Manejo asistencial del paciente con hiperplasia benigna de próstata en España / Clinical Management of Patient With Benign Prostatic Hyperplasia in Spain

Objetivos: Conocer el manejo asistencial de la hiperplasia benigna de próstata (HBP) en España y el uso de recursos sanitarios asociado. Material y métodos: Estudio descriptivo transversal mediante entrevistas telefónicas a médicos de atención primaria (MAP) y urólogos. Se recogió información acerca del diagnóstico, tratamiento y seguimiento. Los resultados se agruparon por patrones asistenciales, definidos a partir de las variables: diagnóstico, clasificación según sintomatología, inicio de tratamiento farmacológico y seguimiento. Resultados: Participaron 153 MAP y 154 urólogos. Se identificaron 7 patrones asistenciales en atención primaria (AP). El uso de recursos sanitarios en el diagnóstico presenta cierta homogeneidad, empleando de 2,0 a 2,6 visitas, siendo las pruebas diagnósticas más habituales el análisis de PSA y de orina. En el seguimiento se observa heterogeneidad en el uso de recursos. Las visitas de seguimiento oscilan entre 3,2 y 7,0 visitas/ paciente/ año y el tipo de pruebas realizadas varía entre patrones y dentro del mismo patrón. En Urología se identificaron tres patrones asistenciales. Existe homogeneidad en el uso de recursos en el diagnóstico y en el seguimiento. La frecuencia de visitas es de 2 para el diagnóstico y entre 2,1 y 3,2 visitas/paciente/año en el seguimiento. Las pruebas más comúnmente realizadas en el diagnóstico y en el seguimiento son el análisis de PSA y el tacto rectal. Conclusiones: En AP la asistencia prestada al paciente con HBP está sujeta a variabilidad, encontrándose 7 patrones asistenciales diferentes con un seguimiento heterogéneo entre patrones y dentro del mismo patrón. Esta situación podría justificar la necesidad de difusión e implantación de protocolos asistenciales (AU)

Objectives: To identify clinical management of benign prostatic hyperplasia (BPH) in Spain and its associated health care resources. Material and methods: A qualitative cross-sectional study was conducted through telephone interviews to general practitioners (GP) and urologists. Information about diagnosis, pharmacologic treatment and follow-up was collected. Results were clustered according to the key variables considered as drivers of clinical practice patterns: BPH diagnosis, severity classification, treatment initiation and follow up of patients. Results: 153 GP and 154 urologists participated in the study. 7 different clinical patterns were identified in primary care (PC). Resource use during diagnosis is relatively homogeneous, reporting a range of 2.0 to 2.6 visits employed and being the most frequent test performed PSA and urine test. Follow-up is heterogeneous; frequency of follow-up visits oscillates from 3.2 to 7.0 visits/patient/year and type of tests performed is different among patterns and within the same pattern. In Urology, 3 clinical patterns were identified. Resource use is homogeneous in the diagnosis and in the follow-up; urologists employed 2 visits in diagnosis and a range of 2.1 to 3.2 visits/patient/year in the follow-up. The most frequent tests both in diagnosis and follow-up are PSA and digital test. Conclusions: BPH management shows variability in PC, identifying 7 different clinical practice patterns with different resource use during the follow-up among patterns and within the same pattern. The implementation of clinical guidelines could be justified to reduce heterogeneity (AU)

[Clinical management of patient with benign prostatic hyperplasia in Spain]. / Manejo asistencial del paciente con hiperplasia benigna de próstata en España.

OBJECTIVES: To identify clinical management of benign prostatic hyperplasia (BPH) in Spain and its associated health care resources. MATERIAL AND METHODS: A qualitative cross-sectional study was conducted through telephone interviews to general practitioners (GP) and urologists. Information about diagnosis, pharmacologic treatment and follow-up was collected. Results were clustered according to the key variables considered as drivers of clinical practice patterns: BPH diagnosis, severity classification, treatment initiation and follow up of patients. RESULTS: 153 GP and 154 urologists participated in the study. 7 different clinical patterns were identified in primary care (PC). Resource use during diagnosis is relatively homogeneous, reporting a range of 2.0 to 2.6 visits employed and being the most frequent test performed PSA and urine test. Follow-up is heterogeneous; frequency of follow-up visits oscillates from 3.2 to 7.0 visits/patient/year and type of tests performed is different among patterns and within the same pattern. In Urology, 3 clinical patterns were identified. Resource use is homogeneous in the diagnosis and in the follow-up; urologists employed 2 visits in diagnosis and a range of 2.1 to 3.2 visits/patient/year in the follow-up. The most frequent tests both in diagnosis and follow-up are PSA and digital test. CONCLUSIONS: BPH management shows variability in PC, identifying 7 different clinical practice patterns with different resource use during the follow-up among patterns and within the same pattern. The implementation of clinical guidelines could be justified to reduce heterogeneity.

Coste-efectividad de la combinación dutasterida y tamsulosina en el tratamiento de la hiperplasia benigna de próstata en España / Cost-Effectiveness of the Combination Therapy of Dutasteride and Tamsulosin in the Treatment of Benign Prostatic Hyperlasia in Spain

Objetivos: evaluar el coste-efectividad incremental (CEI) de la combinación dutasterida y tamsulosina (DUT+TAM) de inicio frente al tratamiento más utilizado, tamsulosina (TAM), en pacientes con hiperplasia benigna de próstata (HBP) moderada-grave con riesgo de progresión. Material y métodos: se diseñó un modelo semi-Markov con un horizonte temporal a 4 y a 35 años desde la perspectiva del Sistema Nacional de Salud español a partir del estudio CombAT. La efectividad de los tratamientos se midió en años de vida ajustados por calidad (AVAC). El uso de recursos sanitarios se obtuvo de un panel de expertos. Los costes unitarios proceden de tarifas publicadas por las Comunidades Autónomas. El coste del tratamiento farmacológico se expresa en PVP-IVA; en el caso de TAM se utilizó el precio del genérico y en el de DUT+TAM el de la combinación a dosis fija. Todos los costes se expresan en euros de 2010. Resultados: DUT+TAM produce una mejoría incremental respecto a TAM de 0,06 AVAC a los 4 años y de 0,4 AVAC a los 35 años. El coste incremental de DUT+TAM es de 810,53 € a los 4 años y 3.443,62 € a los 35 años. Por tanto, El CEI de TAM+DUT respecto a TAM es 14.023,32 €/ AVAC y 8.750,15 €/ AVAC a los 4 y 35 años respectivamente. Conclusiones: el tratamiento de inicio con la combinación DUT+TAM es un tratamiento coste-efectivo frente TAM, el tratamiento más habitual en la práctica clínica española, al encontrase el ratio CEI por debajo del umbral que usualmente se considera para clasificar las tecnologías como coste-efectivas (AU)

Objectives: to evaluate the incremental cost-effectiveness ratio (ICER) of the combination therapy with dutasteride and tamsulosin (DUT+TAM) as initiation treatment versus the most used drug in Spain, tamsulosin (TAM), in the treatment of moderate to severe benign prostatic hyperplasia (BPH) with risk of progression. Methods: a semi-Markov model was developed using 4-year and 35-year time horizons and from the Spanish National Healthcare Service perspective. Data were obtained from the CombAT trial. Effectiveness was measured in terms of quality adjusted life years (QALYs). Health care resources were defined by an experts’ panel, and unitary costs were obtained from published Spanish sources. Pharmacologic cost is expressed in PTPWAT; in the case of TAM, the generic price is used, in the case of DUT+TAM the price of a fixed dose combination is used. Costs are expressed in 2010 Euros. Results: combination therapy with DUT+TAM produces an incremental effectiveness of 0.06QALY at year 4 and 0.4QALY at year 35. DUT+TAM represents an incremental cost of € 810.53 at 4 years and € 3,443.62 at 35 years. Therefore, the ICER for DUT+TAM versus TAM is € 14,023.32/QALY at year 4 and € 8,750.15/QALY at year 35. Conclusions: initiation treatment with DUT+TAM represents a cost-effective treatment versus TAM, the most used treatment in Spain, due to the fact the ICER is below the threshold that usually allows a technology to be considered as cost-effective (AU)

[Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain]. / Coste-efectividad de la combinación dutasterida y tamsulosina en el tratamiento de la hiperplasia benigna de próstata en España.

OBJECTIVES: to evaluate the incremental cost-effectiveness ratio (ICER) of the combination therapy with dutasteride and tamsulosin (DUT+TAM) as initiation treatment versus the most used drug in Spain, tamsulosin (TAM), in the treatment of moderate to severe benign prostatic hyperplasia (BPH) with risk of progression. METHODS: a semi-Markov model was developed using 4-year and 35-year time horizons and from the Spanish National Healthcare Service perspective. Data were obtained from the CombAT trial. Effectiveness was measured in terms of quality adjusted life years (QALYs). Health care resources were defined by an experts' panel, and unitary costs were obtained from published Spanish sources. Pharmacologic cost is expressed in PTP(WAT); in the case of TAM, the generic price is used, in the case of DUT+TAM the price of a fixed dose combination is used. Costs are expressed in 2010 Euros. RESULTS: combination therapy with DUT+TAM produces an incremental effectiveness of 0.06QALY at year 4 and 0.4QALY at year 35. DUT+TAM represents an incremental cost of € 810.53 at 4 years and € 3,443.62 at 35 years. Therefore, the ICER for DUT+TAM versus TAM is € 14,023.32/QALY at year 4 and € 8,750.15/QALY at year 35. CONCLUSIONS: initiation treatment with DUT+TAM represents a cost-effective treatment versus TAM, the most used treatment in Spain, due to the fact the ICER is below the threshold that usually allows a technology to be considered as cost-effective.

[Referral criteria for benign prostatic hyperplasia in primary care.Sociedad Española de Médicos de Atención Primaria, Sociedad Española de Medicina General, Sociedad Española de Medicina de Familia y Comunitaria, Asociación Española de Urología]. / Criterios de derivación en hiperplasia benigna de próstata para atención primaria. Sociedad Española de Médicos de Atención Primaria, Sociedad Española de Medicina General, Sociedad Española de Medicina de Familia y Comunitaria, y la Asociación Española de Urología.

Benign prostatic hyperplasia (BPH) is a high prevalence condition in men over 50 years that requires continued assistance between primary care and urology. Therefore, consensus around common referral criteria was needed to guide and support both levels. Medical history, symptom assessment with International Prostate Symptom Score (IPSS) questionnaire, digital rectal examination and prostate-specific antigen (PSA) measurement are diagnostic tests available for general practitioners that allow setting a correct BPH diagnose. Patients with an IPSS<8 should be monitored by evaluating them annually. Treatment with alpha-blockers and an evaluation at the first and third month is recommended in patients with an IPSS 8-20 and if the prostate is small, if the prostate size is large treatment with alpha-blockers or 5alpha-reductase inhibitors and evaluation at the third and six month is recommended, and in patients with a large prostate and a PSA >1.5 ng/ ml combined treatment and evaluation at the first and sixth month is recommended. Some clear criteria for referral to urology are established in this document, which help in the management of these patients. Those patients with BPH who do not show any improvement at the third month of treatment with alpha-blockers, or the sixth month with 5alpha-reductase inhibitors, will be referred to urology. Patients will also be referred to urology if they have lower urinary tract symptoms, a pathological finding during rectal examination, IPSS>20, PSA>10 ng/ml or PSA>4 ng/ml and free PSA<20% or if they are <50 years with suspected BHP, or if they have any urological complication.

Criterios de derivación en hiperplasia benigna de próstata para atención primaria / Referral criteria for benign prostatic hyperplasia in primary care

La hiperplasia benigna de próstata (HPB) es una enfermedad con alta prevalencia entre los varones de más de 50 años que requiere una continuidad asistencial entre los 2 niveles existentes en nuestro país, el de atención primaria (AP) y el de atención especializada; motivo por el que era necesario consensuar unos criterios de derivación o de continuidad que sirvan de orientación a ambos colectivos. La historia clínica del paciente, el Índice Internacional de Síntomas Prostáticos (IPSS, International Prostate Symptom Score), el tacto rectal y el antígeno prostático específico (PSA, prostate-specific antigen) son herramientas accesibles en el ámbito de la AP que permiten un diagnóstico adecuado de la HBP. Conscientes de tal necesidad, las sociedades científicas de atención primaria (Sociedad Española de Médicos de Atención Primaria [SEMERGEN], Sociedad Española de Medicina General [SEMG], Sociedad Española de Medicina de Familia y Comunitaria [semFYC]) y la Asociación Española de Urología (AEU) elaboraron este documento de consenso. A los pacientes con IPSS<8 se los deberá mantener en vigilancia y evaluar anualmente; en los pacientes con IPSS 8-20, si el tamaño de la próstata es pequeño, se recomienda el tratamiento con bloqueadores alfa y evaluación al primer y tercer mes, si el tamaño de la próstata es grande se recomienda el tratamiento con bloqueadores alfa o inhibidores 5-alfa-reductasa y evaluación al tercer y sexto mes, y en el caso de pacientes con próstata grande y PSA 41,5 ng/ml se recomienda el tratamiento combinado y la evaluación al primer y sexto mes. En este documento se establecen unos criterios de derivación al urólogo claros, que facilitan el tratamiento de este tipo de pacientes. Se derivarán al urólogo aquellos pacientes con HBP que no presenten mejoría al tercer mes de tratamiento con bloqueadores alfa, o al sexto mes de tratamiento con inhibidores 5-alfa-reductasa. Se derivarán también los pacientes con síntomas del tracto urinario inferior en los que se observe algún hallazgo patológico durante el tacto rectal, IPSS >20, PSA >10 ng/ml o PSA >4 ng/ml y PSA libre <20% o pacientes con edades <50 años y sospecha de HBP, así como aquellos pacientes con alguna complicación urológica(AU)

Benign prostatic hyperplasia (BPH) is a high prevalence condition in men over 50 years that requires continued assistance between primary care and urology. Therefore, consensus around common referral criteria was needed to guide and support both levels. Medical history, symptom assessment with International Prostate Symptom Score (IPSS) questionnaire, digital rectal examination and prostate-specific antigen (PSA) measurement are diagnostic tests available for general practitioners that allow setting a correct BPH diagnose. Patients with an IPSS<8 should be monitored by evaluating them annually. Treatment with alpha-blockers and an evaluation at the first and third month is recommended in patients with an IPSS 8-20 and if the prostate is small, if the prostate size is large treatment with alpha-blockers or 5alpha-reductase inhibitors and evaluation at the third and six month is recommended, and in patients with a large prostate and a PSA >1.5 ng/ ml combined treatment and evaluation at the first and sixth month is recommended. Some clear criteria for referral to urology are established in this document, which help in the management of these patients. Those patients with BPH who do not show any improvement at the third month of treatment with alpha-blockers, or the sixth month with 5á-reductase inhibitors, will be referred to urology. Patients will also be referred to urology if they have lower urinary tract symptoms, a pathological finding during rectal examination, IPSS>20, PSA>10 ng/ml or PSA>4 ng/ml and free PSA<20% or if they are <50 years with suspected BHP, or if they have any urological complication(AU)