Evaluation of the disparities in trastuzumab approval, reimbursement and uptake across the 27 European Union Member States (EU-27)

composed by 27 member states (EU-27). The EU implemented several standardizations in laws,

justice and home affairs and shares the consensus that health care should be regulated by the

state. A high level of human protection should be ensured in all its member states. European

health systems are funded and managed by each national government and for historical

reasons health policy and health expenditure are not homogeneous.

Whereas cancer incidence is dependent on factors such as population age, life-style and

genetic predisposition, cancer mortality in general is dependent on the efficacy of health

systems in providing cancer prevention, efficient screening methods and treatments.

Around 20% of the breast cancers show amplification/overexpression of HER2 that is

associated with a more aggressive disease and worse clinical outcome. By targeting the HER2

receptor trastuzumab has significantly improved overall survival and changed the natural

course of this disease.

Objectives: This study aims to evaluate (1) the association of health expenditure with

breast cancer outcome, (2) to explore to which degree the differences in breast cancer survival

are related to the speed of uptake of trastuzumab and its determinants and (3) to evaluate the

real usage of trastuzumab and its relation to breast cancer survival in the EU.

Results: Breast cancer survival was found strongly correlated with health expenditure. A

clear cutoff divides Western and Eastern Europe in that regard, with western countries showing

higher health expenditure and higher breast cancer survival than Eastern Europe. Trastuzumab

reimbursement was faster in Western European countries, a factor associated with higher

health expenditure and better health policy performance. Trastuzumab uptake is increasing all

over Europe in the last 12 years, however it is still being under used in Eastern countries while

in Western Europe the uptake is sufficient to treat virtually all patients in need of the drug.

Conclusion: Important discrepancies in breast cancer survival exist in the EU. Western

Europe has higher breast cancer survival and higher health expenditure than Eastern Europe.

This can be partially explained by the faster approval and increased uptake of trastuzumab in

Western countries. Higher health expenditure and better health policy performance were

factors linked to faster reimbursement and uptake of trastuzumab.