OBJECTIVE: To explore economic evaluation methods for Medical Devices (MDs) and procedures as applied by different Health Technology Assessment (HTA) agencies.

In particular, the aim was to review approaches to handling device-specific characteristics in the HTA of MDs (e.g., learning curve, incremental innovation, dynamic pricing, organizational impact).

Additionally, we propose analytical methods that can be applied in measuring device-specific characteristics, where we focus on medium- and high-risk MDs most likely to undergo HTA.

METHODS: We performed a narrative literature review of different HTAs, including EUnetHTA, RedETSA, and ICER. Here we focused on economic-evaluation sections of MDs and procedure. Next, we reviewed the broader literature to identify methods proposed for measuring and incorporating device-specific characteristics within economic-evaluations. We further studied if and how the intrinsic properties of devices influence measurement of specific characteristics.

RESULTS: Many HTA agencies have separate methods guides for devices, but few address device-specific characteristics or propose methods for including them in economic evaluation. France’s Haute Autorité de Santé, the UK’s National Institute for Health and Care Excellence Medical Technologies Evaluation Programme and Interventional Procedures Programme all mention learning curve and dynamic pricing. HTA agencies in the Asia-Pacific region mention dynamic pricing, product-lifecycle, and organizational feasibility, but provide no guidance on measuring and reporting them in economic evaluation.

Of the four device-specific criteria, learning curve has been extensively studied using methods ranging from simple statistical models to hierarchical models – thus, this aspect could be considered in HTA of MDs. However, dynamic pricing, incremental innovation and organizational impact have not been studied extensively and are not incorporated into formal HTA methods.

CONCLUSION: Despite many HTA agencies developing methods guides for devices, most do not address key characteristics which distinguish them from pharmaceuticals. To ensure more appropriate assessment of devices, further research is required to propose appropriate new methods.