Bridging trial and decision: A checklist to frame health technology assessments for resource allocation decisions

Value in Health

Volumn 14, Issue 5, 2011, Pages 777-784

  Grutters, Janneke P C ^a   Seferina, Shanly C ^b   Tjan Heijnen, Vivianne C G ^b   Van Kampen, Roel J W ^b   Goettsch, Wim G ^c   Joore, Manuela A ^d  

^a MAASTRICHT UNIVERSITY   (Netherlands)

^b MAASTRICHT UNIVERSITY   (Netherlands)

^c Dutch Healthcare Insurance Board   (Netherlands)

^d MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

breast cancer; cost effectiveness; decision making; economic evaluation; evidence based medicine

Indexed keywords

TRASTUZUMAB;

BIOMEDICAL TECHNOLOGY ASSESSMENT; BREAST CANCER; CHECKLIST; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CONCEPTUAL FRAMEWORK; COST EFFECTIVENESS ANALYSIS; EARLY CANCER; ECONOMIC EVALUATION; HEALTH CARE QUALITY; HUMAN; INFORMATION RETRIEVAL; MEDICAL RECORD REVIEW; PRIORITY JOURNAL; RESOURCE ALLOCATION; REVIEW; SYSTEMATIC REVIEW;

EID: 80052475561     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2011.01.005     Document Type: Article

References (58)

1. S.S. Dhruva, S.E. Phurrough, and M.E. Salive CMS's landmark decision on CT colonographyexamining the relevant data N Engl J Med 360 2009 2699 2701
2. P.J. Neumann, and S.R. Tunis Medicare and medical technologythe growing demand for relevant outcomes N Engl J Med 362 2010 377 379
3. J. Raftery Multiple sclerosis risk sharing scheme: a costly failure BMJ 340 2010 c1672
4. M.F. Drummond, J.S. Schwartz, and B. Jonsson Key principles for the improved conduct of health technology assessments for resource allocation decisions Int J Technol Assess Health Care 24 2008 244 258 (Pubitemid 351950160)
5. P.J. Neumann, M.F. Drummond, and B. Jonsson Are Key Principles for improved health technology assessment supported and used by health technology assessment organizations? Int J Technol Assess Health Care 26 2010 71 78
6. G.W. Torrance, J.E. Siegel, and B.R. Luce Framing and designing the cost-effectiveness analysis M.R. Gold, J.E. Siegel, L.B. Russell, Cost-Effectiveness in Health and Medicine 1996 Oxford University Press Oxford
7. J. Fox-Rushby, and J. Cairns Economic evaluation 2005 Open University Press Maidenhead, UK
8. C. McCabe, and S. Dixon Testing the validity of cost-effectiveness models Pharmacoeconomics 17 2000 501 513 (Pubitemid 30398807)
9. Sargent R. Validation and verification of simulation models. Proceedings of the Winter Simulation Conference 2004 (WSC 2004): Volume 1, pp. 1324.
10. M.F. Drummond, M.J. Sculpher, and G.W. Torrance Methods for the Economic Evaluation of Health Care Programmes 3rd ed. 2005 Oxford University Press New York
11. D.A. Revicki, and L. Frank Pharmacoeconomic evaluation in the real world Effectiveness versus efficacy studies Pharmacoeconomics 15 1999 423 434 (Pubitemid 29210946)
12. P.M. Rothwell External validity of randomised controlled trials: "to whom do the results of this trial apply?" Lancet 365 2005 82 93 (Pubitemid 40082150)
13. D.A. Hughes, A. Bagust, and A. Haycox The impact of non-compliance on the cost-effectiveness of pharmaceuticals: a review of the literature Health Econ 10 2001 601 615 (Pubitemid 32998372)
14. A.B. Rosen, A.B. Spaulding, and D. Greenberg Patient adherence: a blind spot in cost-effectiveness analyses? Am J Manag Care 15 2009 626 632
15. D. Craig, C. McDaid, and T. Fonseca Are adverse effects incorporated in economic models? A survey of current practice Int J Technol Assess Health Care 26 2010 323 329
16. C.D. Mullins, R. Montgomery, and S. Tunis Uncertainty in assessing value of oncology treatments Oncologist 15 Suppl. 1 2010 58 64
17. S. Ramsey, R. Willke, and A. Briggs Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report Value Health 8 2005 521 533 (Pubitemid 41727304)
18. S. Evers, M. Goossens, and H. de Vet Criteria list for assessment of methodological quality of economic evaluations: Consensus on Health Economic Criteria Int J Technol Assess Health Care 21 2005 240 245 (Pubitemid 40656554)
19. D. Hailey Toward transparency in health technology assessment: a checklist for HTA reports Int J Technol Assess Health Care 19 2003 1 7 (Pubitemid 36356322)
20. A.L. Chan, H.W. Leung, and C.L. Lu Cost-effectiveness of trastuzumab as adjuvant therapy for early breast cancer: a systematic review Ann Pharmacother 43 2009 296 303
21. A. Briggs, K. Claxton, and M. Sculpher Decision Modelling for Health Economic Evaluation 2006 Oxford University Press New York
22. H.A. Glick, J.A. Doshi, and S.S. Sonnad Economic Evaluation in Clinical Trials 2007 Oxford University Press Oxford
23. A. Jemal, R. Siegel, and E. Ward Cancer statistics, 2009 CA Cancer J Clin 59 2009 225 249
24. D.J. Slamon, G.M. Clark, and S.G. Wong Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene Science 235 1987 177 182 (Pubitemid 17231334)
25. M. Spielmann, H. Roche, and T. Delozier Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial J Clin Oncol 27 2009 6129 6134
26. H. Joensuu, P.L. Kellokumpu-Lehtinen, and P. Bono Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer N Engl J Med 354 2006 809 820 (Pubitemid 43290919)
27. M.J. Piccart-Gebhart, M. Procter, and B. Leyland-Jones Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer N Engl J Med 353 2005 1659 1672 (Pubitemid 41464705)
28. E.H. Romond, E.A. Perez, and J. Bryant Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer N Engl J Med 353 2005 1673 1684 (Pubitemid 41464706)
29. I. Smith, M. Procter, and R.D. Gelber 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial Lancet 369 2007 29 36 (Pubitemid 46039831)
30. H. Joensuu, P. Bono, and V. Kataja Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without trastuzumab, as adjuvant treatments of breast cancer: final results of the FinHer Trial J Clin Oncol 27 2009 5685 5692
31. M.J. Sculpher, F.S. Pang, and A. Manca Generalisability in economic evaluation studies in healthcare: a review and case studies Health Technol Assess 8 2004 iii iv
32. R. Baltussen, A. Ament, and R. Leidl Making cost assessments based on RCTs more useful to decision-makers Health Policy 37 1996 163 183 (Pubitemid 26255178)
33. L.P. Garrison Jr., P.J. Neumann, and P. Erickson Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report Value Health 10 2007 326 335 (Pubitemid 47481104)
34. B. O'Brien Economic evaluation of pharmaceuticals Frankenstein's monster or vampire of trials? Medical Care 34 1996 DS99 DS108
35. C. Bartlett, L. Doyal, and S. Ebrahim The causes and effects of socio-demographic exclusions from clinical trials Health Technol Assess 9 2005 iii iv ixx, 1152
36. K.A. Phillips, D.A. Marshall, and J.S. Haas Clinical practice patterns and cost effectiveness of human epidermal growth receptor 2 testing strategies in breast cancer patients Cancer 115 2009 5166 5174
37. K.J. Dedes, T.D. Szucs, and P. Imesch Cost-effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a model-based analysis of the HERA and FinHer trial Ann Oncol 18 2007 1493 1499 (Pubitemid 47365481)
38. L.P. Garrison Jr, D. Lubeck, and D. Lalla Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer Cancer 110 2007 489 498 (Pubitemid 47106136)
39. A.W. Kurian, R.N. Thompson, and A.F. Gaw A cost-effectiveness analysis of adjuvant trastuzumab regimens in early HER2/neu-positive breast cancer J Clin Oncol 25 2007 634 641 (Pubitemid 350002917)
40. N.L. Liberato, M. Marchetti, and G. Barosi Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer J Clin Oncol 25 2007 625 633 (Pubitemid 350002916)
41. M. Lidgren, B. Jonsson, and C. Rehnberg Cost-effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer Ann Oncol 19 2008 487 495 (Pubitemid 351325669)
42. J.A. Millar, and M.J. Millward Cost effectiveness of trastuzumab in the adjuvant treatment of early breast cancer: a lifetime model Pharmacoeconomics 25 2007 429 442 (Pubitemid 46744472)
43. M. Neyt, M. Huybrechts, and F. Hulstaert Trastuzumab in early stage breast cancer: a cost-effectiveness analysis for Belgium Health Policy 87 2008 146 159
44. J. Norum, J.A. Olsen, and E.A. Wist Trastuzumab in adjuvant breast cancer therapy A model based cost-effectiveness analysis Acta Oncologica 46 2007 153 164
45. T. Shiroiwa, T. Fukuda, and K. Shimozuma The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data Breast Cancer Res Treat 109 2008 559 566 (Pubitemid 351692065)
46. I. Van Vlaenderen, J.L. Canon, and V. Cocquyt Trastuzumab treatment of early stage breast cancer is cost-effective from the perspective of the Belgian health care authorities Acta Clin Belg 64 2009 100 112
47. B.A. Essers, S.C. Seferina, and V.C. Tjan-Heijnen Transferability of model-based economic evaluations: the case of trastuzumab for the adjuvant treatment of HER2-positive early breast cancer in the Netherlands Value Health 13 2010 375 380
48. Pharmacoeconomic guidelines around the worldfrom http://www.ispor.org/ PEguidelines/index.asp [Accessed February 4, 2011]
49. A.H. Briggs Handling uncertainty in cost-effectiveness models Pharmacoeconomics 17 2000 479 500 (Pubitemid 30398806)
50. A. Brennan, and R. Akehurst Modelling in health economic evaluation What is its place? What is its value? Pharmacoeconomics 17 2000 445 459 (Pubitemid 30398804)
51. A. Briggs, K. Ritchie, and E. Fenwick Access with evidence development in the UK: past experience, current initiatives and future potential Pharmacoeconomics 28 2010 163 170
52. S.R. Tunis, D.B. Stryer, and C.M. Clancy Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy JAMA 290 2003 1624 1632 (Pubitemid 37430387)
53. M. Drummond, M. Barbieri, and J. Cook Transferability of economic evaluations across jurisdictions: ISPOR Good Research Practices Task Force report Value Health 12 2009 409 418
54. R. Welte, T. Feenstra, and H. Jager A decision chart for assessing and improving the transferability of economic evaluation results between countries Pharmacoeconomics 22 2004 857 876 (Pubitemid 39273956)
55. B. Hofmann Toward a procedure for integrating moral issues in health technology assessment Int J Technol Assess Health Care 21 2005 312 318 (Pubitemid 41099211)
56. S. Hanney, M. Buxton, and C. Green An assessment of the impact of the NHS Health Technology Assessment Programme Health Technology Assessment (Winchester, England) 11 2007 iii iv
57. P.J. Neumann Why don't Americans use cost-effectiveness analysis? Am J Manag Care 10 2004 308 312 (Pubitemid 38623521)
58. W.J. Oortwijn, S.R. Hanney, and A. Ligtvoet Assessing the impact of health technology assessment in the Netherlands Int J Technol Assess Health Care 24 2008 259 269 (Pubitemid 351950161)