Information on
Licensed Treatments
Definition
What is a licensed treatment?
In the context of this European online advocacy tool, the term 'licensed treatment' refers to a medicine approved for the treatment of lung cancer by one of the following regulatory authorities:
Each regulatory authority has its own processes and timelines for licensing novel therapies. In Europe, it is important to note that obtaining a marketing authorisation from the EMA does not automatically guarantee that a medicine will be available in every country. Access may be delayed by factors such as market conditions, pricing negotiations, reimbursement decisions, and health technology assessment (HTA) requirements.
A major change to the HTA landscape was introduced by the European Commission in January 2022, when it adopted a regulation establishing a joint approach to clinical assessments across the European Union. Under the new Joint Clinical Assessment (JCA) process, a single assessment of a treatment's clinical benefit will be produced and used as the basis for decision-making across all 27 EU member states.
The JCA replaces the voluntary EUnetHTA 21, which ended operations in September 2023. Implementation began in January 2025 with assessments of cancer therapies, will expand to orphan medicines in January 2028, and will cover remaining drug classes from January 2030 onward (Johns et al, 2025).
Despite these reforms, differences in national pricing, reimbursement, and healthcare policies may still affect how quickly licensed treatments become available to patients in different European countries.
Clinical guidance
Where can I find current European guidelines on licensed treatments for lung cancer?
The European Society for Medical Oncology (ESMO) has developed interactive clinical practice guidelines for different types of lung cancer, including:
- Non-small-cell lung cancer (NSCLC)
- Early-stage and locally advanced (non-metastatic) NSCLC
- Oncogene-addicted metastatic NSCLC
- Non-oncogene-addicted metastatic NSCLC
- Small-cell lung cancer (SCLC)
These can be viewed and downloaded via the ESMO website, alongside patient guides, webinars and other guideline-related resources. Patient guides are available in multiple languages.
For many European countries, national guidelines are also available. These do not always align with the ESMO recommendations.
For lung cancer screening programmes across Europe, see:
Interactive Map of Lung Cancer Screening →
Equity & Access
What are the drivers of unequal access to licensed treatments across European countries?
Precision cancer care relies on a highly complex clinical pathway, and it often takes a long time for advances in diagnostic and therapeutic technologies to filter down to cancer clinics. The pace of adoption is limited by multiple financial, organisational, and regulatory hurdles. Examples include:
- Lack of harmonised European treatment guidelines, standardised quality indicators and uniform national lung cancer treatment plans
- Limited implementation of multidisciplinary tumour boards
- Lack of harmonised Health Technology Assessment pathways to promote access to innovation in lung cancer treatment across Europe
- Lack of reimbursement for some diagnostic and therapeutic technologies
- Limited expanded access and compassionate use programmes to promote access to treatments that are licensed but not yet reimbursed
- Limited availability of comprehensive molecular profiling, which in turn limits access to treatments targeting certain mutations and other actionable biomarkers
- Limited availability of other diagnostic technologies, for example imaging and imaging-guided diagnostics, and delay in access to biopsy
- Limited access to modern radiotherapy equipment
- Limited patient involvement in decision-making processes, infrastructure and staffing, both at the national and European levels
In our 2020 position paper, Lung Cancer Europe laid out ten proposals to improve the situation across Europe and further the aims of Europe's Beating Cancer Plan. Many of these proposals are in line with the European Cancer Organisation's essential requirements for quality lung cancer care (ECO, 2020) and the 'Leave No One Behind' action report (Aapro 2021).
Lung Cancer Europe encourages European institutions, national governments, regulatory agencies, and the pharmaceutical industry to implement the proposals laid out in these documents. Our vision is to ensure that everyone living in Europe with lung cancer has the same access to the best diagnostic procedures, treatments, and care as possible, without inequity.
Patient impact
The role of financial toxicity in inequitable access to licensed treatments
The Lung Cancer Europe Access to Treatment Atlas currently includes information on nearly 50 branded treatments (over 30 active substances) licensed for lung cancer in Europe.
Newer lung cancer drugs are helping patients to live longer and with a better quality of life, but in many European countries there remain significant barriers. In some countries, particularly in Eastern Europe, many licensed treatments are not reimbursed, or are available only when paid for by pharmaceutical companies or as an out-of-pocket expense (8th Lung Cancer Europe Report 2024).
Approximately two-thirds (67.5%) of patients and caregivers surveyed by Lung Cancer Europe said that financial difficulties had a negative effect on their mental health (8th LuCE Report 2024).
For more information, read the Lung Cancer Europe report or the ALK-positive specific report.
Source: 8th Lung Cancer Europe Report 2024
Table 1. Services impacted due to impact of lung cancer on personal finances
(n = 711 people with LC / n = 279 caregivers) · 8th LuCE Report 2024
| Ukraine | Poland | Greece | Spain | Finland | Croatia | Denmark | Germany | United Kingdom | Netherlands | France | Italy | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Access to supportive services | 58.8% | 70.0% | 59.0% | 50.0% | 28.6% | 31.8% | 37.5% | 38.5% | 20.2% | 34.8% | 37.3% | 15.8% |
| Access to early or rapid diagnosis | 63.5% | 70.0% | 47.4% | 38.1% | 44.4% | 39.1% | 29.3% | 15.8% | 29.6% | 14.5% | 16.4% | 23.7% |
| Access to innovative treatments | 94.3% | 40.0% | 53.7% | 23.4% | 31.8% | 20.8% | 19.1% | 25.6% | 21.4% | 13.0% | 13.4% | 5.3% |
| Access to clinical trials | 65.4% | 50.0% | 43.6% | 21.9% | 27.0% | 9.1% | 14.6% | 14.3% | 6.1% | 11.6% | 6.0% | 2.6% |
Explore
Exploring the Lung Cancer Europe Access to Treatment Atlas
Every effort is made to ensure that the Lung Cancer Europe Access to Treatment Atlas accurately reflects access to licensed lung cancer treatments at the country level. However, disparities in access also exist within countries, at the local or regional level, and the Atlas may not accurately reflect these variations.
Click here to explore the Atlas. You can filter the database by medicine, by country or by selecting other parameters including biomarker, lung cancer type, stage of disease and line of treatment.
Access to treatment may also be possible through clinical trials:
accelerating-clinical-trials.europa.eu →
Interactive Clinical Trials Map →
Ready to explore the Atlas?
Start comparing treatment access across Europe through our interactive map.
Open the Atlas How to use the AtlasReferences
- Aapro M, Lievens Y, Baird AM, et al., January 2021. Leave No One Behind – Delivering Innovation in Lung Cancer Care. European Cancer Organisation; Brussels. Free full text
- Berghmans T, Lievens Y, Aapro M, et al. European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCC): Lung cancer. Lung Cancer. 2020:150:221-239. Full text
- Johns A, Andrade A, Johal S, Ryan J. EU Joint Clinical Assessment: A Framework for Optimising Use with Cost-Effectiveness Decision-Making. J Mark Access Health Policy. 2025;13(4):52.
- Lung Cancer Europe, December 2022. Call to Action: Fighting lung cancer together as equals. Free full text
- Lung Cancer Europe, November 2023. 8th Edition Of The LuCE Report – Financial Impact Of Lung Cancer: A European Perspective. Free full text
- Manxhuka B, Gustafsson A, Hofmarcher T; IHE, April 2024. Patient access to treatment in advanced NSCLC – Are European health systems ready to measure what matters? Free full text