Early market access of cancer drugs in the EU.
Patient access to new cancer 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 cancer 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.
European Medicines Agency (EMA), London, UK.
J
J
Martinalbo
European Medicines Agency (EMA), London, UK.
D
D
Bowen
Spanish Agency for Medicines and Healthcare Products (AEMPS), Madrid, Spain.
J
J
Camarero
European Medicines Agency (EMA), London, UK.
M
M
Chapelin
French National Agency for Medicines and Health Products Safety (ANSM), Paris, France.
P
P
Démolis
Italian Medicines Agency (AIFA), Rome, Italy.
P
P
Foggi
Swedish Medical Products Agency (MPA), Uppsala, Sweden.
B
B
Jonsson
European Medicines Agency (EMA), London, UK.
J
J
Llinares
French National Agency for Medicines and Health Products Safety (ANSM), Paris, France.
A
A
Moreau
Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.
D
D
O'Connor
Portuguese Institute of Oncology (IPO), Lisbon, Portugal.
J
J
Oliveira
European Medicines Agency (EMA), London, UK.
S
S
Vamvakas
European Medicines Agency (EMA), London, UK francesco.pignatti@ema.europa.eu.
F
F
Pignatti
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017277:Drug Approval; D005062:European Union; D006297:Health Services Accessibility; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents
HTA; accelerated approval; adaptive pathways; conditional approval; early access