COST-EFFECTIVENESS OF CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICES

2013 ◽  
Vol 29 (3) ◽  
pp. 254-260 ◽  
Author(s):  
Mattias Neyt ◽  
Ann Van den Bruel ◽  
Yolba Smit ◽  
Nicolaas De Jonge ◽  
Michiel Erasmus ◽  
...  

Objectives: Mechanical circulatory support through left ventricular assist devices (LVADs) improves survival and quality of life for patients with end-stage heart failure who are ineligible for cardiac transplantation. Our aim was to calculate the cost-effectiveness of continuous-flow LVADs.Methods: A cost-utility analysis from a societal perspective was performed. A lifetime Markov model was set up in which continuous-flow LVAD was compared with optimal medical therapy (OMT). The treatment effect was modeled indirectly combining the results of the REMATCH trial comparing OMT with a pulsatile-flow LVAD and the HeartMate II Destination Therapy Trial comparing a pulsatile-flow LVAD with a continuous-flow LVAD. Cost data were based on real-world financial data of sixty-nine patients with a HeartMate II implantation from the University Medical Centre Utrecht (the Netherlands). One-way and probabilistic sensitivity analyses were performed.Results: Comparing the continuous-flow HeartMate II with OMT, 3.23 (95 percent confidence interval [CI], 2.18–4.49) life-years were gained (LYG) or 2.83 (95 percent CI, 1.91–3.90) quality-adjusted life-years (QALYs). The cost of an LVAD implant was approximately €126,000, of which the device itself represented the largest cost, being €70,000. Total incremental costs amounted to €299,100 (95 percent CI, 190,500–521,000). This resulted in an incremental cost-effectiveness ratio of €94,100 (95 percent CI, 59,100–160,100) per LYG or €107,600 (95 percent CI, 66,700–181,100) per QALY. Sensitivity analyses showed these results were robust.Conclusions: Although LVAD destination therapy improves survival and quality of life, it remains a relatively expensive intervention which renders the reimbursement of this therapy questionable.

ASAIO Journal ◽  
2014 ◽  
Vol 60 (4) ◽  
pp. 369-371 ◽  
Author(s):  
Nicholas G. Kounis ◽  
George D. Soufras ◽  
Periklis Davlouros ◽  
Grigorios Tsigkas ◽  
George Hahalis

2013 ◽  
Vol 29 (4) ◽  
pp. 365-373 ◽  
Author(s):  
Annetine C. Gelijns ◽  
Mark J. Russo ◽  
Kimberly N. Hong ◽  
Lawrence D. Brown ◽  
Deborah D. Ascheim ◽  
...  

Background: In recent years, there has been growing interest in evaluating the health and economic impact of medical devices. Payers increasingly rely on cost-effectiveness analyses in making their coverage decisions, and are adopting value-based purchasing initiatives. These analytic approaches, however, have been shaped heavily by their use in the pharmaceutical realm, and are ill-adapted to the medical device context.Methods: This study focuses on the development and evaluation of left ventricular assist devices (LVADs) to highlight the unique challenges involved in the design and conduct of device trials compared with pharmaceuticals.Results: Devices are moving targets characterized by a much higher degree of post-introduction innovation and “learning by using” than pharmaceuticals. The cost effectiveness ratio of left ventricular assist devices for destination therapy, for example, decreased from around $600,000 per life year saved based on results from the pivotal trial to around $100,000 within a relatively short time period.Conclusions: These dynamics pose fundamental challenges to the evaluation enterprise as well as the policy-making world, which this paper addresses.


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