Artículo
RWE Insights: The contribution of German claims data to scientific evidence generation
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Christian Jacob, PhD
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Svitlana Schnaidt, MSc
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Sebastian Braun, PhD
Explore how Germany's Health Data Lab is expanding access to real-world evidence, and what it means for product lifecycle decisions, regulatory frameworks, and health technology assessment across Europe.
Over the past two decades, real-world evidence (RWE) derived from real-world data (RWD) collected during routine clinical care has become an indispensable resource for evaluating the safety and effectiveness of medicinal products. Applications span the entire product lifecycle from early market assessment and clinical development through regulatory decision-making and post-launch evidence generation. Both the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published guidance frameworks for the use of RWD and RWE, and their role is expanding further with the introduction of the European Regulation on Health Technology Assessment (HTAR) and joint clinical assessments.
In Germany, access to large-scale claims data has been significantly enhanced since October 2025, when the Health Data Lab (HDL; Forschungsdatenzentrum Gesundheit – FDZ), part of the Federal Institute for Drugs and Medical Devices (BfArM), began providing centralized access to statutory health insurance (SHI) claims data covering approximately 90% of the German population. Researchers from registered institutions may access a Secure Processing Environment (SPE) for approved research purposes as defined under § 303e subsection 2 SGB V.
In Germany, access to large-scale claims data has been significantly enhanced since October 2025, when the Health Data Lab (HDL; Forschungsdatenzentrum Gesundheit – FDZ), part of the Federal Institute for Drugs and Medical Devices (BfArM), began providing centralized access to statutory health insurance (SHI) claims data covering approximately 90% of the German population. Researchers from registered institutions may access a Secure Processing Environment (SPE) for approved research purposes as defined under § 303e subsection 2 SGB V.
At launch, the HDL database encompassed 15 years of longitudinal data (2009–2023), with 2024 data expected by the end of 2026 and quarterly preliminary updates planned thereafter — representing one of the most comprehensive claims datasets in Europe.
German claims data
Germany is one of Europe's largest pharmaceutical markets, with a population of 83.6 million, of whom approximately 90% are covered by statutory health insurance (SHI). All SHI funds offer a standardized, comprehensive benefit package irrespective of employer, providing a uniquely consistent and longitudinal data landscape for research. German claims data are applicable across the entire pharmaceutical product lifecycle and offer insights into patient populations, including children, elderly individuals, and the severely ill, that are typically underrepresented in randomized clinical trials.
The breadth and depth of these data enable researchers, healthcare providers, and national authorities to better understand real-world treatment patterns, disease burden, and healthcare resource utilisation at the population and sub-population level.
Content of German Claims Data
German claims data consist of longitudinal, anonymized patient-level data linkable across healthcare sectors. Key data domains include:
Age, gender, date of birth, region of residence, insurance status (member/retired/family), and start/end dates of coverage.
Procedures and International Classification of Diseases, Tenth Revision, German Modification (ICD-10-GM) diagnoses (quarterly) across all outpatient specialties, covering examinations, diagnostics, vaccinations, and ambulatory surgeries; procedures recorded daily with reimbursed costs.
Hospital admissions with ICD-10-GM codes (primary/secondary), German Diagnosis-Related Group (G-DRG) codes, length of stay, admission reason, operative procedures, in-hospital mortality, and DRG-level costs.
Dispensed drugs identified by Pharmazentralnummer (mapped to Anatomical Therapeutic Chemical [ATC] Classification codes), including defined daily doses, prescription and dispensing dates, SHI-perspective costs, and prescribing physician specialty.
Type, code, quantity, care provider, start/end dates, and costs for remedies (e.g., physiotherapy, speech therapy) and devices/aids (e.g., wheelchairs, measuring devices).
ICD-10-GM diagnoses per sick leave episode, episode duration, start/end dates of sick leave and payments, physician type, and associated costs.
Potential research topics
German SHI claims data open a remarkably broad spectrum of research opportunities that extend far beyond what traditional randomized clinical trials can offer. In everyday care, treatment outcomes often look strikingly different from those observed under controlled trial conditions, and this is precisely where the unique value of studies based on RWE becomes apparent. From assessing the population-level impact of national immunization programmes to evaluating the comparative effectiveness of anticoagulation therapies in routine practice, German claims data have proven their capacity to generate robust, population-wide insights that complement and extend the findings of clinical trials.
Analyses of day-to-day treatment patterns, adherence, and persistence reveal how patients navigate the healthcare system and use their therapies outside of controlled settings. Studies on vaccination schedules, biologic therapies in psoriatic arthritis, and disease-modifying treatments in multiple sclerosis consistently illustrate that even highly effective therapies frequently fall short of their full potential in routine care, a clear signal for the need for targeted patient support strategies and treatment pathway optimisation.
Analyses of day-to-day treatment patterns, adherence, and persistence reveal how patients navigate the healthcare system and use their therapies outside of controlled settings. Studies on vaccination schedules, biologic therapies in psoriatic arthritis, and disease-modifying treatments in multiple sclerosis consistently illustrate that even highly effective therapies frequently fall short of their full potential in routine care, a clear signal for the need for targeted patient support strategies and treatment pathway optimisation.
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The domain of drug safety is equally well-served by claims data, enabling large-scale post-marketing surveillance across diverse and vulnerable patient populations. Examples include analyses of drug-drug interactions in patients receiving antiretroviral therapy and tolerability assessments of treatments for alcohol dependence. Both studies highlight how routine care data can surface clinically meaningful safety signals that may not be detectable in the controlled environment of a clinical trial.
Finally, studies on burden of disease, unmet need, and healthcare resource utilisation bring the broader societal and economic consequences of illness into focus. Across a range of conditions, from chronic liver disease and rare metabolic disorders to celiac disease and severe coronavirus disease 2019 (COVID-19), claims-based analyses have quantified the substantial impact of disease on patients and health systems alike and identified critical gaps where current treatment options remain insufficient. Taken together, these research domains establish German claims data as one of the most powerful instruments available in contemporary health services research and evidence-based health policy.
Finally, studies on burden of disease, unmet need, and healthcare resource utilisation bring the broader societal and economic consequences of illness into focus. Across a range of conditions, from chronic liver disease and rare metabolic disorders to celiac disease and severe coronavirus disease 2019 (COVID-19), claims-based analyses have quantified the substantial impact of disease on patients and health systems alike and identified critical gaps where current treatment options remain insufficient. Taken together, these research domains establish German claims data as one of the most powerful instruments available in contemporary health services research and evidence-based health policy.
Conclusion
German SHI claims data represent a uniquely valuable resource for RWE generation, offering longitudinal, population-representative coverage of healthcare utilisation across all major sectors. The breadth of available data, spanning outpatient and inpatient care, pharmacy dispensing, medical devices, and sick leave, enables rigorous investigation of disease epidemiology, treatment patterns, clinical outcomes, and health economic burden.
The establishment of the HDL as a centralized access point for nationwide SHI data marks a significant step forward in facilitating systematic, reproducible research at scale. Combined with the evolving European regulatory and Health Technology Assessment (HTA) landscape — including the HTAR and the European Health Data Space — the scientific community is well positioned to generate robust, peer-reviewed evidence that can meaningfully inform clinical practice, health policy, and patient care.
As methods for analyzing large-scale claims data continue to mature, ensuring methodological rigor, transparency, and reproducibility will remain central to the credibility and utility of RWE in regulatory and HTA contexts. Ongoing collaboration between researchers, data holders, regulators, and HTA bodies will be essential to realizing the full potential of German claims data for evidence-based decision-making.
The establishment of the HDL as a centralized access point for nationwide SHI data marks a significant step forward in facilitating systematic, reproducible research at scale. Combined with the evolving European regulatory and Health Technology Assessment (HTA) landscape — including the HTAR and the European Health Data Space — the scientific community is well positioned to generate robust, peer-reviewed evidence that can meaningfully inform clinical practice, health policy, and patient care.
As methods for analyzing large-scale claims data continue to mature, ensuring methodological rigor, transparency, and reproducibility will remain central to the credibility and utility of RWE in regulatory and HTA contexts. Ongoing collaboration between researchers, data holders, regulators, and HTA bodies will be essential to realizing the full potential of German claims data for evidence-based decision-making.
Note: Sources listed below
Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc. strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
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