Tanja Cufer1, Tudor E Ciuleanu2, Peter Berzinec3, Gabriela Galffy4, Marko Jakopovic5, Jacek Jassem6, Dragana Jovanovic7, Zhasmina Mihaylova8, Gyula Ostoros9, Christiane Thallinger10, Milada Zemanova11, Christoph Zielinski12. 1. Medical Faculty Ljubljana, University Clinic Golnik, Ljubljana, Slovenia. 2. Department of Medical Oncology, "Prof. Dr. Ion Chiricuta" Institute of Oncology, Cluj-Napoca, Romania. 3. Department of Oncology, Hospital of St Zoerardus Zobor, Nitra, Slovakia. 4. Department of Chest Surgery, Pest County Pulmonology Hospital, Törökbálint, Hungary. 5. Department for Respiratory Disease Jordanovic, University Hospital Centre Zagreb, Zagreb, Croatia. 6. Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland. 7. Department of Palliative Medicine, University Hospital of Pulmonology, Clinical Center of Serbia, Belgrade, Serbia. 8. Department of Medical Oncology, Military Medical Academy, Sofia, Bulgaria. 9. Department of Pulmunology, National Koranyi Institute of Pulmunology, Budapest, Hungary. 10. Department of Medicine I, Medical University of Vienna - General Hospital, Vienna, Austria and Central European Cooperative Oncology Group (CECOG) christiane.thallinger@meduniwien.ac.at. 11. Department of Oncology, University Hospital, Prague, Czech Republic. 12. Vienna Cancer Center, Medical University of Vienna - General Hospital, Vienna, Austria and Central European Cooperative Oncology Group (CECOG).
Abstract
BACKGROUND: Treatment of non-small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune-oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel drugs for NSCLC are poorly accessible in Central and Eastern European (CEE) countries. MATERIAL AND METHODS: The Central European Cooperative Oncology Group conducted a survey among experts from 10 CEE countries to provide an overview on the availability of novel drugs for NSCLC and time from registration to reimbursement decision in their countries. RESULTS: Although first-generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries, for other registered therapies-even for ALK inhibitors and checkpoint inhibitors in first-line-there were apparent gaps in availability and/or reimbursement. There was a trend for better availability of drugs with longer time from EMA marketing authorization. Substantial differences in access to novel drugs among CEE countries were observed. In general, the availability of drugs is not in accordance with the Magnitude of Clinical Benefit Scale (MCBS), as defined by the European Society for Medical Oncology (ESMO). Time spans between drug registrations and national decisions on reimbursement vary greatly, from less than 3 months in one country to more than 1 year in the majority of countries. CONCLUSION: The access to novel drugs for NSCLC in CEE countries is suboptimal. To enable access to the most effective compounds within the shortest possible time, reimbursement decisions should be faster and ESMO MCBS should be incorporated into decision making.
BACKGROUND: Treatment of non-small cell lung cancer (NSCLC) improved substantially in the last decades. Novel targeted and immune-oncologic drugs were introduced into routine treatment. Despite accelerated development and subsequent drug registrations by the European Medicinal Agency (EMA), novel drugs for NSCLC are poorly accessible in Central and Eastern European (CEE) countries. MATERIAL AND METHODS: The Central European Cooperative Oncology Group conducted a survey among experts from 10 CEE countries to provide an overview on the availability of novel drugs for NSCLC and time from registration to reimbursement decision in their countries. RESULTS: Although first-generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries, for other registered therapies-even for ALK inhibitors and checkpoint inhibitors in first-line-there were apparent gaps in availability and/or reimbursement. There was a trend for better availability of drugs with longer time from EMA marketing authorization. Substantial differences in access to novel drugs among CEE countries were observed. In general, the availability of drugs is not in accordance with the Magnitude of Clinical Benefit Scale (MCBS), as defined by the European Society for Medical Oncology (ESMO). Time spans between drug registrations and national decisions on reimbursement vary greatly, from less than 3 months in one country to more than 1 year in the majority of countries. CONCLUSION: The access to novel drugs for NSCLC in CEE countries is suboptimal. To enable access to the most effective compounds within the shortest possible time, reimbursement decisions should be faster and ESMO MCBS should be incorporated into decision making.
Authors: N I Cherny; R Sullivan; U Dafni; J M Kerst; A Sobrero; C Zielinski; E G E de Vries; M J Piccart Journal: Ann Oncol Date: 2015-05-30 Impact factor: 32.976
Authors: Eduard Vrdoljak; Gyorgy Bodoky; Jacek Jassem; Razvan A Popescu; Jozef Mardiak; Robert Pirker; Tanja Čufer; Semir Bešlija; Alexandru Eniu; Vladimir Todorović; Kateřina Kubáčková; Galia Kurteva; Zorica Tomašević; Agim Sallaku; Snezhana Smichkoska; Žarko Bajić; Branimir I Šikić Journal: Oncologist Date: 2016-07-08
Authors: Claudia Allemani; Tomohiro Matsuda; Veronica Di Carlo; Rhea Harewood; Melissa Matz; Maja Nikšić; Audrey Bonaventure; Mikhail Valkov; Christopher J Johnson; Jacques Estève; Olufemi J Ogunbiyi; Gulnar Azevedo E Silva; Wan-Qing Chen; Sultan Eser; Gerda Engholm; Charles A Stiller; Alain Monnereau; Ryan R Woods; Otto Visser; Gek Hsiang Lim; Joanne Aitken; Hannah K Weir; Michel P Coleman Journal: Lancet Date: 2018-01-31 Impact factor: 79.321