Health Technology Assessment–Informed Decision Making by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care in Germany and the National Institute for Health and Care Excellence in England: The Role of Budget Impact.

This study aimed to test (official) evaluation criteria including the potential role of budget impact (BI) on health technology assessment (HTA) outcomes published by the Federal Joint Committee (Gemeinsamer Bundesausschuss [GBA]) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) in Germany as well as the National Institute for Health and Care Excellence (NICE) in England. Data were extracted from all publicly available GBA decisions and IQWiG assessments as well as NICE single technology appraisals between January 2011 and June 2018, and information with regard to evaluation criteria used by these agencies was collected. Data were analyzed using logistic regression to estimate the effect of the BI on the HTA outcomes while controlling for criteria used by GBA/IQWiG and NICE. NICE recommendations are largely driven by the incremental cost-effectiveness ratio and, if applicable, by end-of-life criteria (P <.01). While IQWiG assessments are significantly affected by the availability of randomized controlled trials and patient-relevant endpoints (P <.01), GBA appraisals primarily focus on endpoints (P <.01). The BI correlated with NICE single technology appraisals (inverted-U relationship, P <.1) and IQWiG recommendations (increasing linear relationship, P <.05), but not with GBA decisions (P >.1). Nevertheless, given that IQWiG assessments seem to be more rigorous than GBA appraisals regarding the consideration of evidence-based evaluation criteria, decisions by GBA might be negatively associated with the BI. Results reveal that GBA/IQWiG and NICE follow their official evaluation criteria consistently. After controlling for all significant variables, the BI seems to have an (independent) effect on HTA outcomes as well. • Empirical studies usually focus on the effect of evaluation criteria on recommendations by health technology assessment (HTA) agencies or compare assessment outcomes and underlying regulations. • Findings add to the existing evidence that both the Federal Joint Committee (Gemeinsamer Bundesausschuss [GBA])/Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) and the National Institute for Health and Care Excellence (NICE) follow their evaluation criteria consistently, as also reflected in the frequent occurrence of variation in recommendations. Furthermore, budget impact seems to have an effect on HTAs by GBA/IQWiG and NICE. • This article will contribute to health policy making in Europe, in particular to the debate whether and, if so, to what extent budget impact analyses shall be included in HTA to inform decision makers in England and Germany. [ABSTRACT FROM AUTHOR]