Articolo
Framing five-year forecasts with German Real-World Evidence: Recent changes in G-BA rules of procedure and implications for the use of claims data in German AMNOG dossiers
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Kathrin Gerchow, MPH
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Timotheus Stremel, MSc
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Christian Jacob, PhD
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Sebastian Braun, PhD
How can manufacturers predict the future using real-world evidence in German benefit assessments? Pharmaceutical companies are now required to provide forward-looking trend estimates that focus on expected changes in the number of patients with statutory health insurance within the target population for the new drug over the next five years.
Health Technology Assessment in Germany
The Act on the Reform of the Market for Medicinal Products (AMNOG), introduced in 2011, has fundamentally transformed the landscape of Health Technology Assessment (HTA) in Germany. By mandating that pharmaceutical companies submit detailed value dossiers to the Federal Joint Committee (G-BA) at market launch, AMNOG introduced a structured framework for evaluating the added benefit of new medicinal products. These dossiers contribute to the allocation of statutory health insurance (SHI) resources and aim to enhance transparency by making benefit assessments publicly accessible on the G-BA website (www.g-ba.de).
The G-BA is a public legal entity comprising key organizations in the German healthcare system, including associations of physicians, dentists, hospitals, and health insurance funds, with patient representatives participating in formal decision-making sessions (meetings where resolutions on healthcare regulations and benefit assessments are discussed and adopted) without voting rights. Established on January 1, 2004, the G-BA replaced earlier federal healthcare committees and began its fifth term on July 1, 2024. Its work is governed by the German Social Code, Book Five (SGB V), which outlines its mandates, member appointments, patient involvement, and procedural framework, with further details defined in its bylaws approved by the Federal Ministry of Health. The G-BA operates under the supervision of the Federal Ministry of Health, which audits its resolutions before publication in the Federal Gazette.
A German AMNOG dossier is structured into five main modules covering the summary of statements in the dossier, general information about the drug and approved indications, appropriate comparative therapy, patient populations, and costs, the medical and therapeutic benefit assessment, and additional supporting materials. In Module 3, the number of patients with meaningful benefit, including medical need, epidemiology of the underlying disease, and the target population of the drug under investigation, must be described.
In 2024, the G-BA introduced revisions to the requirements for Module 3 of AMNOG dossiers. Regarding the epidemiology of the underlying disease and the target population, pharmaceutical companies are now required to provide trend estimates predicting expected changes in the number of SHI patients within the target population for the new drug over the next five years. This shift from a focus on epidemiology of the underlying disease to the development of the projected size of the target population will provide more meaningful information for healthcare decision-making.
A German AMNOG dossier is structured into five main modules covering the summary of statements in the dossier, general information about the drug and approved indications, appropriate comparative therapy, patient populations, and costs, the medical and therapeutic benefit assessment, and additional supporting materials. In Module 3, the number of patients with meaningful benefit, including medical need, epidemiology of the underlying disease, and the target population of the drug under investigation, must be described.
In 2024, the G-BA introduced revisions to the requirements for Module 3 of AMNOG dossiers. Regarding the epidemiology of the underlying disease and the target population, pharmaceutical companies are now required to provide trend estimates predicting expected changes in the number of SHI patients within the target population for the new drug over the next five years. This shift from a focus on epidemiology of the underlying disease to the development of the projected size of the target population will provide more meaningful information for healthcare decision-making.
Real-world evidence in AMNOG dossiers
Real-world evidence (RWE), derived from sources such as electronic health records, claims data, and patient registries, offers insights into the real-world use and outcomes of therapeutic interventions. In the context of Module 3 of AMNOG dossiers, RWE may serve as the empirical foundation for the epidemiology of the underlying disease, the size of the target population, and the related trend analyses. These trend analyses usually involve using several years of historical claims and epidemiological data, supplemented by demographic projections, to model and extrapolate anticipated changes in the SHI patient population over the next five years. RWE can provide additional detail and context-specific understanding of patient populations, complementing traditional epidemiological data. Public platforms such as the Centre for Cancer Registry Data (ZfKD) and the Institute for Hospital Remuneration System (InEK) have recently gained more attention as data sources of epidemiological data on the underlying disease for Module 3 assessments. Both provide public data browsers, a cost-effective and efficient means of conducting rapid data analyses, typically complemented by literature to support the quantification of complex target populations. However, the ZfKD also offers the option of formal data access requests, enabling access to highly detailed datasets beyond what is available through its public interface. This approach is of particular value when estimating target populations, where tailored approaches are required by the label of the pharmaceutical product. In contrast, such detailed data access is not available for InEK, which remains limited to its aggregated public data offerings.
A valid approach to integrate RWE
The analysis of German SHI claims data to support Module 3 of the AMNOG dossier is also a frequently used method. All individual German health insurances offer the same comprehensive benefit package, as the benefits to be reimbursed are set in Social Law. SHI claims data includes information on all different healthcare sectors such as inpatient, outpatient, the pharmacy sector, remedies, devices, and aids, and provides detailed information on resource use and healthcare cost of provided services, including the inability to work and sick leave payments.
German claims data are an established and well-accepted data source by the G-BA, especially adjusted analysis samples structured to represent the German population. Available databases consist of longitudinal data from one or more different SHIs with up to 1.5 to 10 million covered lives, depending on the database. Typical time frames range from four to ten years, with exceptions providing up to 15 years of data.
By using SHI claims data, pharmaceutical companies can implement a tailored approach to identify the target population of interest by applying, for example, the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, German Modification (ICD-10-GM), the Anatomical Therapeutic Chemical (ATC) classification system, or the Key of Operations and Procedures (OPS) codes to identify patients with a respective diagnosis in combination with specific prescriptions, treatments, interventions, and aids.
German claims data are an established and well-accepted data source by the G-BA, especially adjusted analysis samples structured to represent the German population. Available databases consist of longitudinal data from one or more different SHIs with up to 1.5 to 10 million covered lives, depending on the database. Typical time frames range from four to ten years, with exceptions providing up to 15 years of data.
By using SHI claims data, pharmaceutical companies can implement a tailored approach to identify the target population of interest by applying, for example, the International Statistical Classification of Diseases and Related Health Problems, 10th Revision, German Modification (ICD-10-GM), the Anatomical Therapeutic Chemical (ATC) classification system, or the Key of Operations and Procedures (OPS) codes to identify patients with a respective diagnosis in combination with specific prescriptions, treatments, interventions, and aids.
Implications for AMNOG dossiers
For pharmaceutical companies, the revised requirements present both challenges and opportunities. The integration of RWE and the focus on SHI target populations may require additional investments in data infrastructure and analytical capabilities. However, by aligning their dossiers with the updated G-BA guidelines, companies can better position their products for successful market access and reimbursement decisions.
The transitional phase observed in late 2024 and early 2025 highlights the challenges and opportunities associated with the updated guidelines. While some companies have fully embraced the new standards, others continue to follow the old guidelines during the transition phase (see Figure 1).
Figure 1. Distribution of Module 3 by submission period and applied guidelines
The transitional phase observed in late 2024 and early 2025 highlights the challenges and opportunities associated with the updated guidelines. While some companies have fully embraced the new standards, others continue to follow the old guidelines during the transition phase (see Figure 1).
Figure 1. Distribution of Module 3 by submission period and applied guidelines
Looking ahead
Looking ahead, the choice of databases for future dossiers will also depend on the specific indication, as outlined below:
Oncological indications: ZfKD data
- For basic queries: Free online tools available on the ZfKD website can be utilised for straightforward analyses.
- For complex tasks: Comprehensive datasets can be accessed through formal data requests, which are particularly useful for more advanced tasks such as defining complex target populations.
Non-oncological indications: SHI claims data
- SHI claims data remains a proven data source if a detailed approach for non-oncological indications is desired.
- However, identifying orphan diseases within small claims databases can be challenging due to their limited coverage of the SHI population. In such cases, the new Health Data Lab (HDL; Forschungsdatenzentrum Gesundheit, www.forschungsdatenzentrum-gesundheit.de/en/) database may serve as an alternative. The HDL provides full coverage of SHI claims data in Germany and represents the largest SHI dataset in Europe.
Considerations for HDL vs single SHI or pooled claims databases:
- HDL database: While offering comprehensive data of the entire German SHI population, HDL has certain limitations. It is a relatively new resource with evolving workflows, high demand, and a time-consuming access process.
- Single SHI / pooled claims databases: These have advantages due to their faster approval processes, well-established workflows, and the ability to enable rapid analysis.
Given the potential of RWE to inform benefit assessments of new therapies in the German healthcare system, the careful selection of an appropriate data source can be crucial to a successful market launch in this key market.
Sources listed below.
Disclaimer:
This article summarises Cencora’s understanding of the topic based on publicly available information at the time of writing (see listed sources) and the authors’ expertise in this area. Any recommendations provided in the article may not be applicable to all situations and do not constitute legal advice; readers should not rely on the article in making decisions related to the topics discussed.
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Sources
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- Gemeinsamer Bundesausschuss (G-BA). The Federal Joint Committee: Who we are and what we do. Accessed February 13, 2026. https://www.g-ba.de/english/structure/
- Gemeinsamer Bundesausschuss (G-BA). Anlage II.5: Modul 3. Dokumentvorlage, Version from November 2025. Accessed February 13, 2026. https://www.g-ba.de/downloads/17-98-4824/2025-11-18_Anl2_5_Modul3.pdf
- Gemeinsamer Bundesausschuss (G-BA). Beschluss Verfahrensordnung: Änderung der Anlage II zum 5. Kapitel (Modul 3), Beschlussdatum: April 4, 2024. Accessed February 13, 2026. https://www.g-ba.de/beschluesse/6547/
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