Description
In this report we describe the German healthcare system which operates as a complex, multi-payer model, providing universal coverage through a dual public-private structure. Its governance is centralized by federal law, with implementation responsibilities shared between federal and state authorities. The system is primarily funded through Statutory Health Insurance (SHI), known as Gesetzliche Krankenversicherung (GKV), which covers approximately 89% of the population via numerous sickness funds (Krankenkassen), financed by income-based contributions from employees and employers. Around 11% of the population, including high-income earners, self-employed individuals, and civil servants, opt for Private Health Insurance (PKV). Navigating this system, particularly for novel molecular in vitro diagnostic (IVD) tools in oncology, requires a tailored approach involving several key institutions and processes. The Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) sets the overall legal framework and national health policy. The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is the highest decision-making authority on SHI-covered services, evaluating new IVDs for medical benefit, necessity, and efficiency to decide on their reimbursement. The Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) supports the G-BA by conducting evidence-based Health Technology Assessments (HTAs), evaluating clinical utility, economic impact, and system benefit.
For outpatient settings, manufacturers submit reimbursement requests via the Evaluation Committee (Bewertungsausschuss, BeWa), supported by the Institute of the Evaluation Committee (Institut des Bewertungsausschusses, InBA). The BeWa decides on inclusion and reimbursement rates within the Einheitlicher Bewertungsmaßstab (EBM) catalogue. Due to potentially lengthy EBM inclusion timelines (up to 3 years), manufacturers may pursue individual contracts directly with sickness funds (Krankenkassen).
In inpatient settings, diagnostics are reimbursed through Diagnosis-Related Group (DRG) codes, with the Institute for Hospital Remuneration Systems (Institut für das Entgeltsystem im Krankenhaus, InEK) managing DRG assignment and evaluating applications for code inclusion or adjustment. Hospitals can also apply annually to InEK for temporary reimbursement for innovative diagnostics not yet priced within the DRG system via the Neue Untersuchungs- und Behandlungsmethoden (NUB) pathway, though these often face high rejection rates. To address these challenges and promote innovation, Germany launched the §64e SGB V Model Project in 2023 with €700 million in federal investment, providing a temporary, nationally coordinated reimbursement framework for advanced oncology diagnostics through 2027, aiming for early access and evidence generation. This initiative is part of the National Strategy for Genomic Medicine, genomDE initiative, launched in 2019 to integrate whole-genome sequencing into clinical care. Other key institutions include the Paul-Ehrlich-Institut (PEI) for regulatory oversight and test validation, especially for Companion Diagnostics (CDx), and medical professional societies like the German Society for Hematology and Oncology (DGHO) and the German Society of Pathology (DGP), which define clinical standards and guide biomarker integration. Comprehensive Cancer Centers (CCCs), certified by the German Cancer Society (Deutsche Krebsgesellschaft, DKG), also play a vital role in local adoption and standardizing cancer care. Ultimately, securing reimbursement for new diagnostics in Germany requires a robust demonstration of both clinical utility and cost-effectiveness, along with early engagement with key stakeholders, all of which we describe comprehensively in this report.
🎧 Listen: Navigating German Oncology – Access and Reimbursement for Diagnostics
