Hostname: page-component-586b7cd67f-rdxmf Total loading time: 0 Render date: 2024-11-25T22:18:10.213Z Has data issue: false hasContentIssue false

Assessing emerging technologies—The case of organ replacement technologies: Volume, durability, cost

Published online by Cambridge University Press:  19 June 2007

James E. Stahl
Affiliation:
Harvard Medical School and Massachusetts General Hospital
Joseph P. Vacanti
Affiliation:
Harvard Medical School and Massachusetts General Hospital
Scott Gazelle
Affiliation:
Harvard Medical School and Massachusetts General Hospital

Abstract

Objectives: The aim of this study was to estimate thresholds for production volume, durability, and cost of care for the cost-effective adoption of liver organ replacement technologies (ORTs).

Methods: We constructed a discrete-event simulation model of the liver allocation system in the United States. The model was calibrated against UNOS data (1994–2000). Into this model, we introduced ORTs with varying durability (time to failure), cost of care, and production volume. Primary outputs of interest were time to 5 percent reduction in the waiting list and time to 5 percent increase in expected transplant volume.

Results: Model output for both calibration and validation phases closely matched published data: waiting list length (±2 percent), number of transplants (±2 percent), deaths while waiting (±5 percent), and time to transplant (±11 percent). Reducing the waiting list was dependent on both ORT durability and production volume. The longer the durability, the less production volume needed to reduce the waiting list and vice versa. However, below 250 ORT/year, durability needed to be >2 years for any significant change to be seen in the waiting list. For base-case costs, all ORT production volume and durability scenarios result in more transplants per year at less total cost of care/patient than the current system. ORTs remain cost saving until manufacturing costs are >5 times base-case costs, production is less 500 ORT/year, and durability <6 months.

Conclusions: Although there remain many technical challenges to overcome, as long as ORTs can meet these threshold criteria, they have the potential of transforming the world of end-stage liver disease.

Type
GENERAL ESSAYS
Copyright
© 2007 Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Alagoz O, Bryce C, Schaefer A, Roberts M. 2002. Predicting the future health status of liver disease patients using empiric stochastic models. Society for Medical Decision Making, 2002 annual conference. Baltimore, MD;
Banks J, ed. 1998. Handbook of simulation. New York: John Wiley & Sons, Inc;
Citters RV, Bauer C, Christopherson L, et al. 1985 Artificial heart and assist devices: Directions, needs, costs, societal and ethical issues. Artif Organs. 9: 375415.Google Scholar
Cooley D. 2003 The total artificial heart. Nat Med. 9: 108111.Google Scholar
Coelho D, ed. 1998. The ethics of organ transplants. Amherst, NY: Prometheus Books;
Copeland J, Arabia F, Tsau P, et al. 2003 Total artificial hearts: Bridge to transplantation. Cardiol Clin. 21: 101113.Google Scholar
Department of Health and Human Services. 2004. 2004 Annual Report of the U.S. Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients: Transplant Data 1994-2003. Rockville, MD: Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation;
Dorling A, Riesbeck K, Warrens A, Lechler R. 1997 Clinical xenotransplantation of solid organs. Lancet. 349: 867871.Google Scholar
Federal Register. 1998: Organ procurement and transplantation network. Final rule 42 CFR Part 121. Federal Register: HRSA; 1629516338.
Gold MR, Siegel JE, Russell LB, Weinstein MC. 1996. Cost-effectiveness in health and medicine. New York: Oxford University Press;
Hillier F, Lieberman G. 2005. Introduction to operations research. Dubuque, IA: McGraw-Hill;
Lanza R, Langer R, Vacanti JP, eds. 2007. Principles of tissue engineering. 3rd ed. Burlington, MA: Elsevier Academic Press;
Patrick CW, Mikos AG, McIntire LV. 1998. Frontiers in tissue engineering. New York: Pergamon Press;
Perry S. 1992 Report from the U.S. Institute of Medicine (IOM). The artificial heart: Prototypes, policies, and patient. Int J Technol Assess Health Care. 8: 371.Google Scholar
Platt J. 1997 Approaching the clinical application of xenotransplantation. Am J Med Sci. 313: 315321.Google Scholar
Platt J. 1998 Current status of xenotransplantation: Research and technology. Transplant Proc. 30: 16301633.Google Scholar
Roberts JP, Brown RS Jr, Edwards EB, et al. 2003 Liver and intestine transplantation. Am J Transplant. (Suppl 4): 7890.Google Scholar
Schecter SM, Bryce CL, Alogoz O, et al. 2005 A clinically based discrete-event simulation of end-stage liver disease and the organ allocation process. Med Decis Making. 25: 199209.Google Scholar
Stahl J, Roberts M, Gazelle G. 2003 Optimizing the management and financial performance of the teaching ambulatory care clinic. J Gen Intern Med. 18: 19.Google Scholar
Vacanti J. 1988 Beyond transplantation: Third Annual Samuel Jason Mixter Lecture. Arch Surg. 123: 545549.Google Scholar
Vacanti JP, Saltzman WM, Domb AJ, Perez-Atayde A, Langer R. 1988 Selective cell transplantation using bioabsorbable artificial polymers as matrices. J Pediatr Surg. 23: 39.Google Scholar
William VL. 1999. Expert panel review of the NHLBI total artificial heart (TAH) program. Available at: http://www.nhlbi.nih.gov/resources/docs/tahrpt.pdf.