Abstract

Overcoming obstacles to prosthetic fittings requires frequent tryouts of sockets and components. Repetitions of interventions are upsetting for users and place substantial economic burden on healthcare systems. Encouraging prosthetic care innovations capable of alleviating clinical and financial shortcomings of socket-based solutions is essential. Nonetheless, evidence of socio-economic benefits of an innovation are required to facilitate access to markets. Unfortunately, complex decisions must be made when allocating resources toward the most relevant health economic evaluation (HEE) at a given stage of development of an innovation. This paper first, aimed to show the importance and challenges of HEEs of intervention facilitating prosthetic fittings. Next, the main trends in HEEs at various phases of product development and clinical acceptance of prosthetic care innovations were outlined. Then, opportunities for a basic framework of a preliminary cost-utility analysis (CUA) during the mid-stage of development of prosthetic care innovations were highlighted. To do this, fundamental and applied health economic literature and prosthetic-specific publications were reviewed to extract and analyse the trends in HEEs of new medical and prosthetic technologies, respectively. The findings show there is consensus around the weaknesses of full CUAs (e.g., lack of timeliness, resource-intensive) and strengths of preliminary CUAs (e.g., identify evidence gaps, educate design of full CUA, fast-track approval). However, several obstacles must be overcome before preliminary CUA of prosthetic care innovations will be routinely carried out. Disparities of methods and constructs of usual preliminary CUA are barriers that could be alleviated by a more standardized framework. The paper concludes by identifying that there are opportunities for the development of a basic framework of preliminary CUA of prosthetic care innovations. Ultimately, the collaborative design of a framework could simplify selection of the methods, standardise outcomes, ease comparisons between innovations and streamline pathways for adoption. This might facilitate access to economical solutions that could improve the life of individuals suffering from limb loss.

Highlights

  • Alfred Nobel (1833-1896) said the following about innovation “If I have a thousand ideas and only one turns out to be good, I am satisfied.”In healthcare, the difference between a “good” or a not so good innovation is made during health technology assessment (HTA) and/or health economic evaluation (HEE).[1]

  • The findings show there is consensus around the weaknesses of full cost-utility analysis (CUA) and strengths of preliminary CUAs

  • The difference between a “good” or a not so good innovation is made during health technology assessment (HTA) and/or health economic evaluation

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Summary

INTRODUCTION

Alfred Nobel (1833-1896) said the following about innovation “If I have a thousand ideas and only one turns out to be good, I am satisfied.”. Ijzerman and Steuten (2011) systematically described that early, preliminary and full CUAs can be conducted at the early, mid and late stage of clinical acceptance of any medical treatment, respectively.[37] More recently, new insights were provided by Kannenberg and Seidinger (2019) who explained how these three types of CUAs should be performed by prosthetic manufacturers at early, mid and late phase development of a prosthetic product.[38] The authors indicated that CUA during the product’s life cycle is beneficial in three ways It allows potential cost-effectiveness to be estimated and included in investment decision processes and mitigates the risk of investing in technology unlikely to be costeffective. These analyses tend to be based on best guestimates of most likely costs and utilities collected with case-series studies and/or extracted from the literature often produced outside the relevant jurisdiction

Analytical methods
Conflicts of interest
CONCLUSION
DECLARATION OF CONFLICTING INTERESTS
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