Girling, Alan J., Freeman, Guy, Gordon, Jason P., Poole-Wilson, Philip, Scott, David A. and Lilford, Richard J.. (2007) Modeling payback from research into the efficacy of left-ventricular assist devices as destination therapy. International Journal of Technology Assessment in Health Care, Vol.23 (No.2). pp. 269-277. ISSN 0266-4623

Preview

PDF WRAP_Freeman_Modeling_payback.pdf - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader Download (144Kb)

Abstract

Objectives: Ongoing developments in design have improved the outlook for left-ventricular assist device (LVAD) implantation as a therapy in end-stage heart failure. Nevertheless, early cost-effectiveness assessments, based on first-generation devices, have not been encouraging. Against this background, we set out (i) to examine the survival benefit that LVADs would need to generate before they could be deemed cost-effective; (ii) to provide insight into the likelihood that this benefit will be achieved; and (iii) from the perspective of a healthcare provider, to assess the value of discovering the actual size of this benefit by means of a Bayesian value of information analysis. Methods: Cost-effectiveness assessments are made from the perspective of the healthcare provider, using current UK norms for the value of a quality-adjusted life-year (QALY). The treatment model is grounded in published analyses of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial of first-generation LVADs, translated into a UK cost setting. The prospects for patient survival with second-generation devices is assessed using Bayesian prior distributions, elicited from a group of leading clinicians in the field. Results: Using established thresholds, cost-effectiveness probabilities under these priors are found to be low (.2 percent) for devices costing as much as £60,000. Sensitivity of the conclusions to both device cost and QALY valuation is examined. Conclusions: In the event that the price of the device in use would reduce to £40,000, the value of the survival information can readily justify investment in further trials.

Item Type:	Journal Article
Subjects:	R Medicine > RA Public aspects of medicine
Divisions:	Faculty of Science > Statistics
Library of Congress Subject Headings (LCSH):	Heart -- Left ventricle -- Surgery, Medical care, Cost of -- Great Britain, Bayesian statistical decision theory, Medical economics
Journal or Publication Title:	International Journal of Technology Assessment in Health Care
Publisher:	Cambridge University Press
ISSN:	0266-4623
Date:	16 April 2007
Volume:	Vol.23
Number:	No.2
Page Range:	pp. 269-277
Identification Number:	10.1017/S0266462307070365
Status:	Peer Reviewed
Access rights to Published version:	Open Access
Funder:	Engineering and Physical Sciences Research Council (EPSRC)
Grant number:	GR/S29874/01 (EPSRC)
References:	1. Ades, AE, Lu, G, Claxton, K. Expected value of sample information calculations in medical decision modeling. Med Decis Making. 2004; 24: 207–227. 2. American Heart Association. Heart disease and stroke statistics – 2006 Update. Dallas, TX: American Heart Association; 2006. 3. Anon. Ventricular assist system: Summary of safety and effectiveness. Food and Drug Administration. 2002. Available at: http://www.fda.gov/ohrms/dockets/ac/02/briefing/3843b1_01_SSE_draft.pdf. 4. Anon. Special Report: Cost-effectiveness of left-ventricular assist devices as destination therapy for end-stage heart failure. Technol Eval Cent Asses Program Exec Summ. 2004; 19: 1. 5. Brown, A, Young, T, Meenan, B. Medical device prices follow the experimental curve. J Med Marketing. In press. 6. Claxton, K, Lacey, LF, Walker, SG. Selecting treatments: A decision theoretic approach. J R Stat Soc Ser A Stat Soc. 2000; 163: 211–225. 7. Claxton, K. The irrelevance of inference: A decision-making approach to the stochastic evaluation of health care technologies. J Health Econ. 1999; 18: 341–364. 8. Claxton, K, Ginnelly, L, Sculpher, M et al., A pilot study on the use of decision theory and value of information analysis as part of the NHS health technology assessment programme. Health Technol Assess. 2004; 8: 1–103, iii. 9. Claxton, K, Posnett, J. An economic approach to clinical trial design and research priority-setting. Health Econ. 1996; 5: 513–524. 10. Claxton, K, Sculpher, M, Drummond, M. A rational framework for decision making by the National Institute For Clinical Excellence (NICE). Lancet. 2002; 360: 711–715. 11. Clegg, AJ, Scott, DA, Loveman, E et al., The clinical and cost-effectiveness of left ventricular assist devices for end-stage heart failure: A systematic review and economic evaluation. Health Technol Assess. 2005; 9: 1–148. 12. Cleland, JG. Heart failure: A medical hydra. Lancet. 1998; 352 (Suppl 1): SI1–SI2. 13. Day, GS, Montgomery, DB. Diagnosing the experience curve. J Mark. 1983; 47: 44–58. 14. Derose, J, Jarvik, R. Axial flow pumps. In: Goldstein, DJ Oz, MC, eds. Cardiac assist devices. New York: Futura Publishing; 359–374. 2000. 15. Dominguez, LJ, Parrinello, G, Amato, P et al., Trends of congestive heart failure epidemiology: Contrast with clinical trial results. Cardiologia. 1999; 44: 801–808. 16. Evans, RW. Cardiac replacement: Estimation of need, demand and supply. In: Rose, EA Stevenson, LW, eds. Management of end-stage heart disease. Philadelphia PA: Lippincott-Raven; 1998: 13–24. 17. Federal Drug Administration. FDA approves heart assist pump for permanent use. FDA. 2002. Available at: http://www.fda. gov/bbs/topics/NEWS/2002/NEW00851.htm. 18. Felli, JC, Hazen, GB. Sensitivity analysis and the expected value of perfect information. Med Decis Making. 1998; 18: 95–109. 19. Fenwick, E, Claxton, K, Sculpher, M et al., Improving the efficiency and relevance of health technology assessment: The role of iterative decision analytic modelling. Report No. Discussion Paper 179. York: Centre for Health Economics; 2000. 20. Fisher, DC, Lake, KD, Reutzel, TJ et al., Changes in health-related quality of life and depression in heart transplant recipients. J Heart Lung Transplant. 1995; 14: 373–381. 21. Garthwaite, PH, Kadane, JB, O'Hagan, A. Statistical methods for eliciting probability distributions. J Am Stat Assoc. 2005; 100: 680–700. 22. Henderson, BD. The application and misapplication of the experience curve. J Bus Strategy. 1984; 4: 3–9. 23. HM, Treasury. The green book: Appraisal and evaluation in central government. London: HMT; 2003. 24. Hoshi, H, Shinshi, T, Takatani, S. Third-generation blood pumps with mechanical noncontact magnetic bearings. Artif Organs. 2006; 30: 324–338. 25. Hussey, JC, Bond, ZC, Collett, D et al., 2004. on behalf of UK Transplant Cardiothoracic Advisory Group. Long-term patient survival for heart transplant recipients in the UK. 26. John, R. Donor management and selection for heart transplantation. Semin Thorac Cardiovasc Surg. 2004; 16: 364–369. 27. Kirklin, JK, Holman, WL. Mechanical circulatory support therapy as a bridge to transplant or recovery (new advances). Curr Opin Cardiol. 2006; 21: 120–126. 28. Lietz, K, Miller, LW. Will left-ventricular assist device therapy replace heart transplantation in the foreseeable future? Curr Opin Cardiol. 2005; 20: 132–137. 29. Lilford, RJ, Braunholtz, D. The statistical basis of public policy: A paradigm shift is overdue. BMJ. 1996; 313: 603–607. 30. Long, JW, Kfoury, AG, Slaughter, MS et al., Long-term destination therapy with the HeartMate XVE left ventricular assist device. Improved outcomes since the REMATCH Study. Congest Heart Fail. 2005; 11: 133–138. 31. Miller, LW, Nelson, KE, Bostic, RR et al., Hospital costs for left ventricular assist devices for destination therapy: Lower costs for implantation in the post-REMATCH era. J Heart Lung Transplant. 2006; 25: 778–784. 32. Morris, PA. Decision analysis expert use. Manage Sci. 1974; 20: 1233–1241. 33. Moskowitz, AJ, Weinberg, AD, Oz, MC et al., Quality of life with an implanted left ventricular assist device. Ann Thorac Surg. 1997; 64: 1764–1769. 34. Noon, GP, Morley, D, Irwin, S et al., The DeBakey ventricular assist device. In: Goldstein, DJ, Oz, MC eds. Cardiac assist devices. New York: Futura Publishing; 2000:375–386. 35. Oz, MC, Gelijns, AC, Miller, L et al., Left ventricular assist devices as permanent heart failure therapy: The price of progress. Ann Surg. 2003; 238: 577–583. 36. Park, SJ, Tector, A, Piccioni, W et al., Left ventricular assist devices as destination therapy: A new look at survival. J Thorac Cardiovasc Surg. 2005; 129: 9–17. 37. Philbin, EF. Comprehensive multidisciplinary programs for the management of patients with congestive heart failure. J Gen Intern Med. 1999; 14: 130–135. 38. Raiffa, H, Schlaifer, R. Applied statistical decision theory. Boston: Harvard University, Graduate School of Business Administration; 1961. 39. Rawlins, MD, Culyer, AJ. National Institute for Clinical Excellence and its value judgments. BMJ. 2004; 329: 224–227. 40. Richards, PS, Nelson, KA, Frazier, OH et al., Why referred potential heart donors aren't used. Tex Heart Inst J. 1993; 20: 218–222. 41. Rose, EA, Moskowitz, AJ, Packer, M et al., The REMATCH Trial: Rationale, design, and end points. randomized evaluation of mechanical assistance for the treatment of congestive heart failure. Ann Thorac Surg. 1999; 67: 723–730. 42. Rose, EA, Gelijns, AC, Moskowitz, AJ; and the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001; 345: 1435–1443. 43. Savage, LJ. The foundations of statistics. New York: John Wiley; 1954. 44. Siegenthaler, MP, Westaby, S, Frazier, OH et al., Advanced heart failure: Feasibility study of long-term continuous axial flow pump support. Eur Heart J. 2005; 26: 1031–1038. 45. Spiegelhalter, DJ, Abrams, KR, Myles, JP. Bayesian approaches to clinical trials and health-care evaluation. New York: Wiley; 2004. 46. Stevenson, LW, Shekar, P. Ventricular assist devices for durable support. Circulation. 2005; 112: e111–e115. 47. Takatani, S. Progress of rotary blood pumps. Artif Organs. 2006; 30: 317–321. 48. Tsukui, H, Winowich, S, Stanford, E et al., Does a rotary pump provide full cardiac decompression and circulatory support?— from clinical experiences of HeartMate II with severe congestive heart failure patients. ASAIO. 2005; 51: 2. 49. Willan, AR, Pinto, EM. The value of information and optimal clinical trial design. Stat Med. 2005; 24: 1791–1806. 50. Zaman, SN. Managing elderly patients with end-stage heart failure. CME J Geriatr Med. 2001; 3: 105–109.
URI:	http://wrap.warwick.ac.uk/id/eprint/657

Request changes to a record

Actions (login required)

View Item