[Economics and management of CAR T- cell therapy : Status quo and future perspectives]. / Ökonomie und Management bei der CAR-T-Zell-Therapie : Status quo und Ausblick.

BACKGROUND: Virtually no other topic has attracted more attention in oncology in recent years than chimeric antigen receptor (CAR) T­cell therapy (CAR T). On the one hand it opens up completely new treatment options for cancer patients, while on the other it generates treatment costs exceeding € 300,000 per treatment. OBJECTIVES: The aim of this work is to analyze the economic, procedural and organizational challenges of CAR T­cell therapy from the perspective of the service provider, the cost-bearer and the pharmaceutical manufacturer. MATERIAL AND METHODS: The current German diagnosis-related-group (G-DRG) catalog, the G­DRG tariff, of the German Federal Joint Committee (G-BA) guidelines and G­DRG coding principles were used to evaluate the reimbursement and remuneration system in Germany. Practical experiences of medical sites were integrated in the analysis. RESULTS: The findings demonstrate great economic challenges especially from the perspective of a CAR T site. Increasing certification and qualification efforts lead to financial pressure. Insufficient reimbursement and inadequate cost-covering for CAR T treatment result in budget restrictions for hospitals. CONCLUSION: High drug costs as well as enormous personnel and infrastructural requirements demand transparent and sufficient reimbursement for hospitals. Interaction between hospital and pharmaceutical manufacturer in the CAR T process might enable new means of cooperation.

[Various scenarios for billing and remuneration of preoperative management of iron deficiency anemia in the German healthcare system]. / Verschiedene Szenarien zu Abrechnung und Kostenerstattung eines präoperativen Managements der Eisenmangelanämie im deutschen Gesundheitssystem.

More than 30% of all patients undergoing surgery suffer from preoperative anemia. Iron deficiency anemia is the most common type of anemia. The diagnostics and treatment of iron deficiency anemia can be carried out before patients undergo surgery as an alternative to blood transfusion and is an interdisciplinary task. This article gives an overview of various billing modalities and payment arrangements for management of preoperative anemia in the German healthcare system.

Impact of TP53 mutation status on systemic treatment outcome in ALK-rearranged non-small-cell lung cancer.

Background: We analyzed whether co-occurring mutations influence the outcome of systemic therapy in ALK-rearranged non-small-cell lung cancer (NSCLC). Patients and methods: ALK-rearranged stage IIIB/IV NSCLC patients were analyzed with next-generation sequencing and fluorescence in situ hybridization analyses on a centralized diagnostic platform. Median progression-free survival (PFS) and overall survival (OS) were determined in the total cohort and in treatment-related sub-cohorts. Cox regression analyses were carried out to exclude confounders. Results: Among 216 patients with ALK-rearranged NSCLC, the frequency of pathogenic TP53 mutations was 23.8%, while other co-occurring mutations were rare events. In ALK/TP53 co-mutated patients, median PFS and OS were significantly lower compared with TP53 wildtype patients [PFS 3.9 months (95% CI: 2.4-5.6) versus 10.3 months (95% CI: 8.6-12.0), P < 0.001; OS 15.0 months (95% CI: 5.0-24.9) versus 50.0 months (95% CI: 22.9-77.1), P = 0.002]. This difference was confirmed in all treatment-related subgroups including chemotherapy only [PFS first-line chemotherapy 2.6 months (95% CI: 1.3-4.1) versus 6.2 months (95% CI: 1.8-10.5), P = 0.021; OS 2.0 months (95% CI: 0.0-4.6) versus 9.0 months (95% CI: 6.1-11.9), P = 0.035], crizotinib plus chemotherapy [PFS crizotinib 5.0 months (95% CI: 2.9-7.2) versus 14.0 months (95% CI: 8.0-20.1), P < 0.001; OS 17.0 months (95% CI: 6.7-27.3) versus not reached, P = 0.049] and crizotinib followed by next-generation ALK-inhibitor [PFS next-generation inhibitor 5.4 months (95% CI: 0.1-10.7) versus 9.9 months (95% CI: 6.4-13.5), P = 0.039; OS 7.0 months versus 50.0 months (95% CI: not reached), P = 0.001). Conclusions: In ALK-rearranged NSCLC co-occurring TP53 mutations predict an unfavorable outcome of systemic therapy. Our observations encourage future research to understand the underlying molecular mechanisms and to improve treatment outcome of the ALK/TP53 co-mutated subgroup.

[Profit center analysis of esophagectomy : Economical analysis of transthoracic esophagectomy depending on postoperative complications]. / Profit-Center-Analyse der Ösophagektomie : Ökonomische Analyse der transthorakalen Ösophagektomie in Abhängigkeit von postoperativen Komplikationen.

Due to increasing medical costs and yet limited financial resources, medical treatment and economic analyses can no longer be separated; therefore, direct costing and cost unit accounting become more and more relevant as controlling tools in hospital management. Transthoracic esophagectomy is an integral part of the current treatment concept in patients with esophageal carcinoma. The question of the present study was whether the present diagnosis-related groups (DRG) system is a cost-effective tool to represent transthoracic esophagectomy. In this retrospective study at a high-volume center, 161 consecutive patients with esophageal carcinoma were included. All patients were surgically treated according to the current S3 guidelines by a transthoracic esophagectomy. Detailed and standardized documentation of the postoperative complications was made according to the classification of Clavien-Dindo and the guidelines of the Esophagectomy Complications Consensus Group (ECCG). For each individual patient, the respective actual costs were analyzed according to the Institute for the Remuneration System in Hospitals (InEK) cost accounting approach comparing DRG payments (DRG G03A) on a case level including all extra fees per DRG catalogue. The mean costs per case of all included 161 patients were 24,338 € (median: 19,210 €, range: 12,149-127,376 €), while mean payments per case of 22,591 € were recorded. For the entire study population, the profit margin was -281,330 € (mean: -1747 €). Only patients with an uncomplicated course (Clavien-Dindo 0) yielded a slightly positive profit margin of 2514 €. With increasing complication score the profit margin became increasingly negative (Clavien-Dindo I: -2878 €, Clavien-Dindo IVb: -58,543 €). Within the analysis of the InEK target cost matrix, main cost drivers can be identified as medical services (22.3%) and non-medical infrastructure (18.7%). Surgical treatment according to the existing guidelines of patients with esophageal carcinoma is not cost-covering in high-volume centers and cannot be solely financed by existing DRG revenues.

Economic burden of clinical trials in lung cancer in a German Comprehensive Cancer Center.

OBJECTIVES: The recent success of individualized lung cancer therapy has triggered fundamental changes in clinical research strategies. To date there is a strong focus on early proof of concept trials in genetically preselected small patient subgroups. This analysis focuses on the economic burden caused by such trials for advanced lung cancer patients in a German Comprehensive Cancer Center (CCC). METHODS: The profit margins between recruiting groups with ≤3 and >3 patients were compared. Clinical and economic data from clinical trials for advanced lung cancer (LC), pharma-sponsored trials (PhST) as well as investigator initiated trials (IIT), conducted between 2011 and 2015 at the Center for Integrated Oncology (CIO) Cologne, were analyzed using a profit-center calculation model. RESULTS: 161 patients were enrolled in 27 clinical trials. The key economic parameter determining costs and payments was the 'trial visits'. In comparison of the two groups (A≤3; B>3 patients enrolled) we found negative profit margins for the low recruiting group (€ -1444). Concerning the number of visits significant differences were found between PhST and IIT (p=0.009). Additionally, sub-analysis show structural differences in cost composition by conducting PhST and IIT. CONCLUSION: Trials with low patient numbers and IIT, do not cover the cost. To ensure adequate, cost-covering compensation by pharmaceutical companies CCCs have to thoroughly calculate the cost of early proof of concept trials. The findings of this study also underline the need for novel structures in public funding for investigator-initiated clinical trials in precision medicine.