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Volumn 7, Issue 1, 2012, Pages

Paying for the Orphan Drug System: Break or bend? Is it time for a new evaluation system for payers in Europe to take account of new rare disease treatments?

Author keywords

[No Author keywords available]

Indexed keywords

ORPHAN DRUG;

EID: 84866564048     PISSN: None     EISSN: 17501172     Source Type: Journal    
DOI: 10.1186/1750-1172-7-74     Document Type: Article
Times cited : (139)

References (33)
  • 2
    • 84874464450 scopus 로고    scopus 로고
    • Orphanet: http://www.orpha.net/consor/cgi-bin/Drugs-ListOrphanDrugs.php? lng=EN
    • Community Register http://ec.europa.eu/health/documents/community- register/html/index-en.htm, Orphanet: http://www.orpha.net/consor/cgi-bin/Drugs- ListOrphanDrugs.php?lng=EN
    • Community Register
  • 4
    • 84874502077 scopus 로고    scopus 로고
    • Joint EBE and EuropaBio statement: http://www.europabio.org/healthcare/ press/ebe-and-europabio-hail-eu-orphan-medicinal-products-regulation-success
    • EURORDIS statement http://www.eurordis.org/content/celebrating-10-years- orphan-drug-regulation-europe; Joint EBE and EuropaBio statement: http://www.europabio.org/healthcare/press/ebe-and-europabio-hail-eu-orphan- medicinal-products-regulation-success
    • EURORDIS Statement
  • 5
    • 84874497342 scopus 로고    scopus 로고
    • Orphan legislation does more good than harm, 7 December 2010, Rapid response to Article
    • Published 16 November 2010
    • Orphan legislation does more good than harm, 7 December 2010, Rapid response to Article "The problem of orphan drugs. Hall A, 341 2010 c6456 Published 16 November 2010," [ http://www.bmj.com/content/341/bmj.c6456? tab=responses ]
    • (2010) The Problem of Orphan Drugs , vol.341 , pp. 6456
    • Hall, A.1
  • 7
    • 84874451032 scopus 로고    scopus 로고
    • For France, other tax exemption authorised by EU in 2002 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2002:284:0002:0002: EN:PDF
    • For Belgium: law of 10 June 2006 (state aid authorised by the EU until 31/12/2013) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:229: 0005:0008:EN:PDF. For France, other tax exemption authorised by EU in 2002 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2002:284:0002:0002: EN:PDF
    • For Belgium: Law of 10 June 2006 (State Aid Authorised by the EU until 31/12/2013)
  • 10
    • 77953354292 scopus 로고    scopus 로고
    • Budget impact analysis of orphan drugs in Belgium: Estimates from 2008 to 2013
    • Budget impact analysis of orphan drugs in Belgium: estimates from 2008 to 2013. Denis, et al. J Med Eco 2010 2 295 301
    • (2010) J Med Eco , vol.2 , pp. 295-301
    • Denis1
  • 11
    • 77953354292 scopus 로고    scopus 로고
    • Policies for Rare Diseases and Orphan Drugs. KCE Report 112C 2009, Also published as: Denis A, Mergaert L, Fostier C, Cleemput I, Simoens S. Budget impact analysis of orphan drugs in Belgium: Estimates from 2008 to 2013
    • Federal Centre For Healthcare Belgian Health Care Knowledge Centre 10.3111/13696998.2010.491427 20482245
    • Policies for Rare Diseases and Orphan Drugs. KCE Report 112C" 2009, Also published as: Denis A, Mergaert L, Fostier C, Cleemput I, Simoens S. "Budget impact analysis of orphan drugs in Belgium: estimates from 2008 to 2013. Belgian Federal Centre for Healthcare Belgian Health Care Knowledge Centre, J Med Econ 2010 13 2 295 301 10.3111/13696998.2010.491427 20482245
    • (2010) J Med Econ , vol.13 , Issue.2 , pp. 295-301
  • 12
    • 79959415264 scopus 로고    scopus 로고
    • ALCIMED, Phase I, 2004
    • ALCIMED, Study on orphan drugs 2004 Phase I, 2004 http://ec.europa.eu/ health/files/orphanmp/doc/pricestudy/final-final-report-part-1-web-en.pdf
    • (2004) Study on Orphan Drugs
  • 13
    • 77956289514 scopus 로고    scopus 로고
    • Global spending on orphan drugs in France, Germany, the UK, Italy and Spain during 2007
    • Global spending on orphan drugs in France, Germany, the UK, Italy and Spain during 2007. Orofino, et al. Appl Health Econ Health Policy 2010 8 5
    • (2010) Appl Health Econ Health Policy , vol.8 , pp. 5
    • Orofino1
  • 14
    • 80053379101 scopus 로고    scopus 로고
    • Estimating the budget impact of orphan medicines in Europe: 2010 - 2020
    • 10.1186/1750-1172-6-62 21951518
    • Estimating the budget impact of orphan medicines in Europe: 2010-2020. Carina S, Tsveta M, Adam H, Orphanet J Rare Dis 2011 6 62 10.1186/1750-1172-6-62 21951518
    • (2011) Orphanet J Rare Dis , vol.6 , pp. 62
    • Carina, S.1    Tsveta, M.2    Adam, H.3
  • 15
    • 33947712686 scopus 로고    scopus 로고
    • Stratified medicine: Strategic and economic implications of combining drugs and clinical biomarkers
    • DOI 10.1038/nrd2251, PII NRD2251
    • Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Trusheim MR, Berndt ER, Douglas FL, Nat Rev Drug Discov 2007 6 4 287 293 10.1038/nrd2251 17380152 (Pubitemid 46505879)
    • (2007) Nature Reviews Drug Discovery , vol.6 , Issue.4 , pp. 287-293
    • Trusheim, M.R.1    Berndt, E.R.2    Douglas, F.L.3
  • 17
    • 78449275391 scopus 로고    scopus 로고
    • Orphan drug pricing may warrant a competition law investigation
    • published 16 November 2010 10.1136/bmj.c6471
    • Orphan drug pricing may warrant a competition law investigation. Roos JC, Hyry HI, Cox TM, BMJ 2010 341 published 16 November 2010 10.1136/bmj.c6471
    • (2010) BMJ , vol.341
    • Roos, J.C.1    Hyry, H.I.2    Cox, T.M.3
  • 18
    • 79958849417 scopus 로고    scopus 로고
    • Pricing & Reimbursement of Orphan Drugs: The need for more transparency
    • 17 June 2011 10.1186/1750-1172-6-42 21682893
    • Pricing & Reimbursement of Orphan Drugs: the need for more transparency. Simoens S, Orphanet J Rare Dis 2011 6 42 17 June 2011 10.1186/1750-1172-6-42 21682893
    • (2011) Orphanet J Rare Dis , vol.6 , pp. 42
    • Simoens, S.1
  • 19
    • 84874492644 scopus 로고    scopus 로고
    • European Commission, Research and Innovation-Health, International Rare Diseases Research Consortium http://ec.europa.eu/research/health/medical- research/rare-diseases/irdirc-en.html
    • International Rare Diseases Research Consortium
  • 20
    • 20044366257 scopus 로고    scopus 로고
    • Endothelin antagonism in pulmonary hypertension, heart failure, and beyond
    • DOI 10.1136/hrt.2004.053991
    • Endothelin antagonism in pulmonary hypertension, heart failure, and beyond. Attina T, Camidge R, Newby DE, Webb DJ, Heart 2005 91 6 825 831 10.1136/hrt.2004.053991 15894792 (Pubitemid 40769240)
    • (2005) Heart , vol.91 , Issue.6 , pp. 825-831
    • Attina, T.1    Camidge, R.2    Newby, D.E.3    Webb, D.J.4
  • 21
    • 84872215217 scopus 로고    scopus 로고
    • What price do we pay for repurposing medicines for rare diseases?
    • 4th January 2012
    • What price do we pay for repurposing medicines for rare diseases? Simoens S, Picavet E, Cassiman D, Dooms M, Brit Med J 2012 4th January 2012 http://www.bmj.com/rapid-response/2011/11/27/re-orphan-diseases-which-ones-do- we-adopt
    • (2012) Brit Med J
    • Simoens, S.1    Picavet, E.2    Cassiman, D.3    Dooms, M.4
  • 24
    • 80052487434 scopus 로고    scopus 로고
    • Are some orphan drugs for rare diseases too expensive? A study of purchase versus compounding costs
    • 10.2165/11601640-000000000-00000
    • Are some orphan drugs for rare diseases too expensive? A study of purchase versus compounding costs. Simoens S, Cassiman D, Picavet E, Dooms M, Drugs Ther Perspect 2011 27 10 24 26 10.2165/11601640-000000000-00000
    • (2011) Drugs Ther Perspect , vol.27 , Issue.10 , pp. 24-26
    • Simoens, S.1    Cassiman, D.2    Picavet, E.3    Dooms, M.4
  • 27
    • 34447263989 scopus 로고    scopus 로고
    • (DRAFT v3)
    • National Institute for Health and Clinical Excellence (NICE), Appraising Orphan Drugs http://www.nice.org.uk/niceMedia/pdf/smt/120705item4.pdf (DRAFT v3)
    • Appraising Orphan Drugs
  • 28
    • 33748604772 scopus 로고    scopus 로고
    • Priority setting of health interventions: The need for multi-criteria decision analysis
    • DOI 10.1186/1478-7547-4-14
    • Priority setting of health interventions: the need for multi-criteria decision analysis. Baltussen R, Niessen L, Cost Eff Resour Alloc 2006 4 14 10.1186/1478-7547-4-14 16923181 (Pubitemid 44377737)
    • (2006) Cost Effectiveness and Resource Allocation , vol.4 , pp. 14
    • Baltussen, R.1    Niessen, L.2
  • 30
    • 0003187521 scopus 로고    scopus 로고
    • Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products
    • 22.01.2000
    • Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. Article 3(1)(a) European Parliament, Off J Eur Communities 2000 L18 2 3 http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF, 22.01.2000
    • (2000) Off J Eur Communities , vol.18 , pp. 2-3
  • 31
    • 84874477321 scopus 로고    scopus 로고
    • Presentation at European Conference on Rare Diseases & Orphan Drugs 23237499
    • Lange S, IQWiG's approach in Germany Presentation at European Conference on Rare Diseases & Orphan Drugs 2012 http://www.rare-diseases.eu/2012/ Second-Day-Programme 23237499
    • (2012) IQWiG's Approach in Germany
    • Lange, S.1
  • 32
    • 77950937284 scopus 로고    scopus 로고
    • The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?
    • Epub 2009 Dec 29 20036435
    • The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity? Wellman-Labadie O, Zhou Y, Health Policy 2009 95 2-3 216 228 Epub 2009 Dec 29 20036435
    • (2009) Health Policy , vol.95 , Issue.2-3 , pp. 216-228
    • Wellman-Labadie, O.1    Zhou, Y.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.