Análisis coste-efectividad de la cirugía del glioma maligno guiada por fluorescencia con ácido 5-aminolevulínico / Cost-effectiveness of 5-aminolevulinic acid-induced fluorescence in malignant glioma surgery

Objetivo: Evaluar el coste-efectividad del ácido 5-aminolevulínico (5-ALA, Gliolan(R)) en pacientes intervenidos quirúrgicamente de glioma maligno, en condiciones de práctica médica habitual en España. Material y métodos: Se determinaron las ratios de coste incremental por resección completa (RC) y de coste incremental por año de vida ajustado por calidad (AVAC) ganado, sobre la base de los datos recogidos en el estudio observacional VISIONA. Resultados. El coste incremental con 5-ALA frente a la cirugía convencional con luz blanca asciende a 4.550 Euros por RC adicional conseguida y a 9.021 Euros por AVAC ganado. Estos resultados se muestran consistentes en un análisis de sensibilidad. Conclusión: La cirugía del glioma maligno guiada por fluorescencia con 5-ALA conlleva un incremento de costes moderado respecto a la práctica quirúrgica actual y muestra una relación coste-efectividad favorable

Objective: This study evaluates the cost-effectiveness of 5-aminolevulinic acid (5-ALA, Gliolan®) in patients undergoing surgery for malignant glioma, in standard clinical practice conditions in Spain. Material and methods: Cost-effectiveness ratios were determined in terms of incremental cost per complete resection (CR) and incremental cost per additional quality-adjusted life year (QALY), based on data collected in the VISIONA observational study. Results: Incremental cost with 5-ALA versus conventional surgery using white light only amounts to Euros 4550 per additional CR achieved and Euros 9021 per QALY gained. A sensitivity analysis shows these results to be robust. Conclusion: Malignant glioma surgery guided by 5-ALA fluorescence entails a moderate increase in hospital costs compared to current surgical practice and can be considered a cost-effective innovation

Cost-effectiveness of 5-aminolevulinic acid-induced fluorescence in malignant glioma surgery.

OBJECTIVE: This study evaluates the cost-effectiveness of 5-aminolevulinic acid (5-ALA, Gliolan®) in patients undergoing surgery for malignant glioma, in standard clinical practice conditions in Spain. MATERIAL AND METHODS: Cost-effectiveness ratios were determined in terms of incremental cost per complete resection (CR) and incremental cost per additional quality-adjusted life year (QALY), based on data collected in the VISIONA observational study. RESULTS: Incremental cost with 5-ALA versus conventional surgery using white light only amounts to € 4550 per additional CR achieved and € 9021 per QALY gained. A sensitivity analysis shows these results to be robust. CONCLUSION: Malignant glioma surgery guided by 5-ALA fluorescence entails a moderate increase in hospital costs compared to current surgical practice and can be considered a cost-effective innovation.

Estudio observacional retrospectivo sobre la efectividad del ácido 5-aminolevulínico en la cirugía de los gliomas malignos en España (Estudio VISIONA) / Observational, retrospective study of the effectiveness of 5-aminolevulinic acid in malignant glioma surgery in Spain (The VISIONA study)

Objetivo: Evaluar la efectividad del ácido 5-aminolevulínico (5-ALA, Gliolan(R)) mediante la tasa de resecciones completas (RC) y supervivencia libre de progresión a los 6 meses (SLP6) en pacientes intervenidos quirúrgicamente de glioma maligno, en condiciones de práctica médica habitual en España. Material y métodos: Revisión retrospectiva en 18 servicios de neurocirugía, divididos en centros que usan habitualmente 5-ALA y centros que no. Se incluyó a pacientes adultos con sospecha de glioma maligno, en los que la intención de tratar incluyó resección completa y posterior radioterapia y quimioterapia con temozolomida. Era necesaria la existencia de resonancia magnética posquirúrgica y datos clínicos al menos durante 6 meses. Se comparó la diferencia entre pacientes con o sin 5-ALA en la tasa de RC y en la SLP6. Resultados: Se obtuvieron 251 casos evaluables. La tasa de RC y la tasa de SLP6 fueron significativamente mayores en el grupo de pacientes operados con 5-ALA: RC, 67% frente a 45%, p = 0,000, y SLP6 en el caso de los gliomas de grado IV , 69% frente a 48%; p = 0,002. Estas diferencias se mantuvieron relevantes y significativas tras ajustarlas por todas las covariables estudiadas, que incluyeron edad, estado funcional y localización en área elocuente o no. Conclusiones: En esta serie retrospectiva, el uso de 5-ALA en la cirugía del glioma maligno en la práctica habitual en España se asoció a un incremento en la tasa de resecciones completas y, en el caso de los gliomas de grado IV , a un incremento en la supervivencia libre de progresión a los 6 meses

Objective: To assess effectiveness of 5-aminolevulinic acid (5-ALA, Gliolan(R)) in patients treated for malignant glioma under typical daily practice conditions in Spain, using complete resection rate (CR) and progression free survival at 6 months (PFS6). Materials and methods: Retrospective review of data from 18 neurosurgery departments that were categorised as either using or not using 5-ALA. The study included adult patients with suspected malignant gliomas for whom the intended treatment plan included complete resection followed by radiotherapy and chemotherapy with temozolomide. Postoperative MRI and clinical data representing at least 6 months were required for inclusion. Rates of CR and PFS6 were compared between patients with 5-ALA treatment and those without. Results: The study included 251 evaluable cases. CR and PFS6 rates were significantly higher in the group of patients treated surgically with 5-ALA: CR, 67% versus 45%, P = .000; PFS6 for patients with grade IV tumours, 69% versus 48%; P = .002. The differences retained their significance and magnitude after adjusting for all covariates including age, functional status, and whether gliomas were located in eloquent areas. Conclusions: In this retrospective series, use of 5-ALA during habitual surgical procedures in Spain was associated with a higher complete resection rate for malignant glioma and increased PFS6 for grade IV glioma

Observational, retrospective study of the effectiveness of 5-aminolevulinic acid in malignant glioma surgery in Spain (The VISIONA study).

OBJECTIVE: To assess effectiveness of 5-aminolevulinic acid (5-ALA, Gliolan(®)) in patients treated for malignant glioma under typical daily practice conditions in Spain, using complete resection rate (CR) and progression free survival at 6 months (PFS6). MATERIAL AND METHODS: Retrospective review of data from 18 neurosurgery departments that were categorised as either using or not using 5-ALA. The study included adult patients with suspected malignant gliomas for whom the intended treatment plan included complete resection followed by radiotherapy and chemotherapy with temozolomide. Postoperative MRI and clinical data representing at least 6 months were required for inclusion. Rates of CR and PFS6 were compared between patients with 5-ALA treatment and those without. RESULTS: The study included 251 evaluable cases. CR and PFS6 rates were significantly higher in the group of patients treated surgically with 5-ALA: CR, 67% versus 45%, p=.000; PFS6 for patients with grade IV tumours, 69% versus 48%; p=.002. The differences retained their significance and magnitude after adjusting for all covariates including age, functional status, and whether gliomas were located in eloquent areas. CONCLUSIONS: In this retrospective series, use of 5-ALA during habitual surgical procedures in Spain was associated with a higher complete resection rate for malignant glioma and increased PFS6 for grade iv glioma.

[Almotriptan vs. ergotamine plus caffeine for acute migraine treatment. A cost-efficacy analysis]. / Almotriptán frente a ergotamina más cafeína en el tratamiento de las crisis agudas de migraña. Análisis de coste-eficacia.

INTRODUCTION: Almotriptan has proven to be more efficacious and tolerable than ergotamine plus caffeine but is more expensive, thus raising the question about its cost-efficacy. METHODS: The course of migraine attacks during 24 hours treated with almotriptan and ergotamine plus caffeine was modelled with a decision tree, using efficacy data from a recent randomized, double-blind clinical trial comparing the two drugs. Costs were calculated from the social perspective (including indirect costs due to absenteeism and loss of productivity) and from the Spanish National Health System (NHS) perspective (only including drug costs). The impact on quality of life was estimated using utilities assigned in the literature to different health states of migraine patients. RESULTS: Treatment response was 57.7% for patients treated with almotriptan vs. 44.5% with ergotamine plus caffeine. Sustained pain-free status was achieved by 20.3% vs. 11.5%. Working days lost due to absenteeism and reduced productivity amounted to 0.24 vs. 0.38 days. Quality of life during attacks was estimated at an average utility of 0.548 vs. 0.422. From the NHS perspective, incremental costs per attack treated with almotriptan vs. ergotamine plus caffeine was euro 5.05, rendering an incremental cost-efficacy ratio of euro38.26 per additional response, euro57.39 per additional complete response, and euro14,709 per quality- adjusted life-year gained. From the social perspective almotriptan saved euro7.50 vs. ergotamine plus caffeine. CONCLUSIONS: Almotriptan can be considered cost-efficacious vs. ergotamine plus caffeine from the NHS perspective and is the dominant option (both more efficacious and more economical) from the social perspective.

Almotriptán frente a ergotaminamás cafeína en el tratamientode las crisis agudas de migraña. Análisis de coste-eficacia / Almotriptan vs. ergotamine plus caffeine for acute migraine treatment. A cost-efficacy analysis

Introducción. Almotriptán ha mostrado ser más eficaz y tolerableque ergotamina más cafeína, pero tiene un precio superior, por loque se plantea la pregunta de su coste-eficacia.Métodos. Se modeló mediante un árbol de decisión el curso durante24 h de ataques de migraña tratados con ambos fármacosusando datos de eficacia de un reciente ensayo clínico doble ciegoaleatorizado. Los costes fueron determinados desde las perspectivassocial y del sistema sanitario. El impacto sobre la calidad de vida seestimó a partir de índices asignados en la literatura a los diferentesestados de salud posibles en pacientes con migraña.Resultados. La respuesta al tratamiento fue del 57,7% con almotriptánfrente a 44,5% con ergotamina más cafeína; 20,3 frente a11,5% de pacientes alcanzaron ausencia mantenida de dolor durante24 h. Se perdieron 0,24 frente a 0,38 días laborales por absentismoy baja productividad. La calidad de vida durante el ataque sevaloró en una utilidad media de 0,548 frente a 0,422. Desde la perspectivadel sistema sanitario el diferencial de costes fue de 5,05 por ataque, resultando en un coste incremental de 38,26 por respuestaadicional conseguida con almotriptán, de 57,39 por respuestacompleta adicional y de 14.709 por año de vida ajustado por calidadganado. Desde la perspectiva social, almotriptán ahorró 7,50 por ataque en comparación con ergotamina más cafeína.Conclusiones. Almotriptán puede considerarse coste-eficazfrente a ergotamina más cafeína desde la perspectiva del sistema sanitarioy es la opción dominante (simultáneamente más eficaz y máseconómica) desde la perspectiva social (U)

Introduction. Almotriptan has proven to be more efficaciousand tolerable than ergotamine plus caffeine but is more expensive,thus raising the question about its cost-efficacy.Methods. The course of migraine attacks during 24 hours treatedwith almotriptan and ergotamine plus caffeine was modelledwith a decision tree, using efficacy data from a recent randomized,double-blind clinical trial comparing the two drugs. Costs werecalculated from the social perspective (including indirect costs dueto absenteeism and loss of productivity) and from the Spanish NationalHealth System (NHS) perspective (only including drug costs).The impact on quality of life was estimated using utilities assignedin the literature to different health states of migraine patients.Results. Treatment response was 57.7% for patients treatedwith almotriptan vs. 44.5% with ergotamine plus caffeine. Sustainedpain-free status was achieved by 20.3% vs. 11.5%. Workingdays lost due to absenteeism and reduced productivityamounted to 0.24 vs. 0.38 days. Quality of life during attackswas estimated at an average utility of 0.548 vs. 0.422. From theNHS perspective, incremental costs per attack treated with almotriptanvs. ergotamine plus caffeine was 5.05, rendering an incrementalcost-efficacy ratio of 38.26 per additional response, 57.39 per additional complete response, and 14,709 per quality-adjusted life-year gained. From the social perspective almotriptansaved 7.50 vs. ergotamine plus caffeineConclusions. Almotriptan can be considered cost-efficaciousvs. ergotamine plus caffeine from the NHS perspective and is thedominant option (both more efficacious and more economical)from the social perspective (AU)

[Economic evaluation of medical treatment of benign prostatic hyperplasia (BPH) in the specialised care setting in Spain. Application to the cost-effectiveness of two drugs frequently used in its treatment]. / Evaluación económica del tratamiento médico de la hiperplasia benigna de próstata (HBP) en España en atención especializada. Aplicación al coste- efectividad de dos fármacos habitualmente utilizados en su tratamiento.

OBJECTIVES: To develop a pharmacoeconomic study in order to know the average cost of BPH diagnosis and follow-up in Spain in the Urology Department setting from the perspective of the public health system, considering two frequently used drugs in the Spanish Healthcare environment, an alpha-blocker (tamsulosin) and the lipido-sterolic extract of Serenoa repens (Permixon). MATERIAL AND METHODS: Direct healthcare costs of BPH diagnosis and treatment were determined for each clinical stage according to the International Prostate Symptom Score (IPSS): mild, moderate and severe. Data on the usage and unit costs of healthcare resources were obtained from a semi-structured interview with clinical experts. The clinical efficacy of the medical treatments was obtained from the PERMAL clinical study, where therapeutic equivalence between the two studied drugs was observed. RESULTS: For patients treated in the Urology Department setting, the average annual cost of diagnostic tests and medical visits related to mild, moderate or severe BPH symptoms were, respectively, Euro 124, Euro 207, and Euro 286. The average annual cost of the drugs, including adverse effects treatment, was Euro 211 for Permixon and Euro 346 for tamsulosin. DISCUSSION: Costs of medical care of BPH increases with symptom intensity. Pharmacological treatment makes up a significant part of the disease's cost. According to the model used, treatment with Permixon is considerably more cost-effective than with tamsulosin, offering average yearly savings of Euro 135 per patient.

[Cost-efficacy analysis of fixed combinations of prostaglandin/prostamide for treating glaucoma]. / Análisis coste-eficacia de las combinaciones fijas de prostaglandinas/prostamida para el tratamiento del glaucoma.

OBJECTIVE: To assess the cost-efficacy of three fixed-combination glaucoma treatments currently available in Spain [bimatoprost with timolol (BT)- Ganfort, latanoprost with timolol (LT)- Xalacom, and travoprost with timolol (TT)- DuoTrav]. METHODS: Because no studies are available that give a direct comparison of these drugs, a systematic review was carried out to assess their efficacy. Resource consumption and costs were estimated using a model of usual local practice. For each of the three drugs, average and incremental cost-efficacy ratios were determined in terms of euros per percentage point of reduction of intraocular pressure (IOP) over a three-month period. RESULTS: BT reduced IOP by 35.1%, LT by 35.0% and TT by 34.7%. Average cost-efficacy was estimated to be euro 5.34 per percentage point of IOP reduction with BT, euro 5.40 with LT, and euro 5.45 with TT. Incremental cost-efficacy (incremental cost per incremental percentage point of IOP reduction) was estimated to be euro 94.65 for LT vs. TT, and was negative for BT vs. TT and BT vs. LT, since in both cases BT was more efficacious and less expensive. CONCLUSIONS: Compared to travoprost/timolol and latanoprost/timolol, bimatoprost/timolol appears to be the most economic alternative, with equal or better efficacy and safety results.

Evaluación económica del tratamiento médico de la hiperplasia benigna de próstata (HBP) en España en atención especializada. Aplicación al coste-efectividad de dos fármacos habitualmente utilizados en su tratamiento / Economic evaluation of medical treatment of benign prostatic hyperplasia (BPH) in the specialised care setting in Spain. Application to the cost-effectiveness of two drugs frequently used in its treatment

Objetivos: Llevar a cabo un estudio fármaco económico para conocer el coste medio del diagnóstico y seguimiento de la HBP en España en el ámbito de la atención especializada desde la perspectiva del sistema público de salud, considerando dos fármacos frecuentemente utilizados en el entorno sanitario español, un alfabloqueante (tamsulosina) y el extracto lipido esterólico de Serenoa repens (Permixón(R)).Material y métodos: Se determinaron los costes sanitarios directos del diagnóstico y tratamiento de la HBP para cada presentación clínica según el valor del International Prostate Symptom Score (IPSS): leve, moderada y grave. Los datos sobre el consumo y los costes unitarios de los recursos sanitarios se recogieron mediante una encuesta semi-estructurada a expertos clínicos. La eficacia clínica del tratamiento médico fue obtenida del estudio clínico PERMAL, en el que se observó equivalencia terapéutica entre ambos fármacos. Resultados: El coste medio anual de pruebas diagnósticas y visitas médicas de la HBP sintomática según fuese leve, moderada o grave fueron, respectivamente, 124 €, 207€ y 286€ para pacientes tratados en atención especializada. El coste medio anual del tratamiento médico, incluyendo la atención de los efectos adversos fue de 211€ para Permixón(R) y 346 € paratamsulosina. Discusión: El coste de la atención médica de la HBP es proporcional a la intensidad de la sintomatología. El tratamiento farmacológico constituye una parte significativa del coste de la enfermedad. En base al modelo utilizado, el tratamiento con Permixón(R) es sensiblemente más coste-efectivo que el tratamiento con tamsulosina, representando un ahorro medio de 135€ por paciente y año (AU)

Objectives: To develop a pharmaco economic study in order to know the average cost of BPH diagnosis and follow-up in Spain in the Urology Department setting from the perspective of the public health system, considering two frequently used drugs in the Spanish Healthcare environment, an alpha-blocker (tamsulosin) and the lipido-sterolic extract of Serenoa repens (Permixon(R)).Material and methods: Direct healthcare costs of BPH diagnosis and treatment were determined for each clinical stage according to the International Prostate Symptom Score (IPSS): mild, moderate and severe. Data on the usage and unit costs of healthcare resources were obtained from a semi-structured interview with clinical experts. The clinical efficacy of the medical treatments was obtained from the PERMAL clinical study, where therapeutic equivalence between the two studied drugs was observed. Results: For patients treated in the Urology Department setting, the average annual cost of diagnostic tests and medical visits related to mild, moderate or severe BPH symptoms were, respectively, € 124, € 207, and € 286. The average annual cost of the drugs, including adverse effects treatment, was € 211 for Permixon(R) and € 346 for tamsulosin. Discussion: Costs of medical care of BPH increases with symptom intensity. Pharmacological treatment makes up a significant part of the disease’s cost. According to the model used, treatment with Permixon(R) is considerably more cost-effective than with tamsulosin, offering average yearly savings of € 135 per patient (AU)

Evaluación económica del tratamiento de la crisis aguda de migraña con triptanes en España / Economic evaluation of acute migraine attack treatment with triptans in Spain

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Costes del manejo clínico de los efectos adversos torácicos y del sistema nervioso central asociados al tratamiento de las crisis agudas de migraña con triptanes orales / Management costs of chest and CNS-related adverse events associated with the treatment of acute migraine attacks with oral triptans

Introducción. Aunque los efectos adversos de los triptanes no suelen tener importancia clínica, pueden preocupar al paciente y llevarle a consumir recursos sanitarios. Métodos. Se utilizó un modelo de decisión para representar el comportamiento y manejo de pacientes que experimentan efectos adversos después de tomar triptanes. A partir de datos sobre la incidencia, el comportamiento y manejo de pacientes y los costes unitarios de recursos sanitarios consumidos se calcularon los costes del tratamiento de efectos adversos, así como el factor de coste iatrogénico de los triptanes disponibles en España. Resultados. Entre un 10 y 20 % de los pacientes que sufren efectos adversos torácicos o del sistema nervioso central (SNC) relacionados con la utilización de triptanes acuden a un médico. El coste del manejo de efectos adversos torácicos se estimó en 66,43, 33,09 o 137,01 €, según si el paciente acude a un neurólogo, un médico de atención primaria o a urgencias hospitalarias, respectivamente. Para efectos adversos del SNC el coste se estimó en 52,88, 16,89 o 102,17 €, respectivamente. Sin contar el efecto placebo, el factor iatrogénico resultante varía entre 1 para el almotriptán 12,5 mg y 1,21 para el zolmitriptán 2,5 mg. En términos absolutos, el coste medio por paciente (por encima de placebo) varía entre 0 € para el almotriptán 12,5 mg y 1,17 € para el eletriptán 80 mg. Conclusiones. El manejo de efectos adversos puede añadir al tratamiento con triptanes costes de cierta consideración. Estos costes varían notablemente entre los triptanes debido a las diferencias en la incidencia de los efectos adversos. Los menores costes se obtuvieron para el almotriptán 12,5 mg

Introduction. Although adverse events of triptans are usually not important from a clinical point of view, they can worry patients and lead them to consume healthcare resources. Methods. A decision analytic model was used to represent the behavior and management of patients who suffered adverse events after taking a triptan. Using data about the incidence of adverse events, the behavior and management of patients, and the unit cost of the healthcare resource consumed, the costs of treating adverse events were calculated, as was the iatrogenic cost factor of the triptans available in Spain. Results. 10 % to 20 % of patients who suffer a chest or CNS-related adverse advent related to triptan use seek medical attention. The management cost of a chest-related event was estimated to be € 66,43, € 33,09, or € 137,01, depending on whether the patient consulted a neurologist, a primary care physician, or a hospital emergency department. For CNS-related events the management cost was estimated to be € 52,88, € 16,89 or € 102,17, respectively. Excluding the placebo effect, the resulting iatrogenic cost factor varied between 1 for almotriptan 12,5 mg and 1,21 for zolmitriptan 2,5 mg. In absolute values, the average cost per patient (above placebo) varied between O € for almotriptan 12,5 mg and € 1,17 for eletriptan 80 mg. Conclusions. The management of adverse events can add substantial costs to a treatment with triptans. These costs vary considerably between triptans due to differences in the incidence of adverse events. Lowest costs were found for almotriptan 12,5 mg

[Management costs of chest and CNS-related adverse events associated with the treatment of acute migraine attacks with oral triptans]. / Costes del manejo clínico de los efectos adversos torácicos y del sistema nervioso central asociados al tratamiento de las crisis agudas de migraña con triptanes orales.

INTRODUCTION: Although adverse events of triptans are usually not important from a clinical point of view, they can worry patients and lead them to consume healthcare resources. METHODS: A decision analytic model was used to represent the behavior and management of patients who suffered adverse events after taking a triptan. Using data about the incidence of adverse events, the behavior and management of patients, and the unit cost of the healthcare resource consumed, the costs of treating adverse events were calculated, as was the iatrogenic cost factor of the triptans available in Spain. RESULTS: 10 % to 20 % of patients who suffer a chest or CNS-related adverse advent related to triptan use seek medical attention. The management cost of a chest-related event was estimated to be euros 66,43, euros 33,09, or euros 137,01, depending on whether the patient consulted a neurologist, a primary care physician, or a hospital emergency department. For CNS-related events the management cost was estimated to be euros 52,88, euros 16,89 or euros 102,17, respectively. Excluding the placebo effect, the resulting iatrogenic cost factor varied between 1 for almotriptan 12,5 mg and 1,21 for zolmitriptan 2,5 mg. In absolute values, the average cost per patient (above placebo) varied between 0 euros for almotriptan 12,5 mg and euros 1,17 for eletriptan 80 mg. CONCLUSIONS: The management of adverse events can add substantial costs to a treatment with triptans. These costs vary considerably between triptans due to differences in the incidence of adverse events. Lowest costs were found for almotriptan 12,5 mg.