Health Technology Assessment as Theoretical Framework to Assess Lower-Limb Prosthetics—Issues and Opportunities from an International Perspective

Abstract

ABSTRACT Lower-limb prosthetics is rapidly advancing through innovative technologies. Simultaneously, patients in need of prosthetic rehabilitation treatments are expected to double by 2050. Unfortunately, available economic resources are not growing at a comparable pace. The result is the widening gap between what is technologically possible and what is economically sustainable. In this context, health technology assessment (HTA) stands out as a multidisciplinary process, grounded on scientific evidence, that can support decision makers on how best to allocate limited funds to health interventions and technologies. The aim of this contribution is to introduce the HTA concepts and methods of possible interest for the field of orthotics and prosthetics (O&P) in general and lower-limb prosthetics, in particular, from an international perspective. This will be accomplished by answering six questions: 1. What is HTA and how does it differ from evidence-based practice (EBP)? 2. Why should we care about HTA in O&P? 3. Do policy makers care about HTA reports? 4. Are there structured tools to run HTA appraisals that are suitable for the O&P field? 5. Are there challenges to consider when running an HTA on medical devices, including lower-limb prosthetics? 6. Are there strategies to adopt to improve evidence collection and HTA on lower-limb prosthetics? Collectively, the answers culminate in the position that HTA is highly desirable, but poses challenges to O&P, because medical devices have unique features (e.g., incremental innovation and operator dependence), and because the level of evidence is generally low. To address these challenges, we proposed seven driving concepts that can improve evidence collection and the HTA of lower-limb prosthetics. Among them, managed entry agreements, registry big data, and Internet-of-things strategies can support value-for-money approaches and can mark a true change in lower-limb prosthetic accessibility.