OBJECTIVES: :The main objective of this study was to assess the patient population with advanced non-small cell lung cancer (NSCLC) with EGFR (epidermal growth factor receptor) positive mutation in Germany who are eligible for tyrosine-kinase inhibitor (TKI) therapy. An accurate assessment of the relevant patient population provides the basis for budget impact analyses in health technology assessments. METHODS: A systematic literature review was conducted. In addition, data from various cancer registries, cohort studies and surveillance studies were analyzed and compared with the findings in the literature.   RESULTS: :In a first step the proportion of patients with NSCLC was determined. Data was further differentiated by histologic subgroup (adenocarcinoma, large-cell carcinoma, squamous carcinoma and other carcinoma). The analysis revealed that the proportion of adenocarcinoma among the group of NSCLC has increased in Germany, especially among women from about 40% in 2000 to over 58% in 2009, in men from 28% to almost 40%, respectively. The proportion of patients with locally advanced or metastatic NSCLC (stage IIIb/IV) ranged between 51%-70%. The proportion of patients harbouring an EGFR mutation ranged between 5%-17%, differing by histologic subgroup, with the highest EGFR mutation rates (9%-26%) in patients with adenocarcinoma. The distribution of patients by ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) showed that at diagnosis 63%-92% had an ECOG-PS 0-1. On average, first line therapy was received by over 80% of patients, while only 52%-65% underwent second line therapy and third line therapy was received by 15%-25% only. CONCLUSIONS: By analyzing all available data it is possible to provide good estimates of the relevant patient population. Although significant advances have been made in reporting and data collection for relevant patient subgroups related to NSCLC, there still is a large lack of representative data on a national level in Germany.