Comparison of the design and methodology of Phase 3 clinical trials of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir-based dual therapy (DTG) in HIV: a systematic review of the literature

Introduction: Current recommended antiretroviral regimens include a combination of two (dual; DT) or three (triple; TT) antiretroviral drugs. This study aims to determine whether the quality of evidence from clinical trials of dolutegravir (dolutegravir/lamivudine [DTG/3TC] or dolutegravir/rilpivirine [DTG/RPV]) is methodologically comparable to that of clinical trials conducted with bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Areas covered: A systematic review of the medical literature was carried out in PubMed without date or language restrictions, following the PRISMA guidelines. All aspects of the methodological design of phase 3 randomized clinical trials (RCTs) of DT and TT, evaluated by the European Medicines Agency (registration trials), were reviewed. The quality of clinical trials was assessed using the Jadad scale. Expert opinion: The search identified 5, 3 and 2 phase 3 RCTs with BIC/FTC/TAF, DTG/3TC and DTG/RPV, respectively, that met the inclusion criteria. The designs would not be comparable due to differences in pre-randomization losses, blinding, patient recruitment, as well as differences in methodological quality, with the average score of the RCTs conducted with BIC/FTC/TAF, DTG/3TC and DTG/RPV being 4.2 (high quality), 3.0 (medium quality) and 3.0 (medium quality), respectively. Due to methodological differences between the BIC/FTC/TAF, DTG/3TC and DTG/RPV RCTs, the results of these are not comparable

¿Qué es una intervención sanitaria eficiente en España en 2020?

Hace más de 15 años que en Gaceta Sanitaria se publicó el artículo titulado «¿Qué es una tecnología sanitaria eficiente en España?». El creciente interés por fijar el precio de las nuevas tecnologías en función del valor que estas proporcionan a los sistemas de salud y la experiencia acumulada por los países de nuestro entorno hacen oportuno revisar qué es una intervención sanitaria eficiente en España en el año 2020. El análisis de coste-efectividad sigue siendo el método de referencia para maximizar los resultados en salud de la sociedad con los recursos disponibles. La interpretación de sus resultados requiere establecer unos valores de referencia que sirvan de guía sobre lo que constituye un valor razonable para el sistema sanitario. Los umbrales de eficiencia deben ser flexibles y dinámicos, y actualizarse periódicamente. Su aplicación debe estar basada en la gradualidad y la transparencia, considerando, además, otros factores que reflejen las preferencias sociales. Aunque la fijación de los umbrales corresponde a los decisores políticos, en España puede ser razonable utilizar unos valores de referencia como punto de partida que podrían estar comprendidos entre los 25.000 y los 60.000 euros por año de vida ajustado por calidad. No obstante, en la actualidad, más que la determinación de las cifras exactas de dicho umbral, la cuestión clave es si el Sistema Nacional de Salud está preparado y dispuesto a implantar un modelo de pago basado en el valor, que contribuya a lograr la gradualidad en las decisiones de financiación y, sobre todo, a mejorar la previsibilidad, la consistencia y la transparencia del proceso.Fifteen years ago, Gaceta Sanitaria published the article entitled “What is an efficient health technology in Spain?” The growing interest in setting the price of new technologies based on the value they provide to health systems and the experience accumulated by the countries in our environment make it opportune to review what constitutes an efficient health intervention in Spain in 2020. Cost-effectiveness analysis continues to be the reference method to maximize social health outcomes with the available resources. The interpretation of its results requires establishing reference values that serve as a guide on what constitutes a reasonable value for the health care system. Efficiency thresholds must be flexible and dynamic, and they need to be updated periodically. Its application should be based on and transparency, and consider other factors that reflect social preferences. Although setting thresholds is down to political decision-makers, in Spain it could be reasonable to use thresholds of 25,000 and 60,000 Euros per QALY. However, currently, in addition to determining exactfigures for the threshold,the key question is whether the Spanish National Health System is able and willing to implement a payment model based on value, towards achieving gradual financing decisions and, above all, to improve the predictability, consistency and transparency of the process