Stellungnahme der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) zur Ramucirumab-Nutzenbewertung gemäß § 35a SGB V des G-BA

Prof. Dr. Markus Möhler, Mainz

• Literaturverzeichnis

• 1 Ellis LM, Bernstein DS, Voest EE et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 2014; 32: 1277-1280
• 2 Hartmann M, Mayer-Nicolai C, Pfaff O. Approval probabilities and regulatory review patterns for anticancer drugs in the European Union. Crit Rev Oncol Hematol 2013; 87: 112-121
• 3 Moehler M, Al-Batran SE, Andus T et al. German S3-guideline "Diagnosis and treatment of esophagogastric cancer”. Z Gastroenterol 2011; 49: 461-531
• 4 EMA. Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf Zugegriffen: 10. Aug. 2014
• 5 FDA. Patient-focused drug development: Disease Area Meetings planned for fiscal years 2013–2015. http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm Zugegriffen: 10. Aug. 2014
• 6 FDA. The voice of the patient. A series of reports from the FDA’s patient-focused drug development initiative. Lung disease. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM379698.pdf Zugegriffen: 10. Aug. 2014
• 7 Hörn N, Nink K, McGauran N et al. Early benefit assessment of new drugs in Germany – results from 2011 to 2012. Health Policy 2014; 116: 147-153
• 8 Ruof J, Schwart FW, Schulenburg JM et al. Early benefit assessment (EBA) in Germany: analyzing decisions 18 months after introducing the new AMNOG legislation. Eur J Health Econ 2014; 15: 577-589
• 9 Kripp M, Al-Batran SE, Rosowski J et al. Quality of life of older adult patients receiving docetaxel-based chemotherapy triplets for esophagogastric ade-nocarcinoma: a randomized study of the Arbeitsgemeinschaft Internistische Onkologie (AIO). Gastric Cancer 2014; 17: 181-187
• 10 Wimberger P 1, Gilet H, Gonschior AK et al. Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II / III study com-paring paracentesis plus catumaxomab with paracentesis alone. Ann Oncol 2012; 23: 1979-1985
• 11 Al-Batran SE 1, Ajani JA. Impact of chemotherapy on quality of life in patients with metastatic esophagogastric cancer. Cancer 2010; 116: 2511-2518
• 12 Earle CC, Landrum MB, Souza JM et al. Aggressiveness of cancer care near the end of life: is it a quality-of-care issue?. J Clin Oncol 2008; 26: 3860-3866
• 13 Kao S, Shafiq F, Vardy J, Adams D. Use of chemotherapy at end of life in oncology patients. Ann Oncol 2009; 2: 1555-1559
• 14 Hofheinz RD, Al-Batran SE, Ridwelski K et al. Population-based patterns of care in the first-line treatment of patients with advanced esophagogastric adenocarcinoma in Germany. Onkologie 2010; 33: 512-518
• 15 Gemeinsamer Bundesausschuss (2014) Arzneimittel-Richtlinie Anlage XII.