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Annals of Oncology Advance Access published online on October 14, 2008
Annals of Oncology, doi:10.1093/annonc/mdn603
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

review

Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective

C. McCabe1, L. Bergmann2, N. Bosanquet3, M. Ellis4, H. Enzmann5, M. von Euler6, B. Jönsson7, K-J. Kallen8, D. Newling9, V. Nüssler10, B. Paschen11, R. de Wilde12, N. Wilking13, C. Teale14, H. Zwierzina15,* and Biotherapy Development Association

1 Leeds Institute of Health Sciences, Leeds, UK
2 Cancer Center Rhein-Main, J.W. Goethe University, Frankfurt, Germany
3 Department of Health Policy, Imperial College, London
4 Biotherapy Development Association, Cranleigh, Surrey, UK
5 Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany
6 Pharma Development Clinical Oncology, Roche, Welwyn Garden City, UK
7 Medical Products Agency, Uppsala, Sweden
8 Global Clinical Development Unit, Oncology, Merck Serono KGaA, Darmstadt, Germany
9 Medical Director Urology, AstraZeneca, Alderley Park, Macclesfield, UK
10 Department of Medical Oncology, Ludwig-Maximilians University, Munich
11 Department of Pricing and Reimbursement, Merck Serono KGaA, Darmstadt, Germany
12 Department of Pricing and Reimbursement, Johnson & Johnson Pharmaceutical Services, Beerse, Belgium
13 Department of Oncology & Pathology, Karolinska Institutet, Stockholm, Sweden
14 Global Marketing, AstraZeneca, Alderley Park Macclesfield, UK
15 Medical University, Innsbruck, Austria

* Correspondence to: Prof. H. Zwierzina, Medizinische Universitätsklinik, Anichstrasse 35, A-6020 Innsbruck, Austria. Tel: +43 512 504 24206; Fax: +43 512 504 24209; E-mail: heinz.zwierzina{at}i-med.ac.at

To air challenging issues related to patient and market access to new anticancer agents, the Biotherapy Development Association—an international group focused on developing targeted cancer therapies using biological agents—convened a meeting on 29 November 2007 in Brussels, Belgium. The meeting provided a forum for representatives of pharmaceutical companies and academia to interact with European regulatory and postregulatory agencies. The goal was to increase all parties' understanding of their counterparts' roles in the development, licensure, and appraisal of new agents for cancer treatment, events guided by an understanding that cancer patients should have rapid and equitable access to life-prolonging treatments. Among the outcomes of the meeting were a greater understanding of the barriers facing drug developers in an evolving postregulatory world, clarity about what regulatory and postregulatory bodies expect to see in dossiers of new anticancer agents as they contemplate licensure and reimbursement, and several sets of recommendations to optimize patients' access to innovative, safe, effective, and fairly priced cancer treatments.

cost effectiveness, drug approval, health-care access, health expenditures, innovative therapies, oncology

Received for publication June 5, 2008. Revision received August 1, 2008. Accepted for publication August 5, 2008.


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