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Volumn 8, Issue , 2014, Pages

Hurdles and delays in access to anti-cancer drugs in Europe

Author keywords

Drug uptake; European medicines agency (EMA); European Union; Marketing authorization; Prescription and compliance; Pricing and reimbursement

Indexed keywords

ANTINEOPLASTIC AGENT;

EID: 84919949607     PISSN: None     EISSN: 17546605     Source Type: Journal    
DOI: 10.3332/ecancer.2014.482     Document Type: Article
Times cited : (20)

References (49)
  • 1
    • 84919929067 scopus 로고    scopus 로고
    • ee-2012-2-en.pdf. At http://ec.europa.eu/economy-finance/publications/european-economy/2012/pdf/ee-2012-2-en.pdf
  • 2
    • 14044276281 scopus 로고    scopus 로고
    • The impact of new drug launches on longevity: Evidence from longitudinal, disease-level data from 52 countries, 1982-2001
    • PMID: 15714263
    • Lichtenberg FR (2005) The impact of new drug launches on longevity: evidence from longitudinal, disease-level data from 52 countries, 1982-2001 Int J Health Care Finance Econ 5 47-73 DOI: 10.1007/s10754-005-6601-7 PMID: 15714263
    • (2005) Int J Health Care Finance Econ , vol.5 , pp. 47-73
    • Lichtenberg, F.R.1
  • 6
    • 84896525622 scopus 로고    scopus 로고
    • Similarities and differences in the oncology drug approval process between FDA and European Union with emphasis on in vitro companion diagnostics
    • PMID:24634467
    • Senderowicz, AM & Pfaff, O Similarities and Differences in the Oncology Drug Approval Process between FDA and European Union with Emphasis on In Vitro Companion Diagnostics Clin Cancer Res 20 1445-1452 (2014) DOI: 10.1158/1078-0432. CCR-13-1761 PMID:24634467
    • (2014) Clin Cancer Res , vol.20 , pp. 1445-1452
    • Senderowicz, A.M.1    Pfaff, O.2
  • 8
    • 84881235007 scopus 로고    scopus 로고
    • Approval probabilities and regulatory review patterns for anticancer drugs in the European
    • PMID: 23433721
    • Hartmann M, Mayer-Nicolai C and Pfaff O (2013) Approval probabilities and regulatory review patterns for anticancer drugs in the European Union Crit Rev Oncol Hematol DOI: 10.1016/j.critrevonc.2013.01.004 PMID: 23433721
    • (2013) Union Crit Rev Oncol Hematol
    • Hartmann, M.1    Mayer-Nicolai, C.2    Pfaff, O.3
  • 9
    • 0036460607 scopus 로고    scopus 로고
    • The review of drug applications submitted to the European Medicines Evaluation Agency: Frequently raised objections, and outcome
    • Pignatti F et al (2007) The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcome Eur J Clin Pharmacol 58 573-80 DOI: 10.1007/s00228-002-0532-8
    • (2007) Eur J Clin Pharmacol , vol.58 , pp. 573-580
    • Pignatti, F.1
  • 10
    • 54349086618 scopus 로고    scopus 로고
    • Cancer research and development and the drug development process
    • Cancer research and development and the drug development process Ann Oncol 18 iii49-iii54
    • Ann Oncol , vol.18 , pp. iii49-iii54
  • 11
    • 0026580288 scopus 로고
    • The drug lag issue: The debate seen from an international perspective
    • PMID: 1735628
    • Andersson F (1992) The drug lag issue: the debate seen from an international perspective Int J Health Serv 22 53-72 DOI:10.2190/9Y32-X86Y-M3F0-JQFC PMID: 1735628
    • (1992) Int J Health Serv , vol.22 , pp. 53-72
    • Andersson, F.1
  • 12
    • 84876831538 scopus 로고
    • New drug approval times and safety warnings in the United States and Canada, 1992-2011
    • Rawson NS (1992) New drug approval times and safety warnings in the United States and Canada, 1992-2011 J Popul Ther Clin Pharmacol 20 e67-81
    • (1992) J Popul Ther Clin Pharmacol , vol.20 , pp. e67-81
    • Rawson, N.S.1
  • 13
    • 70349914121 scopus 로고    scopus 로고
    • Using effectiveness and cost-effectiveness to make drug coverage decisions: A comparison of Britain, Australia, and Canada
    • PMID: 19809025
    • Clement FM et al (2009) Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada JAMA 302 1437-43 DOI: 10.1001/jama.2009.1409 PMID: 19809025
    • (2009) JAMA , vol.302 , pp. 1437-1443
    • Clement, F.M.1
  • 14
    • 0029853437 scopus 로고    scopus 로고
    • Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan
    • PMID: 8946904
    • Kessler DA et al (1996) Approval of new drugs in the United States. Comparison with the United Kingdom, Germany, and Japan JAMA 276 1826-1831 DOI: 10.1001/jama.1996.03540220050030 PMID: 8946904
    • (1996) JAMA , vol.276 , pp. 1826-1831
    • Kessler, D.A.1
  • 15
    • 23844484145 scopus 로고    scopus 로고
    • The review of new drug applications in Japan: The decline in approval times after the introduction of an internalized review system
    • Ono S et al (2005) The review of new drug applications in Japan: the decline in approval times after the introduction of an internalized review system Drug Inf J 39 279-290
    • (2005) Drug Inf J , vol.39 , pp. 279-290
    • Ono, S.1
  • 16
    • 28344452694 scopus 로고    scopus 로고
    • New drug approval times and clinical evidence in Japan
    • PMID: 16122988
    • Ono S et al (2005) New drug approval times and clinical evidence in Japan Contemp Clin Trials 26 660-672 DOI: 10.1016/j.cct.2005.07.003 PMID: 16122988
    • (2005) Contemp Clin Trials , vol.26 , pp. 660-672
    • Ono, S.1
  • 17
    • 32444431722 scopus 로고    scopus 로고
    • European Union centralised procedure for marketing authorisation of oncology drugs: An in-depth review of its efficiency
    • Netzer T (2006) European Union centralised procedure for marketing authorisation of oncology drugs: an in-depth review of its efficiency Eur J Cancer 42 446-455 DOI: 10.1016/j.ejca.2005.04.045
    • (2006) Eur J Cancer , vol.42 , pp. 446-455
    • Netzer, T.1
  • 19
    • 84958241142 scopus 로고    scopus 로고
    • eds. R Magjarevic & JH Nagel Springer Berlin Heidelberg
    • Christofides S et al World Congress on Medical Physics and Biomedical Engineering 2006, eds. R Magjarevic & JH Nagel (Springer Berlin Heidelberg, 2007) pp. 3722-6. At http://link.springer.com/chapter/10.1007/978-3-540-36841-0-942 DOI: 10.1007/978-3-540-36841-0-942
    • (2007) World Congress on Medical Physics and Biomedical Engineering 2006 , pp. 3722-3726
    • Christofides, S.1
  • 21
    • 84919929060 scopus 로고    scopus 로고
    • Home
    • INAHTA - Home. At http://www.inahta.org/
    • INAHTA1
  • 27
    • 54349117527 scopus 로고    scopus 로고
    • Market access for cancer drugs and the role of health economics
    • Market access for cancer drugs and the role of health economics Ann Oncol 18 iii55-iii66 (2007)
    • (2007) Ann Oncol , vol.18 , pp. iii55-iii66
  • 30
    • 78651063688 scopus 로고    scopus 로고
    • The social value of a QALY: Raising the bar or barring the raise?
    • Donaldson C et al (2011) The social value of a QALY: raising the bar or barring the raise? BMC Health Serv Res 11 (8) DOI:10.1186/1472-6963-11-8
    • (2011) BMC Health Serv Res , vol.11 , Issue.8
    • Donaldson, C.1
  • 31
    • 84919929056 scopus 로고    scopus 로고
    • Echoutcome. At http://www.echoutcome.eu/
    • Echoutcome1
  • 32
    • 77957958434 scopus 로고    scopus 로고
    • Legislating against use of cost-effectiveness information
    • Neumann PJ and Weinstein MC (2010) Legislating against use of cost-effectiveness information N Eng J Med 363 1495-7 DOI:10.1056/NEJMp1007168
    • (2010) N Eng J Med , vol.363 , pp. 1495-1497
    • Neumann, P.J.1    Weinstein, M.C.2
  • 33
    • 77957123635 scopus 로고    scopus 로고
    • Time to market and patient access to new oncology products in Italy: A multistep pathway from European context to regional health care providers
    • PMID: 20335370
    • Russo P et al (2010) Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers Ann Oncol 21 2081-7 DOI: 10.1093/annonc/mdq097 PMID: 20335370
    • (2010) Ann Oncol , vol.21 , pp. 2081-2087
    • Russo, P.1
  • 35
    • 84871874725 scopus 로고    scopus 로고
    • The high cost of cancer drugs and what we can do about it
    • PMID: 23036669 PMCID: 3538397
    • Siddiqui M and Rajkumar SV (2012) The high cost of cancer drugs and what we can do about it Mayo Clin Proc 87 935-43 DOI:10.1016/j.mayocp. 2012.07.007 PMID: 23036669 PMCID: 3538397
    • (2012) Mayo Clin Proc , vol.87 , pp. 935-943
    • Siddiqui, M.1    Rajkumar, S.V.2
  • 36
    • 84919929054 scopus 로고    scopus 로고
    • What we do | About | NICE. At http://www.nice.org.uk/about/what-we-do
  • 38
    • 67651160419 scopus 로고    scopus 로고
    • Medical bankruptcy in the United States, 2007: Results of a national study
    • PMID: 19501347
    • Himmelstein DU et al (2009) Medical bankruptcy in the United States, 2007: results of a national study Am J Med 122 741-6 DOI:10.1016/j.amjmed.2009.04.012 PMID: 19501347
    • (2009) Am J Med , vol.122 , pp. 741-746
    • Himmelstein, D.U.1
  • 39
    • 25844477670 scopus 로고    scopus 로고
    • Medicare and cost-effectiveness analysis
    • PMID: 16207857
    • Neumann PJ, Rosen AB and Weinstein MC (2005) Medicare and cost-effectiveness analysis N Engl J Med 353 1516-22 DOI:10.1056/NEJMsb050564 PMID: 16207857
    • (2005) N Engl J Med , vol.353 , pp. 1516-1522
    • Neumann, P.J.1    Rosen, A.B.2    Weinstein, M.C.3
  • 42
    • 33746926720 scopus 로고    scopus 로고
    • Emerging lessons from the drug effectiveness review project
    • Neumann PJ (2006) Emerging lessons from the drug effectiveness review project Health Aff (Millwood) 25 W262-71 DOI: 10.1377/hlthaff.25.w262
    • (2006) Health Aff (Millwood) , vol.25 , pp. W262-W271
    • Neumann, P.J.1
  • 43
    • 77954629858 scopus 로고    scopus 로고
    • The role of the U. S. Food and Drug Administration review process: Clinical trial endpoints in oncology
    • PMID: 20237212
    • McKee AE et al (2010) The role of the U. S. Food and Drug Administration review process: clinical trial endpoints in oncology Oncologist 15 Suppl 1 13-18 DOI: 10.1634/theoncologist.2010-S1-13 PMID: 20237212
    • (2010) Oncologist , vol.15 , pp. 13-18
    • McKee, A.E.1
  • 45
    • 84883167013 scopus 로고    scopus 로고
    • Legal foundations of adaptive licensing
    • PMID:23963219
    • Oye K et al (2013) Legal foundations of adaptive licensing Clin Pharmacol Ther 94 309-311 DOI: 10.1038/clpt.2013.95 PMID:23963219
    • (2013) Clin Pharmacol Ther , vol.94 , pp. 309-311
    • Oye, K.1
  • 46
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: Taking the next step in the evolution of drug approval
    • PMID: 22336591
    • Eichler H-G et al (2012) Adaptive licensing: taking the next step in the evolution of drug approval Clin Pharmacol Ther 91 426-37 DOI: 10.1038/clpt.2011.345 PMID: 22336591
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 426-437
    • Eichler, H.-G.1
  • 47
    • 0021734387 scopus 로고
    • Compliance with chemotherapy among breast cancer patients
    • PMID: 6536503
    • Taylor SE, Lichtman RR and Wood JV (1984) Compliance with chemotherapy among breast cancer patients Health Psychol 3 553-62 DOI: 10.1037/0278-6133.3.6.553 PMID: 6536503
    • (1984) Health Psychol , vol.3 , pp. 553-562
    • Taylor, S.E.1    Lichtman, R.R.2    Wood, J.V.3
  • 48
    • 0036566758 scopus 로고    scopus 로고
    • Adherence to therapy with oral antineoplastic agents
    • PMID: 11983753
    • Partridge AH et al (2002) Adherence to therapy with oral antineoplastic agents J Natl Cancer Inst 94 652-61 DOI: 10.1093/jnci/94.9.652 PMID: 11983753
    • (2002) J Natl Cancer Inst , vol.94 , pp. 652-661
    • Partridge, A.H.1
  • 49
    • 34247154393 scopus 로고    scopus 로고
    • Adherence to endocrine therapy for breast cancer
    • Chlebowski RT and Geller ML (2006) Adherence to endocrine therapy for breast cancer Oncology 71 1-9
    • (2006) Oncology , vol.71 , pp. 1-9
    • Chlebowski, R.T.1    Geller, M.L.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.