Economic impact of managing invasive mold disease with isavuconazole compared with liposomal amphotericin B followed by posaconazole in Spain.

BACKGROUND: Invasive fungal infections (IFI) are associated with significant morbidity and mortality. The objective of this work was to compare the costs per adult patient, associated with intravenous isavuconazole (ISAV) followed by oral ISAV versus the regimen of liposomal amphotericin B followed by posaconazole (L-AMB→POSA) in the treatment of IFI. The comparison was conducted from the perspective of the Spanish National Health System (SNS). METHODS: As indirect comparisons have demonstrated similar efficacy between the comparators, a cost-minimization approach was taken. Drug acquisition, administration, hospitalization, laboratory tests and adverse events costs were evaluated from SNS perspective. Deterministic and probabilistic sensitivity analyzes were performed. RESULTS: Total costs per-patient were €24,715.54 with ISAV versus €29,753.53 with L-AMB→POSA, resulting in cost-savings per patient treated with ISAV of €5,037.99 (-16.9%). Treatment costs of IFI remained lower for ISAV than for L-AMB→POSA across all sensitivity analyses (-7,968.89€ to -326.59€), being treatment duration the most influential parameter. CONCLUSION: According to the present model, the treatment of IFIs with ISAV would generate savings for the SNS compared to L-AMB→POSA. These savings are attributed to the shorter duration of IV treatment, reduced use of healthcare resources and lower costs associated with managing adverse effects when ISAV was employed.

Cost-effectiveness of somatrogon in the Spanish pediatric population with growth hormone deficiency.

OBJECTIVE: To analyze the cost-effectiveness of weekly somatrogon compared to daily growth hormones (GH-d) in the pediatric population of Spain with growth hormone deficiency (GHD). METHODS: Markov model with two states (patients with or without GH-d or somatrogon treatment) in prepubertal children (3 to 11 years and 3 to 12 years in girls and boys, respectively) with GHD in isolation or as part of multiple pituitary hormone deficiency and without previous treatment, from the perspective of the National Health System. The simulation of the economic model ends at the age of 18. The costs of hormones and monitoring were obtained from Spanish sources. The utilities were obtained from the literature. Spanish clinical experts validated the assumptions of the model. RESULTS: In the deterministic analysis, somatrogon would be cost-effective, compared to GH-d, with a cost per QALY (quality-adjusted life year) gained of €19,259 and a clinically relevant QALY gain (0.336). This result was confirmed in deterministic sensitivity analyses. According to the probabilistic analysis, somatrogon would be the dominant treatment, with a 61% probability of a willingness to pay of €25,000 per QALY gained. CONCLUSION: Compared to GH-d, somatrogon is cost-effective in the Spanish pediatric population with GHD.

Cost-effectiveness of Cladribine Tablets and fingolimod in the treatment of relapsing multiple sclerosis with high disease activity in Spain.

OBJECTIVE: To estimate the cost-effectiveness of Cladribine Tablets in the treatment of relapsing multiple sclerosis (RMS) with high disease activity compared with fingolimod, from the perspective of the National Health System (NHS) in Spain. METHODS: A Markov model was developed. The annual transition probabilities, were adjusted to patients with RMS with high disease activity. The effect of the treatments compared on the Expanded Disability Status Scale (EDSS) was modeled by hazard ratios for the confirmed progression of disability. The annual relapse rate and the probability of suffering adverse reactions were obtained from a meta-analysis and the literature. The derived costs were calculated from Spanish unit costs. The utilities were obtained from the CLARITY clinical trial and the literature. Deterministic and probabilistic sensitivity analyzes were performed. RESULTS: Cladribine tablets was the dominant treatment: lower costs (-86,536 €) and more effective (+1.11 quality-adjusted life years - QALYs) compared to fingolimod. The probability that Cladribine Tablets was cost-effective compared to fingolimod ranged between 94.6% and 96.1% for willingness to pay from € 20,000 to € 30,000 per QALY gained. CONCLUSIONS: Cladribine Tablets is a cost-effective treatment, compared to fingolimod, for the treatment of RMS with high disease activity. EXPERT OPINION: According to the present study, compared to fingolimod, treatment with Cladribine Tablets of relapsing multiple sclerosis with high disease activity is an option that could generate savings for the Spanish National Health System, with a considerable gain in QALYs. Cladribine Tablets is considered cost-effective and dominant (less costs and more effectiveness) than fingolimod treatment option in this population.

Prospective, multicenter study on the economic and clinical impact of gene-expression assays in early-stage breast cancer from a single region: the PREGECAM registry experience.

INTRODUCTION: The aim of this study is to evaluate the cost-effectiveness and impact of gene-expression assays (GEAs) on treatment decisions in a real-world setting of early-stage breast cancer (ESBC) patients. METHODS: This is a regional, prospective study promoted by the Council Health Authorities in Madrid. Enrolment was offered to women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, node-negative or micrometastatic, stage I or II breast cancer from 21 hospitals in Madrid. Treatment recommendations were recorded before and after knowledge of tests results. An economic model compared the cost-effectiveness of treatment, guided by GEAs or by common prognostic factors. RESULTS: 907 tests (440 Oncotype DX® and 467 MammaPrint®) were performed between February 2012 and November 2014. Treatment recommendation changed in 42.6% of patients. The shift was predominantly from chemohormonal (CHT) to hormonal therapy (HT) alone, in 30.5% of patients. GEAs increased patients' confidence in treatment decision making. Tumor grade, progesterone receptor positivity and Ki67 expression were associated with the likelihood of change from CHT to HT (P < 0.001) and from HT to CHT (P < 0.001). Compared with current clinical practice genomic testing increased quality-adjusted life years by 0.00787 per patient and was cost-saving from a national health care system (by 13.867€ per patient) and from a societal perspective (by 32.678€ per patient). CONCLUSION: Using GEAs to guide adjuvant therapy in ESBC is cost-effective in Spain and has a significant impact on treatment decisions.

Cost-effectiveness of three echinocandins and fluconazole in the treatment of candidemia and/or invasive candidiasis in nonneutropenic adult patients.

OBJECTIVE: To estimate the cost-effectiveness of three echinocandins (anidulafungin, caspofungin, and micafungin) and generic fluconazole in the treatment of nonneutropenic adult patients with candidemia and/or invasive candidiasis in intensive care units in Spain. MATERIALS AND METHODS: A decision-tree model was applied. The success and safety (hepatic and renal adverse effects) of first-line treatments were obtained from meta-analyses and systematic reviews of clinical trials. In the case of failure, a second-line treatment (liposomal amphotericin B after the echinocandins, or one of the echinocandins after fluconazole) was administered. The duration of the treatments (14 days total) was established by a panel of clinical experts using the Delphi method and according to Infectious Diseases Society of America guidelines. The cost of the medications and renal toxicity were considered. Deterministic and probabilistic sensitivity analysis using Monte Carlo simulations were carried out. RESULTS: The total cost of the treatment of candidemia and/or invasive candidiasis with anidulafungin, caspofungin, micafungin, and fluconazole was €5,483, €5,968, €6,231, and €2,088, respectively. Anidulafungin was the dominant treatment (more effective, less expensive) compared to micafungin and caspofungin. The cost of achieving one more patient successfully treated with anidulafungin, caspofungin, and micafungin compared to fluconazole was €17,199, €23,962, and €27,339, respectively. The result remained stable, despite modification of the duration of the first-line and second-line treatments, as well as most of the dosing regimens. The probabilistic analysis also remained stable. CONCLUSION: In accordance with this economic study, anidulafungin would produce savings and would be the dominant treatment compared with micafungin and caspofungin in nonneutropenic adult patients with candidemia and/or invasive candidiasis in intensive care units in Spain.

Economic assessment of fidaxomicin for the treatment of Clostridium difficile infection (CDI) in special populations (patients with cancer, concomitant antibiotic treatment or renal impairment) in Spain.

The objective of this paper was to assess the cost-utility of fidaxomicin versus vancomycin in the treatment of Clostridium difficile infection (CDI) in three specific CDI patient subgroups: those with cancer, treated with concomitant antibiotic therapy or with renal impairment. A Markov model with six health states was developed to assess the cost-utility of fidaxomicin versus vancomycin in the patient subgroups over a period of 1 year from initial infection. Cost and outcome data used to parameterise the model were taken from Spanish sources and published literature. The costs were from the Spanish hospital perspective, in Euros (€) and for 2013. For CDI patients with cancer, fidaxomicin was dominant versus vancomycin [gain of 0.016 quality-adjusted life-years (QALYs) and savings of €2,397 per patient]. At a cost-effectiveness threshold of €30,000 per QALY gained, the probability that fidaxomicin was cost-effective was 96 %. For CDI patients treated with concomitant antibiotic therapy, fidaxomicin was the dominant treatment versus vancomycin (gain of 0.014 QALYs and savings of €1,452 per patient), with a probability that fidaxomicin was cost-effective of 94 %. For CDI patients with renal impairment, fidaxomicin was also dominant versus vancomycin (gain of 0.013 QALYs and savings of €1,432 per patient), with a probability that fidaxomicin was cost-effective of 96 %. Over a 1-year time horizon, when fidaxomicin is compared to vancomycin in CDI patients with cancer, treated with concomitant antibiotic therapy or with renal impairment, the use of fidaxomicin would be expected to result in increased QALYs for patients and reduced overall costs.

Economic analysis of thrombo inCode, a clinical-genetic function for assessing the risk of venous thromboembolism.

BACKGROUND: Patients with venous thromboembolism (VTE) commonly have an underlying genetic predisposition. However, genetic tests nowadays in use have very low sensitivity for identifying subjects at risk of VTE. Thrombo inCode(®) is a new genetic tool that has demonstrated very good sensitivity, thanks to very good coverage of the genetic variants that modify the function of the coagulation pathway. OBJECTIVE: To conduct an economic analysis of risk assessment of VTE from the perspective of the Spanish National Health System with Thrombo inCode(®) (a clinical-genetic function for assessing the risk of VTE) versus the conventional/standard method used to date (factor V Leiden and prothrombin G20210A). METHODS: An economic model was created from the National Health System perspective, using a decision tree in patients aged 45 years with a life expectancy of 81 years. The predictive capacity of VTE, based on identification of thrombophilia using Thrombo inCode(®) and using the standard method, was obtained from two case-control studies conducted in two different populations (S. PAU and MARTHA; 1,451 patients in all). Although this is not always the case, patients who were identified as suffering from thrombophilia were subject to preventive treatment of VTE with warfarin, leading to a reduction in the number of VTE events and an increased risk of severe bleeding. The health state utilities (quality-adjusted life-years [QALYs]) and costs (in 2013 EUR values) were obtained from the literature and Spanish sources. RESULTS: On the basis of a price of EUR 180 for Thrombo inCode(®), this would be the dominant option (more effective and with lower costs than the standard method) in both populations. The Monte Carlo probabilistic analyses indicate that the dominance would occur in 100 % of the simulations in both populations. The threshold price of Thrombo inCode(®) needed to reach the incremental cost-effectiveness ratio (ICER) generally accepted in Spain (EUR 30,000 per QALY gained) would be between EUR 3,950 (in the MARTHA population) and EUR 11,993 (in the S. PAU population). CONCLUSION: According to the economic model, Thrombo inCode(®) is the dominant option in assessing the risk of VTE, compared with the standard method currently used.

Economic evaluation of Cardio inCode®, a clinical-genetic function for coronary heart disease risk assessment.

BACKGROUND: A clinical­genetic function (Cardio inCode®) was generated using genetic variants associated with coronary heart disease (CHD), but not with classical CHD risk factors, to achieve a more precise estimation of the CHD risk of individuals by incorporating genetics into risk equations [Framingham and REGICOR (Registre Gironí del Cor)]. OBJECTIVE: The objective of this study was to conduct an economic analysis of the CHD risk assessment with Cardio inCode®, which incorporates the patient's genetic risk into the functions of REGICOR and Framingham, compared with the standard method (using only the functions). METHODS: A Markov model was developed with seven states of health (low CHD risk, moderate CHD risk, high CHD risk, CHD event, recurrent CHD, chronic CHD, and death). The reclassification of CHD risk derived from genetic information and transition probabilities between states was obtained from a validation study conducted in cohorts of REGICOR (Spain) and Framingham (USA). It was assumed that patients classified as at moderate risk by the standard method were the best candidates to test the risk reclassification with Cardio inCode®. The utilities and costs (€; year 2011 values) of Markov states were obtained from the literature and Spanish sources. The analysis was performed from the perspective of the Spanish National Health System, for a life expectancy of 82 years in Spain. An annual discount rate of 3.5 % for costs and benefits was applied. RESULTS: For a Cardio inCode® price of €400, the cost per QALY gained compared with the standard method [incremental cost-effectiveness ratio (ICER)] would be €12,969 and €21,385 in REGICOR and Framingham cohorts, respectively. The threshold price of Cardio inCode® to reach the ICER threshold generally accepted in Spain (€30,000/QALY) would range between €668 and €836. The greatest benefit occurred in the subgroup of patients with moderate­high risk, with a high-risk reclassification of 22.8 % and 12 % of patients and an ICER of €1,652/QALY and €5,884/QALY in the REGICOR and Framingham cohorts, respectively. Sensitivity analyses confirmed the stability of the study results. CONCLUSIONS: Cardio inCode® is a cost-effective risk score option in CHD risk assessment compared with the standard method.

Análisis coste-efectividad de apixaban frente a dabigatrán en la prevención de la tromboembolia venosa en pacientes intervenidos de artroplastia total de rodilla o de cadera / Cost-effectiveness analysis of apixaban compared to dabigatran in the prevention of venous thromboembolism in patients subjected to total knee or hip replacement

Objetivo. Análisis de coste-efectividad de apixaban frente a dabigatrán en la prevención de la tromboembolia venosa (TEV) en la artroplastia total de rodilla (ATR) o cadera (ATC). Métodos. Modelo con 2 periodos: posprevención de 90 días (corto plazo) y a 5 años (Markov). Se incluyeron las complicaciones de la TEV (trombosis venosa profunda distal y proximal, embolia pulmonar, sangrados y síndrome postrombótico). La eficacia comparada se obtuvo de un metaanálisis y los costes de fuentes españolas. Se aplicó una tasa de descuento del 3,5% anual para costes y beneficios. Resultados. Según el metaanálisis, el riesgo relativo (RR) de TEV o muerte, frente a enoxaparina, fue menor con apixaban que con dabigatrán en ATR (RR: 0,89; IC 95% 0,32-1,65 y RR: 1,35, IC 95% 0,19-3,39) y en ATC (RR: 0,35, IC 95% 0,05-2,51 y RR: 0,89, IC 95% 0,22-3,21, respectivamente). A corto plazo, con apixaban se obtendrían más años de vida (AVG) y más años de vida ajustados por calidad (AVAC) por paciente, tanto en ATR (0,2037; 0,1908) como en ATC (0,2417; 0,1921) que con dabigatrán (0,1818; 0,1901, y 0,2345; 0,1918, respectivamente). Habría menos costes por paciente con apixaban en ATR (-14 €) por lo que este sería el tratamiento dominante. En ATC se producirían costes adicionales (15 €) con un coste por AVG de 2.083 y de 50.000 € por AVAC ganado. A 5 años, apixaban fue más barato y más efectivo en ATR y en ATC. Conclusiones. Según el presente estudio, apixaban es un tratamiento coste-efectivo en comparación con dabigatrán en la prevención de la TEV (AU)

Objective. Cost-effectiveness analysis of apixaban vs. dabigatran in preventing venous thromboembolism (VTE) in total knee (TKR) or hip (THR) replacement. Methods. Model with two periods: post-prophylaxis period of 90 days (short term) and 5 years (Markov). VTE complications (distal and proximal deep vein thrombosis, pulmonary embolism, bleeding and post-thrombotic syndrome) were included. The comparative efficacy was obtained from a meta-analysis, and the costs from Spanish sources. An annual discount rate of 3.5% for costs and benefits was applied. Results. According to the meta-analysis, the relative risk (RR) of VTE or death, compared with enoxaparin, was lower with apixaban than with dabigatran in TKR (RR 0.89, 95% CI 0.32 to 1.65 and RR 1.35, 95% CI, 0.19 to 3.39) and THR (RR 0.35, 95% CI, 0.05 to 2.51 and RR 0.89, 95% CI 0.22 to 3.21, respectively). In the short term, there were more life years (LYG) and more quality-adjusted life years (QALY) per patient in TKR (0.2037; 0.1908) and THR (0.2417; 0.1921) with apixaban than with dabigatran (0.1818; 0.1901 and 0.2345; 0.1918, respectively) were obtained. With apixaban lower costs per patient in TKR (-14 €) were generated, so it was the dominant treatment. Additional costs (15 €) could be incurred in THR, with a cost per LYG of 2,083 € and 50,000 € per QALY gained. In 5 years, apixaban was cheaper and more effective in both TKR and THR. Conclusions. According to this study, apixaban was shown to be a cost-effective treatment compared with dabigatran for VTE prevention (AU)

[Cost-effectiveness analysis of apixaban compared to dabigatran in the prevention of venous thromboembolism in patients subjected to total knee or hip replacement]. / Análisis coste-efectividad de apixaban frente a dabigatrán en la prevención de la tromboembolia venosa en pacientes intervenidos de artroplastia total de rodilla o de cadera.

OBJECTIVE: Cost-effectiveness analysis of apixaban vs. dabigatran in preventing venous thromboembolism (VTE) in total knee (TKR) or hip (THR) replacement. METHODS: Model with two periods: post-prophylaxis period of 90 days (short term) and 5 years (Markov). VTE complications (distal and proximal deep vein thrombosis, pulmonary embolism, bleeding and post-thrombotic syndrome) were included. The comparative efficacy was obtained from a meta-analysis, and the costs from Spanish sources. An annual discount rate of 3.5% for costs and benefits was applied. RESULTS: According to the meta-analysis, the relative risk (RR) of VTE or death, compared with enoxaparin, was lower with apixaban than with dabigatran in TKR (RR 0.89, 95% CI 0.32 to 1.65 and RR 1.35, 95% CI, 0.19 to 3.39) and THR (RR 0.35, 95% CI, 0.05 to 2.51 and RR 0.89, 95% CI 0.22 to 3.21, respectively). In the short term, there were more life years (LYG) and more quality-adjusted life years (QALY) per patient in TKR (0.2037; 0.1908) and THR (0.2417; 0.1921) with apixaban than with dabigatran (0.1818; 0.1901 and 0.2345; 0.1918, respectively) were obtained. With apixaban lower costs per patient in TKR (-14 €) were generated, so it was the dominant treatment. Additional costs (15 €) could be incurred in THR, with a cost per LYG of 2,083 € and 50,000 € per QALY gained. In 5 years, apixaban was cheaper and more effective in both TKR and THR. CONCLUSIONS: According to this study, apixaban was shown to be a cost-effective treatment compared with dabigatran for VTE prevention.

Análisis de costes del tratamiento de la diabetes mellitus tipo 2 con insulina glargina o detemir / Costs analysis of type 2 diabetes mellitus treatment with insulin glargine or detemir

Introducción: Diversos estudios publicados han revelado que algunos pacientesque inician el tratamiento con insulina detemir, cuya administraciónrecomendada es de una vez al día, requieren finalmente una administracióndos veces al día para optimizar el control de la glucosa sanguínea. Los resultadosclínicos se han evaluado en esta población seleccionada mediante unensayo clínico aleatorizado. Objetivo: Comparar los costes de dos tratamientoscon insulina (glargina y detemir) en la diabetes mellitus tipo 2 en pacientesno controlados con antidiabéticos orales. Métodos: Análisis de compensaciónde costes sanitarios, modelizado desde la perspectiva del Sistema Nacional deSalud español (considerando únicamente los costes directos sanitarios). Sesimuló la utilización de los recursos asociados al tratamiento de la diabetestipo 2 con glargina y detemir, respecto a las dosis de insulina administradas, lautilización de tiras reactivas para el autoanálisis de la glucemia y el consumode agujas desechables. Las dosis de glargina y detemir se obtuvieron de unensayo clínico que comparó ambas insulinas durante 24 semanas. La utilizaciónde tiras reactivas y de agujas desechables se estimó de acuerdo con lapráctica clínica en España. Los costes unitarios se tomaron de fuentes y basesde datos españolas. Resultados: En los pacientes tratados con glargina seadministró una menor dosis diaria de insulina que con detemir y, por tanto, seprodujo un menor coste diario del tratamiento insulínico, así como un menorconsumo de tiras reactivas y agujas. En consecuencia, la utilización de glarginaen lugar de detemir se asociaría a un ahorro anual de 765,03 € por pacientecon diabetes tipo 2, lo que supone un ahorro de un 43,3% con glarginafrente a detemir. En el análisis de sensibilidad, el ahorro anual por pacientetratado con glargina osciló entre 646,05 y 810,55 €(AU)

Conclusiones: Deacuerdo con el presente modelo, en la población estudiada la insulina glarginaes un tratamiento de la diabetes tipo 2 más coste-efectiva que la insulina detemiry se asocia a unos menores costes anuales de tratamiento(AU)

Introduction: Large published data suggested that some patients initiatingwith the recommended once daily insulin detemir administration require twicedaily dosing to optimise blood glucose control. Therefore the clinical outcomein this selected population was tested in a randomized controlled trial. Objective:To compare the costs of two treatments of type 2 diabetes mellitus, insulinglargine and insulin detemir, in patients with type 2 diabetes not controlledwith oral antidiabetic agents. Methods: Costs-offset analysis was modelledfrom the Spanish National Health System perspective, taking into account thehealth direct costs. A simulation of resources use related with glargine and detemirin type 2 diabetes treatment was performed, taking into account insulinadministered doses, utilization of test strips for glycemia control and disposableneedles used. The glargine and detemir doses were obtained from one clinicaltrial comparing both insulins for 24 weeks. The test strips and disposableneed les use were estimated from the Spanish clinical practice. Unit costs weretaken from Spanish sources and databases. Results: Lower daily doses were administeredwith glargine than with detemir. Therefore, the use of glargine insteaddetemir would result in a lower daily cost of insulin treatment, and alower use of test strips and disposable needles. As a consequence, the glargineuse would result in an annual saving of 765.03 € for a patient with type 2diabetes, 43.3% savings with glargine versus detemir. According to the sensitivityanalysis, the annual saving for a patient treated with glargine was between646.05 and 810.55 €. Conclusions: According to this model, in the abovementioned population, glargine insulin is a more cost-effective treatment thandetemir insulin, with lower annual treatment costs(AU)

Cost of bacteraemia caused by methicillin-resistant vs. methicillin-susceptible Staphylococcus aureus in Spain: a retrospective cohort study.

The aim of this study was to determine the impact on healthcare resource utilization and associated costs of bacteraemia due to methicillin-resistant Staphylococcus aureus (MRSA) vs. methicillin-susceptible S. aureus (MSSA) strains in Spain. An observational, retrospective, cohort multicentre study was conducted during 2005. The target population comprised Spanish patients with S. aureus bacteraemia (five and ten cases per hospital for resistant and susceptible strains, respectively). The resources used were obtained from the hospital patient records. The unit costs were obtained from the participating hospitals and from Spanish databases; the costs of a bacteraemic episode were estimated from resource utilization results and expressed in euros (euro). Univariate sensitivity analyses were performed. The clinical records of 366 valid patients with S. aureus bacteraemia (121 MRSA and 245 MSSA) from 27 Spanish hospitals were reviewed. Resource use per bacteraemic episode was higher for MRSA cases than for MSSA cases, with longer antibiotic treatment (3.1 additional days) and greater length of hospital stay (LOS) (2.2 additional days), more diagnostic tests, and higher rates of admission to the intensive-care unit (ICU) (7.6%). As a consequence, a higher cost per episode was incurred, with an additional euro1205 in episodes of MRSA infections (1.12-fold increase). The main drivers of the cost difference were the higher rates of ICU admission and hospital re-admission and increased LOS. The analysis confirmed that there were additional costs due to resistant strains, ranging from euro293 to euro5188. Overall, MRSA was associated with higher costs in bacteraemic patients, and this was attributable mainly to the greater rate of ICU admissions and increased LOS.

Análisis crítico del artículo «Utilización y coste de los modificadores biológicos de la artritis reumatoide en España (estudio PRAXIS)» / No disponible

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Análisis coste-efectividad de la prevención de la reagudización de la esquizofrenia en el estudio longitudinal Ziprasidone Extended Use in Schizophrenia (ZEUS) / Cost-effectiveness analysis of the prevention of relapse of schizophrenia in the longitudinal study Ziprasidone Extended Use in Schizophrenia (ZEUS)

Objetivo. Estimar el coste-efectividad de la prevención de la reagudización de la esquizofrenia en el estudio longitudinal Ziprasidone Extended Use in Schizophrenia Study (ZEUS) en el que se compara ziprasidona con la opción de no tratar. Métodos. Se analizó 1 año de tratamiento usando los datos de un ensayo clínico aleatorizado (estudio ZEUS) con un modelo determinista, del tipo análisis coste-efectividad, realizado desde la perspectiva del Sistema Nacional de Salud (SNS). Resultados. El coste medio anual adicional por reagudización evitada con ziprasidona fue de 186 € para la dosis media, oscilando entre -556 € (ahorro) con la dosis de 80 mg/día y 1.014 € con 160 mg/día, inferiores en todos los casos al coste mínimo de una reagudización (2.830 €), considerado como valor umbral para establecer el coste-efectividad del tratamiento con ziprasidona. Conclusiones. La prevención de la reagudización de la esquizofrenia con ziprasidona a largo plazo es coste-efectiva en comparación con la opción de no tratar. El tratamiento con ziprasidona evita episodios de recidivas a un coste razonable generando ahorros para el SNS

Objective. Estimate the cost-effectiveness of the prevention of relapse of schizophrenia in the ZEUS (Ziprasidone Extended Use in Schizophrenia Study) longitudinal study that compares ziprasidone with the option of not treating. Methods. One year of treatment was analyzed using the randomized clinical trial data (ZEUS study) with a deterministic model, having cost-effectiveness analysis type, conducted from the perspective of the National Health Care System (NHCS). Results. Additional mean yearly cost for worsening avoided with ziprasidone was 186 € for the mean dose, ranging from -556 € (savings) with the 80 mg/day dose and 1,014 € with 160 mg/day, which was always lower than the minimum cost of a relapse (2,830 €), considered as threshold value to establish cost-effectiveness of treatment with ziprasidone. Conclusions. Prevention of relapse of schizophrenia with long-term ziprasidone is cost-effective in comparison with the option of not treating. Treatment with ziprasidone avoids relapse episodes at a reasonable cost, generating savings for the NHCS

[Use and cost of biological disease-modifying anti-rheumatic drugs in Spain (PRAXIS study)]. / Utilización y coste de los modificadores biológicos de la artritis reumatoide en España (estudio PRAXIS).

OBJECTIVE: To analyse the use of health care resources and the associated costs in patients with rheumatoid arthritis (RA) treated with three biological disease-modifying anti-rheumatic drugs (bDMARDs): etanercept, infliximab and adalimumab. DESIGN: observational, retrospective, multicentre study. Length of study: 6 months. TARGET POPULATION: patients with RA, who have been undergoing treatment for at least one year. SCOPE: Spanish National Health System hospitals. Use of resources: review of the patient records of all patients included in the study by the Hospital Pharmacy Departments. Health care costs: the unit costs were obtained from Spanish databases; disease costs per patient were estimated from the use of resources results (euro in July 2006). Sensitivity analysis: univariate of base case. Budget impact analysis: replacement of infliximab and adalimumab by etanercept for three hospital populations. RESULTS: 1,111 patient records from 41 Spanish hospitals were reviewed, 432 patients were treated with etanercept, 396 were treated with infliximab and 283 with adalimumab. Mean doses: etanercept: 48.90 mg per week; infliximab: 4.14 mg/kg every 8 weeks; adalimumab: 41.58 mg every two weeks (97.8, 138 and 104% respectively, of recommended doses). Treatment with etanercept led to fewer costs. Compared to infliximab, six-monthly costs per patient were reduced with etanercept as follows: bDMARD treatment (232.23 euro), treatment failure (163.42 euro), consultations (54.88 euro), tests (22.52 euro) and costs associated to bDMARD administration (euro 474.42). The saving per patient treated with etanercept compared to infliximab for six months was 577.94 euro. With respect to adalimumab, the savings with etanercept were mainly related to bDMARDs (1,111.74 euro) and test costs (10.16 euro), obtaining a six-monthly saving of euro 906.68 per patient treated with etanercept. Sensitivity analysis confirmed the robustness of the base case in the majority of cases, with six-monthly savings of 395.79-644.32 euro per patient compared to infliximab and of 672.09-1.159.46 euro compared to adalimumab. Infliximab treatment was less expensive than etanercept and adalimumab treatment when taking into consideration the minimum possible number of doses of infliximab (3 doses for six months). Hospital budget savings could be obtained as a consequence of a reduction in costs due to use of etanercept, ranging from 14,500-231,100 euro when replacing infliximab with etanercept and from 22,600-362,600 euro when replacing adalimumab with etanercept, according to the hospital population included (50 to 200 patients). CONCLUSIONS: Our results showed that in most cases, the treatment of rheumatoid arthritis with etanercept compared to infliximab and adalimumab reduced hospital costs.

Cost-effectiveness analysis of the prevention of relapse of schizophrenia in the longitudinal study Ziprasidone Extended Use in Schizophrenia (ZEUS).

OBJECTIVE: Estimate the cost-effectiveness of the prevention of relapse of schizophrenia in the ZEUS (Ziprasidone Extended Use in Schizophrenia Study) longitudinal study that compares ziprasidone with the option of not treating. METHODS: One year of treatment was analyzed using the randomized clinical trial data (ZEUS study) with a deterministic model, having cost-effectiveness analysis type, conducted from the perspective of the National Health Care System (NHCS). RESULTS: Additional mean yearly cost for worsening avoided with ziprasidone was 186 Pounds for the mean dose, ranging from -556 Pounds (savings) with the 80 mg/day dose and 1,014 Pounds with 160 mg/day, which was always lower than the minimum cost of a relapse (2,830 Pounds), considered as threshold value to establish cost-effectiveness of treatment with ziprasidone. CONCLUSIONS: Prevention of relapse of schizophrenia with long-term ziprasidone is cost-effective in comparison with the option of not treating. Treatment with ziprasidone avoids relapse episodes at a reasonable cost, generating savings for the NHCS.