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Background: Based on the Act on the Reform of the Market for Medicinal Products (AMNOG), newly approved drugs containing new active substances are subject to an early benefit assessment after market entry according to §35a SGB V and pharmaceutical companies are required to submit a dossier in this context [1]. Module 3 of this dossier contains, amongst other things, information on the number of patients who are eligible for the medicinal product within the statutory health insurance (SHI), so called SHI target population. Since the AMNOG came into force, 44% (426/970) of all benefit assessments have been conducted in the field of oncology (data as of Q1/2026) [2]. Commonly used data sources for identifying the SHI target population in this therapeutic area include routine data of the SHI and cancer registry data. A particular challenge arises when both data sources are compared and produce different results.The aim is to compare incidence and prevalence estimates for selected indications for which analyses of routine data and cancer registry data were available.

Methods: Published AMNOG-Dossiers were screened regarding the use of routine data and cancer registry data for the purpose of calculating the size of the SHI target population. On this basis, prostate cancer (PCA) was selected as an example for determining prevalence and chronic myeloid leukaemia (CML) for determining incidence, and possible reasons for discrepancies were discussed [3].

Results: Depending on the specific data source used, differences in the number of patients can be observed. For example, a variation of up to six times in incidence was observed for CML, and a variation of up to approximately 25% in prevalence was observed for PCA. With regard to the analyzed indications and statistical disease frequencies, various factors within the data sources – such as the choice of the pre-observation period and the completeness of the data – can be identified as influencing the number of patients.

Conclusion: Routine data and registry data are significant data sources used to determine the size of the SHI target population in the context of benefit assessments. In this regard, the relevant aspects of the data sources and their methodology must be taken into account when interpreting the data.

Literatur

[1] Deutscher Bundestag. Gesetz zur Neuordnung des Arzneimittelmarktes in der gesetzlichen Krankenversicherung (Arzneimittelmarktneuordnungsgesetz – AMNOG). 2010 [accessed 2026 Aug 25]. Available from: http://www.bgbl.de/xaver/bgbl/start.xav?startbk=Bundesanzeiger_BGBl&jumpTo=bgbl110s2262.pdf
[2] Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen. Projekte und Ergebnisse. 2026. Available from: https://www.iqwig.de/projekte/projekte-und-ergebnisse/#searchQuery=query=*&page=1&rows=10&sortBy=score&sortOrder=desc&facet.filter.language=de
[3] Gemeinsamer Bundesausschuss. Nutzenbewertung von Arzneimitteln (gefiltert) Verfahren nach § 35a SGB V (AMNOG). 2026 [accessed 2026 Aug 25]. Available from: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/?suchwort=&anfangsbuchstabe=&therapiegebietsgruppe=6&indikation=&verfahrensstatus=&orphandrug=&verfahrensart=