Potential of German claims data to characterize utilization of new cancer drugs: the example of crizotinib

Aims: Premarketing clinical trials are typically conducted under controlled conditions and in selected study populations, so real-world information on the utilization of new cancer drugs is limited. We aimed to explore the potential of German claims data in this regard, exemplified by the ALK inhibitor crizotinib, used in non-small-cell lung cancer therapy. Materials & methods: We identified patients treated with crizotinib in the German Pharmacoepidemiological Research Database (2004–2017; 20% of the German population) and assessed patient characteristics, treatment and survival. Results: We identified 348 crizotinib-treated patients (56% female; 25% first-line users). After 2 years, overall survival was 48%, with higher survival in men than in women (58 vs 40%). Overall, 76% of patients discontinued crizotinib treatment. Of those, 41% received another ALK inhibitor afterward. Conclusion: The results underline the potential of German claims data for real-world monitoring of oncological drug utilization.

Individual mortality information in the German Pharmacoepidemiological Research Database (GePaRD): a validation study using a record linkage with a large cancer registry

ObjectiveClaims data need to be validated to assess their use for epidemiological research. This study aimed to examine the validity of mortality information in the German Pharmacoepidemiological Research Database (GePaRD).DesignValidation study, secondary data, medical claims.SettingClaims data of two German nationwide acting statutory health insurance providers (SHIs) contributing data for GePaRD; record linkage with epidemiological cancer registry providing individual official mortality information.ParticipantsAll women insured with the two SHIs whose insurance coverage ended in the period 2006–2013 and who were residents of North Rhine Westphalia.MeasuresDescriptive statistics were used to analyse the performance of the linkage procedure. Further, we calculated measures of agreement between the official and the GePaRD-based vital status and assessed differences between the official and the GePaRD-based date of death.ResultsOf the 256 111 women of the linkage sample, 25 528 were classified as ‘deceased’ in GePaRD and the others as ‘alive’. Compared with the official data, the GePaRD-based vital status showed a sensitivity of 95.9% and a specificity of 99.4%. The negative predictive value was 99.6% and the positive predictive value 94.3%. The date of death agreed in 96.3% between both data sources.ConclusionsThe vital status recorded in GePaRD was of high accuracy and discrepancies between dates of death in GePaRD and official dates were rare. This underlines the potential of the database for conducting large cohort studies with mortality as the endpoint.