Spanish National Health Service Research Articles

PP502 AQuAS Learnings From Implementing GRADE Approach, Especially The Evidence To Decision Framework And Multidisciplinary Final Consensus

IntroductionIn recent years, the GRADE system has been adopted internationally to make judgments about evidence and/or recommendations. Recently, the Spanish Network of HTA (RedETS) has promoted among its members the use of the GRADE system, especially the “Evidence to Decision” tool (EtD) where a multidisciplinary panel is involved. The objective is to describe the methodological approach with the first AQuAS experience using this methodology in HTA, focused on inclusion/exclusion of these technologies in the Spanish National Health Service (NHS) portfolio.MethodsThe standard EtD tool was used for clinical and financial decisions. Four multidisciplinary panels were constituted by relevant professionals in clinical practice and, where possible, patients. The four panels discussed on the following four interventions: in two cases, AQuAS prepared preliminary recommendations and participants provided feedback, while in the other two cases, experts received the evidence review and were asked to formulate recommendations. These recommendations were voted on and, in the case of disagreement, adapted and then voted on for a second time. Finally, any discrepancies were noted in the report. Evaluated interventions were: maxillofacial 3D-reconstruction, cataract surgery equipment, non-invasive surgery in obesity and pharmacological treatment in secondary fracture prevention.ResultsEspecially when more than one evaluative question was addressed in the HTA report the EtD and the consensus results required discussion. Consensus was fast but not immediate. Meeting length depended on the number of HTA questions and the amount of original disagreement in the recommendations. The nuances on how to write recommendations also affected the panel duration. All panels were successful in formulating the final recommendations.ConclusionsStandardizing methodologies increased the homogeneity across HTA reports. The GRADE system is a feasible and useful tool because it favors transparency and rigor in drawing up recommendations on the inclusion/exclusion of technologies in the NHS portfolio. The EtD framework complements GRADE tables, which display the relevant evidence in a way that can be used by multidisciplinary groups to reach a consensual recommendation.Although all participants received a short training video, more experience in the use of these methodologies might shorten the duration of the process and facilitate reaching consensus. Some considerations on how to overcome the difficulties and complexity of this methodological approach are discussed.

Impact of a multifaceted intervention to improve antibiotic prescribing: a pragmatic cluster-randomised controlled trial

ObjectivesThis study sought to assess the effectiveness and return on investment (ROI) of a multifaceted intervention aimed at improving antibiotic prescribing for acute respiratory infections in primary care.DesignLarge-sized, two-arm, open-label, pragmatic, cluster-randomised controlled trial.SettingAll primary care physicians working for the Spanish National Health Service (NHS) in Galicia (region in north-west Spain).ParticipantsThe seven spatial clusters were distributed by unequal randomisation (3:4) of the intervention and control groups. A total of 1217 physicians (1.30 million patients) were recruited from intervention clusters and 1393 physicians (1.46 million patients) from control clusters.InterventionsOne-hour educational outreach visits tailored to training needs identified in a previous study; an online course integrated in practice accreditation; and a clinical decision support system.Main outcome measuresChanges in the ESAC (European Surveillance of Antimicrobial Consumption) quality indicators for outpatient antibiotic use. We used generalised linear mixed and conducted a ROI analysis to ascertain the overall cost savings.ResultsMedian follow-up was 19 months. The adjusted effect on overall antibiotic prescribing attributable to the intervention was − 4.2% (95% CI: − 5.3% to − 3.2%), with this being more pronounced for penicillins − 6.5 (95% CI: − 7.9% to − 5.2%) and for the ratio of consumption of broad- to narrow-spectrum penicillins, cephalosporins, and macrolides − 9.0% (95% CI: − 14.0 to − 4.1%). The cost of the intervention was €87 per physician. Direct savings per physician attributable to the reduction in antibiotic prescriptions was €311 for the NHS and €573 for patient contributions, with an ROI of €2.57 and €5.59 respectively.ConclusionsInterventions designed on the basis of gaps in physicians’ knowledge of and attitudes to misprescription can improve antibiotic prescribing and yield important direct cost savings.Trial registration: Current Controlled Trials ISRCTN24158380. Registered 5 February 2009.

Surgical treatment for colorectal cancer: analysis of the influence of an enhanced recovery programme on long-term oncological outcomes—a study protocol for a prospective, multicentre, observational cohort study

IntroductionThe evidence currently available from enhanced recovery after surgery (ERAS) programmes concerns their benefits in the immediate postoperative period, but there is still very little evidence as to whether their...

Good practice regarding smoking cessation management in Spain: Challenges and opportunities for primary care physicians and nurses.

INTRODUCTIONWe analyze the activities carried out by primary care (PC) physicians and nurses with respect to smoking cessation and evaluate their self-reported training, knowledge, and behavior.METHODSA cross-sectional study was conducted including 1514 PC physicians and nurses from June 2016 to March 2017, in Spain. The main variable was Good Practice (GP) in attention to smokers. To identify associated factors, a multilevel logistic regression model was used adjusted for sex, age, type of center, contract, years of employment, tobacco consumption, and self-reported training/knowledge.RESULTSOf the 792 physicians and 722 nurses, 48.6% referred to GP in smoking cessation management. The finding related to: being a non-smoker (OR=1.8; 95% CI: 1.2–2.5) or ex-smoker (OR=1.4; 95% CI: 1.02–2.1), having a good level of knowledge (OR=1.8; 95% CI: 1.3–2.4) and training (OR=2.4; 95% CI: 1.8–3.2), and, to a lesser extent, being female (OR=1.3; 95% CI: 1.03–1.7), and work experience >10 years (OR=1.4; 95% CI: 1.03–1.9). The main GP barriers were: lack of time (45.5%), organizational problems (48.4%), and 35.4% lack of training.CONCLUSIONSThe GP of PC physicians and nurses regarding smoking cessation management is related to being non-smokers or ex-smokers, and having sufficient training and knowledge. Lack of time and organizational problems were considered to be the main barriers. The promotion of training activities in the Spanish National Health Service with the support of scientific societies is required.

Free prescriptions for low-income pensioners? The cost of returning to free-of-charge drugs in the Spanish National Health Service.

This study estimated the impact of reducing a capped low coinsurance rate for outpatient medicines to nil for low-income pensioners and disabled individuals in the Valencian Community (Spain). This reduction was implemented in January 2016 as a regional reform which modified the national cost-sharing reform adopted in July 2012. The impact of this intervention on the number of monthly prescriptions dispensed between July 2012 and December 2018 was estimated using two different approaches of the synthetic control method, the classical method and the method based on Bayesian structural time series. The estimates from both methods were similar, showing significant overall increases of 6.34% and 6.70% [95% credible interval: 4.05, 9.47], respectively in the number of prescriptions dispensed in this region. These results are similar to those of the previous studies indicating that reducing price from a small amount to zero discontinuously boosts demand. This evidence indicates that the impact of this intervention on the budget of the regional health service is far greater than the amount of the subsidy in the public budget. These results are useful for making accurate budgetary projections for similar eliminations of charges for low-income pensioners in the Spanish National Health Service.

Cost of Relapse Management in Patients with Schizophrenia in Italy and Spain: Comparison Between Lurasidone and Quetiapine XR.

Background and ObjectiveSchizophrenia is a low-prevalence mental disorder with a global age-standardized prevalence of 21 million people (2016). Second-generation antipsychotics (lurasidone and quetiapine XR) are recommended as the first-line treatment for schizophrenia. It is interesting to investigate how the results of clinical studies translate into direct medical costs. The objective of this analysis was to assess the direct medical costs related to pharmaceutical treatments and the management of relapses in patients affected with schizophrenia treated with lurasidone (74 mg) vs quetiapine XR (300 mg) assuming the Italian and Spanish National Health Service perspective.MethodsA health economic model was developed based on a previously published model. The analysis considered direct medical costs related to the pharmacological therapies and inpatient or outpatient management of relapses (direct medical costs referred to 2019). The probability of relapses and related costs were derived from two systematic reviews. A deterministic sensitivity analysis was implemented to test the robustness of the results.ResultsThe use of lurasidone (74 mg) compared with quetiapine XR (300 mg) would lead to a reduction in direct medical costs in Italy and Spain, with a lower cost per patient of − 163.7 € (− 9.0%) and − 327.2 € (− 22.7%), respectively. In detail, it would lead to an increase in the cost of therapy of + 53.8% and of + 30.5% in Italy and Spain, respectively, to a decrease in the cost of relapses with hospitalization of − 135.7%, and to an increase in the cost of relapses without hospitalization of + 24.5%.ConclusionsThe use of lurasidone (74 mg) for the treatment of patients affected with schizophrenia, compared with quetiapine XR (300 mg), would be a cost-saving strategy in the two contexts investigated assuming the National Health Service point of view.Electronic supplementary materialThe online version of this article (10.1007/s40261-020-00944-0) contains supplementary material, which is available to authorized users.

Impact of a health alert and its implementation on flutamide prescriptions for women: an interrupted time series analysis

BackgroundOff-label drug use among ambulatory patients is often based on little or no scientific support. This paper reports the impact of a health warning about the risks of off-label flutamide use by women and the actions subsequently implemented by the public health service targeting such use.MethodThe study was undertaken in a region in north-west Spain. We designed a segmented regression model of an interrupted time series, in which the dependent variable was the monthly value of defined daily doses of flutamide per 1000 inhabitants/day (DDD/TID), both total and stratified by sex. The following two data sources were used: flutamide prescriptions billed to the Spanish National Health Service; and flutamide deliveries made by wholesale drug distributors to pharmacies. The intervention assessed consisted of the issue of an official health warning and the actions subsequently taken to implement it.ResultsThere was an immediate reduction of 49.33% in DDD/TID billed to the Spanish National Health Service in respect of women; the mean value of the population percentage of DDD/TID of flutamide billed in respect of women fell from 34.4% pre-intervention to 23.72% post-intervention. There was an immediate reduction of 19.92% (95%CI: 6.68–33.15%) in total DDD/TID invoiced. There were no significant changes in DDD/TID billed in respect of men or in flutamide use in the private medical sector.ConclusionsOff-label drug misuse is a reality among ambulatory patients, even after actions are implemented following a toxicity warning issued by the competent Health Authority.

Differences in in-hospital mortality after STEMI versus NSTEMI by sex. Eleven-year trend in the Spanish National Health Service

Introduction and objectivesConflicting results have been reported on the possible existence of sex differences in mortality after myocardial infarction (MI). There is also a scarcity of data on the impact of sex on outcomes after ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI). The aim of this study was to analyze sex difference trends in sex-related differences in mortality for STEMI and NSTEMI. MethodsA retrospective analysis of 445 145 episodes of MI (2005-2015) was carried out using information from the Spanish National Health System. The incidence rates were expressed as events per 10 000 person-years. The denominators (age-specific groups) were obtained from the nationwide census. We calculated crude and adjusted (multilevel logistic regression) mortality. Poisson regression analysis was used to study temporal trends for in-hospital mortality. ResultsA total of 69.8% episodes occurred in men. The mean age in men was 66.1±13.3 years, which was significantly younger than in women, 74.9±12.1 (P<.001). A total of 272 407 (61.2%) episodes were STEMI, and 172 738 (38.8%) were NSTEMI. Women accounted for 28.8% of STEMI and 33.9% of NSTEMI episodes (P <.001). The effect of female sex on risk-adjusted models for in-hospital mortality was the opposite in STEMI (OR for women, 1.18; 95%CI, 1.14-1.22; P <.001) and NSTEMI (OR for women, 0.85; 95%CI, 0.81-0.89; P <.001). MI hospitalization rates were higher in men than in women for all age groups [20 vs 7.7 per 10 000 individuals aged 35-94 years (P <.001)], with a trend to diminish in both sexes. ConclusionsWomen had a slight but significantly increased risk of in-hospital mortality after MI, but the effect of sex depended on MI type, with women exhibiting higher mortality for STEMI and lower mortality for NSTEMI

From trivalent to quadrivalent influenza vaccines: Public health and economic burden for different immunization strategies in Spain.

Quadrivalent influenza vaccine (QIV) includes the same strains as trivalent influenza vaccine (TIV) plus an additional B strain of the other B lineage. The aim of the study was to analyse the public health and economic impact of replacing TIV with QIV in different scenarios in Spain. A dynamic transmission model was developed to estimate the number of influenza B cases prevented under TIV and QIV strategies (<65 years (high risk) and ≥65 years). This model considers cross-protective immunity induced by different lineages of influenza B. The output of the transmission model was used as input for a decision tree model that estimated the economic impact of switching TIV to QIV. The models were populated with Spanish data whenever possible. Deterministic univariate and probabilistic multivariate sensitivity analyses were performed. Replacing TIV with QIV in all eligible patients with current vaccine coverage in Spain may have prevented 138,707 influenza B cases per season and, therefore avoided 10,748 outpatient visits, 3,179 hospitalizations and 192 deaths. The replacement could save €532,768 in outpatient visit costs, €13 million in hospitalization costs, and €3 million in costs of influenza-related deaths per year. An additional €5 million costs associated with productivity loss could be saved per year, from the societal perspective. The budget impact from societal perspective would be €6.5 million, and the incremental cost-effectiveness ratio (ICER) €1,527 per quality-adjusted life year (QALY). Sensitivity analyses showed robust results. In additional scenarios, QIV also showed an impact at public health level reducing influenza B related cases, outpatient visits, hospitalizations and deaths. Our results show public health and economic benefits for influenza prevention with QIV. It would be an efficient intervention for the Spanish National Health Service with major health benefits especially in the population ≥65-year.

Effects of pain neuroscience education and dry needling for the management of patients with chronic myofascial neck pain: a randomized clinical trial.

The aim of this study was to observe the medium-term effects on pain, disability, and psychological factors of a combination of myofascial trigger point (MTrP) dry needling (DN) with pain neuroscience education (PNE) versus DN alone versus control care as usual (CUC) in patients with chronic neck pain. A total of 60 patients were randomly selected in a Spanish National Health Service Public Hospital and divided into three groups: 6 sessions of DN with 3 sessions of PNE (TrPDN + PNE group, n = 21), 6 sessions of DN alone (TrPDN group, n = 20), or 10 sessions of usual care (CUC group, n = 19). The primary outcome was neck pain intensity, while neck disability, medication intake, and psychological factors were secondary outcomes. These variables were measured at baseline, post-treatment, and at 1 month and 3 months after treatment. TrPDN + PNE and DN alone were associated with greater reductions in pain intensity and disability compared to CUC (p < 0.01). TrPDN + PNE resulted in greater improvements in kinesiophobia, pain anxiety, and pain-related beliefs than DN alone and CUC (p < 0.01). No differences between groups were observed in medication intake, quality of life, catastrophizing, depression, or fear of pain (p > 0.05). Provision of PNE and DN in the management of chronic neck pain in a Spanish National Health Service Public Hospital was associated with greater improvements in psychological factors than DN therapy only. DN alone was more effective at reducing chronic non-specific neck pain and disability than CUC at 3-month follow-up. However, the inclusion of PNE combined with DN resulted in greater improvements in kinesiophobia, pain anxiety, and pain-related beliefs. NCT03095365 (ClinicalTrials.gov).

Budget Impact Analysis Of Subcutaneous Belimumab In Patients With Systemic Lupus Erythematosus In Spain.

ObjectiveTo evaluate the budget impact and the direct costs of the introduction of subcutaneous belimumab (SC) into the Spanish National Health Service (NHS) for patients with systemic lupus erythematosus (SLE) in Spain.MethodsThis study was conducted from the Spanish NHS perspective with a time horizon of 3 years. The budget impact analysis compared the cost difference between two scenarios: current market (standard therapy (ST) and intravenous belimumab (IV)) and other market in which patients switched from belimumab IV to belimumab SC until reaching 17% of the total market share. The eligible population was calculated to receive treatment with belimumab, applying the EPISER (study of the prevalence of rheumatic diseases in adult population in Spain) prevalence (91 per 100,000 inhabitants), Autoimmune Systemic Diseases Study Group (GEAS) incidence (2 per 100,000 inhabitants), and the risk of annual mortality to the Spanish adult population. Patients with severe active lupus nephritis and with severe active CNS lupus were excluded. Patients’ characteristics, flare rates and severity, and healthcare resource consumption were evaluated based on data from the literature and interviews with an expert panel. A sensitivity analysis was performed.ResultsCurrently, there is an estimated 34,697 adult patients with SLE in Spain and 3849 patients who are eligible to be treated with belimumab. The introduction of belimumab SC into the Spanish NHS could generate savings in direct healthcare costs of 6 million euros over the 3 years.ConclusionThe introduction of belimumab SC shows direct savings for the Spanish NHS. These savings could contribute to sustainability and decision-making.

Patient Satisfaction in the Spanish National Health Service: Partial Least Squares Structural Equation Modeling.

The aim of this article was to determine which key indicators influence patient satisfaction with the Spanish NHS to provide useful information for policy decision-making. A total of 33 variables for each of the 17 Spanish autonomous communities were collected from the statistical portal of the Spanish Ministry of Health, Social Services, and Equality between 2005 and 2016. A cross-sectional study was applied using Partial Least Squares to a Structural Equation Model (PLS-SEM). The influence of expenditures, resource allocation, and safety were hypothesized about patient satisfaction. Gross Domestic Product (GDP) and life expectancy were used as control variables. Moreover, the influence of resource allocation on use was tested. The model explained 57.1% of patient satisfaction with the Spanish NHS. It was positively influenced mainly by resource allocation and expenditures, followed by safety and life expectancy. Additionally, resources directly influenced the level of use. The number of hospital beds, hemodialysis equipment, rate of adverse drug reactions, and expenditure positively influenced patient satisfaction. In contrast, the number of posts in day hospitals, the hospital infection rate, and the percentage of pharmacy spending negatively influenced patient satisfaction.

Health investment management based on patient satisfaction with the primary care doctor in the Spanish national health service context. A gender perspective

Health investment management based on patient satisfaction with the primary care doctor in the Spanish national health service context. A gender perspective

P3815Cost and burden of poor control of the level of anticoagulation in patients with non-valvular atrial fibrillation treated with vitamin K antagonist in the Spanish National Health Service

Abstract Introduction Poorly controlled non-valvular atrial fibrillation (NVAF) patients treated with vitamin K antagonists (VKA) experience higher rates of clinical events compared to well controlled patients. In Spain a high percentage of NVAF patients present an inadequate control of anticoagulation therapy, whose economic impact has not been reported yet. Purpose To estimate the impact on resource consumption, clinical events and mortality of poorly controlled NVAF patients≥65 years treated with VKA in Spain. Methods A cost-consequence analytic model was developed to estimate differences on clinical events and cost between poorly controlled (TTR&lt;65%) and well controlled (TTR≥65%) NVAF patients treated with VKA over 1 year. A hypothetical cohort of NVAF patients was estimated by using local epidemiological studies. Anticoagulation control rates, as measured by Rosendaal method, were retrieved from a literature review of Spanish real-world studies. Clinical event rates (ischemic stroke-IS-, hemorrhagic stroke-HS-, major bleeding-MB-, systemic embolism-SE- and death for any cause) were derived from a post-hoc analysis of SPORTIF III/V trials. A sensitivity analysis (SA) was performed by using event rates from a prospective single-center study carried out in Spain. Societal and National Health Service (NHS) perspectives were considered. Total annual costs (€ 2018) included clinical event direct, non-direct healthcare cost and indirect-costs. Potential life years lost (PLYL) were calculated to report impact on mortality. An expert panel composed by a cardiologist, a haematologist and general practitioners validated the model inputs. Results The target population comprised 594,855 NVAF patients treated with VKA (mean age 73.2 years, 49.4% women, 74.1% CHADS≥2). Poorly controlled anticoagulated patients accounted for 48.3% of the cohort. The inadequate control of anticoagulation was associated with a higher incidence of clinical events compared to well controlled patients within a year (additional 2,143 IS, 390 HS, 201 SE, 6,190 MB and 6,856 deaths). From NHS perspective, the incremental total annual costs associated to poorly controlled patients were €46,685,756.60 (€173.96/patient-year). When considering the societal perspective, the incremental total annual costs of inadequate anticoagulation control reached €97,787,872.59 (€367.51/patient-year). Mortality due to poorly anticoagulation control implied 80,830.65 PLYL (0.136 PLYL/patient-year). The SA confirmed the base case results. Conclusions In the Spanish NHS, around 50% of NVAF patients ≥65 years treated with VKA present an inadequate control of the anticoagulation therapy (287,089 patients), which is associated with the increase of clinical events, mortality and costs (up to €100 million). The results of this study highlight a call to action to increase the awareness of the consequences of a poor anticoagulation control and emphasize the need for a better clinical of patients receiving anticoagulation. Acknowledgement/Funding BMS and PFIZER contributed to finance the no conditioned to the results of this work.

Cost-effectiveness analysis of a surveillance program to prevent hip dislocation in children with cerebral palsy

ObjectiveIn this study we conducted an economic evaluation of a surveillance programme to prevent hip dislocation in children with cerebral palsy. MethodWe developed a model that compared costs and health outcomes of children with cerebral palsy with and without a surveillance programme. Information from a number of sources was combined into a decision analytical model, primarily based on data from a comparative study with a 20-year follow-up. Effectiveness was measured using Quality-Adjusted Life Years (QALYs). The analysis took the perspective of the Spanish National Health Service. We undertook extensive sensitivity analyses including a probabilistic sensitivity analysis. ResultsThe surveillance programme led to higher QALYs and higher health care costs, with an estimated incremental cost per QALY gained of 12,282€. The results were robust to model assumptions. The probability that the programme was cost-effective was estimated to be over 80% at the threshold of 25.000€/QALY recommended in Spain. ConclusionThis study indicates that surveillance programmes to prevent hip dislocation in children with cerebral palsy are likely to be cost-effective.

The nurse work environment in Spanish nurses following an economic recession: From 2009 to 2014.

To detect possible changes in perception of the nurse work environment, job satisfaction and burnout between the years 2009 and 2014 among nurses working in the Spanish National Health System. The global economic crisis has had a great impact on nurses in the Spanish National Health Service: tougher working conditions, lower pay and a reduction in social benefits. It is not known whether these changes affect the nurses' work environment, job satisfaction and burnout. Comparative, cross-sectional study performed in seven hospitals in the Spanish National Health System between 2009 and 2014, through 1,454 surveys of nurses working in internal medicine, surgery and intensive care. Nurses participating in the second period (2012-2014) were more satisfied with their current job (p=0.001), perceived their work environment to be more favourable (p<0.001) and had lower levels of burnout (p<0.01). Professional factors as 'autonomy at work,' 'opportunities for advancement,' 'professional status' and 'nursing foundations for quality care,' as well as 'collegial nurse-physician relations' and 'nurse participation in hospital affairs' were the most important variables associated with these topics. Professional factors may influence these changes more than labour conditions and remuneration aspects. In times of economic recession, encouraging interpersonal relationships, autonomy and participation in decision-making may improve the work environment, satisfaction and burnout of nurses.

Long term COST-minimization analysis of robot-assisted hysterectomy versus conventional laparoscopic hysterectomy

BackgroundThe aim of this study is to carry out the economic evaluation, in term of a cost-minimization analysis that considers healthcare costs and indirect costs, of robot-assisted hysterectomy (RAH) compared with conventional laparoscopic hysterectomy (CLH) in female adults scheduled for total laparoscopic hysterectomy for benign conditions.MethodsCost-minimization analysis based on an analytic observational study of prospective cohorts with a five-year time horizon. Eligible participants were all female adults scheduled for total laparoscopic hysterectomy for benign conditions at tertiary hospital. The economic evaluation was conducted from a Spanish National Health Service and societal perspective, including healthcare costs and indirect costs. The costs are expressed in Euros from the year 2015.ResultsOne hundred sixty nine patients were analyzed, 68 in the RAH group and 101 in the CLH group. Average cost for the RAH group was €8982.42 compared to €8015.14 for the CLH group (incremental cost €967.27; p = 0.054). Healthcare cost is the most important component of total cost and represents 86.4% for the RAH group and 82.3% for the CLH group. The difference of €1169 (p = 0.01) in the average healthcare cost is mainly due to the cost of purchasing and maintaining the equipment (difference of €1206.39 in favor of RAH; p < 0.005). With regard to indirect costs, for patients in the RAH group the costs associated with loss of productivity were lower (difference of €203.42; p = 0.17), while the cost of trips to the hospital was higher (difference of €1.98; p = 0.66) in respect to CLH.ConclusionsOur findings reveal similar effectiveness between RAH and CLH, although CLH is the more efficient option from the point of view of an economic analysis based on cost-minimization.

Economic Impact of Etanercept in Patients with Psoriasis and Psoriatic Arthritis in Spain: A Systematic Review.

IntroductionEtanercept (ETN), a highly effective biological agent for the treatment of psoriasis (PSO) and psoriatic arthritis (PsA), is widely used in Spain. However, evidence of its economic impact is limited, indicating the need for a systematic review of the economic assessments conducted on the use of ETN in the treatment of both PSO and PsA in Spain.MethodsA systematic review was carried out in PubMed, Embase, Cochrane Library, Health Technology Assessment reports and not indexed sources up to November 2018. The inclusion criteria were economic evaluations (total and partial) and dose optimization studies published in English or Spanish on the use of ETN to treat PSO and PsA for ETN in Spain.ResultsA total of 402 publications were identified, of which 32 were selected for inclusion in the review; of these 32 publications, 81.3% analyzed PSO (14 full economic evaluations, 5 partial economic evaluations and 7 dose optimization studies) and 18.8% analyzed PsA (1 economic analysis and 5 dose optimization studies). The perspective of the Spanish National Health Service (NHS) was used in 90.0% (n = 18) of the full and partial economic evaluations. The time horizons ranged from 12 weeks to 2 years. Reductions in the Psoriasis Area and Severity Index (PASI) of 50, 75 and 90% (PASI 50, 75 and 90, respectively) were most commonly used as efficacy outcomes in the complete evaluations. The economic impact of ETN ranged from €9110–14,337/PASI 75 at 12 weeks (50 mg/week) to €82,279/PASI 90 at 2 years, depending on the health outcome, time horizon and ETN dose used. Only one study determined the cost of using ETN for the treatment of PSO (€29,430–52,367/QALY for dose 2 × 25 mg/week or 50 mg/week, respectively). Only one partial economic evaluation on PSA was identified (NHS perspective), resulting in an ETN annual cost of €8585/patient-year.ConclusionConsistent evidence on the economic impact of ETN for the treatment of PSO and PSA in Spain is lacking, mainly due to the highly heterogeneous methodology used and the broad range of outcomes found in the economic evaluations published to date.FundingPfizer S.L.U.Electronic supplementary materialThe online version of this article (10.1007/s13555-019-0301-6) contains supplementary material, which is available to authorized users.

The consequences of implementing non-invasive prenatal testing with cell-free foetal DNA for the detection of Down syndrome in the Spanish National Health Service: a cost-effectiveness analysis

BackgroundDNA-based non-invasive prenatal testing (NIPT) using maternal blood constitutes an emerging technology for the detection of Down syndrome (DS). The aim of the study was to conduct a cost-effectiveness analysis to evaluate the economic costs and health implications of the introduction of NIPT based on cell-free foetal DNA analysis through different screening strategies for the detection of DS.MethodsAn analytical short-term decision model was developed, from the payer´s perspective (Spanish National Health Service). The main outcome measure was the number of DS cases detected. Secondary measures included associated miscarriages, women undergoing current screening, women undergoing NIPT, positive NIPT and invasive procedures performed. The study setting was the Spanish National Health Service. Three strategies were compared: (a) first- and second-trimester screening (current screening); (b) NIPT as contingent testing; and (c) NIPT as first-line testing. Modelling was based on a hypothetical cohort of 100,000 Spanish pregnant women. Population data were obtained from the database of the Basque Antenatal Screening Programme. Deterministic sensitivity analyses were performed to assess variations in the cost of NIPT, screening risk cut-off, screening uptake-rate and rate of failure of NIPT.ResultsNIPT as contingent testing (strategy b) led to fewer miscarriages following invasive procedures and a slight reduction in the number of DS cases detected compared to current screening. However, lowering the screening cut-off to ≥ 1:500 would improve the overall effectiveness of NIPT as contingent testing, increasing the number of DS cases detected and decreasing foetal losses as compared to the current screening, despite there would be an extra-cost of 3.5%. When NIPT was used as first-line testing (strategy c), the screening would be more effective but also more expensive, with incremental cost-effectiveness ratios (ICERs) per additional case of DS detected of €1,299,763 and €1,232,763, compared with strategies a and b, respectively. Results were sensitive to the different parameters considered in the analysis.ConclusionsBoth, as first-line testing and as contingent testing when screening cut-off was lowered ≥ 1:500, NIPT would lead to more favourable outcomes as compared to the current screening (both in terms of DS cases detected and miscarriages avoided), but at a greater cost.

Stereoelectroencephalography for Refractory Epileptic Patients Considered for Surgery: Systematic Review, Meta-Analysis, and Economic Evaluation.

Stereoelectroencephalography (SEEG) has been shown to be a valuable tool for the anatomoelectroclinical definition of the epileptogenic zone (EZ) in patients with medically refractory epilepsy considered for surgery (RES patients). In Spain, many of those patients are not offered this diagnostic procedure. To evaluate the effectiveness, safety, and cost-effectiveness of SEEG to define the EZ in RES patients compared to no SEEG intervention, ie, remaining with further antiepileptic drugs. We undertook a systematic review with meta-analyses on the effectiveness and safety of SEEG. A cost-effectiveness analysis was conducted using a Markov model, which simulates the costs and health outcomes of individuals for a lifetime horizon from the perspective of the Spanish National Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. The EZ was found in 92% of patients who underwent SEEG (95% confidence interval [CI]: 0.87-0.96); 72% were eligible for epilepsy surgery (95% CI: 0.66-0.78) and 33% were free of seizures after surgery (95% CI: 0.27-0.42). Of the patients who underwent surgery, 47% were free of seizures after surgery (95% CI: 0.37-0.58). Complications related to implantation and monitoring of SEEG and the subsequent intervention occurred in 1.3% of patients (95% CI: 0.01-0.02). In the base case analysis, SEEG led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio of 10 368 EUR per QALY (95% CI: dominant-113 911), making the probability of cost-effectiveness between 75% and 88%. Further sensitivity analyses showed that the results of the study were robust. SEEG is a cost-effective technology in RES patients when compared to no SEEG intervention.