A cost-utility analysis of increasing percutaneous coronary intervention use in elderly patients with acute coronary syndromes in six European countries.

AIMS: Percutaneous coronary intervention reduces mortality in acute coronary syndrome patients but the cost-utility of increasing its use in elderly acute coronary syndrome patients is unknown. METHODS: We assessed the efficiency of increased percutaneous coronary intervention use compared to current practice in patients aged ≥75 years admitted for acute coronary syndrome in France, Germany, Greece, Italy, Portugal and Spain with a semi-Markov state transition model. In-hospital mortality reduction estimates by percutaneous coronary intervention use and costs were derived from the EUROpean Treatment & Reduction of Acute Coronary Syndromes cost analysis EU project (n = 28,600). Risk of recurrence and out-of-hospital all-cause mortality were obtained from the Information System for the Development of Research in Primary Care (SIDIAP) database from North-Eastern Spain (n = 55,564). In-hospital mortality was modelled using stratified propensity score analysis. The 8-year acute coronary syndrome recurrence risk and out-of-hospital mortality were estimated with a multistate survival model. The scenarios analysed were to increase percutaneous coronary intervention use among patients with the highest, moderate and lowest probability of receiving percutaneous coronary intervention based on the propensity score analysis. RESULTS: France, Greece and Portugal showed similar total costs/1000 individuals (7.29-11.05 m €); while in Germany, Italy and Spain, costs were higher (13.53-22.57 m €). Incremental cost-utility ratios of providing percutaneous coronary intervention to all patients ranged from 2262.8 €/quality adjusted life year gained for German males to 6324.3 €/quality adjusted life year gained for Italian females. Increasing percutaneous coronary intervention use was cost-effective at a willingness-to-pay threshold of 10,000 €/quality adjusted life year gained for all scenarios in the six countries, in males and females. CONCLUSION: Compared to current clinical practice, broadening percutaneous coronary intervention use in elderly acute coronary syndrome patients would be cost-effective across different healthcare systems in Europe, regardless of the selected strategy.

Analysis of the implementation of a personalized care model in diabetes mellitus as an example of chronic disease with information and communication technology support.

INTRODUCTION: Diabetes mellitus affects 13.8% of the adult population in Spain, representing some 8.2% of total Spanish health spending, which may be reduced by optimizing treatment and disease monitoring. Areas covered: This perspective article aims to evaluate the possible clinical and economic outcomes of implementing a theoretical personalized care model in diabetes supported by information and communications technology in Spain vs. conventional care. Moreover, we assessed the value of emminens® eConecta, a solution designed to support the operational implementation of this model, which enables the connection and participation of patients and health professionals, facilitates patient education, decision-making, access to information, and data analysis. We carried out a review of the available evidence, consultations with experts and a clinical and cost estimation. Expert commentary: The experts consulted considered that the proposed model is consistent with Spanish strategies on chronicity, supports the management of chronicity/diabetes, and may improve the most important aspects of disease management. In the literature, this type of care models improved or provided equal disease control compared with conventional care, potentiated self-management strategies and reduced the high use of resources. Cost estimation showed a reduction of -12% in total direct costs and around -34% in the costs of outpatient visits.

Estimate of the total costs of allergic rhinitis in specialized care based on real-world data: the FERIN Study.

BACKGROUND: Despite the socioeconomic importance of allergic rhinitis (AR), very few prospective studies have been performed under conditions of clinical practice and with a sufficiently long observation period outside the clinical trial scenario. We prospectively estimated the direct and indirect costs of AR in patients attending specialized clinics in Spain. METHODS: Patients were recruited at random from allergy outpatient clinics in 101 health centers throughout Spain over 12 months. We performed a multicenter, observational, prospective study under conditions of clinical practice. We analyzed direct costs from a funder perspective (healthcare costs) and from a societal perspective (healthcare and non-healthcare costs). Indirect costs (absenteeism and presenteeism [productivity lost in the workplace]) were also calculated. The cost of treating conjunctivitis was evaluated alongside that of AR. RESULTS: The total mean cost of AR per patient-year (n = 498) was €2326.70 (direct, €553.80; indirect, €1772.90). Direct costs were significantly higher in women (€600.34 vs €484.46, P = 0.02). Total costs for intermittent AR were significantly lower than for persistent AR (€1484.98 vs €2655.86, P < 0.001). Total indirect costs reached €1772.90 (presenteeism, €1682.71; absenteeism, €90.19). The direct costs of AR in patients with intermittent asthma (€507.35) were lower than in patients with mild-persistent asthma (€719.07) and moderate-persistent asthma (€798.71) (P = 0.006). CONCLUSIONS: The total cost of AR for society is considerable. Greater frequency of symptoms and more severe AR are associated with higher costs. Indirect costs are almost threefold direct costs, especially in presenteeism. A reduction in presenteeism would generate considerable savings for society.

Análisis de minimización de costes entre fingolimod y natalizumab en segunda línea de tratamiento de esclerosis múltiple remitente-recurrente / Cost minimisation analysis of fingolimod vs natalizumab as a second line of treatment for relapsing-remitting multiple sclerosis

Introducción: Actualmente, existe una ausencia de evaluaciones económicas en el manejo de la esclerosis múltiple remitente-recurrente en segunda línea. El objetivo del trabajo fue comparar la eficiencia de fingolimod y natalizumab en España. Métodos: Se desarrolló un modelo de minimización de costes en un horizonte temporal de 2 años. La tasa de recaída aplicada fue la misma para los 2 tratamientos y los recursos utilizados fueron calculados a partir de los costes vigentes en España en euros de 2012. Se aplicó la perspectiva del Sistema Nacional de Salud, con un descuento anual del 3% de los costes futuros. Se desarrolló un análisis de sensibilidad para comprobar la consistencia del modelo. Resultados: La comparación indirecta de fingolimod con natalizumab no fue significativa (hazard ratio entre 0,82 y 1,07). Los costes directos para el horizonte temporal de 2 años, considerando una tasa media anual de recaídas de 0,22 y el descuento por Real Decreto del 7,5%, fueron de 40.914,72 D para fingolimod y 45.890,53 D para natalizumab. Del total de costes directos valorados, el máximo ahorro por paciente derivado del uso de fingolimod fue de 4.363,63 D y correspondió a la reducción en los costes de administración y mantenimiento. En función del análisis de sensibilidad considerado, fingolimod generó ahorros medios del 11% (rango 3,1%-18,7%). Conclusiones: Fingolimod es un tratamiento eficiente de segunda línea para el tratamiento de la esclerosis múltiple remitente-recurrente comparado con natalizumab, generando ahorros para el Sistema Nacional de Salud

Introduction: At present, there is a lack of economic assessments of second-line treatments for relapsing-recurring multiple sclerosis. The aim of this study was to compare the efficiency between fingolimod and natalizumab in Spain. Methods: A cost minimisation analysis model was developed for a 2-year horizon. The same relapse rate was applied to both treatment arms and the cost of resources was calculated using pain’s stipulated rates for 2012 in euros. The analysis was conducted from the perspective of Spain’s national health system and an annual discount rate of 3% was applied to future costs. A sensitivity analysis was performed to validate the robustness of the model. Results: Indirect comparison of fingolimod with natalizumab revealed no significant differences (hazard ratio between 0.82 and 1.07). The total direct cost, considering a 2-year analytical horizon, a 7.5% discount stipulated by Royal Decree, and a mean annual relapse rate of 0.22, Was D 40 914.72 for fingolimod and D 45 890.53 for natalizumab. Of the total direct costs that were analysed, the maximum cost savings derived from prescribing fingolimod prescription was D 4363.63, corresponding to lower administration and treatment maintenance costs. Based on the sensitivity analysis performed, fingolimod use was associated with average savings of 11% (range 3.1%-18.7%). Conclusions: Fingolimod is more efficient than natalizumab as a second-line treatment option for relapsing-remitting multiple sclerosis and it generates savings for the Spanish national health system

Cost minimisation analysis of fingolimod vs natalizumab as a second line of treatment for relapsing-remitting multiple sclerosis.

INTRODUCTION: At present, there is a lack of economic assessments of second-line treatments for relapsing-recurring multiple sclerosis. The aim of this study was to compare the efficiency between fingolimod and natalizumab in Spain. METHODS: A cost minimisation analysis model was developed for a 2-year horizon. The same relapse rate was applied to both treatment arms and the cost of resources was calculated using Spain's stipulated rates for 2012 in euros. The analysis was conducted from the perspective of Spain's national health system and an annual discount rate of 3% was applied to future costs. A sensitivity analysis was performed to validate the robustness of the model. RESULTS: Indirect comparison of fingolimod with natalizumab revealed no significant differences (hazard ratio between 0.82 and 1.07). The total direct cost, considering a 2-year analytical horizon, a 7.5% discount stipulated by Royal Decree, and a mean annual relapse rate of 0.22, was € 40914.72 for fingolimod and € 45890.53 for natalizumab. Of the total direct costs that were analysed, the maximum cost savings derived from prescribing fingolimod prescription was € 4363.63, corresponding to lower administration and treatment maintenance costs. Based on the sensitivity analysis performed, fingolimod use was associated with average savings of 11% (range 3.1%-18.7%). CONCLUSIONS: Fingolimod is more efficient than natalizumab as a second-line treatment option for relapsing-remitting multiple sclerosis and it generates savings for the Spanish national health system.

Cost-effectiveness impact of rivaroxaban versus new and existing prophylaxis for the prevention of venous thromboembolism after total hip or knee replacement surgery in France, Italy and Spain.

Venous thromboembolism (VTE) has a significant impact on healthcare costs but is largely preventable with anticoagulant prophylaxis using low-molecular-weight heparins (LMWHs), such as enoxaparin or dalteparin. Rivaroxaban and dabigatran etexilate are two new oral anticoagulants (NOACs) both compared with enoxaparin in separate trials. A decision analytic model with a healthcare and national payer perspective over a five-year time horizon was used to evaluate the cost-effectiveness of the NOACs for VTE prophylaxis after total hip replacement (THR) or total knee replacement (TKR) in France, Italy and Spain. Efficacy and safety data were obtained from randomised controlled trials of rivaroxaban vs enoxaparin and an indirect statistical comparison for rivaroxaban vs dabigatran. Rivaroxaban demonstrated dominance across all comparisons, indications and countries. In THR, total per-patient costs were reduced by up to €160 in the enoxaparin comparison and €115 in the dabigatran comparison, respectively. In addition, quality-adjusted life-years (QALYs) were increased by up to 0.0011 and 0.0012 in each comparison, respectively. Similarly, total costs were reduced in TKR by up to €137 and €28 in the enoxaparin and dabigatran comparisons, respectively. The total number of QALYs was increased by up to 0.0014 in the enoxaparin comparison and 0.0005 in the dabigatran comparison. The results were driven by costs since the incremental benefits were minimal. Rivaroxaban use could result in substantial healthcare cost savings and improved quality of life. The results are applicable across three European countries with differing healthcare systems so, potentially, could be generalised to a much wider population.

Treatment patterns, use of resources, and costs of advanced non-small-cell lung cancer patients in Spain: results from a Delphi panel

INTRODUCTION: Approximately 80-85% of lung cancer patients are diagnosed with non-small-cell lung cancer (NSCLC), of which 50% of patients present with advanced or metastatic disease. The objective of this study was to describe treatment patterns, use of resources and costs associated with treating advanced or metastatic NSCLC patients in Spain. METHODS: A two-round Delphi consensus panel of clinical experts was carried out to describe local clinical patterns based on treatment algorithms from SEOM and ASCO treatment guidelines. The panel consisted of 19 oncologists and 1 hospital pharmacist, who were asked during the first round to define therapeutic pathways for NSCLC by the patients' performance status, age and histology; to quantify the use of resources associated with the preparation and administration of anticancer pharmacotherapy; management of adverse events associated with anticancer pharmacotherapy; and best supportive care (BSC). The second round was used to try to reduce the variability of responses in some questions and to further describe differences between intravenous and oral therapy. 2009 unit costs were applied to the use of resources described by the clinical experts. The perspective of the study was from the Spanish National Healthcare System. RESULTS: Performance status guided therapy decision and led to differences in costs. Patients with a performance status of 0-2 were expected to receive anticancer pharmacotherapy while patients with a performance status of 3-4 received BSC including analgesics and corticosteroids. Anticancer pharmacotherapies containing cisplatin or carboplatin were used preferably in first-line treatment, while the usual second- and third-line treatments were docetaxel, erlotinib or pemetrexed monotherapy. The importance of the cost of anticancer pharmacotherapy as a proportion of total healthcare costs was higher for combination therapies containing bevacizumab or pemetrexed. The anticancer pharmacotherapies associated with adverse events like febrile neutropenia or infection increased the total treatment cost. Administration costs were more relevant in regimens containing cisplatin and were low for orally administered therapies. The total cost per patient with advanced or metastatic NSCLC from starting anticancer therapy until death was estimated to be between €11,301 and €32,754 depending on the number of treatment lines received. CONCLUSIONS: In the treatment of advanced or metastatic NSCLC, healthcare costs are impacted by line of treatment, patient performance status, type of administration of therapy and adverse event management (AU)

Análisis de los costes y la efectividad del uso de cilostazol frente a naftidrofurilo y pentoxifilina en el tratamiento de la claudicación intermitente en España / Cost-effectiveness analysis of cilostazol vs naftidrofuryl and pentoxifylline for the treatment of intermittent claudication in Spain

Introducción: El cilostazol es un inhibidor reversible de la fosfodiesterasa III que presenta actividad antiagregante plaquetaria y vasodilatadora. El objetivo de este estudio fue estimar las consecuencias clínicas y económicas del uso de cilostazol en comparación con naftidrofurilo y pentoxifilina en el tratamiento de la claudicación intermitente (CI) en España. Métodos: Se ha construido un modelo fármaco económico basado en la literatura para describir el manejo de la CI y sus consecuencias clínicas y económicas para cada opción terapéutica evaluada en pacientes con 40 o más años y una historia de CI sintomática, secundaria a enfermedad vascular periférica de las extremidades inferiores. Los resultados clínicos provienen de una revisión de los ensayos clínicos respectivos. Se utilizaron costes unitarios españoles para medir las consecuencias económicas asociadas al uso de recursos sanitarios a partir de un estudio similar realizado en el Reino Unido. Resultados: Iniciar el tratamiento con cilostazol en lugar de pentoxifilina aumentaría la distancia máxima recorrida en un 72%, reduciendo los costes en un 11,5%. En comparación con naftidrofurilo, cilostazol se asoció a un aumento de la efectividad del 34% y un aumento de los costes sanitarios del 11,2%. Estos resultados suponen que cilostazol, naftidrofurilo y pentoxifilina presentarían ratios de coste por punto porcentual de aumento de la distancia máxima recorrida de 7,8, 9,1 y 14,7 € respectivamente. Conclusiones: Los resultados de este estudio muestran que iniciar tratamiento con cilostazol presenta una relación de costes y efectividad más favorable respecto a otros tratamientos para la CI en España(AU)

Introduction: Cilostazol is a reversible selective inhibitor of phosphodiesterase III which has platelet antiaggregating and vasodilatory activity. The aim of this study was to estimate the clinical and economic consequences of the use of cilostazol compared with naftidrofuryl and pentoxifylline in the treatment of intermittent claudication (IC) in Spain. Methods: A pharmaco economic model was built based on the literature to describe the management of IC and its clinical and economic consequences for each treatment option evaluated in patients 40 years or older with a medical history of symptomatic IC secondary to peripheral vascular disease of the lower extremities. Clinical results were obtained from a review of clinical trials of the comparators. Spanish unit costs were used to measure the economic consequences associated with the use of healthcare resources based on a similar study performed in the UK. Results: Starting treatment with cilostazol instead of pentoxifylline would increase the maximum distance covered by 72%, reducing costs by 11.5%. Compared with naftidrofuryl, cilostazol was associated with an increase in effectiveness of 34% and an increase in healthcare costs of 11.2%. These results mean that cilostazol, naftidrofuryl and pentoxifylline would have a cost, per one percentage point increase of the maximum distance covered, of € 7.8, € 9.1 and € 14.7, respectively. Conclusions: The study results demonstrate that starting treatment with cilostazol has a more favourable cost-effectiveness ratio compared to other treatments for IC in Spain(AU)

Economic evaluation of the levonorgestrel-releasing intrauterine system for the treatment of dysfunctional uterine bleeding in Spain.

OBJECTIVE: To compare the cost and effectiveness of the levonorgestrel-releasing intrauterine system (LNG-IUS) versus combined oral contraception (COC) and progestogens (PROG) in first-line treatment of dysfunctional uterine bleeding (DUB) in Spain. STUDY DESIGN: A cost-effectiveness and cost-utility analysis of LNG-IUS, COC and PROG was carried out using a Markov model based on clinical data from the literature and expert opinion. The population studied were women with a previous diagnosis of idiopathic heavy menstrual bleeding. The analysis was performed from the National Health System perspective, discounting both costs and future effects at 3%. In addition, a sensitivity analysis (univariate and probabilistic) was conducted. RESULTS: The results show that the greater efficacy of LNG-IUS translates into a gain of 1.92 and 3.89 symptom-free months (SFM) after six months of treatment versus COC and PROG, respectively (which represents an increase of 33% and 60% of symptom-free time). Regarding costs, LNG-IUS produces savings of € 174.2-309.95 and € 230.54-577.61 versus COC and PROG, respectively, after 6 months-5 years. Apart from cost savings and gains in SFM, quality-adjusted life months (QALM) are also favourable to LNG-IUS in all scenarios, with a range of gains between 1 and 2 QALM compared to COC and PROG. CONCLUSIONS: The results indicate that first-line use of the LNG-IUS is the dominant therapeutic option (less costly and more effective) in comparison with first-line use of COC or PROG for the treatment of DUB in Spain. LNG-IUS as first line is also the option that provides greatest health-related quality of life to patients.

Sacral neuromodulation for the treatment of fecal incontinence: analysis of cost-effectiveness.

PURPOSE: The cost-effectiveness and budget impact of introducing sacral nerve modulation (SNM) as a treatment for fecal incontinence in Italy were evaluated in a simulation model. METHODS: A decision-analysis model with a Markov submodel was used to represent clinical pathways for treatment of patients with fecal incontinence in a scenario with SNM and a scenario without SNM. Data were obtained from published studies and from an expert panel. Evaluation of resource consumption was conducted from the perspective of the Italian National Health Service, and costs were retrieved from the Italian NHS procedures reimbursement list. The time horizon was 5 years, and a 3% discount rate was applied to costs and outcomes. Effectiveness was measured in symptom-free years and in quality-adjusted life-years (QALYs). Fecal incontinence prevalence data and SNM usage forecasts were used to estimate budget impact over the next 5 years. RESULTS: The incremental cost-effectiveness ratio for introducing SNM was €28,285 per QALY gained for patients with a structurally deficient anal sphincter and €38,662 per QALY gained for patients with intact anal sphincters. If a threshold of €40,000 per QALY gained is set as the level that a decision-maker would regard as cost-effective, the probability that the introduction of SNM will be cost-effective would be 99% for patients with a structurally deficient sphincter and 53% for patients with an intact sphincter. Budget impact analysis showed that introducing SNM would have an estimated budget impact of 0.56% over 5 years on the budget allocated for fecal incontinence treatment. CONCLUSION: Our data show SNM to be an efficient investment with an acceptable incremental cost-effectiveness ratio and a limited impact on the total allocated budget for fecal incontinence.

The burden of hospital malnutrition in Spain: methods and development of the PREDyCES® study / El coste de la desnutrición hospitalaria en España: método y desarrollo del estudio PREDyCES®

It is well known that hospital malnutrition is ahighly prevalent condition associated to increase morbidity and mortality as well as related healthcarecosts. Although previous studies have already measured the prevalence and/or costs of hospital nutrition in our country, their local focus (at regionalor even hospital level) make that the true prevalence and economic impact of hospital malnutrition for the National Health System remain unknown inSpain. The PREDyCES® (Prevalence of hospitalmal nutrition and associated costs in Spain) study was aimed to assess the prevalence of hospital malnutrition in Spain and to estimate related costs.Some aspects made this study unique: a) It was the first study in a representative sample of hospitals ofSpain; b) different measures to assess hospital malnutrition (NRS2002, MNA as well as anthropometric and biochemical markers) where used both at admission and discharge and, c) the economic consequences of malnutrition where estimated using the perspective of the Spanish National Health System (AU)

Es bien sabido que la desnutrición hospitalaria es un proceso altamente prevalente asociado al aumento de la morbilidad y mortalidad, así como a elevados costes sanitarios. Aunque estudios previos han medido la prevalencia y/o los costes de la nutrición hospitalaria en nuestro país, su enfoque local(regional o incluso a nivel hospitalario) hacen que la verdadera prevalencia e impacto económico de la desnutrición hospitalaria para el Sistema Nacional de Salud sean aún desconocidos en España. El objetivo del estudio PREDyCES®(Prevalencia de la Desnutrición hospitalaria y los Costes asociados en ESpaña) fue evaluar la prevalencia de la desnutrición hospitalaria en España y estimar sus costes asociados.Algunos aspectos de este estudio lo hicieron singular: a) Fue el primer estudio de este tipo con una muestra representativa de los hospitales de España, b) se utilizaron diferente medidas para evaluar la desnutrición hospitalaria (NRS 2002,MNA, así como marcadores antropométricos y bioquímicos)tanto en el momento del ingreso como al alta hospitalaria y, c)se estimaron las consecuencias económicas de la desnutrición desde la perspectiva del Sistema Nacional de Salud español (AU)

The burden of hospital malnutrition in Spain: methods and development of the PREDyCES® study.

It is well known that hospital malnutrition is a highly prevalent condition associated to increase morbidity and mortality as well as related healthcare costs. Although previous studies have already measured the prevalence and/or costs of hospital nutrition in our country, their local focus (at regional or even hospital level) make that the true prevalence and economic impact of hospital malnutrition for the National Health System remain unknown in Spain. The PREDyCES® (Prevalence of hospital malnutrition and associated costs in Spain) study was aimed to assess the prevalence of hospital malnutrition in Spain and to estimate related costs. Some aspects made this study unique: a) It was the first study in a representative sample of hospitals of Spain; b) different measures to assess hospital malnutrition (NRS2002, MNA as well as anthropometric and biochemical markers) where used both at admission and discharge and, c) the economic consequences of malnutrition where estimated using the perspective of the Spanish National Health System.

Cost-effectiveness analysis of sunitinib in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) after progression or intolerance with imatinib.

INTRODUCTION: Sunitinib is a multiselective oral inhibitor of several tyrosine-kinase receptors that has demonstrated its efficacy in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) who were resistant to or intolerant to previous treatment with imatinib. The purpose of this study is to assess the cost-effectiveness of sunitinib vs. best supportive care (BSC) in GIST as a second- line treatment, from the perspective of the Spanish National Health System. MATERIALS AND METHODS: A Markov model was used to assess the cost effectiveness of sunitinib (50 mg/day, 4 weeks "on" and 2 weeks "off") vs. BSC in GIST as a second-line treatment. Transition probabilities between the three health states considered in the model (progression-free survival (PFS), progression and death) were obtained from a clinical trial [Demetri et al. (2006) Lancet 368:1329-1338]. Health resource data (drugs, medical visits, laboratory and radiology tests, palliative care and adverse events) were obtained from an expert panel. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Projected PFS years, life years (LY) and quality of life adjusted years (QALYs) were higher for sunitinib compared with BSC: 0.50 vs. 0.24, 1.59 vs. 0.88 and 1.00 vs. 0.55. Mean costs per patient were 23,259 euros with sunitinib and 1,622 euros with BSC. The incremental cost-effectiveness ratios (ICERs) obtained were: 4,090 euros/month PFS, 30,242 euros/LY and 49,090 euros/QALY gained. The most influential variables for the results were the efficacy and unit cost of sunitinib. CONCLUSIONS: According to the efficiency thresholds for oncology patients in developed countries, sunitinib is considered cost-effective vs. BSC with acceptable costs per LY and QALY gained.

Cost-effectiveness analysis of sunitinib in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) after progression or intolerance with imatinib

INTRODUCTION: Sunitinib is a multiselective oral inhibitor of several tyrosine-kinase receptors that has demonstrated its efficacy in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) who were resistant to or intolerant to previous treatment with imatinib. The purpose of this study is to assess the cost-effectiveness of sunitinib vs. best supportive care (BSC) in GIST as a second- line treatment, from the perspective of the Spanish National Health System. MATERIALS AND METHODS: A Markov model was used to assess the cost effectiveness of sunitinib (50 mg/day, 4 weeks "on" and 2 weeks "off") vs. BSC in GIST as a second-line treatment. Transition probabilities between the three health states considered in the model (progression-free survival (PFS), progression and death) were obtained from a clinical trial [Demetri et al. (2006) Lancet 368:1329-1338]. Health resource data (drugs, medical visits, laboratory and radiology tests, palliative care and adverse events) were obtained from an expert panel. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Projected PFS years, life years (LY) and quality of life adjusted years (QALYs) were higher for sunitinib compared with BSC: 0.50 vs. 0.24, 1.59 vs. 0.88 and 1.00 vs. 0.55. Mean costs per patient were 23,259 euros with sunitinib and 1,622 euros with BSC. The incremental cost-effectiveness ratios (ICERs) obtained were: 4,090 euros/month PFS, 30,242 euros/LY and 49,090 euros/QALY gained. The most influential variables for the results were the efficacy and unit cost of sunitinib. CONCLUSIONS: According to the efficiency thresholds for oncology patients in developed countries, sunitinib is considered cost-effective vs. BSC with acceptable costs per LY and QALY gained (AU)

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Clinical and cost effectiveness of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) has better results and safety than other surgical procedures for faecal incontinence. This prospective study assessed the clinical effectiveness and costs of SNS at a single centre. METHODS: Patients who had experienced one or more episodes of faecal incontinence were studied for up to 5 years by continence diary, anorectal manometry and quality of life questionnaires. Direct medical costs were calculated and the cost-effectiveness of the treatment was analysed. RESULTS: Fifty-seven percutaneous nerve evaluations were performed in 47 patients between June 1999 and February 2006; 29 patients underwent permanent implantation. After a median follow-up of 34.7 (range 2.3-81.2) months, 25 of the 29 patients had a significant reduction in incontinence episodes; 14 patients were in complete remission. At 3-year follow-up, the mean reduction in incontinence episodes was 89 per cent. No change was observed in anal manometric values. Patients reported a significant improvement in quality of life. The introduction of SNS has an incremental cost-effectiveness ratio, below the accepted Spanish threshold. CONCLUSION: The introduction of SNS to the management of faecal incontinence within the Spanish setting is both effective and efficient.

Iatrogenic cost factors incorporating mild and moderate adverse events in the economic comparison of aceclofenac and other NSAIDs.

OBJECTIVE: To perform a modelled economic analysis of the efficacy and tolerability of aceclofenac in comparison with those of other nonsteroidal antiinflammatory drugs (NSAIDs) used in the treatment of common arthritic disorders including osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. DESIGN: A decision analytical model was constructed to represent the clinical and economic consequences of NSAID treatment. Probabilities of noncompliance, lack of efficacy and incidence of adverse events were obtained from comparative randomised double-blind clinical trials. Local unit treatment costs were used and an expert panel was convened to estimate resource use. Both classical foldback analysis and bootstrap methods were used to compute point estimates and 95% confidence limits of costs for NSAID treatment. PATIENTS AND INTERVENTIONS: Data were obtained from 12 randomised double-blind clinical trials included in an earlier meta-analysis. MAIN OUTCOME MEASURES: Total costs to the healthcare provider, including NSAID treatment costs (drug acquisition costs and physician visits for prescription) and iatrogenic costs (substitution treatment costs for patients not achieving clinical efficacy and costs of medical visits, treatment, diagnostic tests and hospital stays associated with adverse events) and the iatrogenic cost factor (ICF) were used as the primary outcome measures. RESULTS: Means and 95% confidence intervals revealed no statistically significant differences in total costs between aceclofenac and other NSAIDs, with the exception of piroxicam, despite substantial differences in drug acquisition costs. The ICF for aceclofenac was lower than that for all other comparators, and differences in ICF between aceclofenac 200 mg/day and diclofenac 150 mg/day, indomethacin 100 mg/day, naproxen 1000 mg/day, tenoxicam 20 mg/day or ketoprofen 150 mg/day were statistically significant. CONCLUSION: These results show that the comparative overall costs of NSAIDs bears little relation to drug acquisition cost, and that the ICF is one of the most important determinants of overall costs.

[A cost-effectiveness analysis of strategies for the diagnosis-treatment of Helicobacter pylori-associated peptic ulcer in primary care]. / Análisis coste-efectividad de estrategias de diagnóstico-tratamiento del ulcus péptico asociados a Helicobacter pylori en atención primaria.

OBJECTIVES: To undertake an economic evaluation of three strategies for diagnosing and treating Helicobacter pylori (HP)-related peptic ulcers (PU), and to find the most efficacious and efficient combination of medication for the most cost-effective strategy. DESIGN: Cost-effectiveness analysis based on retrospective information (systematic review of the literature) and Markov models for the simulation of a hypothetical cohort of patients with PU. PATIENTS: Patients seeking medical care at the primary level for an acute PU attack. The costs and health effects of the management of an attack were evaluated in a hypothetical cohort of adults (> 18 years old) with symptomatic peptic ulcer confirmed endoscopically and not associated with consumption of non-steroidal anti-inflammatory drugs (NSAIDs). INTERVENTIONS: Three strategies for handling PU patients were compared: pre- and post-treatment diagnosis of HP, pre-treatment diagnosis and empirical treatment. Then the most efficient strategy for comparing 6 combinations of antibiotics was used. RESULTS: The empirical treatment strategy was markedly less costly (saving of between 15000 and 39000 pesetas per patient treated) than the diagnosis strategies, and obtained equivalent effectiveness under all analytical hypotheses. In comparing drug combinations, the classic triple therapies based on bismuth subcitrate were more effective and less costly than other therapies. CONCLUSIONS: Empirical treatment with combinations of irradicatory drugs was the most efficient strategy for tackling the diagnosis/therapy of patients with HP-related PU. In terms of efficiency, the choice between the various combinations of irradicatory drugs with over 80% success depends basically on the cost of the drugs.

[Evidence-based medicine, health costs and treatment of intra-abdominal infection]. / Medicina basada en la evidencia, costes sanitarios y tratamiento de la infección intraabdominal.

BACKGROUND: Anti-infectious drugs are among the most-prescribed medications in the community, in 1997 being more than 9% of all drugs prescribed by the Spanish National Health System. In the particular case of the treatment of patients with moderate or severe intra-abdominal infection, economic aspects are important. Antimicrobial therapy is responsible for as much as 50% of the drug budget in some Spanish hospitals. On the other hand, as more options become available for the treatment of intra-abdominal infection, it is important to know their clinical and economic consequences. Imipenem/cilastatin (IC) is a broad-spectrum beta-lactam antibiotic that has demonstrated its effectiveness in the treatment of nosocomial and community-acquired bacterial infections. OBJECTIVE: The objective of this study was to determine if IC has a favorable cost-effectiveness relation compared to other antibiotic therapies for the treatment of intra-abdominal infections. METHODS: A cost-effectiveness analysis was made based on retrospective information on the treatment of patients over 18 with clinical suspicion of moderate-to-severe intra-abdominal infection. Health-care results were measured in natural health units (percentage of clinically favorable cases) in a systematic review of the literature. Direct health-care costs associated with the treatments compared were calculated. The other options studied, apart from IC, included the most common and least expensive option (a combination of an aminoglycoside and an anaerobicide [AA]) and an antibiotic from the same family as IC, meropenem (M). RESULTS: The results, in terms of the percentage of patients with clinically favorable results, showed that the effectiveness of IC was equivalent to that of M (95.2% vs. 96.4%) and the AA association (88.0% vs. 86.6%). Analysis of cost minimization showed that the total cost per patient treated with the IC and M options was similar, but that the lower price of IC slightly reduced the total cost per patient treated (ptas. 455,320 IC and ptas. 483,404 M). In the comparison of IC and AA, the higher price of IC was compensated for by the lower cost associated with the duration of hospitalization in patients treated with IC (total cost per patients treated ptas. 844,678 IC and ptas. 1,009,180 AA). CONCLUSIONS: The results of the meta-analysis showed that imipenem/cilastatin was highly effective (more than 90% clinically favorable results) and that it can be considered a minimum equivalent to meropenem and to the combination of an aminoglycoside and anaerobicide for the treatment of patients with moderate or severe intra-abdominal infection. Given the equivalence in effectiveness of the options studied, analysis of cost minimization was used to study their relative effectiveness. This analysis showed that IC was accompanied by lower costs per patient than M and AA. The most relevant variables in the study of the efficiency of the treatment of intra-abdominal infections were, in conditions of equivalent effectiveness, days of hospitalization (and associated costs) and drug price.