Early market access of oncologic drugs in the EU
Cet article décrit les mécanismes européens permettant d'accélérer le processus d'autorisation de mise sur le marché de médicaments anti-cancéreux répondant à des besoins médicaux non satisfaits et compare les décisions prises en matière de remboursement dans les principaux marchés de l'Union Européenne
Patient access to new oncologic drugs in the EU involves centralised licensing decisions by regulators as well as reimbursement recommendations in the context of national healthcare systems. Differences in assessment criteria and evidence requirements may result in divergent decisions at central and national levels, ultimately compromising effective access to patients. Early access decisions are particularly challenging due to the limited clinical evidence available to conclude on the benefit-risk and relative (cost-) effectiveness of new high-priced oncologic drugs. We describe mechanisms to accelerate approval of promising anticancer drugs that fulfil an unmet medical need, review the experience from the European Medicines Agency, compare timelines and outcomes of reimbursement decisions in major EU markets, and discuss shortcomings of the current system, ongoing initiatives and future steps to facilitate effective early access.
Annals of Oncology 2015