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Updated: Dec 26, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Access to Novel Drugs for Non-Small Cell Lung Cancer in Central and Southeastern Europe: A Central European
Tanja Cufer1, Tudor E Ciuleanu2, Peter Berzinec3
1Medical Faculty Ljubljana, University Clinic Golnik, Ljubljana, Slovenia.
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.
Insights
Novel cancer drugs for non-small cell lung cancer (NSCLC) show limited access in Central and Eastern European countries, despite EMA approval. Faster reimbursement decisions and incorporating clinical benefit scales are crucial for timely patient access.
Area of Science:
- Oncology
- Pharmacoeconomics
- Public Health
Background:
- Non-small cell lung cancer (NSCLC) treatment has advanced with novel targeted and immune therapies.
- Despite regulatory approvals by the European Medicines Agency (EMA), access to these drugs is challenging in Central and Eastern European (CEE) countries.
Purpose of the Study:
- To survey experts in 10 CEE countries regarding the availability of novel NSCLC drugs.
- To assess the time from EMA registration to national reimbursement decisions for these therapies.
Main Methods:
- A survey was conducted among oncology experts across 10 Central and Eastern European countries.
- Data collected focused on the availability and reimbursement status of novel NSCLC drugs.
Main Results:
- First-generation EGFR tyrosine kinase inhibitors are widely available, but other novel therapies, including ALK inhibitors and first-line checkpoint inhibitors, show significant access gaps.
- Drug availability generally correlates with longer times since EMA marketing authorization, with substantial inter-country variations.
- Observed drug availability does not consistently align with the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale (ESMO MCBS).
Conclusions:
- Patient access to novel NSCLC drugs in CEE countries is suboptimal.
- Expediting reimbursement decisions and integrating the ESMO MCBS into the decision-making process are recommended to improve timely access to effective treatments.
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