RESUMO
BACKGROUND: Our study aimed to assess whether there was a relationship between clinical benefits and reimbursement decisions as well as the inclusion of economic evaluations in therapeutic positioning reports (IPTs) and to explore factors influencing reimbursement decisions. MATERIALS AND METHODS: We analysed all anti-cancer drugs approved in Spain from 2010 to September 2022. The clinical benefit of each drug were evaluated using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) 1.1. The characteristics of these drugs were obtained from the Spanish Agency of Medicines and Medical Devices. Reimbursement status information was obtained using BIFIMED, a web resource available in Spanish and consulted the agreements of the Interministerial Committee on Pricing of Medicines (CIPM). RESULTS: In total, 73 drugs were included involving 197 indications. Almost half of the indications had substantial clinical benefit (49.8% yes vs. 50.3% no). Of the 153 indications with a reimbursement decision, 61 (56.5%) reimbursed indications had substantial clinical benefit compared to 14 (31.1%) of the non-reimbursed (p < 0.01). The median gain of overall survival was 4.9 months (2.8-11.2) for reimbursed indications and 2.9 months (1.7-5) in non-reimbursed (p < 0.05). Only six (3%) indications had an economic evaluation in the IPT. CONCLUSION: Our study revealed that there is a relationship between substantial clinical benefit and the reimbursement decision in Spain. However, we also found that the overall survival gain was modest, and a significant proportion of the reimbursed indications had no substantial clinical benefit. Economic evaluations in IPTs are infrequent and cost-effectiveness analysis is not provided by CIPM.
Assuntos
Antineoplásicos , Neoplasias , Humanos , Espanha , Antineoplásicos/uso terapêutico , Oncologia , Análise Custo-Benefício , Neoplasias/tratamento farmacológicoRESUMO
Objetivos: Realizar una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con cáncer de próstata no metastásico resistente a la castración (CPRCnm) con alto riesgo de progresión a enfermedad metastásica. Material y métodos: Tras realizar una búsqueda bibliográfica se llevó a cabo una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica siguiendo el método de Bucher et al. Como variables se seleccionaron la supervivencia libre de metástasis (SLM) y la tasa de respuesta al PSA (TRPSA). Resultados: No se observaron diferencias estadísticamente significativas para las variables evaluadas entre enzalutamida y apalutamida. Para la comparación enzalutamida + TDA vs. Apalutamida + TDA: SLM obtuvo un HR (IC95%) = 1,036 (0,781-1,373) y TRPSA obtuvo un RR (IC95%) = 0,81 (0,339-1,938). Conclusiones: La comparación indirecta ajustada realizada en este estudio muestra que no existen diferencias estadísticamente significativas en términos de eficacia, a nivel de SLM y TRPSA, entre enzalutamida + TDA y apalutamida + TDA en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica. Sin embargo, se debería diseñar un ensayo independiente en el que se comparasen directamente ambos fármacos para confirmar estos resultados
Objectives: To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease. Material and methods: After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR). Results: There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide + ADT vs. apalutamide + ADT: MFS a HR (95% CI) = 1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI) = 0.81 (0.339-1.938) was obtained. Conclusions: The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide + ADT and apalutamide + ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required
Assuntos
Humanos , Masculino , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Antagonistas de Androgênios/administração & dosagem , Intervalo Livre de Doença , Ensaios Clínicos como Assunto , Fatores de TempoRESUMO
OBJECTIVES: To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease. MATERIAL AND METHODS: After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR). RESULTS: There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide+ADT vs. apalutamide+ADT: MFS a HR (95% CI)=1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI)=0.81 (0.339-1.938) was obtained. CONCLUSIONS: The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide+ADT and apalutamide+ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required.
