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.
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.
Authors: David T Felson; Anthony C Redmond; Graham J Chapman; Toby O Smith; David F Hamilton; Richard K Jones; Cathy A Holt; Michael J Callaghan; Deborah J Mason; Philip G Conaghan Journal: Rheumatology (Oxford) Date: 2015-09-10 Impact factor: 7.580
Authors: Maximilian Blüher; Sita J Saunders; Virginie Mittard; Rafael Torrejon Torres; Jason A Davis; Rhodri Saunders Journal: Front Med (Lausanne) Date: 2019-11-29
Authors: Rita Daubner-Bendes; Sándor Kovács; Maciej Niewada; Mirjana Huic; Michael Drummond; Oriana Ciani; Carl Rudolf Blankart; Olena Mandrik; Aleksandra Torbica; John Yfantopoulos; Guenka Petrova; Malwina Holownia-Voloskova; Rod S Taylor; Maiwenn Al; Oresta Piniazhko; László Lorenzovici; Rosanna Tarricone; Antal Zemplényi; Zoltán Kaló Journal: Front Public Health Date: 2021-01-08
Authors: Sandor Kovács; Zoltán Kaló; Rita Daubner-Bendes; Katarzyna Kolasa; Rok Hren; Tomas Tesar; Vivian Reckers-Droog; Werner Brouwer; Carlo Federici; Mike Drummond; Antal Tamás Zemplényi Journal: Health Econ Date: 2022-03-23 Impact factor: 2.395