Early market access of cancer drugs in the EU
- 20 October 2015
- journal article
- review article
- Published by Elsevier BV in Annals Of Oncology
- Vol. 27 (1), 96-105
- https://doi.org/10.1093/annonc/mdv506
Abstract
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.This publication has 44 references indexed in Scilit:
- Why do cancer drugs get such an easy ride?BMJ, 2015
- Pricing in the Market for Anticancer DrugsJournal of Economic Perspectives, 2015
- American Society of Clinical Oncology Perspective: Raising the Bar for Clinical Trials by Defining Clinically Meaningful OutcomesJournal of Clinical Oncology, 2014
- Cancer Drugs in the United States: Justum Pretium—The Just PriceJournal of Clinical Oncology, 2013
- The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML expertsPublished by American Society of Hematology ,2013
- The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug RegulationClinical Cancer Research, 2011
- Bridging the efficacy–effectiveness gap: a regulator's perspective on addressing variability of drug responseNature Reviews Drug Discovery, 2011
- Oncogenic Targets, Magnitude of Benefit, and Market Pricing of Antineoplastic DrugsJournal of Clinical Oncology, 2011
- Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemmaNature Reviews Drug Discovery, 2008
- The political logic of regulatory errorNature Reviews Drug Discovery, 2005