Presentation (CTI)

OBJECTIVES: This study evaluates the impact of health-related quality of life (hrQoL) measurements on Health Technology Assessment (HTA) outcomes in Germany, specifically the contribution to an additional benefit.
METHODS: The analysis included resolutions of the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) from 2020 to 2024. Data was extracted from G-BA database using the AMNOG-Monitor, which included the proportion of hrQoL data submitted, accepted, and showing relevant positive effects for G-BA. Additionally, the proportion of relevant positive effects in endpoint categories such as mortality, morbidity, and side effects, as well as HTA rating was considered. A binary logistic regression adjusted for other endpoint categories was conducted to assess the relevance of hrQoL in determining a positive rating.
RESULTS: The study found that hrQoL data was submitted on an average of 63.6%, with a 39.1% acceptance rate. Positive effects on hrQoL were univariate associated with a positive benefit rating in 100%, whereas an additional benefit was found in 28% lacking hrQoL effects. However, the multivariate analysis revealed no statistical association of hrQoL with the probability of an additional benefit, in contrast to mortality, morbidity, and side effects. This means that accepted hrQoL measurements with relevant positive effects were never solely decisive for an additional benefit but exclusively coincided with positive outcomes in other endpoint categories.
CONCLUSIONS: Our findings suggest that effects on hrQoL are a consequence of outcomes in other endpoint categories and thus, do not occur independently of them, counteracting its value as a standalone endpoint category. Further research is required to explore if hrQoL is mediated by mortality, morbidity, and safety in German HTA.