Felipe Ades1, Chistelle Senterre2, Dimitrios Zardavas3, Evandro de Azambuja1, Razvan Popescu4, Florence Parent5, Martine Piccart6. 1. Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Boulevard de Waterloo 121 (7th Floor), 1000 Brussels, Belgium. 2. Research Center of Epidemiology, Biostatistics and Clinical Research, School of Public Health, Université Libre de Bruxelles, Campus Erasme - CP598, Route de Lennik 808, 1070 Brussels, Belgium. 3. Breast International Group Headquarters (BIG-aisbl), Brussels, Belgium. 4. Department of Medical Oncology, Hirslanden Clinic Aarau, Schänisweg, 5001 Aarau, Switzerland. 5. Research Center of Social Approaches of Health, School of Public Health, Université Libre de Bruxelles, Campus Erasme - CP 596, Route de Lennik, 808, 1070 Brussels, Belgium. 6. Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Boulevard de Waterloo 121 (7th Floor), 1000 Brussels, Belgium. Electronic address: martine.piccart@bordet.be.
Abstract
BACKGROUND: The European Union (EU) has adopted a common procedure for granting marketing authorisation for cancer drugs. Nevertheless, pricing and reimbursement decisions are a competency of EU national governments, and their policies are diverse. We aimed to evaluate the time for trastuzumab reimbursement approval and its association to health expenditure, to health policy performance, to the availability of cost-effectiveness studies and to breast cancer outcome. METHODS: Breast cancer outcome was estimated by the mortality/incidence (M/I) ratio. Trastuzumab reimbursement approval dates were provided by Roche. Spearman's rank correlation and Wilcoxon rank-sum test were used to evaluate associations and/or differences between the variables studied. Additional analyses were made by grouping countries according to compliance to the 180 day timeframe stipulated in the EU 89/105/EEC Directive for drug pricing and reimbursement. RESULTS: A statistically significant inverse and strong correlation between breast cancer M/I ratio and health expenditure (r(s)=-0.730, p<0.001) and health policy performance (r(s)=-0.711, p<0.001) was found, meaning the better the score and the higher the expenditure, the fewer patients died after a breast cancer diagnosis. Factors associated with trastuzumab faster reimbursement and compliance to the 89/105/EEC Directive were better health policy score, higher health expenditure and availability of cost-effectiveness studies. CONCLUSION: Higher health policy scores and health expenditure are associated with faster reimbursement of trastuzumab and better breast cancer outcome. Although the study design does not allow inference of causal associations, a marked difference is observed between Eastern and Western Europe, with long delays and increased breast cancer mortality identified in Eastern European countries.
BACKGROUND: The European Union (EU) has adopted a common procedure for granting marketing authorisation for cancer drugs. Nevertheless, pricing and reimbursement decisions are a competency of EU national governments, and their policies are diverse. We aimed to evaluate the time for trastuzumab reimbursement approval and its association to health expenditure, to health policy performance, to the availability of cost-effectiveness studies and to breast cancer outcome. METHODS:Breast cancer outcome was estimated by the mortality/incidence (M/I) ratio. Trastuzumab reimbursement approval dates were provided by Roche. Spearman's rank correlation and Wilcoxon rank-sum test were used to evaluate associations and/or differences between the variables studied. Additional analyses were made by grouping countries according to compliance to the 180 day timeframe stipulated in the EU 89/105/EEC Directive for drug pricing and reimbursement. RESULTS: A statistically significant inverse and strong correlation between breast cancer M/I ratio and health expenditure (r(s)=-0.730, p<0.001) and health policy performance (r(s)=-0.711, p<0.001) was found, meaning the better the score and the higher the expenditure, the fewer patients died after a breast cancer diagnosis. Factors associated with trastuzumab faster reimbursement and compliance to the 89/105/EEC Directive were better health policy score, higher health expenditure and availability of cost-effectiveness studies. CONCLUSION: Higher health policy scores and health expenditure are associated with faster reimbursement of trastuzumab and better breast cancer outcome. Although the study design does not allow inference of causal associations, a marked difference is observed between Eastern and Western Europe, with long delays and increased breast cancer mortality identified in Eastern European countries.
Authors: Zoltán Kaló; Adrian Gheorghe; Mirjana Huic; Marcell Csanádi; Finn Boerlum Kristensen Journal: Health Econ Date: 2016-01-14 Impact factor: 3.046