihood of nonadherence compared with patients prescribed VKAs, which could negatively affect their effectiveness in clinical practice. Identified correlates were similar to those shown in the limited evidence for other medications. DISCLOSURES: This work was partially supported by the 2013 Collaboration Agreement between the Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO) from the Valencia Ministry of Health and Boehringer Ingelheim, a nonconditioned program to conduct independent research in chronic health care, pharmacoepidemiology, and medical practice variation. Rodriguez-Bernal was funded by the Instituto de Salud Carlos III, Spanish Ministry of Health, and cofinanced by the European Regional Development Fund (grant number RD12/0001/0005). The views presented here are those of the authors and not necessarily those of the FISABIO Foundation, the Valencia Ministry of Health, or the study sponsors. The funding sources had no access to study data and did not participate in any way in the design or conduct of the study, data analysis, decisions regarding the dissemination of findings, the development of the manuscript, or its publication. Peiró has received fees for participation in scientific meetings and courses sponsored by Novartis and Ferrer International. In 2014, Sanfélix-Gimeno participated in an advisory meeting of Boehringer Ingelheim. García-Sempere is a former employee of Boehringer Ingelheim. Rodriguez-Bernal and Hurtado have no relationships relevant to the contents of this article to disclose. This work was previously submitted as an abstract (podium presentation) at the 31st International Society of Pharmacoepidemiology (ISPE) Annual Conference; August 22-26, 2015; Boston, Massachusetts.

Effect of cost sharing on adherence to evidence-based medications in patients with acute coronary syndrome.

OBJECTIVES: Cost-sharing scheme for pharmaceuticals in Spain changed in July 2012. Our aim was to assess the impact of this change on adherence to essential medication in patients with acute coronary syndrome (ACS) in the region of Valencia. METHODS: Population-based retrospective cohort of 10 563 patients discharged alive after an ACS in 2009-2011. We examined a control group (low-income working population) that did not change their coinsurance status, and two intervention groups: pensioners who moved from full coverage to 10% coinsurance and middle-income to high-income working population, for whom coinsurance rose from 40% to 50% or 60%. Weekly adherence rates measured from the date of the first prescription. Days with available medication were estimated by linking prescribed and filled medications during the follow-up period. RESULTS: Cost-sharing change made no significant differences in adherence between intervention and control groups for essential medications with low price and low patient maximum coinsurance, such as antiplatelet and beta-blockers. For costlier ACE inhibitor or an angiotensin II receptor blocker (ACEI/ARB) and statins, it had an immediate effect in the proportion of adherence in the pensioner group as compared with the control group (6.8% and 8.3% decrease of adherence, respectively, p<0.01 for both). Adherence to statins decreased for the middle-income to high-income group as compared with the control group (7.8% increase of non-adherence, p<0.01). These effects seemed temporary. CONCLUSIONS: Coinsurance changes may lead to decreased adherence to proven, effective therapies, especially for higher priced agents with higher patient cost share. Consideration should be given to fully exempt high-risk patients from drug cost sharing.

Trends and area variations in Potentially Preventable Admissions for COPD in Spain (2002-2013): a significant decline and convergence between areas.

BACKGROUND: Potentially Preventable Hospitalizations (PPH) are hospital admissions for conditions which are preventable with timely and appropriate outpatient care being Chronic Obstructive Pulmonary Disease (COPD) admissions one of the most relevant PPH. We estimate the population age-sex standardized relative risk of admission for COPD-PPH by year and area of residence in the Spanish National Health System (sNHS) during the period 2002-2013. METHODS: The study was conducted in the 203 Hospital Service Areas of the sNHS, using the 2002 to 2013 hospital admissions for a COPD-PPH condition of patients aged 20 and over. We use conventional small area variation statistics and a Bayesian hierarchical approach to model the different risk structures of dependence in both space and time. RESULTS: COPD-PPH admissions declined from 24.5 to 15.5 per 10,000 persons-year (Men: from 40.6 to 25.1; Women: from 9.1 to 6.4). The relative risk declined from 1.19 (19 % above 2002-2013 average) in 2002 to 0.77 (30 % below average) in 2013. Both the starting point and the slope were different for the different regions. Variation among admission rates between extreme areas dropped from 6.7 times higher in 2002 to 4.6 times higher in 2013. CONCLUSIONS: COPD-PPH conditions in Spain have undergone a strong decline and a reduction in geographical variation in the last 12 years, suggesting a general improvement in health policies and health care over time. Variability among areas still remains, with a substantial room for improvement.

The quality of reporting methods and results of cost-effectiveness analyses in Spain: a methodological systematic review.

BACKGROUND: Cost-effectiveness analysis has been recognized as an important tool to determine the efficiency of healthcare interventions and services. There is a need for evaluating the reporting of methods and results of cost-effectiveness analyses and establishing their validity. We describe and examine reporting characteristics of methods and results of cost-effectiveness analyses conducted in Spain during more than two decades. METHODS: A methodological systematic review was conducted with the information obtained through an updated literature review in PubMed and complementary databases (e.g. Scopus, ISI Web of Science, National Health Service Economic Evaluation Database (NHS EED) and Health Technology Assessment (HTA) databases from Centre for Reviews and Dissemination (CRD), Índice Médico Español (IME) Índice Bibliográfico Español en Ciencias de la Salud (IBECS)). We identified cost-effectiveness analyses conducted in Spain that used quality-adjusted life years (QALYs) as outcome measures (period 1989-December 2014). Two reviewers independently extracted the data from each paper. The data were analysed descriptively. RESULTS: In total, 223 studies were included. Very few studies (10; 4.5 %) reported working from a protocol. Most studies (200; 89.7 %) were simulation models and included a median of 1000 patients. Only 105 (47.1 %) studies presented an adequate description of the characteristics of the target population. Most study interventions were categorized as therapeutic (189; 84.8 %) and nearly half (111; 49.8 %) considered an active alternative as the comparator. Effectiveness of data was derived from a single study in 87 (39.0 %) reports, and only few (40; 17.9 %) used evidence synthesis-based estimates. Few studies (42; 18.8 %) reported a full description of methods for QALY calculation. The majority of the studies (147; 65.9 %) reported that the study intervention produced "more costs and more QALYs" than the comparator. Most studies (200; 89.7 %) reported favourable conclusions. Main funding source was the private for-profit sector (135; 60.5 %). Conflicts of interest were not disclosed in 88 (39.5 %) studies. CONCLUSIONS: This methodological review reflects that reporting of several important aspects of methods and results are frequently missing in published cost-effectiveness analyses. Without full and transparent reporting of how studies were designed and conducted, it is difficult to assess the validity of study findings and conclusions.

Workload, time and costs of the informal cares in patients with tele-monitoring of pacemakers: the PONIENTE study.

OBJECTIVES: The purpose of this study was to assess the burden borne by and the costs to informal caregivers of patients with remotely monitored (RM) pacemakers. METHODS: The PONIENTE study was a controlled, non-randomised clinical trial, with data collected from informal caregivers, 12 months after implantation of pacemakers. The survey on disabilities, personal autonomy, and dependency situations was used to gather information on demographic and social characteristics, levels of professionalism, time and types of care, difficulties in providing care, health status, professional aspects, economic and family or leisure impacts due to informal caregiving for patients with pacemakers. RESULTS: During 14 months, 76 caregivers were enrolled in the PONIENTE trial. Of which, 26 were included in the RM group and 50 in the hospital-monitored group (HM). The mean ages were 58.62 ± 16.51 and 61.10 ± 12.67 years, respectively (p = 0.56) in the groups, and 69.7 % were females. The majority (96.1 %) of the caregivers declared that they had to provide their services between 6 and 7 days per week (88.5 % in RM group versus 100 % in HM group; p = 0.037). The costs related to care provided by the informal caregivers were 21.38 % lower in the RM group than in the HM group (p = 0.033). CONCLUSIONS: The PONIENTE study shows a significant impact of informal care on relatives and friends of patients with pacemakers in terms of their well-being and costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT02234245.

[Barriers for introducing a health technology assessment organization to inform health care decision-making in the Spanish National Health System]. / Barreras a la introducción de una agencia evaluadora para informar la financiación o la desinversión de prestaciones sanitarias del Sistema Nacional de Salud.

BACKGROUND: To identify difficulties, obstacles and limitations to establish an organizational structure devoted to the evaluation of healthcare technologies for incorporation, maintenance or removal from the services portfolio of the Spanish National Health System (sNHS). METHODS: Panel of 14 experts, structured according to processes adapted from brainstorming, nominal group, and Rand consensus method techniques. RESULTS: The panel proposed 77 items as potential obstacles to the establishment of an official and independent "agency" able to inform on sNHS healthcare benefits funding or selective disinvestment. These items were focused on: 1) lack of political motivation to introduce the cost-effectiveness analysis from the state and regional governments and lack of independence and transparency of the evaluation processes, 2) the tension between a decentralized health system and evaluation activities with significant scale economies, 3) technical difficulties of the evaluation processes, including their ability to influence decision making and 4) social and professional refusal to the exclusion of healthcare benefits when it is perceived as indiscriminate. CONCLUSION: Although there is a different number and type of obstacles for developing the capacity of the sNHS to include or exclude healthcare benefits based on the evaluation of their effectiveness and efficiency, experts place in the political arena (political motivation, transparency, governance) the main difficulties to advance in this field.

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.

[Dabigatran versus acenocumarol for the prevention of stroke in atrial fibrillation: budget impact analysis in one health department in Spain]. / Dabigatrón versus acenocumarol para la prevención del ictus en la fibrilación atrial: análisis de impacto presupuestario en un departamento sanitario.

BACKGROUND: To Estimate, in the context of a Health Department of the Valencia Health Agency, the budgetary impact of the widespread use of dabigatran at doses of 110 and 150 mg in patients with non-valvular atrial fibrillation (AF), regarding the current scenario with acenocoumarol therapy. METHODS: Budget impact analysis of three scenarios of oral anticoagulation use in AF: a) current treatment with acenocoumarol, b) widespread replacement of acenocoumarol for Dabigatran 110 mg and, c) idem at doses of 150 mg. The analysis was conducted from the perspective of the Valencia Health Agency with a time horizon of one year (2009). The effectiveness and adverse effects were extrapolated from the RE-LY study, while prevalence and cost data correspond to the Health Department estimates in 2009. RESULTS: We included 5889 patients (2.4% of the population > 18 years) diagnosed with AF, of which 3726 (63.2%) were treated with acenocoumarol. The total costs of each scenario were € 1,119,412 (€ 300 patient/year) for acenocoumarol, € 4,985,095 (€ 1,337 patient/year) for dabigatran 110 and € 4,981,226 (€ 1,336 patient/year) for dabigatran 150, with a budget impact of 1,037 euros/year per patient shifted from acenocumarol to dabigatran-150. CONCLUSIONS: The high budgetary impact of moving to a scenario of widespread substitution of warfarin for Dabigatran supports the restriction of this therapeutic strategy to subgroups of patients at high risk or difficult control.