Clearing up the hazy road from bench to bedside: A framework for integrating the fourth hurdle into translational medicine

BMC Health Services Research

Volumn 8, Issue , 2008, Pages

  Rogowski, Wolf H ^a   Hartz, Susanne C ^a   John, Jürgen H ^a  

^a INSTITUTE OF EPIDEMIOLOGY   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICINE; DECISION MAKING; HEALTH CARE; MEDICAL LITERATURE; MEDICAL RESEARCH; MEDICAL SOCIETY; REIMBURSEMENT; COMPARATIVE STUDY; GERMANY; HEALTH SERVICES RESEARCH; HUMAN; INTERVIEW; NONBIOLOGICAL MODEL; ORGANIZATION; ORGANIZATION AND MANAGEMENT; TECHNOLOGY; UNITED KINGDOM; UNITED STATES;

BIOLOGICAL SCIENCE DISCIPLINES; DECISION MAKING, ORGANIZATIONAL; ENGLAND; GERMANY; HEALTH SERVICES RESEARCH; HUMANS; INTERVIEWS AS TOPIC; MODELS, ORGANIZATIONAL; REIMBURSEMENT MECHANISMS; TECHNOLOGY TRANSFER; UNITED STATES;

EID: 54049127711     PISSN: None     EISSN: 14726963     Source Type: Journal    
DOI: 10.1186/1472-6963-8-194     Document Type: Article

References (79)

1. Central challenges facing the national clinical research enterprise. NS Sung WF Crowley Jr M Genel P Salber L Sandy LM Sherwood SB Johnson V Catanese H Tilson K Getz, Jama 2003 289 10 1278 1287 10.1001/jama.289.10.1278 12633190
2. Research translation: a new frontier for clinical laboratories. M Plebani FM Marincola, Clin Chem Lab Med 2006 44 11 1303 1312 10.1515/CCLM.2006.238 17087640
3. Translational medicine: can it really facilitate the transition of research "from bench to bedside"? M Wehling, Eur J Clin Pharmacol 2006 62 2 91 95 10.1007/s00228-005-0060-4 16344921
4. Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. RS Taylor MF Drummond G Salkeld SD Sullivan, BMJ 2004 329 7472 972 975 15499118 10.1136/bmj.329.7472.972
5. Defining the "Health Benefit Basket" in nine European countries. Evidence from the European Union Health BASKET Project. J Schreyögg T Stargardt M Velasco-Garrido R Busse, Eur J Health Econ 2005 Suppl 2 10 10.1007/s10198-005-0312-3 16270212
6. Framework for describing and classifying decision-making systems using technology assessment to determine the reimbursement of health technologies (fourth hurdle systems). J Hutton C McGrath JM Frybourg M Tremblay E Bramley-Harker C Henshall, Int J Technol Assess Health Care 2006 22 1 10 18 10.1017/S0266462306050781 16673675
7. Beitrag des GSF-Instituts für Gesundheitsökonomie und Management im Gesundheitswesen. W Rogowski J John A Langer S Hartz R Leidl, Regenerationstechnologien für Medizin und Biologie - Beiträge für ein strategisches Förderkonzept (details available from the authors upon request) Berlin: Bundesministerium für Bildung und Forschung 2007
8. Entscheidungsprozesse über die Kostenerstattung für neue medizinische Verfahren in den USA. TEIL 1: Medicare. S Hartz W Rogowski, Gesundheitsökonomie und Qualitätsmanagement
9. Entscheidungsprozesse über die Kostenerstattung für neue medizinische Verfahren in den USA. TEIL 2: Private Versicherungsträger. S Hartz W Rogowski, Gesundheitsökonomie und Qualitätsmanagement
10. Clinical and cost-effectiveness of autologous chondrocyte implantation for cartilage defects in knee joints: systematic review and economic evaluation. C Clar E Cummins L McIntyre S Thomas J Lamb L Bain P Jobanputra N Waugh, Health Technol Assess 2005 9 47 iii iv ix-x, 1-82. 16336842
11. E Mossialos M Mrazek T Walley, Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality Maidenhead: Open Univ. Press 2004
12. Marktzugang und Preisbildung auf Arzneimittelmärkten im internationalen Vergleich. J Wasem S Greß D Niebuhr, Diskussionsbeiträge aus dem Fachbereich Wirtschaftswissenschaften Universität Duisburg-Essen, Campus Essen Essen: Univ. Duisburg-Essen Standort Essen Fachbereich Wirtschaftswissenschaft 2005
13. 5 NICE years. MD Rawlins, Lancet 2005 365 9462 904 908 10.1016/S0140-6736(05)71050-3 15752536
14. A DATA BOOK. Healthcare Spending and the Medicare Program. http://www.medpac.gov/publications/congressional_reports/ Jun06DataBook_Entire_report.pdf
15. D Niebuhr H Rothgang J Wasem S Greß Die Bestimmung des Leistungskataloges in der gesetzlichen Krankenversicherung.Verfahren und Kriterien zur Konkretisierung des Leistungskatalogs in der gesetzlichen Krankenversicherung vor dem Hintergrund internationaler Erfahrungen Düsseldorf: Hans-Böckler-Stiftung 2004 2
16. National Center for Health Statistics, Health, United States, 2005. With Chartbook on Trends in the Health of Americans Hyattsville, Maryland: U.S. Department of Health and Human Services, National Center for Health Statistics 2005
17. The major role of clinicians in the discovery of off-label drug therapies. HJ Demonaco A Ali E Hippel, Pharmacotherapy 2006 26 3 323 332 10.1592/phco.26.3.323 16503712
18. [Post-marketing surveillance studies]. I Pigeot J Windeler, Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2005 48 5 580 585 10.1007/s00103-005-1033-6 15887069
19. Coverage options for promising technologies: Medicare's 'coverage with evidence development'. SR Tunis SD Pearson, Health Aff (Millwood) 2006 25 5 1218 1230 10.1377/hlthaff.25.5.1218 16966717
20. Coverage with evidence development: an examination of conceptual and policy issues. J Hutton P Trueman C Henshall, Int J Technol Assess Health Care 2007 23 4 425 432 10.1017/S0266462307070651 17937829
21. Medicare's coverage of colorectal cancer drugs: a case study in evidence development and policy. T Carino RD Williams 2nd AM Colbert P Bridger, Health Aff (Millwood) 2006 25 5 1231 1239 10.1377/hlthaff.25.5.1231 16966718
22. A descriptive framework for country-level analysis of health care financing arrangements. J Kutzin, Health Policy 2001 56 3 171 204 10.1016/S0168-8510(00)00149-4 11399345
23. Kennzahlen und Faustformeln zur gesetzlichen Krankenversicherung. http://www.bmg.bund.de/cln_117/nn_1193098/SharedDocs/Downloads/DE/Statistiken/ Gesetzliche-Krankenversicherung/Kennzahlen-und-Faustformeln/Kennzahlen-und- Faustformeln.html
24. Reimbursement decisions in health policy - extending our understanding of the elements of decision-making. V Wirtz A Cribb N Barber, Health Policy 2005 73 3 330 338 10.1016/j.healthpol.2004.12.002 16039351
25. Priority setting for health technology assessments: a systematic review of current practical approaches. HZ Noorani DR Husereau R Boudreau B Skidmore, Int J Technol Assess Health Care 2007 23 3 310 315 10.1017/S026646230707050X 17579932
26. Verfahrensordnung des gemeinsamen Bundesausschusses. http://www.g-ba.de/ downloads/62-492-83/VerfO_2006-04-18.pdf
27. R Busse A Riesberg, Health Care Systems in Transition: Germany Copenhagen: WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies 2004 6
28. Guide to the Methods of technology appraisal. http://www.nice.org.uk/ aboutnice/howwework/devnicetech/technologyappraisalprocessguides/ guidetothemethodsoftechnologyappraisal.jsp
29. EMEA and the evaluation of health-related quality of life data in the drug regulatory process. S Papanicolaou D Sykes E Mossialos, Int J Technol Assess Health Care 2004 20 3 311 324 10.1017/S0266462304001138 15446761
30. Patientenrelevante Endpunkte - Stand der Diskussion im Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). PT Sawicki, Dtsch Med Wochenschr 2006 131 Suppl 1 S16 20 10.1055/s-2006-941735
31. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. D Moher KF Schulz D Altman, Explore (NY) 2005 1 1 40 45 16791967
32. MF Drummond, Methods for the economic evaluation of health care programmes Oxford: Oxford Univ. Press 3 2005
33. Developing guidance for budget impact analysis. P Trueman M Drummond J Hutton, Pharmacoeconomics 2001 19 6 609 621 10.2165/00019053-200119060-00001 11456210
34. Health economic guidelines - similarities, differences and some implications. J Hjelmgren F Berggren F Andersson, Value Health 2001 4 3 225 250 10.1046/j.1524-4733.2001.43040.x 11705185
35. Methoden. Version 2.0 vom 19.12.2006. http://www.iqwig.de/download/ Methoden_IQWiG_V-2-0.pdf
36. Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System. http://www.iqwig.de/download/08-01- 24_Methods_of_the_Relation_of_Benefits_to_Costs_Version_1_0.pdf
37. [Comments by the Working Group for Methods of Economic Evaluation in Health Care (AG MEG) to IQWiG's Draft Guidelines "Methods for Assessment of the Relation of Benefits to Costs in the German Statutory Health Care System"]. C Krauth J John P Aidelsburger B Brüggenjürgen T Hansmeier F Hessel T Kohlmann J Moock H Rothgang B Schweikert, Gesundheitswesen 2008 70 6 e1 16 10.1055/s-2008-1077059 18661452
38. Allgemeine Methoden V. 3.0. http://www.iqwig.de/download/ IQWiG_Methoden_Version_3_0.pdf
39. A strategic plan for integrating cost-effectiveness analysis into the US healthcare system. PJ Neumann JA Palmer N Daniels K Quigley MR Gold S Chao, Am J Manag Care 2008 14 4 185 188 18402510
40. AMCP Guidance for Submission of Clinical and Economic Evaluation Data to Support Formulary Listing in U.S. Health Plans and Pharmacy Benefits Management Organizations. SD Sullivan A Lyles B Luce J Grigar, Journal of Managed Care Pharmacy 2001 7 4 272 282
41. Cost-effectiveness and evidence evaluation as criteria for coverage policy. AM Garber, Health Aff (Millwood) 2004 Suppl Web Exclusives W4-284 296
42. Determining the "Health Benefit Basket" of the Statutory Health Insurance scheme in Germany: methodologies and criteria. R Busse T Stargardt J Schreyögg, Eur J Health Econ 2005 Suppl 30 36 16270210 10.1007/s10198-005- 0316-z
43. Social value judgements. Principles for the development of NICE guidance. http://www.nice.org.uk/media/873/2F/SocialValueJudgementsDec05.pdf
44. NICE's use of cost effectiveness as an exemplar of a deliberative process. A Culyer, Health Economics, Policy and Law 2006 1 3 299 318 10.1017/S1744133106004026
45. National Institute for Clinical Excellence and its value judgments. MD Rawlins AJ Culyer, BMJ 2004 329 7459 224 227 15271836 10.1136/bmj.329.7459.224
46. Evidence-based coverage policy. AM Garber, Health Aff (Millwood) 2001 20 5 62 82 10.1377/hlthaff.20.5.62 11558722
47. Bekanntmachung eines Beschlusses des Gemeinsamen Bundesausschusses über Maβnahmen zur Qualitätssicherung bei autologer Chondrozytenimplantation am Kniegelenk. Gemeinsamer Bundesausschuss, Bundesanzeiger 2007 131 6979
48. The use of autologous chondrocyte implantation for the treatment of cartilage defects in knee joints. Technology Apraisal 89. http://www.nice.org. uk/nicemedia/pdf/TA089guidance.pdf
49. AB Casto E Layman, Principles of Healthcare Reimbursement Chicago, Illinois, USA: American Health Information Management Assocation 2006
50. Determinants of the diffusion of computed tomography and magnetic resonance imaging. EH Oh Y Imanaka E Evans, Int J Technol Assess Health Care 2005 21 1 73 80 10.1017/S0266462305050099 15736517
51. R Bantle, Determinanten der Innovation und Diffusion des medizinisch-technischen Fortschritts Bayreuth: Verl. PCO 1996
52. [Applicability of diagnostic related groups (DRG) in an international comparison]. M Lungen KW Lauterbach, Chirurg 2000 71 10 1288 1295 10.1007/s001040051218 11077594
53. European healthcare policies for controlling drug expenditure. SM Ess S Schneeweiss TD Szucs, Pharmacoeconomics 2003 21 2 89 103 10.2165/00019053- 200321020-00002 12515571
54. Methods to determine reimbursement rates for diagnosis related groups (DRG): a comparison of nine European countries. J Schreyögg T Stargardt O Tiemann R Busse, Health Care Manag Sci 2006 9 3 215 223 10.1007/s10729-006-9040- 1 17016927
55. VE Amelung H Schumacher A Amelung, Managed care: neue Wege im Gesundheitsmanagement; mit 12 Fallstudien aus den USA, der Schweiz und Deutschland. 3., vollst. überarb. und erw. Aufl edition Wiesbaden: Gabler u.a 2004
56. Medicare's Requirement for Research Participation as a Condition for Coverage: Is it ethical? SD Pearson FG Miller EJ Emanuel, Jama 2006 296 8 988 991 10.1001/jama.296.8.988 16926358
57. Relevance of health technology assessment for benefit decisions in Germany now and in the future. R Busse, Gesundh Okon Qual Manage 2005
58. A closer look at the managed care backlash. PF Cooper KI Simon J Vistnes, Med Care 2006 44 5 Suppl I4 11 16625063
59. A rational framework for decision making by the National Institute For Clinical Excellence (NICE). K Claxton M Sculpher M Drummond, Lancet 2002 360 9334 711 715 10.1016/S0140-6736(02)09832-X 12241891
60. Reimbursement of pharmaceuticals in the European Union. A McGuire M Drummond F Rutten, Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality Maidenhead: Open Univ. Press, Mossialos E, Mrazek M, Walley T, 2004 131 143
61. Autologe Chondrozytenimplantation (ACI). http://www.g-ba.de/downloads/40- 268-262/HTA-ACI.pdf
62. Health technology assessment in four countries: response from political science. D Chinitz, Int J Technol Assess Health Care 2004 20 1 55 60 10.1017/S0266462304000789 15176177
63. Setting priorities for the evaluation of health interventions: when theory does not meet practice. F Sassi, Health Policy 2003 63 2 141 154 10.1016/S0168-8510(02)00061-1 12543527
64. Weighting up the evidence. http://www.chsrf.ca/other_documents/pdf/ weighing_up_the_evidence_e.pdf
65. The ethics of accountability in managed care reform. N Daniels J Sabin, Health Aff (Millwood) 1998 17 5 50 64 10.1377/hlthaff.17.5.50 9769571
66. Current impact of gene technology on healthcare A map of economic assessments. W Rogowski, Health Policy 2007 80 340 357 10.1016/j.healthpol.2006. 03.009 16678930
67. The contribution of economic evaluation to decision-making in early phases of product development: a methodological and empirical review. S Hartz J John, Int J Technol Assess Health Care 1399335
68. Public health policy decisions on medical innovations: What role can early economic evaluation play? S Hartz J John, Health Policy 2008 18619704
69. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. G Permanand E Mossialos M McKee, Clin Med 2006 6 1 87 90 16521363
70. The US and European regulatory systems: a comparison. K Redmond, J Ambul Care Manage 2004 27 2 105 114 15069987
71. [Regulatory aspects of clinical trials for medical devices and in vitro diagnostics]. JA Schwarz, Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2005 48 5 556 561 10.1007/s00103-005-1036-3 15887066
72. Health technology diffusion rates. Statins, coronary stents, and MRI in England. N Booth-Clibborn C Packer A Stevens, Int J Technol Assess Health Care 2000 16 3 781 786 10.1017/S0266462300102053 11028133
73. An analysis of the diffusion of new antidepressants: variety, quality, and marketing efforts. ER Berndt A Bhattacharjya DN Mishol A Arcelus T Lasky, J Ment Health Policy Econ 2002 5 1 3 19 12529566
74. The diffusion of medical technology, local conditions, and technology re-invention: a comparative case study on coronary stenting. H Hashimoto H Noguchi P Heidenreich O Saynina A Moreland S Miyazaki S Ikeda Y Kaneko N Ikegami, Health Policy 2006 79 2-3 221 230 10.1016/j.healthpol.2006.01.005 16473435
75. Incorporating economic evaluations into decision-making: the Ontario experience. A Laupacis, Med Care 2005 43 7 Suppl 15 19 16056004
76. Health plans' coverage determinations for technology-based interventions: the case of electrical bone growth stimulation. AJ Huang MP Gemperli L Bergthold SS Singer A Garber, Am J Manag Care 2004 10 12 957 962 15617371
77. N Daniels J Sabin, The ethics of accountability in managed care reform: recent efforts at reforming managed care practices have one thing in common; a call for accountability to consumers 1998
78. Federal Register Notice: Revised Process for Making Medicare National Coverage Determinations. Centers for Medicare and Medicaid Services, Federal Register 2003 86 187
79. Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis. N Devlin D Parkin, Health Econ 2004 13 5 437 452 10.1002/hec.864 15127424