Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European Cooperative Oncology Group Analysis
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Research Support, Non-U.S. Gov't
PubMed
32162818
PubMed Central
PMC7066717
DOI
10.1634/theoncologist.2019-0523
Knihovny.cz E-resources
- MeSH
- Pharmaceutical Preparations * MeSH
- Medical Oncology MeSH
- Humans MeSH
- Lung Neoplasms * drug therapy MeSH
- Carcinoma, Non-Small-Cell Lung * drug therapy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Pharmaceutical Preparations * MeSH
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.
Department for Respiratory Disease Jordanovic University Hospital Centre Zagreb Zagreb Croatia
Department of Chest Surgery Pest County Pulmonology Hospital Törökbálint Hungary
Department of Medical Oncology Military Medical Academy Sofia Bulgaria
Department of Medical Oncology Prof Dr Ion Chiricuta Institute of Oncology Cluj Napoca Romania
Department of Oncology and Radiotherapy Medical University of Gdansk Gdansk Poland
Department of Oncology Hospital of St Zoerardus Zobor Nitra Slovakia
Department of Oncology University Hospital Prague Czech Republic
Department of Pulmunology National Koranyi Institute of Pulmunology Budapest Hungary
Medical Faculty Ljubljana University Clinic Golnik Ljubljana Slovenia
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Bray F, Ferlay J, Soerjomataram I et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394–424. PubMed
Allemani C, Matsuda T, Di Carlo V et al. Global surveillance of trends in cancer survival 2000‐14 (CONCORD‐3): Analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population‐based registries in 71 countries. Lancet 2018;391:1023–1075. PubMed PMC
Planchard D, Popat S, Kerr K et al. Metastatic non‐small‐cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow‐up. Ann Oncol 2018;29(suppl 4):iv192–iv237. PubMed
Ferrera R, Mezquita L, Besse B. Progress in the management of advanced thoracic malignancies in 2017. J Thorac Oncol 2018;13:301–322. PubMed
Cherny N, Sullivan R, Torode J et al. ESMO European Consortium Study on the availability, out‐of‐pocket costs and accessibility of antineoplastic medicines in Europe. Ann Oncol 2016;27:1423–1443. PubMed
Vrdoljak E, Bodoky G, Jassem J et al. Cancer control in Central and Eastern Europe: Current situation and recommendations for improvement. The Oncologist 2016;21:1183–1190. PubMed PMC
Ryska A, Buiga R, Fakirova A et al. Non‐small cell lung cancer in countries of Central and Southeastern Europe: Diagnostic procedures and treatment reimbursement surveyed by the Central European Cooperative Oncology Group. The Oncologist 2018;23:e152–e158. PubMed PMC
Cherny N, Sullivan R, Dafni U et al. A standardized, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti‐cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO‐MCBS). Ann Oncol 2015;26:1547–1573. PubMed
Hammerman A, Greenberg‐Dotan S, Feldhamer I et al. The ESMO‐Magnitude of Clinical Benefit Scale for novel oncology drugs: Correspondence with three years of reimbursement decisions in Israel. Expert Rev Pharmacoecon Outcomes Res 2018;18:119–122. PubMed
Vrdoljak E, Bodoky G, Jassem J et al. Expenditures on oncology drugs and cancer mortality‐to‐incidence ratio in Central and Eastern Europe. The Oncologist 2019;24:30–37. PubMed PMC