The introduction of new and innovative treatment options for cancer patients is accompanied by a tremendous increase in healthcare costs. Consequently, new financing approaches are strongly needed to reduce the burden on the healthcare system. The introduction of biosimilars - biological drugs containing the active substance of an already approved reference biological drug - can potentially relieve the burden on healthcare systems. Calculating the costs for three frequently used biosimilars, we simulated the health-economic impact of biosimilars in the real world for the German healthcare system. Based on available health-economic analyses, the actual prescription and cost containment potential of biosimilars compared to the originator were calculated exemplarily for the cost-intensive therapies trastuzumab in breast cancer, rituximab in follicular lymphoma and G-CSF in supportive care. Incidence calculations were based e.g. on data from the Robert-Koch-Institution, Munich Cancer Registry, and quality indicators of certified centres. Cost calculation was based on Lauer-Taxe® (official reference for pharmaceutical price information). The application of biosimilars would generate potential annual savings for the chosen examples of up to 4.9 Mio EUR for rituximab in follicular lymphoma, 40.5 Mio EUR for filgrastim, 56.4 Mio EUR for pegfilgrastim, and between 95.9 and 120.5 Mio EUR for trastuzumab. The consequent use of biosimilars allows a considerable reduction of overall treatment costs, especially for cost-intensive long-term maintenance treatments and therapies with high incidences. If the option of biosimilar usage is fully exploited, enormous resources could be released within the healthcare system in order to offset financing new innovative therapies.

Background: In the past decades, highly innovative treatments in the field of diffuse large B-cell lymphoma (DLBCL) became available in clinical practice. The aim of this study was to assess the cost–benefit relation of third-line interventions in DLBCL from a German payer perspective. Methods: Clinical benefit of allogeneic stem cell transplantation (alloSCT), chimeric antigen receptor T cells therapy (CAR T) [tisagenlecleucel (tisa-cel) and axicabtagene ciloleucel (axi-cel)] and best supportive care (BSC) was assessed in terms of median overall survival (median OS) derived from a systematic literature review in PubMed. Real-world treatment costs were retrieved from the university hospitals Cologne and Hamburg-Eppendorf. The cost–benefit relation was analysed using the efficiency frontier concept. Results: Median OS varied from 6.3 months in BSC to 23.5 months in CAR T (axi-cel), while median real-world treatment costs ranged likewise widely from €26,918 in BSC to €340,458 in CAR T (axi-cel). Shown by the efficiency frontier, alloSCT and axi-cel were found as most efficient interventions. Conclusion: The efficiency frontier supports the pricing of innovative therapies, such as third-line interventions in DLBCL, in relation to appropriate comparators. Yet, studies with longer follow-up periods are needed to include studies with unreached median OS and to reflect experiences gained with CAR T in clinical practice.

9085 Background: The Network Genomic Medicine (NGM) Lung Cancer is a health care provider network offering comprehensive next generation sequencing (NGS)-based multiplex genotyping on a central diagnostics platform in Cologne for inoperable lung cancer patients (pts) in Germany. Methods: The NGS panel used consists of 14 genes and 102 amplicons to cover potentially targetable aberrations. Mutation analyses were run on an Illumina (MySeq) platform, FISH analyses were performed separately. In 2015, we have started the second outcome evaluation for all NGM pts who had received NGS-based molecular diagnostics. In particular, we have focused on pts with activating EGFR mutation (EGFR+), ALK translocation (ALK+), BRAF-V600E mutation (BRAF+), HER2 amplification (HER2+) and ROS1 translocation (ROS1+) and on the outcome of pts treated in clinical trials (ct). Results: From 2013-2015 6210 lung cancer pts (n = 4244 non-squamous NSCLC) were genotyped. Overall survival (OS) is shown for 934 NSCLC pts including 110 pts treated in ct. For 108 EGFR+ pts, the OS of pts treated in ct with different 3^rd generation EGFR-TKIs was 55 months (n = 25) vs 22 months in the control group (n = 83) (p = 0,002; mean OS: 29 months; 95%CI: 36-83 months). For 85 ALK+ pts, the OS of pts treated in ct with next-generation ALK-inhibitor after crizotinib failure was 35 months (n = 19) compared to OS of 23 months for 45 pts treated with crizotinib only and 8 months for 19 pts treated with no ALK inhibitors (p < 0,0001; mean OS: 22 months; 95%CI: 22-33 months). For 32 BRAF+ pts and 11 HER2+ pts, the mean OS was 23 months (95%CI: 12-26 months) and 25 months (95%CI: 15-34 months) (p = 0,022). The mean OS of 13 ROS1+ pts was not reached (95%CI: 58-100 months). Conclusions: Here we show successful implementation of NGS-based molecular diagnostics in clinical routine use. Moreover, molecular diagnostics triggers personalized therapy in – and outside clinical trials and improves survival for EGFR+, ALK+, ROS1+, BRAF+ and HER2+ pts. In particular, the use of next-gen. inhibitors after failure of first gen. inhibitors in EGFR+ and ALK+ pts leads to a significant and substantial additional survival benefit.

9018 Background: KRAS mutations in non-small cell lung cancer (NSCLC) still remain therapeutically untargetable. Assuming that these mutations are not mutually exclusive with other driver aberrations, we set out this study in order to describe and analyze co-occurring mutations and their potential therapeutic impact. In a subset of patients with co-occuring driver mutations, we performed additionally whole-exome sequencing (WES) to define clonal and evolutional status of the mutations. Results were compared with data from The Cancer Genome Atlas' (TCGA) for NSCLC. Methods: In a timeframe of 20 months, 4507 patients of a local screening initiative (Network Genomic Medicine Lung Cancer) were analyzed using next-generation parallel sequencing (NGS). The NGS panel consisted of 102 amplicons and 14 genes: KRAS, PIK3CA, BRAF, EGFR, ERBB2, NRAS, DDR2, TP53, ALK, CTNNB1, MET, AKT1, PTEN and MAP2K1. In subsets of patients, fluorescence in-situ hybridization (FISH) was performed for MET, FGFR1, and HER2 amplification and for RET, ALK and ROS1rearrangements. Clinical parameters, therapy, survival and smoking status were also collected. Results: We identified 1207 patients (26.8%) harboring a KRAS mutation, whereof 1080 patients (89.5%) underwent the complete diagnostic panel. The most common mutation was G12C accounting for 41.2%. In a total of 308 patients (28.8%) additional aberrations could be detected, including MET (prevalence 15.3%), FGFR1 (5.0%) and HER2 (12.7%) amplification and mutations in PIK3CA (3.4%), DDR2 (4.4%), PTEN (1.9%), CTNNB1 (1.7%), BRAF (1.3%) and EGFR (1.4%). Less frequently, mutations within NRAS, AKT1, ALK, MET, and MAP2K1 could be detected. 459 patients (42.9%) had co-occurring TP53mutations.. WES on selected cases confirmed the presence of these mutations. Conclusions: To our knowlege our data represent the largest analysis of co-occuring mutations in KRAS- mutated NSCLC. They show that KRAS-mutated NSCLC represents a heterogenous group of tumors with a substantial portion harboring a wide spectrum of additional targetable mutations. Further studies will show whether these findings translate into new therapeutic options in KRAS-mutated NSCLC.

Introduction: The treatment of cancer patients in Germany is characterized by sectoral separation of the in- and outpatient care accompanied by 2 separate reimbursement systems. By introducing the Guideline of Outpatient Medical Specialist Care in accordance with §116b SGB V (ASV) in 2014, the German legislation empowers office-based physicians and hospitals to jointly provide medical care in the ambulatory setting. Methods: A 1-year period each before and after the introduction of ASV was compared by means of data from the Center for Integrated Oncology Cologne at the University Hospital of Cologne. Only adults with a reliable diagnosis of gastrointestinal tumor (GIT) were considered. Results: Overall, 1,872 cases were considered in the analysis showing significant (p < 0.001) higher median values of revenues across ICD-subgroups for ASV (EUR 427.46) compared to Ambulatory Treatments in Hospitals (EUR 234.21). The exemplary analysis of revenues in neoplasms of the pancreas shows EUR 173.69 on average which are only invoiceable through ASV: flat rate incl. surcharges (EUR 117.79; 68%), structure lump sum (EUR 29.49; 17%), positron-emission tomography (PET)/CT (EUR 13.53; 18%), and ASV consultation hour (EUR 12.89; 7%). Discussion/Conclusion: ASV leads to significant higher revenues across different ICD-subgroups for patients suffering from severe GIT. The collaboration of hospital and office-based physicians ensures patient-centered care with accumulated expertise and avoidance of double examinations. Thus, the inclusion of additional services in the Uniform Value Scale (invoiceable for ASV) is legitimated and enables cost-covering care for the involved parties.