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Introduction: Rheumatoid arthritis (RA) is the most common chronic inflammatory rheumatic disease, its management and morbidity impose a great burden to healthcare systems. Development and rollout of biological disease modifying anti-rheumatic drugs has contributed to improvements for patients, however, high costs have prevented them to be widely used. This is being addressed with biosimilars, with equal benefit-risk profile and reduced costs. The objective is to analyze the cost-effectiveness of subcutaneous biosimilar tocilizumab (bsTCZ) for patients with moderate-severe RA in Spain from a healthcare system perspective., Methods: A Markov model was developed with a lifetime horizon including 5 health states: remission of the disease; low, moderate, or high activity; and death. A PICO-S-T search retrieved efficacy of treatments in meta-analysis and network meta-analysis, and was further complemented with published clinical trials. Pharmacological costs were obtained from the BotPlus database, and medical resources costs from regional tariffs. Deterministic and probabilistic sensitivity analysis were performed to validate the robustness of results. Incremental cost-effectiveness ratio (ICER) for cost/percentage of remission and cost/quality-adjusted life year (QALY) gain were calculated., Results: Lifetime cost of bsTCZ was 183 741€ (lowest) versus comparative costs ranging from 184 317€ for infliximab to 201 972€ (highest) for certolizumab. QALYs were 13.74 for upadacitinib and 13.73 for sarilumab and tocilizumab with values between 13.53 and 13.72 for the comparators. ICERs as €/remission and €/QALY showed that bsTCZ was either dominant in most of the comparisons or the most cost-effective alternative. The sensitivity analysis showed that bsTCZ long term cost, and transition from low to moderate disease activity health status were the most influential factors. Moreover, bsTCZ was either dominant or cost-effective in all the comparisons., Conclusions: bsTCZ demonstrated to be a cost-effective and cost-saving alternative for the treatment of patients with RA in Spain when compared to all the available therapeutic alternatives., Competing Interests: Declaration of competing interest FPR has earned advisory fees from protalix, horizon, arthrosis, and LG Pharma; speaker fees from Menarini, and Bioepis; and research grants from Asociación de Reumatólogos de Cruces. CCD has earned fees from: Abbvie, Almirall, Amgen, Biogen, Bristol Myers Squibb, Fresenius Kabi, Janssen-Cilag, Kern Pharma, Merck Sharp Done, Pfizer, Roche, UCB Pharma. JASA has earned fees from Fresenius Kabi and IQVIA. MC and CC are employees of Axentiva, a consulting firm that works for several pharmaceutical and medical devices companies. MAG and JIPF are employees of Fresenius Kabi Spain. MCM has earned fees from Abbvie, Fresenius Kabi, Janssen-Cilag, Kern Pharma, Leo-Pharma, Pfizer, and Roche., (Copyright © 2024. Publicado por Elsevier España, S.L.U.)

Objective: To compare the costs and length of hospital stay among patients with a confirmed diagnosis of lung cancer (LC) prior to surgery versus those without confirmation., Methods: This retrospective, single-center study was conducted in patients who underwent a surgical procedure for LC, with or without a pathologically confirmed LC diagnosis prior to surgery, between March 2017 and December 2019. The main outcomes were costs and length of hospital stay (LOS)., Results: Among the 269 patients who underwent surgery for lung cancer between March 2017 and December 2019, 203 (75.5%) patients underwent surgery due to a histopathological diagnosis, and 66 (24.5%) because of a Multidisciplinary Cancer Committee indication. The unadjusted mean cost was significantly lower in Group II (patients with surgery based on Multidisciplinary Cancer Committee criteria) (Є2,581.80 ± Є1,002.50) than in Group I (patients with histopathological diagnosis) (Є4,244.60 ± Є2,008.80), P < 0.0001. Once adjusted for covariables, there was a mean difference of -Є1,437.20 in the costs of Group II, P < 0.0001. Unadjusted mean hospital stay was significantly longer in Group I (5.6 days) than in Group II (3.5 days)., Conclusions: The results suggest that indicating surgical resection of lung cancer based on Multidisciplinary Cancer Committee criteria, rather than performing CT-guided percutaneous lung biopsy, may result in a significant decrease in cost and length of hospital stay., (Copyright © 2023 AEC. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction and Objectives: Despite advances in treatment, cardiovascular disease is the second leading cause of death in Spain. The objective of this study was to determine the cost-effectiveness of the CNIC-Polypill strategy (acetylsalicylic acid 100 mg, atorvastatin 20/40 mg, ramipril 2.5/5/10 mg) compared with the same separate monocomponents for the secondary prevention of recurrent cardiovascular events in adults in Spain., Materials and Methods: A Markov cost-utility model was adapted considering 4 health states (stable, subsequent major adverse cardiovascular event, subsequent ischemic stroke and death) and the SMART risk equation over a lifetime horizon from the perspective of the Spanish National Healthcare System. The CNIC-Polypill strategy was compared with monocomponents in a hypothetical cohort of 1000 secondary prevention patients. Effectiveness, epidemiological, cost and utilities data were obtained from the NEPTUNO study, official databases and literature. Outcomes were costs (in 2021 euros) per life-year (LY) and quality-adjusted LY (QALY) gained. A 3% discount rate was applied. Deterministic one-way and probabilistic sensitivity analyses evaluated the robustness of the model., Results: The CNIC-Polypill strategy in secondary prevention results in more LY (13.22) and QALY (11.64) gains at a lower cost than monocomponents. The CNIC-Polypill is dominant and saves є280.68 per patient compared with monocomponents. The probabilistic sensitivity analysis shows that 82.4% of the simulations are below the threshold of є25,000 per QALY gained., Conclusions: The CNIC-Polypill strategy in secondary cardiovascular prevention is cost-effective compared with the same separate monocomponents, resulting in a cost-saving strategy to the Spanish National Healthcare System., (Copyright © 2023 The Author(s). Published by Elsevier España, S.L.U. All rights reserved.)

Inflammatory bowel disease includes two chronic inflammatory diseases, ulcerative colitis and Crohn's disease. The burden of disease is increasing worldwide. A few reviews evaluating the paediatric use of tumour necrosis factor (TNF) antagonists have been published, although these mostly include observational studies and do not consider economic evaluations. This systematic review evaluated the available evidence regarding the efficacy, safety, and cost-effectiveness of TNF antagonist therapy for paediatric inflammatory bowel disease. We searched PubMed/MEDLINE, Embase, and Cochrane Central (up to May 2022). Nine randomized clinical trials and four economic evaluations that examined any anti-TNF drugs (e.g., infliximab, adalimumab, golimumab, and certolizumab) against different alternatives were included. In studies evaluating the efficacy of anti-TNF drugs in Crohn's disease, most assessed the efficacy of maintenance regimen in patients who had previously responded to induction (response=28%-63%, and clinical remission=17%-83% depending on dose, drug, and follow-up). In ulcerative colitis, maintenance treatment with anti-TNF drugs reported clinical remission rates between 17% and 44%. Nine studies reported information on adverse events. No clinical trials comparing different anti-TNF drugs were found. The findings from this review suggest that maintenance treatment with anti-TNF drugs (such as infliximab and adalimumab) in paediatric inflammatory bowel disease is probably effective and safe. However, the economic evaluations reported contradictory results of the cost-effectiveness ratios. Protocol registry: Open Science Framework: https://osf.io/wjmvf., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)

Introduction: high-oxygen nasal cannulas in patients with respiratory failure secondary to SARS-CoV-2 pneumonia have not been studied from a cost-effectiveness point of view., Methods: Retrospective analysis of patients who had entered the COVID-area of an intensive medicine service in a third reference hospital, between March-December 2020. An effectiveness cost analysis was carried out comparing 2therapeutic decisions: the experimental strategy was defined as a mixed strategy consisting of the initial application of high flow nasal oxygen (HFNO) and application of VMI only to HFNO failures. The optimal rational decision was defined as maximizing expected profit, and economic efficiency was assessed by calculating the Incremental Cost-Effectiveness Ratio (ICER) for years of life gained., Results: Of the 185 patients tested, 101 (55%) received invasive mechanical ventilation immediately and 84 (45%) were treated with HFNO at the outset. In the cost-effectiveness analysis, comparing both therapeutic strategies, the probability that the experimental strategy would be more effective was 0.974, reaching statistical significance: Difference in average proportions -0.113; 95% CI:-0.018 to -0.208. This corresponds to an NNT of 9 patients. The optimal decision was HFNO's strategy followed by VMI in HFNO failures. This option had an RCEI of 5582 euros per year of life gained., Conclusions: It is important to establish in the future reliable markers in the use of HFNO so that this therapy improves its cost-effective benefits., (Copyright © 2022 FECA. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To conduct a stratified cost-utility analysis of total versus partial hip arthroplasty as a function of clinical subtype., Method: All cases of this type of intervention were analysed between 2010 and 2016 in the Basque Health Service, gathering data on clinical outcomes and resource use to calculate the cost and utility in quality-adjusted life years (QALYs) at individual level. The statistical analysis included applying the propensity score to balance the groups, and seemingly unrelated regression models to calculate the incremental cost-utility ratio and plot the cost-effectiveness plane. The interaction between age group and American Society of Anesthesiologists (ASA) risk class was assessed in the multivariate analysis., Results: The study identified 5867 patients diagnosed with femoral neck fracture, of whom 1307 and 4560 were treated with total and partial hip arthroplasty, respectively. In the cost-utility analysis based on the seemingly unrelated regression, total hip arthroplasty was found to have a higher cost and higher utility (2465€ and 0.42 QALYs). Considering a willingness-to-pay threshold of €22,000 per QALY, total hip arthroplasty was cost-effective in the under-80-year-old subgroup. Among patients above this age, hemiarthroplasty was cost-effective in ASA class I-II patients and dominant in ASA class III-IV patients., Conclusions: Subgroup analysis supports current daily clinical practice in displaced femoral neck fractures, namely, using partial replacement in most patients and reserving total replacement for younger patients., (Copyright © 2021 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

Microbiological diagnostic stewardship programs promote coordinated measures aimed at optimizing the use of diagnostic techniques, thus favouring the adoption of adequate and cost-effective therapeutic, clinical and preventive decisions. The implementation of microbiological diagnostic stewardship relies upon the creation of multidisciplinary committees led by clinical microbiologists for the design of diagnostic algorithms, the adequacy of the laboratory computer system to monitor the relevance of the requested diagnostic tests, the implementation of a quality control system, the design and performance of studies of cost-effectiveness, the training of the petitioner and the technical and nursing staff and the continuous evaluation of the program. The incorporation of microbiological diagnostic stewardship in routine care reports tangible benefits for the patient while strengthening the pivotal role of the clinical microbiologist in the management of infectious diseases., (Copyright © 2020 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.)

Objective: To analyse the quality and impact of cost-utility evaluations of medical devices carried out by the Spanish Network of Assessment Agencies (RedETS)., Method: The cost-utility evaluations of medical devices were identified by searching the evaluation reports of the RedETS website database (2006-2016). Quality and its impact were evaluated with a RedETS quality checklist, comparing cost-utility results and inclusion in the portfolio of common services of the National Health System. The portfolio inclusion status was analysed considering whether the cost-effectiveness incremental ratio was or was not less than €25,000/quality adjusted life years., Results: 25 cost-utility evaluations of medical devices were found (12 cost-utility, 10 cost-effectiveness and 3 both). Fifteen selected cost-utility studies with 19 cost-utility ratios met at least 18 of 25 verification criteria. Also, 12 of the 15 studies met 19 of the 25 criteria. On the impact, in 6 out of the 19 results, the product was included in the portfolio even though the ratio exceeded €25,000/quality adjusted life years. There are three cases undergoing a re-evaluation process, another case being reconsidered once the efficacy-safety of new devices has been reported and in two cases the portfolio states that protocols are required., Conclusions: Most of the cost-utility evaluations of medical devices published by RedETS fulfil most of the items on the checklist and, therefore, were thorough. These cost-utility evaluations of medical devices are consistent with the decision-making framework to efficiently manage the National Health System portfolio., (Copyright © 2019 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

Fifteen years ago, Gaceta Sanitaria published the article entitled "What is an efficient health technology in Spain?" The growing interest in setting the price of new technologies based on the value they provide to health systems and the experience accumulated by the countries in our environment make it opportune to review what constitutes an efficient health intervention in Spain in 2020. Cost-effectiveness analysis continues to be the reference method to maximize social health outcomes with the available resources. The interpretation of its results requires establishing reference values that serve as a guide on what constitutes a reasonable value for the health care system. Efficiency thresholds must be flexible and dynamic, and they need to be updated periodically. Its application should be based on and transparency, and consider other factors that reflect social preferences. Although setting thresholds is down to political decision-makers, in Spain it could be reasonable to use thresholds of 25,000 and 60,000 Euros per QALY. However, currently, in addition to determining exact figures for the threshold, the key question is whether the Spanish National Health System is able and willing to implement a payment model based on value, towards achieving gradual financing decisions and, above all, to improve the predictability, consistency and transparency of the process., (Copyright © 2019 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To carry out a cost-utility analysis of the application of the Oncotype genomic test to inform the decision to use or not to use chemotherapy in the Basque Country (Spain)., Method: The cost-utility study was carried out using a discrete event simulation model representing the natural history of breast cancer. The decision of treatment with chemotherapy based on Oncotype was compared with the standard of treatment based on clinical-pathological criteria. The model included clinical data from Basque hospitals and the literature and was processed by deterministic and probabilistic analysis to calculate the incremental cost-effectiveness ratio (ICER), the cost-effectiveness plane, the acceptability curve and the expected value of perfect information. The study adopted both a health and societal perspective., Results: From a health perspective, the deterministic analysis estimated an ICER for Oncotype of 17,453 euros/quality-adjusted life year (QALY), discount included, and 9,613 euros/QALY without the discount. Eighty five percent (85%) of the simulations were below the efficiency threshold for Spain. The parametric variability associated with the Oncotype results was the main uncertainty factor in the decision., Conclusions: Oncotype is a cost-effective intervention from a health system perspective since each QALY gained costs less than 25,000 euros. From a societal perspective, it is dominant since it provides greater health and is accompanied by cost savings., (Copyright © 2018 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objectives: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis., Methods: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug)., Results: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45mg > ustekinumab 90mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45mg > ustekinumab 90mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90mg > ustekinumab 45mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period., Conclusions: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment., (Copyright © 2018 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To examine the endorsement of reporting guidelines for economic evaluation studies, such as the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) statement, by Spanish biomedical journals., Method: Cross-sectional analysis of the instructions to authors of Spanish biomedical journals included in the Journal Citation Reports 2017. Two authors examined and extracted the following information: mention of any reporting guideline, the CHEERS statement, the recommendations of the International Committee of Medical Journal Directors (ICMJE) and the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network., Results: Of the 28 journals included, 23 (82.1%; 95% confidence interval [95%CI]: 63.1-93.9%) mentioned at least one reporting guideline in the instructions to authors. Only one journal mentioned the CHEERS statement for health economic evaluations. Twenty-four journals (85.7%; 95%CI: 67.3-96.0%) mentioned the ICMJE recommendations and 8 (28.6%; 95%CI: 13.2-48.7%) mentioned the EQUATOR network. The CONSORT (Consolidated Standards of Reporting Trials) statement for clinical trials was the most- mentioned reporting guideline (n=21; 75.0%; 95%CI: 55.1-89.3%)., Discussion: Most of the instructions to authors do not provide guidance on how to report economic evaluations. Journals should support compliance with reporting guidelines by authors and peer-reviewers., (Copyright © 2019 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: Using a hydrogel plug decreases the number of cases of pneumothorax and reduces the need for pleural drainage tubes in CT-guided lung biopsies. We aimed to analyze the cost-effectiveness of using hydrogel plugs., Material and Methods: We analyzed 171 lung biopsies divided into three groups: Group 1 (n=22): fine-needle aspiration cytology (FNAC) without hydrogel plugs; Group 2 (n=89): FNAC with hydrogel plugs; and Group 3 (n=60): FNAC plus core-needle biopsy (CNB) with hydrogel plugs. We calculated the total costs (direct and indirect) in the three groups. We analyzed the percentage of correct diagnoses, the average and incremental rations, and the most cost-effective option., Results: Total costs: Group 1 = 1,261.28 + 52.65 = € 1,313.93; Group 2 = 1,201.36 + 67.25 = € 1,268.61; Group 3 = 1,220.22 + 47.20 = € 1,267.42. Percentage of correct diagnoses: Group 1 = 77.3%, Group 2 = 85.4%, and Group 3 = 95% (p = 0.04). Average cost-effectiveness ratio: Group 1 = 16.99; Group 2 = 14.85; and Group 3 = 13.34., Conclusions: Group 3 was the best option, with the lowest average cost-effectiveness ratio; therefore, the most cost-effective approach is to do FNAC and CNB using a dehydrated hydrogel plug at the end of the procedure., (Copyright © 2019 SERAM. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objectives: Locoregional lymph node ultrasound is not typically included in guidelines as part of the staging process prior to sentinel lymph node biopsy (SLNB). The objective of the present study was to make a clinical and economic analysis of lymph node ultrasound prior to SLNB., Materials and Methods: We performed a retrospective study of 384 patients with clinical stage I-II primary melanoma who underwent locorregional lymph node ultrasound (with or without ultrasound-guided biopsy) prior to SLNB between 2004 and 2015. We evaluated the reliability and cost-effectiveness of the strategy., Results: Use of locorregional lymph node ultrasound avoided SLNB in 23 patients (6%). Ultrasound had a sensitivity of 46% and specificity of 76% for the detection of metastatic lymph nodes that were not clinically palpable. False negatives were significantly more common in patients aged over 60 years and in tumors with a thickness of less than 2mm. The staging process using SLNB and ultrasound with ultrasound-guided biopsy produced an increase of €16.30 in the unit price. Our cost-effectiveness analysis identified the staging protocol with ultrasound and SLNB as the dominant strategy, with a lower cost-effectiveness ratio than the alternative, consisting of SLNB alone (8,095.24 vs. €28,605.00)., Conclusions: Ultrasound with ultrasound-guided biopsy for the diagnostic staging of melanoma prior to SLNB is a useful and cost-effective tool. This procedure does not substitute SLNB, though it does allow to avoid SLNB in a not insignificant proportion of patients., (Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.)

The need to reduce the time it takes to establish a microbiological diagnosis and the emergence of new molecular microbiology and proteomic technologies has fuelled the development of rapid and point-of-care techniques, as well as the so-called point-of-care laboratories. These laboratories are responsible for conducting both techniques partially to response to the outsourcing of the conventional hospital laboratories. Their introduction has not always been accompanied with economic studies that address their cost-effectiveness, cost-benefit and cost-utility, but rather tend to be limited to the unit price of the test. The latter, influenced by the purchase procedure, does not usually have a regulated reference value in the same way that medicines do. The cost-effectiveness studies that have recently been conducted on mass spectrometry in the diagnosis of bacteraemia and the use of antimicrobials have had the greatest clinical impact and may act as a model for future economic studies on rapid and point-of-care tests., (Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.)

Objectives: In thyroid cancer treatment, the thyroid-stimulating hormone (TSH) must be elevated before radioiodine ablation, either by exogenous (with recombinant human thyrotropin [rhTSH]) or endogenous stimulation by thyroid hormone withdrawal (THW). The use of rhTSH avoids hypothyroidism and favours the subsequent elimination of radioiodine, but involves the cost of the product. For this reason, a cost-effectiveness analysis was performed, taking into account all costs involved and the benefits associated with the use of this therapy., Material and Methods: Using a Markov modelling with two analysis arms (rhTSH and THW), stratified into high (100mCi/3700 MBq) and low (30mCi/1110 MBq) radioiodine doses, and using 17 weekly cycles, the incremental cost per quality-adjusted life-year (QALY) related to the use of rhTSH was determined. The clinical inputs included in the model were based on published studies and in a treatment survey conducted in Spain., Results: Radioablation preparation with rhTSH is superior to THW, showing additional benefits (0.048 AVAC), as well as cost savings (-€614.16), with an incremental cost-effectiveness rate (ICER) of -€12,795/QALY. The univariate and multivariate sensitivity analyses showed the result to be robust., Conclusions: The use of rhTSH previous to radioablation in Spain has cost savings, as well as a series of health benefits for the patient, making it highly cost-effective., (Copyright © 2017 Elsevier España, S.L.U. y SEMNIM. All rights reserved.)

Flu is a major public health problem, particularly for older people, and creates an important clinical and economic burden. A high mortality rate was reported in Spain during the period 2015 to 2016; 3,101 serious cases were hospitalised with a confirmed diagnosis of flu, of which 11% died (352 cases). Furthermore, financial and health costs are greatly increased by the complications of flu; people aged over 65 years represent approximately 64% of the total costs. Seasonal flu vaccination is the fundamental strategy, as demonstrated by cost-benefit and cost-effectiveness studies. A priority objective is to improve the vaccine's immune response and the search for and inclusion of adjuvants and immunostimulants in vaccines is a major line of research. This positioning report evaluates vaccination for older people and the importance of the adjuvanted vaccine in the elderly in strengthening immunogenicity, by means of a critical review of the literature based on the best evidence available on its immunogenicity and effectiveness, and an economic assessment., (Copyright © 2017 Sociedad Española de Geriatría y Gerontología. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: To examine the relationship between the funding source of cost-effectiveness analyses of healthcare interventions published in Spain and study conclusions., Design: Descriptive cross-sectional study., Location: Scientific literature databases (until December 2014)., Participants (analysis Units): Cohort of cost-effectiveness analysis of healthcare interventions published in Spain between 1989-2014 (n=223) presenting quality-adjusted life years (QALYs) as the outcome measure., Main Measurements: The relationship between qualitative conclusions of the studies and the type of funding source were established using Fisher's exact test in contingency tables. Distributions of the incremental cost-effectiveness ratios by source of funding in relation to hypothetical willingness to pay thresholds between €30,000-€50,000 per QALY were explored., Results: A total of 136 (61.0%) studies were funded by industry. The industry-funded studies were less likely to report unfavorable or neutral conclusions than studies non-funded by industry (2.2% vs. 23.0%; P<.0001), largely driven by studies evaluating drugs (0.9% vs. 21.4%; P<.0001). The incremental cost-effectiveness ratios in studies funded by industry were more likely to be below the hypothetical willingness to pay threshold of €30,000 (73.8% vs. 56.3%; P<.0001) and €50,000 (89.4% vs. 68.2%; P<.0001) per QALY., Conclusions: This study reveals a potential sponsorship bias in cost-effectiveness analyses of healthcare interventions. Studies funded by industry could be favoring the efficiency profile of their products., (Copyright © 2016 Elsevier España, S.L.U. All rights reserved.)

Aims: Cost-effectiveness analysis of sofosbuvir combined with peginterferon alpha-2a and ribavirin (SOF/Peg-IFN/RBV) in early versus advanced fibrosis in previously untreated patients with chronic hepatitis C genotype 1 (CHC-GT1), from the perspective of the Spanish National Health System (NHS)., Methods: A Markov model was developed to compare lifetime costs and outcomes (life years gained [LYGs] and quality-adjusted life years [QALYs]) of 2 treatment strategies: SOF/Peg-IFN/RBV administered during early fibrosis (mild-moderate fibrosis; F2-F3) or advanced fibrosis (cirrhosis; F4). Efficacy (sustained virologic response), annual transition probabilities, disease management costs and utilities were obtained from the literature. Costs and outcomes were discounted annually at 3%. Direct costs were considered, expressed in Euros (€, 2014). Probabilistic sensitivity analysis (PSA) was also performed., Results: SOF/Peg-IFN/RBV therapy at F2-F3 was more effective (19.12 LYGs and 14.14 QALYs) compared to F4. In a cohort of 1,000 patients, SOF/Peg-IFN/RBV prevented 66 cases of decompensated cirrhosis, 60 hepatocellular carcinomas and 4 liver transplantations compared with therapy in advanced fibrosis. The total lifetime cost of early therapy (€43,263) was less than the cost of treatment in the advanced stage (€49,018). Early therapy was a dominant strategy, more effective and less costly in all simulations. In the PSA analysis, administration of SOF/PEG-IFN/RBV at F2-F3 was dominant in all simulations., Conclusions: Starting SOF/Peg-IFN/RBV therapy at F2-F3, compared with therapy at F4, reduced the incidence of liver disease complications and was associated with cost savings for the Spanish NHS in CHC-GT1 patients., (Copyright © 2016 Elsevier España, S.L.U. y AEEH y AEG. All rights reserved.)

In general, new technologies usually increase laboratory costs due to the need for an initial investment. However, as occurred with MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometry, this increase is subsequently offset by the discontinued use of traditional technologies and by the benefits to patients of the new information generated. In the clinical microbiology laboratory, the identification time is reduced with the use of MALDI-TOF (by at least 24 hours) and turnaround is improved, allowing faster production of the microbiological report. This beneficial effect has mainly been studied with blood cultures in patients with bacteraemia. In these patients, the length of hospital stay has been reduced by 1.6-6.6 days, depending on the type of patient and the appropriateness of treatment. This leads to better antimicrobial use and a reduction in total hospital cost of up to 43% per patient. Another factor that has been analysed is the decrease in mortality due to better management of antimicrobial therapy. Future multicentre studies should include other factors such as hospital organisation changes and clinical activity arising in response to the efforts of the clinical microbiology laboratory to rapidly obtain information of clinical value., (Copyright © 2016 Elsevier España, S.L.U. All rights reserved.)

Introduction: Asthma clinics (AC) are hospital outpatient services specialising in the management of asthma. In this study, we analysed the impact of these clinics on asthma management and their cost effectiveness in comparison with standard outpatient services., Methods: A case cross-over study in which all new patients seen in the AC of Lugo in 2012 were included. The case period was defined as one year following the first visit to the AC; the control period was defined as the preceding year. We calculated changes in clinical quality indicators for asthma management, and estimated the incremental cost-effectiveness ratio (ICER) for each additional patient treated and for each quality-adjusted life year (QALY) RESULTS: The number of patients (n=83, mean age 49 ± 15.2 years; 60.2% women) managed in the AC increased from 41% to 86%. The Asthma Control Test score increased from 18.7 ± 4.6 to 22.6 ± 2.3 (p<0.05) and FEV1 increased from 81.4% ± 17.5 to 84.4% ± 16.6 (p<0.05). The number of exacerbations, hospitalisations and visits to accident and emergency fell by 75%. The number of patients given combination LABA+ICS therapy fell from 79.5% to 41%. The use of other drug therapy increased: anticholinergics, from 3.6% to 16.9%; ICS in monotherapy, from 3.6% to 45.8%; and omalizumab, from 0% to 6%. ICERs per patient managed and per QALY gained were €1,399 and €6,876, respectively (social perspective)., Conclusions: Treatment in ACs is cost-effective and beneficial in asthma management., (Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.)

Introduction: The objective of this analysis was to evaluate the clinical and economic value of the use of 50mg-desvenlafaxine compared to the usual care (mix of duloxetine and venlafaxine) in the outpatient treatment of major depressive disorder after first line treatment failure (relapse) in Spain., Materials and Methods: A Markov model was used to follow up a cohort of major depressive disorder patients for one year after failure of first-line treatment with a serotonin-specific reuptake inhibitor and estimate outcome measures (percentage remission and depression-free days) and accrued and direct costs incurred during outpatient treatment of major depressive disorder. In order to obtain the efficacy data related to the treatment alternatives, a literature review of clinical trials was performed. A panel of clinical experts validated the use of clinical resources employed in the estimation of economic outcomes together with model assumptions. The analysis was performed in 2014 from the perspective of the National Health System., Results: Due to fewer discontinuations, initiating second line treatment with desvenlafaxine was associated with more depression-free days and a higher percentage of patients in remission versus usual care: 1.7 days and 0.5%, respectively. This was translated into lower drug and events management costs, and an overall cost reduction of €108 for the National Health System., Conclusions: In patients who have not responded to a first-line serotonin-specific reuptake inhibitor therapy, desvenlafaxine-50mg was clinically similar in effectiveness, but a less costly option, compared with a weighted average of duloxetine and venlafaxine for the second-line treatment of major depressive disorder patients from a payer (National Health System) perspective in Spain., (Copyright © 2015 SEP y SEPB. Published by Elsevier España. All rights reserved.)

Real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is one of the major landmarks in the history of bronchoscopy. In the 10 years since it was introduced, a vast body of literature on the procedure and its results support the use of this technique in the study of various mediastinal and pulmonary lesions. This article is a comprehensive, systematic review of all the available scientific evidence on the more general indications for this technique. Results of specific studies on efficacy, safety and cost-effectiveness available to date are examined. The analysis shows that EBUS-TBNA is a safe, cost-effective technique with a high grade of evidence that is a valuable tool in the diagnosis and mediastinal staging of patients with suspected or confirmed lung cancer. However, more studies are needed to guide decision-making in the case of a negative result. Evidence on the role of EBUS-TBNA in the diagnosis of sarcoidosis and extrathoracic malignancies is also high, but much lower when used in the study of tuberculosis, lymphoma and for the re-staging of lung cancer after neoadjuvant chemotherapy. Nevertheless, due to its good safety record and lack of invasiveness compared to surgical techniques, the grade of evidence for recommending EBUS-TBNA as the initial diagnostic test in patients with these diseases is very high in most cases., (Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.)

Background and Objective: The aim of this study was to measure the cost-effectiveness of the treatment with simeprevir and sofosbuvir in chronic hepatitis C genotype 1 patients with F3-F4 levels of fibrosis, according to the results of the COSMOS trial., Material and Methods: A Markov model was used to estimate the costs and clinical outcomes from the start of therapy. In the model, the progression was simulated alongside the different health states of the chronic liver disease associated with chronic hepatitis C using whole life as time-horizon., Results: The 12-weeks treatment schemes was below the threshold of €40,000 per quality-adjusted life year. On the contrary, despite the 50% cost reduction, the 24-weeks regimen demonstrated a limited level of efficiency when compared with the willingness to pay used in the Spanish medical literature., Conclusions: This finding would support the introduction of a flat rate in the price of drugs without taking into account the duration of treatment to ensure that treatment with 24 weeks was efficient., (Copyright © 2015 Elsevier España, S.L.U. All rights reserved.)

Introduction: Continuation/maintenance electroconvulsive therapy has been shown to be effective for prevention of relapse in affective and psychotic disorders. However, there is a limited nubber of studies that investigate clinical management, associated costs, and perceived quality variables., Material and Methods: A series of 8 cases included during the first 18 months of the Continuation/Maintenance Electroconvulsive Therapy Program of the Psychiatry Department at 12 de Octubre University Hospital is presented. Clinical variables (Clinical Global Impression-Improvement Scale, length of hospitalization, number of Emergency Department visits, number of urgent admissions) before and after inclusion in the continuation/maintenance electroconvulsive therapy program were compared for each patient, as well as associated costs and perceived quality., Results: After inclusion in the program, 50.0% of patients reported feeling « much better » and 37.5% « moderately better » in the Clinical Global Impression-Improvement Scale. In addition, after inclusion in the continuation/maintenance electroconvulsive therapy program, patients were hospitalized for a total of 349 days, visited the Emergency Department on 3 occasions, and had 2 urgent admissions, compared to 690 days of hospitalization (P = .012), 26 Emergency Department visits (P = .011) and 22 urgent admissions (P = .010) during the same period before inclusion in the program. Associated direct costs per day of admission were reduced to 50.6% of the previous costs, and costs associated with Emergency Department visits were reduced to 11.5% of the previous costs. As regards perceived quality, 87.5% of patients assessed the care and treatment received as being « very satisfactory », and 12.5% as « satisfactory »., Conclusions: This continuation/maintenance electroconvulsive therapy program has shown to be clinically useful and to have a favourable economic impact, as well as high perceived quality., (Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.)

Background and Objective: To detect FRAX(®) threshold levels that identify groups of the population that are at high/low risk of osteoporotic fracture in the Spanish female population using a cost-effective assessment., Patients and Methods: This is a cohort study. Eight hundred and sixteen women 40-90 years old selected from the FRIDEX cohort with densitometry and risk factors for fracture at baseline who received no treatment for osteoporosis during the 10 year follow-up period and were stratified into 3 groups/levels of fracture risk (low<10%, 10-20% intermediate and high>20%) according to the real fracture incidence., Results: The thresholds of FRAX(®) baseline for major osteoporotic fracture were: low risk<5; intermediate ≥ 5 to <7.5 and high ≥ 7.5. The incidence of fracture with these values was: low risk (3.6%; 95% CI 2.2-5.9), intermediate risk (13.7%; 95% CI 7.1-24.2) and high risk (21.4%; 95% CI12.9-33.2). The most cost-effective option was to refer to dual energy X-ray absorptiometry (DXA-scan) for FRAX(®)≥ 5 (Intermediate and high risk) to reclassify by FRAX(®) with DXA-scan at high/low risk. These thresholds select 17.5% of women for DXA-scan and 10% for treatment. With these thresholds of FRAX(®), compared with the strategy of opportunistic case finding isolated risk factors, would improve the predictive parameters and reduce 82.5% the DXA-scan, 35.4% osteoporosis prescriptions and 28.7% cost to detect the same number of women who suffer fractures., Conclusions: The use of FRAX ® thresholds identified as high/low risk of osteoporotic fracture in this calibration (FRIDEX model) improve predictive parameters in Spanish women and in a more cost-effective than the traditional model based on the T-score ≤ -2.5 of DXA scan., (Copyright © 2013 Elsevier España, S.L.U. All rights reserved.)

Objectives: The aim of the present clinical research is to analyze, in the light of the best scientific evidence, the performance and the cost of the main diagnostic tools for overactive bladder (OAB)., Methods: It is an exploratory transversal study in which 199 women diagnosed of OAB between 2006 and 2008 were selected and underwent to following prospective analyses: physical examination, urine analysis, micturition diary (MD) and urodynamic study (UDS). A percentage of 80% was assumed as highly sensitive and a diagnostic difference among tests of 10% would be considered clinically relevant. Tests' sensitivity for diagnosis of OAB was statistically established by two ways: isolated and combined. Besides, the direct and indirect costs of these tests performance were conducted. Cost-effectiveness study of clinical history (CH), MD and US for the diagnosis of OAB was performed., Results: Overall sensitivity for OAB diagnosis is low for the 3 tests used in isolated way, whilst the combination of any two tests shows good overall sensitivity. The combination of CH and MD has appeared as the most cost-effective alternative to OAB diagnosis., Conclusions: For OAB diagnosis, CH-DM combination shows the same sensitivity than the association of either of them with the UDS, but unlike to these, it shows the lowest cost., (Copyright © 2013 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.)

Prolonged seizures and status epilepticus are common neurological medical emergencies. Early and appropriate treatment is essential to reduce morbidity and mortality. Most seizures occur in the community, so parents and caregivers must be prepared for their management. Benzodiazepines (BZD) are the first-line drugs used, with rectal diazepam (DZPr) being the most commonly used in pre-hospital treatment in Spain. In September 2011, the European Medicines Agency (EMA) authorized the use of oromucosal midazolam (MDZb) for the treatment of prolonged acute convulsive seizures in patients aged 3 months to <18 years. MDZb has a rapid onset, short duration of effect, and avoids first-pass hepatic metabolism. MDZb has shown to be at least as or more effective than DZPr to stop the seizures. Buccal administration is easier and more socially accepted, especially in adolescents and adults. It is a safe drug with similar effects to other BZD; MDZb improves the overall cost-effectiveness of seizures management., (Copyright © 2014 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.)

Introduction: Transurethral resection of the prostate is the gold standard of surgical treatment of lower urinary tract symptoms associated to benign prostate hyperplasia. The new Green Light Photovaporization has been shown to be an alternative that is as effective for this condition as the transurethral resection of the prostate., Objectives: To compare the efficiency of Green Light Photovaporization 120 W versus transurethral resection of the prostate in the treatment of benign prostate hyperplasia (BPH) in a 2-year time horizon from the perspective of the Spanish health service perspective., Methods: A cost utility analysis was performed retrospectively with the data from 98 patients treated sequentially with transurethral resection of the prostate (n: 50) and Green Light Photovaporization 120 W (n: 48). A Markov model was designed to estimate the cost (2012€) and results (quality adjusted life years) in a 2-year time horizon., Results: The total cost associated to Green Light Photovaporization 120 W treatment was less (3,377€; 95% CI: 3,228; 3,537) than that of the transurethral resection of the prostate (3,770€; 95% CI: 3,579; 3,945). The determining factor of the cost was the surgical phase (difference: -450€; 95% CI: -625; -158) because admission to hospital after surgery was not necessary with the GreenLight-PhotoVaporization., Conclusions: Surgical treatment of BPH patients with GreenLight-PhotoVaporization 120 W is more efficient than transurethral resection of the prostate in the surgical treatment of benign prostate hyperplasia as it has similar effectiveness and lower cost (-393€; 95% CI: -625; -158)., (Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.)

Background and Aims: Transferring the results from clinical trials on type 2 diabetes prevention is the objective of the Diabetes in Europe-Prevention using Lifestyle, Physical Activity and Nutritional intervention (DE-PLAN) project in Catalonia, whose cost-effectiveness analysis is now presented., Patients and Methods: A prospective cohort study was performed in primary care involving individuals without diagnosed diabetes aged 45-75 years (n=2054) screened using the questionnaire Finnish Diabetes Risk Score (FINDRISC) and a subsequent oral glucose tolerance test. Where feasible, high-risk individuals who were identified (n=552) were allocated sequentially to standard care (n=219), a group-based (n=230) or an individual-level (n=103) intensive (structured programme of six hours using specific teaching techniques) lifestyle intervention (n=333). The primary outcome was the development of diabetes (WHO). We evaluated the cost of resources used with comparison of standard care and the intervention groups in terms of effectiveness and quality of life (15D questionnaire)., Results: After 4.2-year median follow-up, the cumulative incidences were 18.3% (14.3-22.9%) in the intensive intervention group and 28.8% (22.9-35.3%) in the standard care group (36.5% relative-risk-reduction). The corresponding 4-year HR was 0.64 (0.47-0.87; P<.004). The incremental cost induced by intensive intervention compared with the standard was 106€ per participant in the individual level and 10€ in the group-based intervention representing 746€ and 108€ per averted case of diabetes, respectively. The estimated incremental cost-utility ratio was 3243€ per quality-adjusted life-years gained., Conclusion: The intensive lifestyle intervention delayed the development of diabetes and was efficient in economic analysis., (Copyright © 2013 Elsevier España, S.L. All rights reserved.)

Background: An independent meta-analysis of randomized comparative trials of peginterferons alfa-2a and alfa-2b, both combined with ribavirin, analyzed the probability of achieving a sustained virological response (SVR)., Objective: To estimate the long-term cost-effectiveness of treatment of patients with chronic hepatitis C with peginterferon alfa-2a (180μg/week) plus ribavirin (800-1200mg/day) vs. alfa-2b (1.5μg/kg/week) plus ribavirin (800-1400mg/day), from the perspective of the Spanish National Health System., Methods: A Markov model was developed with 7 health states to simulate lifetime disease progression. SVR was calculated from the meta-analysis data. Transition probabilities and health state utilities were obtained from published literature. Direct healthcare costs were obtained from the drug catalog, while costs of disease-related complications were obtained from published studies and healthcare cost database. Costs were expressed in 2010€. The annual discount rate applied was 3.5% for both costs and benefits., Results: SVR rate for treatment with alfa-2a was higher than with alfa-2b; the differences were 6.0%, 7.6% and 8.7% for all genotypes, genotypes 1/4 and genotypes 2/3, respectively. Each patient would gain 0.469, 0.600 and 0.685 life-years and 0.155, 0.198 and 0.227 quality-adjusted life-years with alfa-2a vs. alfa-2b, for the respective genotypes. The cost saving per patient treated with alfa-2a would be €705, €672 and €1900, for all genotypes and for genotypes 1/4 and 2/3, respectively, alfa-2a being dominant., Conclusions: According to the present model, treatment of patients with chronic hepatitis C with peginterferon alfa-2a is cost-effective compared with peginterferon alfa-2b, both combined with ribavirin., (Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.)

Morbid obesity is a serious health problem whose prevalence is increasing. Expensive co-morbidities are associated to these patients, as well as a reduction in the survival. Bariatric surgery resolves the co-morbidities (type 2 diabetes mellitus, 86.6%; cardiovascular risk, 79.0%; obstructive sleep apnea syndrome, 83.6%; hypertension, 61.7%), reduces the mortality rate (among 31-40%), and increases the morbid obese patients survival over a 10-years period. It provides significant savings for the National Health System. The obese patients consume a 20% plus of health resources and 68% plus of drugs than general population. Bariatric surgery requires an initial investment (diagnosis-related group cost: 7,468 €), but it is recovered in a cost-effectiveness ratio of 2.5 years. Significant savings are obtained from the third year. To the direct economic benefits associated with reduced health expenditures it should be added an increase in tax collection (sick leave and unemployment reduction is estimated in 18%, with a productivity increase of 57% for self-employed people). Bariatric surgery is one of the most cost-effective procedures in the healthcare system., (Copyright © 2012 AEC. Published by Elsevier Espana. All rights reserved.)

Objective: To describe the cost-effectiveness analyses of medications launched in Spain for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents., Material and Methods: Systematic review of the literature without meta-analysis. A search was made in, PubMed/MEDLINE, SCOPUS, databases of the Centre for Reviews and Dissemination, and the websites of technology assessment agencies from Canada, the United Kingdom and the Spanish Platform AUnETS. Only full economic evaluations were included, considering at least methylphenidate or atomoxetine as pharmacological treatment alternatives in children and/or adolescents with ADHD., Results: Eleven studies published in 9 articles or reports were included. The most frequent characteristics were: cost-utility analysis (82%), health system perspective (82%), short-term horizon (91%), and private funding (50%). Methylphenidate was included in all studies, and atomoxetine in 4 studies. Methylphenidate and atomoxetine are cost-effective alternatives compared to placebo or no treatment, although incremental cost-effectiveness ratios are variable. The few direct treatment-comparisons between methylphenidate and atomoxetine provided contradictory and potentially biased results., Conclusions: The pharmacological treatment of ADHD in children and adolescents, with the reservations arising from the generalization of results to different settings, is probably cost-effective in the short term. The existing studies do not allow the relative efficiency of different treatments to be established, either in the long-term treatment or in patient subgroups with specific characteristics or comorbidities., (Copyright © 2012 SEP y SEPB. Published by Elsevier Espana. All rights reserved.)