USE OF REAL WORLD EVIDENCE IN GERMAN AMNOG APPLICATIONS

Author(s)

Altevers J, Borchert K, Mittendorf T, Braun S
Xcenda GmbH, Hannover, Germany

OBJECTIVES: The statutory health insurance in Germany comprises 90% of the German population covering 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 epidemiology and cost information. 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 also its impact on price discounts. METHODS: German AMNOG assessments submitted until December 2014 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 price discounts. RESULTS: In total, 108 AMNOG dossiers were included. Real world evidence was used in 42.6% of these dossiers to assess prevalence and incidence as well as target populations. German claims data were employed in 8 dossiers (7.4%), registry data in 7 dossiers (6.5%), other data sources like Delphi panels in 37 dossiers (34.3%). The impact of quality of RWE evidence on negotiated discounts is inconclusive with limited data available. German claims data comprise comprehensive information such as demographics, outpatient and inpatient care, prescriptions, devices and aids, incapacity to work and sick leave payments. The routine documentation of diagnoses, procedures and prescriptions as well as the ability to evaluate patient histories are particularly useful for prevalence and incidence analyses, especially regarding the target population and cost estimations which are of paramount importance in price negotiations following the AMNOG assessment. CONCLUSIONS: German claims data constitute a valuable and valid data source for assessing epidemiologic evidence in German AMNOG assessments. Indication specific claims data analyses are a meaningful complement to literature research.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

PHP145

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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