PHP252 - Prevalence and Incidence Estimations in German amnog Applications – The Role of Real-World Evidence (RWE)

Abstract

90% of the German population is insured in the statutory health insurance which covers nearly all healthcare services with only little co-payments. German health insurance claims data therefore constitute an important basis for real world evidence (RWE) on morbidity and healthcare costs. Aim of this study was to investigate to which extent RWE was used for estimation of prevalence and incidence in German AMNOG assessments since introduction 4 years ago and its impact on price discounts. German AMNOG dossiers with published benefit assessments until March 2015 were evaluated. They were screened for use of RWE in assessing prevalence and incidence and also target populations. After description and discussion of methods and data sources used, statistics were applied to explore a potential influence of use and quality of RWE data on magnitude of price discounts. 134 AMNOG dossiers were included of which 50% utilized RWE to assess prevalence, incidence, and target populations. German claims data were employed in 16 dossiers (24%), registry data in 7 dossiers (10%), and other data sources like Delphi panels in 49 dossiers (73%). Claims data were mostly applied for prevalence estimations of both the underlying disease and target populations. Compared to numbers stated by the Federal Joint Committee, target populations were accepted as reported in 56% and underrated numbers in 44% of those dossiers specifically using claims data. Price negotiations were completed for 80 AMNOG assessments. A t-test evaluating the association between use of RWE and negotiated price discounts indicated that price discounts were lower in assessments that did incorporate RWE data (p=0.049). German claims data constitute a valuable and valid data source for assessing epidemiologic evidence in German AMNOG assessments and can be a valuable tool for subsequent price negotiations.