[Cost-utility analysis of two formulations of botulinum toxin type A in the treatment of blepharospasm and cervical dystonia in Spain]. / Analisis coste-utilidad de dos formulaciones de toxina botulinica de tipo A en el tratamiento del blefaroespasmo y la distonia cervical en España.

INTRODUCTION: Studies on focal dystonia showed that the formulations of botulinum toxin type A, incobotulinumtoxin-A (Inco-BTA) and onabotulinumtoxin-A (Ona-BTA), have equivalent efficacy and safety. AIM: To carry-out a cost-utility analysis of Inco-BTA administered on flexible intervals vs. Ona-BTA on a fixed interval, in the treatment of blepharospasm and cervical dystonia. PATIENTS AND METHODS: A probabilistic Markov model was designed to estimate costs (euros, 2017) and benefits (quality-adjusted life years, QALY), from the Spanish National Health Service perspective and on a 5-year time horizon, of treatment of blepharospasm and cervical dystonia with Inco-BTA (6-12 month flexible intervals) versus Ona-BTA (12-month fixed intervals). It is assumed that symptoms will re-emerge some time later in both options. Result was expressed as incremental cost-utility ratio (ICUR). RESULTS: Inco-BTA and Ona-BTA costs were 3,742 and 3,366 euros respectively, in blepharospasm, and 6,673 and 6,419 euros in cervical dystonia. Patients treated with Inco-BTA remained asymptomatic for 22.12, and 21.34 more weeks than those treated with Ona-BTA, leading in 3.040 and 3.012 QALY, respectively, in blepharospasm, and 3.471 and 3.401 QALY, respectively, in cervical dystonia. Differences showed statistical significance in all cases. ICUR was estimated as 13,576 and 4,158 euros/QALY in blepharospasm and cervical dystonia, respectively. CONCLUSIONS: Treatment of blepharospasm and cervical dystonia with Inco-BTA is a cost-effective therapeutic alternative in Spain, based on the flexibility of their administration.

TITLE: Analisis coste-utilidad de dos formulaciones de toxina botulinica de tipo A en el tratamiento del blefaroespasmo y la distonia cervical en España.Introduccion. Las formulaciones de toxina botulinica de tipo A, incobotulinumtoxinA (Inco-TBA) y onabotulinumtoxinA (Ona-TBA), han demostrado eficacia y seguridad similar en los estudios de distonias focales en los que se han comparado. Objetivo. Realizar un analisis coste-utilidad de Inco-TBA, administrada en intervalos flexibles, frente a Ona-TBA, administrada en intervalos fijos, en el tratamiento del blefaroespasmo y la distonia cervical. Pacientes y metodos. Un modelo de Markov probabilistico estimo, desde la perspectiva del Sistema Nacional de Salud español y en un horizonte de cinco años, el coste (euros, 2017) y el resultado (años de vida ajustados a calidad, AVAC) del tratamiento del blefaroespasmo y la distonia cervical mediante intervalos flexibles con Inco-TBA (6-20 semanas) y fijos con Ona-TBA (12 semanas). Se asume que los sintomas reapareceran despues de un tiempo en ambos. El resultado se expreso como ratio coste-utilidad incremental (RCUI). Resultados. El coste de la Inco-TBA y la Ona-TBA fue, respectivamente, de 3.742 y 3.366 euros en el blefaroespasmo y de 6.673 y 6.419 euros en la distonia cervical. Los pacientes tratados con Inco-TBA permanecieron asintomaticos 22,12 y 21,34 semanas mas que los tratados con Ona-TBA, lo que resulto 3,040 y 3,012 AVAC, respectivamente, en el blefaroespasmo, y 3,471 y 3,401 AVAC, respectivamente, en la distonia cervical. En todos los casos, las diferencias presentaron significacion estadistica. La RCUI fue de 13.576 y 4.158 euros/AVAC, respectivamente. Conclusiones. El tratamiento del blefaroespasmo y la distonia cervical con Inco-TBA, administrada siguiendo un esquema posologico de intervalos flexibles, constituye una alternativa terapeutica eficiente en España.

Estudio multicéntrico de costes de 2 técnicas quirúrgicas: láser GreenLight XPS 180 W vs resección transuretral de la próstata / Multicenter Study on Costs Associated With Two Surgical Procedures: GreenLight XPS 180 W Versus the Gold Standard Transurethral Resection of the Prostate

Objetivo: Analizar los costes asociados al tratamiento quirúrgico de la sintomatología del tracto urinario inferior secundaria a hiperplasia benigna de próstata mediante el láser GreenLigh XPS 180 W respecto a la técnica quirúrgica endoscópica de referencia, resección transuretral de la próstata. Métodos: Se realizó un estudio retrospectivo y multicéntrico de costes desde la perspectiva del Sistema Nacional de Salud y en un horizonte temporal de 3 meses, desagregándolos en fases temporales: prequirúrgica, quirúrgica y posquirúrgica. Los datos fueron extraídos de las historias de los pacientes intervenidos secuencialmente, con IPSS = 15, Qmax = 15 ml/seg y volumen prostático de 40-80 ml, incorporando solo costes sanitarios directos (euros de 2013) asociados a la intervención y al manejo de complicaciones. Resultados: Entre julio y octubre de 2012 se intervinieron de forma secuencial 39 pacientes con láser GL XPS y 40 con RTUP. El resultado clínico fue equivalente (94,9 y 92,5%, respectivamente) no mostrando diferencias estadísticamente significativas (p = 0,67). El coste medio total por paciente se redujo en 121 Euros en el grupo láser GL XPS respecto de RTUP; en la fase quirúrgica el coste fue superior con láser GL XPS (diferencia: 1.209 Euros; p < 0,001) mientras que fue inferior en la fase posquirúrgica (diferencia: -1.351 Euros, p < 0,001). Conclusiones: La intervención de los pacientes con STUI secundario a HBP mediante la nueva tecnología láser GL XPS se asocia a una reducción de costes respecto de la RTUP, debida a una menor duración de la estancia hospitalaria, la cual compensa el coste imputado a dicha tecnología

Objective: To analyze the costs associated with two surgical procedures for lower urinary tract symptoms secondary to benign prostatic hyperplasia: GreenLight XPS 180 W versus the gold standard transurethral resection of the prostate. Methods: A multicenter, retrospective cost study was carried out from the National Health Service perspective, over a 3-month time period. Costs were broken down into pre-surgical, surgical and post-surgical phases. Data were extracted from records of patients operated sequentially, with IPSS = 15, Qmax = 15 mL/seg and a prostate volume of 40–80 mL, adding only direct healthcare costs (Euros, 2013) associated with the procedure and management of complications. Results: A total of 79 patients sequentially underwent GL XPS (n: 39) or TURP (n: 40) between July and October 2013. Clinical outcomes were similar (94.9% and 92.5%, GL XPS and TURP, respectively) without significant differences (p = 0.67). The average direct cost per patient was reduced by 114Euros in GL XPS versus TURP patients; the cost was higher in the surgical phase with GL XPS (difference: 1209Euros; p < 0.001) but was lower in the post-surgical phase (difference: Euros − 1351; p < 0.001). Conclusions: The GreenLight XPS 180-W laser system is associated with a reduction in costs with respect to transurethral resection of prostate in the surgical treatment of LUTS secondary to PBH. This reduction is due to a shorter inpatient length of stay that offsets the cost of the new technology

Análisis coste efectividad a 2 años del tratamiento quirúrgico de la hiperplasia benigna de próstata mediante vaporización fotoselectiva de la próstata con GreenLight-PhotoVaporization 120 W versus resección transuretral de la próstata / Cost-effectiveness analysis at 2 years of surgical treatment of benign prostatic hyperplasia by photoselective vaporization of the prostate with GreenLight-Photo vaporization 120 W versus transurethral resection of the prostate

Introducción: El gold standard del tratamiento quirúrgico de la sintomatología del tracto urinario inferior asociado a la hiperplasia benigna de próstata ha sido la resección transuretral de la próstata; GreenLight-PhotoVaporization ha demostrado ser una alternativa quirúrgica tan efectiva como aquella. Objetivo: Analizar la eficiencia comparada, en un horizonte temporal de 2 años, de GreenLight-PhotoVaporization 120 W respecto de la resección transuretral de la próstata en el tratamiento quirúrgico de la hiperplasia benigna de próstata desde la perspectiva del sistema de salud de España. Métodos: Se realizó un análisis de coste utilidad a partir de los resultados obtenidos retrospectivamente en 98 pacientes intervenidos secuencialmente mediante resección transuretral de la próstata (n: 50) y GreenLight-PhotoVaporization 120 W (n: 48). Se utilizó un modelo de Markov para estimar el coste (Euros, 2012) y los resultados (años de vida ajustados a calidad) tras un seguimiento de 2 años. Resultados: El coste total asociado al tratamiento con GreenLight-PhotoVaporization 120 W fue inferior (3.377 Euros; IC 95%: 3.228; 3.537) al de la resección transuretral de la próstata (3.770 Euros; IC 95%: 3.579; 3.945). El determinante del coste se presenta en la fase quirúrgica (diferencia: -450 Euros; IC 95%: -625; -158) debido a que GreenLight-PhotoVaporization 120 W no precisaba ingresar al paciente tras la cirugía. Conclusiones: El tratamiento quirúrgico de los pacientes con HBP mediante GreenLight-PhotoVaporization 120 W muestra mayor eficiencia respecto de la resección transuretral de la próstata al observarse una efectividad similar y un coste inferior (-393 Euros; IC 95%: -625; -158)

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 Euro) 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 Euros; 95% CI: 3,228; 3,537) than that of the transurethral resection of the prostate (3,770 Euros; 95% CI: 3,579; 3,945). The determining factor of the cost was the surgical phase (difference: −450 Euros; 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 Euro; 95% CI: -625; -158)

Cost-effectiveness analysis at 2 years of surgical treatment of benign prostatic hyperplasia by photoselective vaporization of the prostate with GreenLight-Photo vaporization 120 W versus transurethral resection of the prostate.

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).

Multicenter study on costs associated with two surgical procedures: GreenLight XPS 180 W versus the gold standard transurethral resection of the prostate.

OBJECTIVE: To analyze the costs associated with two surgical procedures for lower urinary tract symptoms secondary to benign prostatic hyperplasia: GreenLight XPS 180¦W versus the gold standard transurethral resection of the prostate. METHODS: A multicenter, retrospective cost study was carried out from the National Health Service perspective, over a 3-month time period. Costs were broken down into pre-surgical, surgical and post-surgical phases. Data were extracted from records of patients operated sequentially, with IPSS=15, Qmax=15 mL/seg and a prostate volume of 40-80mL, adding only direct healthcare costs (€, 2013) associated with the procedure and management of complications. RESULTS: A total of 79 patients sequentially underwent GL XPS (n: 39) or TURP (n: 40) between July and October, 2013. Clinical outcomes were similar (94.9% and 92.5%, GL XPS and TURP, respectively) without significant differences (P=.67). The average direct cost per patient was reduced by €114 in GL XPS versus TURP patients; the cost was higher in the surgical phase with GL XPS (difference: €1,209; P<.001) but was lower in the post-surgical phase (difference: €-1,351; P<.001). CONCLUSIONS: The GreenLight XPS 180-W laser system is associated with a reduction in costs with respect to transurethral resection of prostate in the surgical treatment of LUTS secondary to PBH. This reduction is due to a shorter inpatient length of stay that offsets the cost of the new technology.

Analysis of economic evaluations of pharmacological cancer treatments in Spain between 1990 and 2010

Economic evaluation of pharmacological cancer treatment is a critical clinical problem currently under consideration worldwide. We have analysed their main characteristics in Spain between 1990 and 2010 following a systematic review of the 29 complete economic analyses published. The pathology most frequently evaluated was non-small cell lung cancer (31 %). Cost-effectiveness analyses (69 %) were the most frequent analyses. A wide range of incremental cost-effectiveness values (295-160,667 € /QALY) has been reported, and mostly are developed from the perspective of the National Health System (65.5 %). However, none of the studies estimated the indirect costs. The major conclusion is that the absence of regulations concerning the application of the efficiency criterion in decision-making on the subject of price and financing and, most importantly, the fact that these are not included in Spanish hospitals forms make it difficult to analyse the real impact of economic evaluations of cancer treatments on such decisions

Probabilistic cost-minimisation analysis of darbepoetin alpha versus epoetin alpha in treating anaemia secondary to chronic renal failure. Assessment in Spanish clinical practice.

INTRODUCTION: The direct transfer of the results of pharmaco-economic studies between countries may not be suitable if the proper adaptations are not made to take into account differences in treatment patterns, resource use and costs from country to country. OBJECTIVE: To estimate the cost in Spain of treating anaemia secondary to chronic renal failure with darbepoetin alpha or epoetin alpha from a review and analysis of available current information. In addition, the role of the route of administration as a main driver of the cost will be analysed. METHOD: population: patients with chronic kidney failure induced anaemia. DATA: Medline and Embase search of studies directly comparing erythropoiesis stimulating agents. ANALYSIS: Cost minimization analysis from the perspective of a hospital pharmacy department. The main outcome chosen was the difference between the average cost per patient undergoing a 30-day treatment with epoetin alpha versus darbepoetin alpha. RESULTS: (a) haemodialysis: changing from epoetin alpha to darbepoetin alpha is associated with a cost reduction of 8.67%; CI 95%, -1.34 to 17.92 (euro 17.48; CI 95%, -2.70 to 36.13); probabilistic analysis showed that the use of darbepoetin alpha could be associated with a cost-saving probability of 94.9%. The IV administration yielded a decrease in costs of about 16.00%; CI 95%, -2.38 to 36.77 (euro 41.78, CI 95%: -6.21 to 96.04). (b) Pre-dialysis: darbepoetin alpha is associated with a cost reduction of about 11-32%. CONCLUSIONS: The use of darbepoetin alpha for the treatment of chronic renal failure induced anaemia (haemodialysis and pre-dialysis) shows higher cost efficiency than epoetin alpha in Spain; these differences increase with IV administration.

Análisis probabilístico de minimización de costes de darbepoetin alfa frente a epoetina alfa en el tratamiento de la anemia secundaria a insuficiencia renal crónica. Valoración en la práctica clínica española / Probabilistic cost-minimisation analysis of darbepoetin alpha versus epoetin alpha in treating anaemia secondary to chronic renal failure. Assessment in Spanish clinical practice

Introducción: La transferencia directa de los resultados de estudios farmacoeconómicos de un país a otro no es adecuada si no se procede previamente a una adaptación de los datos a cada territorio, debido a la diversidad de utilización de recursos así como a las diferencias de costes entre países. Objetivo: Estimar el coste en España del tratamiento de la anemia secundaria a insuficiencia renal crónica con epoetina alfa o darbepoetin alfa, a partir de una revisión y un análisis de la información actualmente disponible. Además, se analiza el papel de la vía de administración como factor modulador del coste del tratamiento. Método: Población: pacientes con anemia secundaria a insuficiencia renal crónica. Extracción de datos: búsqueda en Medline y Embase de estudios de comparación directa de los agentes estimulantes de eritropoyesis. Tipo de análisis: análisis probabilístico de minimización de costes. Perspectiva: servicio de farmacia del hospital (costes farmacológicos). Variable principal: diferencia del coste medio por paciente del tratamiento de 30 días con epoetina alfa respecto de darbepoetin alfa. Resultados: a) Hemodiálisis: la sustitución de epoetina alfa por darbepoetin alfa se asocia a una reducción mensual de costes del 8,67 %; intervalo de confianza (IC) del 95 %, -1,34 a 17,92 (17,48 €; IC del 95 %, -1,38 a 36,13); el análisis probabilístico mostró una probabilidad del 94,9 % de que la utilización de darbepoetin alfa estuviera asociada a una reducción del (..) (AU)

Introduction: The direct transfer of the results of pharmaco-economic studies between countries may not be suitable if the proper adaptations are not made to take into account differences in treatment patterns, resource use and costs from country to country. Objective: To estimate the cost in Spain of treating anaemia secondary to chronic renal failure with darbepoetin alpha or epoetin alpha from a review and analysis of available current information. In addition, the role of the route of administration as a main driver of the cost will be analysed. Method: Population: patients with chronic kidney failure induced anaemia. Data: Medline and Embase search of studies directly comparing erythropoiesis stimulating agents. Analysis: Cost minimization analysis from the perspective of a hospital pharmacy department. The main outcome chosen was the difference between the average cost per patient undergoing a 30-day treatment with epoetin alpha versus darbepoetin alpha. Results: a) haemodialysis: changing from epoetin alpha to darbepoetin alpha is associated with a cost reduction of 8.67 %; CI 95 %, —1.34 to 17.92 (€ 17.48; CI 95 %, —2.70 to 36.13); probabilistic analysis showed that the use of darbepoetin alpha could be associated with a cost-saving probability of 94.9 %. The IV administration yielded a decrease in costs of about 16.00 %; CI 95 %, —2.38 to 36.77 (€ 41.78, CI 95 %: —6.21 to 96.04). b) Pre-dialysis: darbepoetin alpha is associated with a cost reduction of about 11-32 %.Conclusions: The use of darbepoetin alpha for the treatment of chronic renal failure induced anaemia (haemodialysis and pre-dialysis) shows higher cost efficiency than epoetin alpha in Spain; these differences increase with IV administration (AU)