Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries

BACKGROUND: There is a debate on the added clinical value of new, expensive, anticancer treatments. Among European decision makers, the relevance of commonly used endpoints in trials, especially overall survival (OS), progression-free survival (PFS) and quality of life (QoL) varies, leading to the available evidence being valued differently. This research studies the extent to which the value of endpoints for cancer medicines differs among European decision makers. METHODS: We compared guidelines and relative effectiveness assessments (REAs) of medicines for pricing or reimbursement decisions in England, France, Germany, Netherlands, Poland and Scotland. Anticancer medicines that received marketing authorisation in Europe between 2011-2013 with at least four available national REAs were evaluated. A total of 79 REAs were included. RESULTS: Health technology assessment (HTA) guidelines indicate a preference for clinically and patient relevant endpoints such as OS and QoL above surrogate endpoints. Most guidelines do not specify whether PFS is considered a surrogate or patient-relevant endpoint. The number of REAs included per jurisdiction varied between 7 (The Netherlands) and 18 (Germany). OS data were included in all REAs and were the preferred endpoint by HTA agencies, but these data were not always mature or robust. QoL data are included in only 54% of the REAs, with a limited impact on the recommendations. PFS data are included in 70% of the REAs, but the extent to which HTA agencies find PFS relevant varies. CONCLUSIONS: European decision making on relative effectiveness of anticancer medicines is affected by a gap in requested versus available clinical evidence, mainly because the regulator is willing to accept some degree of clinical uncertainty. A multi-stakeholder debate would be essential to align concrete robust evidence requirements in oncology and a collectively shared definition for relevant clinical benefit, which will benefit patients and society in general

Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries

BACKGROUND: There is a debate on the added clinical value of new, expensive, anticancer treatments. Among European decision makers, the relevance of commonly used endpoints in trials, especially overall survival (OS), progression-free survival (PFS) and quality of life (QoL) varies, leading to the available evidence being valued differently. This research studies the extent to which the value of endpoints for cancer medicines differs among European decision makers. METHODS: We compared guidelines and relative effectiveness assessments (REAs) of medicines for pricing or reimbursement decisions in England, France, Germany, Netherlands, Poland and Scotland. Anticancer medicines that received marketing authorisation in Europe between 2011-2013 with at least four available national REAs were evaluated. A total of 79 REAs were included. RESULTS: Health technology assessment (HTA) guidelines indicate a preference for clinically and patient relevant endpoints such as OS and QoL above surrogate endpoints. Most guidelines do not specify whether PFS is considered a surrogate or patient-relevant endpoint. The number of REAs included per jurisdiction varied between 7 (The Netherlands) and 18 (Germany). OS data were included in all REAs and were the preferred endpoint by HTA agencies, but these data were not always mature or robust. QoL data are included in only 54% of the REAs, with a limited impact on the recommendations. PFS data are included in 70% of the REAs, but the extent to which HTA agencies find PFS relevant varies. CONCLUSIONS: European decision making on relative effectiveness of anticancer medicines is affected by a gap in requested versus available clinical evidence, mainly because the regulator is willing to accept some degree of clinical uncertainty. A multi-stakeholder debate would be essential to align concrete robust evidence requirements in oncology and a collectively shared definition for relevant clinical benefit, which will benefit patients and society in general

Cuba en sus relaciones con el resto del Caribe : continuidades y rupturas tras el restablecimiento de las relaciones diplomáticas entre Cuba y los Estados Unidos

La doctrina de Obama fomentó y facilitó un nivel de compromiso con Cuba que cambió fundamentalmente las relaciones bilaterales entre Cuba y los Estados Unidos y la alejaron de la confrontación, contrario a sus predecesores. Durante los primeros dos años después del 17 de diciembre, el acercamiento con Cuba fue prometedor para garantizar cooperación y armonía hemisférica, así como para mayores beneficios sociales, económicos y de seguridad para Cuba y sus vecinos del Caribe. Sin embargo, a medida que el mundo se adecúa a la nueva administración en Washington, la cuestión de Cuba se ha vuelto a cargar de consideraciones geopolíticas. De hecho, la región del Caribe está atrapada en una telaraña de incertidumbre, ya que la amenaza de parte de Washington para ahogar el compromiso constructivo con Cuba es real. La presidencia de Trump ha desatado legiones de incertidumbres sobre Cuba, el Caribe y la región latinoamericana. Este libro da cuenta de el complejo entramado de relaciones en las diversas actividades de la política, la economía y las relaciones diplomáticas cubanas