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VOLUME 4, ISSUE 2  
 2021 

 

STAKEHOLDER  PERSPECTIVES 

Frossard L. A preliminary cost-utility analysis of the prosthetic care innovations: basic framework. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, 

Issue 2, No.10. https://doi.org/10.33137/cpoj.v4i2.36365 

This article has been invited and reviewed by Co-Editor-In-Chief, Dr. Silvia Ursula Raschke. 
English proofread by: Karin Ryan, M.A., B.Sc., P.T. 
Managing Editor: Dr. Hossein Gholizadeh 
 

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Frossard L. A preliminary cost-utility analysis of the prosthetic care innovations: basic framework. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 
2, No.10. https://doi.org/10.33137/cpoj.v4i2.36365 

 

 

 
STAKEHOLDER  PERSPECTIVES 

 

A PRELIMINARY COST-UTILITY ANALYSIS OF THE PROSTHETIC CARE INNOVATIONS: BASIC 

FRAMEWORK 

Frossard L1-4* 
 

 

1 YourResearchProject Pty Ltd, Brisbane, Australia. 
2 Griffith University, Gold Coast, Australia. 
3 University of the Sunshine Coast, Maroochydore, Australia. 
4 Queensland University of Technology, Brisbane, Australia. 

 

 

 

 

  

 

 

 

 

 

 

 

 

 

 

 

INTRODUCTION 

The revolutionary car maker and industrialist Henry Ford 

(1863-1947) said, “if you think of standardization as the best 

that you know today, but which is to be improved tomorrow; 

you get somewhere.” The automobile and healthcare 

industries might be two worlds apart. However, they both 

thrive on standardization because it is the key to efficiency  

 

 

 

 

 

 

 

 

and safety. Hence, efforts are needed to develop a standard 

of care. Standardization could also be applied to assess the 

socio-economic benefits of prosthetic care intervention. 

This article focuses on developing a basic framework of 

preliminary cost-utility analysis (CUA) of innovations 

suitable to improve prosthetic fittings.   

Economic evaluations of prosthetic care innovations 

Promoters of prosthetic care interventions, including end-

users, providers of prosthetic solutions, and administrators 

of healthcare organizations, are increasingly motivated to 

demonstrate the socio-economic benefits of their 

innovations.1-3 

 
OPEN  ACCESS Volume 4, Issue 2, Article No.10. 2021 

 

 

Journal Homepage: https://jps.library.utoronto.ca/index.php/cpoj/index 

 

ABSTRACT 

A preliminary cost-utility analysis (CUA) of prosthetic care innovations can provide timely information 

during the early stage of product development and clinical usage. Concepts of preliminary CUAs 

are emerging. However, several obstacles must be overcome before these analyses are performed 

routinely. Disparities of methods and high uncertainty make the outcomes of usual preliminary CUAs 

challenging to interpret, appraise and share. These shortcomings create opportunities for a basic 

framework of preliminary CUAs. First, I introduced a basic framework of a preliminary CUA built 

around a series of constructs and hands-on recommendations. Then, I appraised this framework 

considering the strengths and weaknesses, barriers and facilitators, and return on investment. The 

design of the basic framework was determined through the review of health economic and 

prosthetic-specific literature. A preliminary CUA comparing the costs and utilities between usual 

intervention and an innovation could be achieved through a 15-step iterative process focusing on 

feasibility, constructs, analysis, and interpretation of outcomes. This CUA provides sufficient 

evidence to identify knowledge gaps and improvement areas, educate about the design of 

subsequent full CUAs, and obtain fast-track approval from governing bodies. Like previous CUAs, 

the main limitations were inherent to the constructs (e.g., narrow perspective, plausible scenarios, 

mid-term time horizon, substantial assumptions, data mismatch, high uncertainty). Key facilitators 

potentially transferable across preliminary CUAs of prosthetic care innovations included choosing 

abided constructs, capitalizing on prior schedules of expenses, and benchmarking baseline or 

incremental utilities. This new approach with preliminary CUA can simplify the selection of methods, 

standardize outcomes, ease comparisons between innovations, and streamline pathways for 

adoption. Further collegial efforts toward validating standard preliminary CUAs will facilitate access 

to economic prosthetic care innovations, improving the lives of individuals suffering from limb loss 

worldwide. 

CITATION 

Frossard L. A preliminary cost-utility 

analysis of the prosthetic care 

innovations: basic framework. Canadian 

Prosthetics & Orthotics Journal. 2021; 

Volume 4, Issue 2, No.10. 

https://doi.org/10.33137/cpoj.v4i2.36365 

KEYWORDS 

Artificial Limbs, Bionic Limbs, Bone-

Anchored Prosthesis, Cost-

Effectiveness, Cost-Utility, Health 

Economic Evaluation, Health 

Technology Assessment, Prosthesis, 

Socket-Suspended Prosthesis 

 

* CORRESPONDING AUTHOR 

Laurent Frossard (PhD), Professor of Bionics, 
YourResearchProject Pty Ltd, Brisbane, Australia. 

E-mail: laurentfrossard@outlook.com 

ORCID number: https://orcid.org/0000-0002-0248-9589 

Special Issue: Health Economics in Prosthetics & Orthotics 

https://doi.org/10.33137/cpoj.v4i2.36365
https://jps.library.utoronto.ca/index.php/cpoj/index
https://doi.org/10.33137/cpoj.v4i2.36365
mailto:laurentfrossard@outlook.com
https://orcid.org/0000-0002-0248-9589


 

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Frossard L. A preliminary cost-utility analysis of the prosthetic care innovations: basic framework. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 
2, No.10. https://doi.org/10.33137/cpoj.v4i2.36365 

ISSN: 2561-987X 
COST-UTILITY ANALYSIS OF THE PROSTHETIC CARE INNOVATIONS 

Frossard L, 2021 CPOJ 

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Either health technology assessment (HTA) or health 

economic evaluation (HEE), or both of prosthetic care 

innovations are imperative to systematically assess the 

indirect and unintended clinical and economic 

consequences of an intervention.4-6  Practically, there is an 

ever-increasing demand for CUAs comparing the usual and 

new interventions using the incremental cost-utility ratio 

(ICUR). The ICUR is based on the incremental costs 

expressed in monetary units and utilities expressed in 

quality-adjusted life-year (QALY) over time compared to the 

willingness-to-pay threshold (WTP).4-9 

As detailed in Frossard (2021), early, preliminary, and full 

CUAs can be conducted at the early, middle, and late 

phases of product development and clinical acceptance of 

innovations, respectively.3  

Full CUAs, including primary and modeling analyses, can 

produce comprehensive outcomes, but they require 

substantial resources and lack timeliness. Promoters could 

rely on strong recommendations that might be provided 

after a wide clinical adoption. Full CUAs have been used to 

demonstrate the health economic benefits of socket fitting 

interventions and fitting of advanced prosthetic components 

(microprocessor-controlled knees, energy-storing, and 

return feet) for socket-suspended and socket-free 

prostheses.7,8,10-19  

Earlier CUAs could be conducted around the initial and 

middle stages of innovation development when clinical 

usage is still limited. These analyses could provide timely 

outcomes, but they presented high uncertainty. Promoters 

might consider tentative recommendations of likely 

consequences that could be used to refine product 

development and clinical introduction. Recent preliminary 

CUAs considered the potential benefits of transfemoral and 

transtibial bone-anchored prostheses from the Australian 

government’s prosthetic care perspective.7,8,14,20-22  

Emergence of preliminary CUAs 

Concepts of preliminary CUAs are emerging.1 However, 

several obstacles must be overcome before preliminary 

CUAs are routinely performed by promoters of prosthetic 

care innovations. For instance, multiple pathways and 

disparity constructs make the outcomes of these CUAs 

(e.g., costs, utilities, ICURs) challenging to interpret (e.g., 

comparison between innovations, generalization across 

healthcare), appraise (e.g., Consolidated Health Economic 

Evaluation Reporting Standards (CHEERS), Consensus 

Health Economic Criteria (CHEC) extended checklists) and 

share (e.g., publication).3,23-25  

Promoters rely on their abilities to make valid assumptions 

while opting for a specific CUA pathway of innovations.1 

However, this does not mean that preliminary CUAs of a 

given  innovation  must  be  highly  individualized. Arguably,  

 

the organization of the delivery and assessment of 

prosthetic care might be sufficiently transferable across 

innovations to consider a uniform approach to preliminary 

CUAs.7,8,14,20 

Need for a basic framework of a preliminary CUA  

The shortcomings of preliminary CUAs and the 

standardization of prosthetic care create opportunities for a 

basic framework of preliminary CUAs. Such a framework 

should be built based on fundamentals, applied principles of 

health economics, and recent preliminary CUAs of socket-

free attachment for transfemoral and transtibial 

prostheses.7,8,14  

The primary purpose of this article was to introduce a basic 

framework including a 15-step iterative process focusing on 

feasibility, constructs, analysis, and interpretations of 

outcomes of a preliminary CUA of prosthetic care 

innovations. Practically, a series of constructs and hands-

on ways to gather information was presented. Furthermore, 

I recommended some facilitators transferable across 

preliminary CUA of prosthetic care innovations. 

The secondary purpose was to appraise this basic 

framework considering potential strengths and 

weaknesses, barriers and facilitators, and returns on 

investment of the proposed preliminary CUA.  

BASIC FRAMEWORK  

An overview of the iterative process of the basic framework 

of a preliminary CUA of a prosthetic care innovation is 

presented in Figure 1. This preliminary CUA was designed 

to compare the costs and utilities before or without (usual 

intervention) and after or with an innovation suitable to 

improve prosthetic fittings (new intervention).4-6  

Next, all 15 steps of the process were individually 

presented, including a brief description of the concept, the 

specific aim, and some recommendations on ways to 

LIST OF ABBREVIATIONS 

CHEC: Consensus Health Economic Criteria extended 

checklist 

CHEER: Consolidated Health Economic Evaluation Reporting 

Standards checklist 

CUA: Cost-utility analysis 

EQ-5D: EuroQol-5 Dimension 

ICER: Incremental cost-effectiveness ratio 

ICUR: Incremental cost-utility ratio 

K: Medicare Functional Classification Level 

QALY: Quality-adjusted life-year 

SF36: 36-Item Short Form Survey 

WTP: Willingness-to-pay threshold 

https://doi.org/10.33137/cpoj.v4i2.36365


 

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Frossard L. A preliminary cost-utility analysis of the prosthetic care innovations: basic framework. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 
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ISSN: 2561-987X 
COST-UTILITY ANALYSIS OF THE PROSTHETIC CARE INNOVATIONS 

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proceed that could facilitate the process when needed. 

Some barriers and facilitators were presented for the sake 

of completion, although they were basic and possibly 

evident for those astute in HEEs and CUAs (e.g., review 

literature, consult clinicians).4-6  

Appraisal of the proposed preliminary CUA using the 

CHEERS and CHEC-extended checklists is detailed in the 

supplementary material.23-25  

Determine feasibility  

This initial phase determines if the intended preliminary 

CUA is achievable depending on the strength of information 

available (Figure 1.1). This phase is organized around a 

three-step waterfall process with a decision point at every 

step to make sure resources are invested only if preliminary 

CUA is feasible. The analysis can stop at any step if the 

preliminary information is deemed unsatisfactory and could 

be revisited later on. Obtaining sufficient information leads 

to the next steps of the analysis.  

Investigate product (Step 1A)  

This step gathers information about the clinical pathways of 

the innovation, including the technical description of the 

device and the surgical, medical, rehabilitation, and 

prosthetic care procedures like patient screening (e.g., 

clinical indications and contraindications), among others. 

Ultimately, this step reveals the unique value additions of 

the innovation compared to other interventions that  

could alleviate the current shortcomings of prosthetic 

fittings.3,26-31   

Some obvious facilitators include the literature review and 

engagements with suppliers and clinicians to access 

guidelines and expert opinions.  

Search evidence of safety (Step 1B) 

This step searches for what Ijzerman and Steuten (2011) 

called “likely safety” including some indications and 

preferably early evidence of the safety level of the 

2A 

Define 

perspective 

2B 

Define time 

horizon 

2C 

Identify 

scenarios 

2D 

Set 

discount 

2E 

Assess 

uncertainty 

2. Outline constructs 

3A 

Estimate 

costs 

3B 

Estimate 

utilities 

3D 

Compare 

with WTP 

3. Conduct analysis 

4A 

Consider 

limitations 

4B 

Interpret 

outcomes 

4. Interpret outcomes 1. Determine feasibility 

1A 

Investigate 

product 

1B  

    Search evidence 

of safety 

1C  

Search evidence 

of efficacy 

Yes 

No 

No 

No 

Abandon 

and revisit 

later 

Yes 

Yes 

Favourable 

4C  

Outline 

implementation 

Planning CUA 

3C 

Calculate 

ICURs 

No Yes 

Figure 1: Overview of basic framework of preliminary cost-utility analysis (CUA) of prosthetic care innovations including on a 15-step iterative 

process. ICUR: Incremental cost-utility ratio, WTP: Willingness-to-pay threshold. 

https://doi.org/10.33137/cpoj.v4i2.36365


 

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Frossard L. A preliminary cost-utility analysis of the prosthetic care innovations: basic framework. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 
2, No.10. https://doi.org/10.33137/cpoj.v4i2.36365 

ISSN: 2561-987X 
COST-UTILITY ANALYSIS OF THE PROSTHETIC CARE INNOVATIONS 

Frossard L, 2021 CPOJ 

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innovation reported in terms of adverse events.1 Socket-

based solutions should report the incidence of pain, 

slippage, pistoning, skin damages (e.g., allergies), and falls, 

to name a few.29,32-36 Socket-free innovations involving 

endo-skeletal osseointegrated implants with or without 

percutaneous parts should report pain, falls, stoma and soft 

tissue inflammation, loosening, periprosthetic fractures, 

breakage of implant parts, deep and superficial infections, 

intake of antibiotics, and removal of the implant.37-39 Levels 

of evidence (i.e., Level I-VII) and knowledge gaps should be 

considered when deciding the worthiness of the findings.  

Preliminary CUA should be typically conducted shortly after 

commercialization when clinical use remains limited to a 

small group of patients. Therefore, evidence of safety for 

large cohorts (e.g., statistical power) over an extended 

observational study (e.g., several years follow-up) produced 

by independent parties might be desirable but unlikely. 

Alternatively, early evidence provided by manufacturers 

outside or within a registered clinical trial is expected. Level 

VI (e.g., single descriptive or qualitative study) or even Level 

VII (e.g., opinion of authorities and/or reports of expert 

committees) of evidence could be found in this step. 

Contemplating indications of the innovation’s safety with a 

benevolent outlook is acceptable considering that only the 

safety prospect should be deemed sufficient to lead to the 

next step.  

Search evidence of efficacy (Step 1C) 

This step searches for what Ijzerman and Steuten (2011) 

also called “likely efficacy,” including indications and, 

preferably, early evidence of the efficacy of the innovation.1 

Efficacy includes, amongst others, self-reported satisfaction 

(e.g., Orthotics and Prosthetics Survey, Quebec User 

Evaluation of Satisfaction with Assistive Technology, socket 

prosthetic comfort score), the performance of physical tasks 

(e.g., Berg Balance Scale, timed get up and go, walking 

speed, two- or six-minute walk tests, functional ambulation 

profile, amputee mobility predictor with prosthesis), and 

specific (e.g., Questionnaire for Persons with a 

Transfemoral Amputation) and generic (e.g., 36-Item  

Short Form Survey (SF36), EuroQol-5 Dimension (EQ-5D)) 

health-related quality of life indicators (e.g.,  

Quality-Adjusted Life Year, Disability-Adjusted Life 

Year).33,34,36,40-42  

Evidence of efficacy might be easier to find because 

manufacturers tend to assess the benefits of innovations 

before the harms. Nonetheless, finding strong evidence of 

efficacy might be challenging for the same reasons 

indicated in Step 1B.  

Levels of evidence (i.e., Level I-VII) and knowledge gaps 

should be considered when deciding the value of the 

finding. A critical facilitator is the health-related quality of life 

data review that can be readily mapped into QALY (e.g., 

SF36, EQ-5D).43 The absence of convertible health-related 

quality of life data is likely to stop the preliminary CUA 

because completion of Step 3B would be impractical. Any 

datasets that can be used to create either a baseline or 

incremental utility or both utilities with the innovation should 

be considered (e.g., an estimate of gain post-intervention). 

Outline constructs 

This five-step phase defines the list of typical parameters 

framing a preliminary CUA (Figure 1.2).  

Define perspective (Step 2A)  

Preliminary CUAs can be conducted from a broad taxpayer 

or healthcare perspective.6,15 However, surgical, medical, 

and prosthetic care costs are often undertaken in whole  

or in part by tertiary, primary, and secondary or allied  

health care services of government healthcare 

organizations or private companies operating together or 

separately.2,15,20,44-46 All costs are rarely collected in whole 

and reported to relevant services using a single integrated 

financial system. This step determines which perspective 

might be the most sensible, considering that preliminary 

CUAs can focus on a reasonably narrow perspective. 

Considering a government prosthetic care perspective to 

perform a preliminary CUA of a prosthetic care innovation 

seems indicated.7,8,14,21  

Define time horizon (Step 2B) 

The length of time over which the innovation outcomes can 

be evaluated is called the time horizon. Choosing the 

appropriate time horizon can be problematic.47,48 This step 

aims at finding a compromise around a time horizon that is 

long enough to provide realistic and most probable intended 

benefit with the least approximation errors.15,16,47-53 

Funding cycles of a preliminary CUA of an innovation 

advancing prosthetic fittings should consider the lifetime 

of the prosthetic components (e.g., socket, artificial 

joints).7,8,14 

I suggest that a suitable compromise might be, at least, six 

years, because of the predictability of costs and the lifetime 

of components (e.g., two cycles of three years for a foot, 

three cycles of two years for a knee).7,8  

Identify scenarios (Step 2C)  

Scenarios are commonly used to characterize the 

consequences of interventions for various health states and 

specific cases. Improvement in functional outcomes is often 

a consequence of choice. Level of function can be assess 

using Medicare Functional Classification Level (K-level). In 

principle, up to 15 scenarios can be considered when 

comparing possible progressions across the five K-levels 

ranging from K0 to K4 with and without the innovation  

(Table 1). This step identifies a limited series of scenarios 

that are the most plausible.  

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Frossard L. A preliminary cost-utility analysis of the prosthetic care innovations: basic framework. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 
2, No.10. https://doi.org/10.33137/cpoj.v4i2.36365 

ISSN: 2561-987X 
COST-UTILITY ANALYSIS OF THE PROSTHETIC CARE INNOVATIONS 

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I recommend exploring between three and five realistic 

scenarios including, the best, base, and worse cases 

depending on foreseeable costs and utility consequences of 

the innovation.7,8  

Table 1: Matrix of 15 possible scenarios comparing progressions 

of functional outcomes across the five Medicare Functional 

Classification Level (K-level) ranging from K0 to K4 without (usual) 

and with (new) intervention that could be considered in Step 2C. 

 

Set discount (Step 2D) 

Discounting is the process of reducing future values of costs 

and utilities to their present values.48 The standard practice 

for full CUA is to discount values at 3% over the time 

horizon.48 This step ascertains the extent to which this rate 

should apply to the intended preliminary CUA.  

I consider that no discount might be applied when the time 

horizon is reasonably short (e.g., up to six years) and the 

highest costs of the intervention are spent in the first few 

years of the funding cycle.7,8 

Assess uncertainty (Step 2E) 

Estimates of costs and utilities are subjected to uncertainty 

depending on the sources of the data. Comprehensive CUA 

involves complex Markov-state transition models designed 

to investigate the impact of cost and utility estimates and 

provide parameters, models, and generalizable 

uncertainties.15,16,50,51,53 The sensibility of the outcomes of 

these models is also considered based on the probability of 

occurrence of events that might affect the analysis.15 This 

step aims to limit uncertainty by considering a limited 

number of practical events or health states.  

I recommend making conservative assumptions that the 

innovation marginally improves the prosthetic fittings (e.g., 

reduce socket fittings by only one per annum). Considering 

multiple events or health states is beyond the scope of this 

analysis (e.g., reduce socket fittings by two, three, or more 

per annum). 

Uncertainty of cost information of real and estimated costs, 

extracted from the schedule and financial records, can be 

reported using a variable called “prediction” presented in 

Frossard et al. (2018, 2020).7,8 This variable corresponds to 

the relative real over the total costs. A prediction of 0% and 

100% indicated that the total cost is fully extracted from 

schedules and financial records, respectively.  

Sensibility of datasets and the outcomes can be reported 

using basic descriptive statistics (e.g., mean, standard 

deviation, coefficient of variation, median, interquartile 

range, 95% confidence intervals, minimum, maximum, 

range).7,8,14 In some cases, inter-participant variability of 

costs might be reported using the coefficient of variation, 

where coefficients inferior to 33%, between 34% and 66%, 

and superior to 66% indicate low, moderate, and high inter-

variability, respectively.8   

Conduct analysis 

This four-step phase estimates costs, utilities, and ICURs 

based on the constructs determined in the previous phase 

(Figure 1.3). 

Estimate costs (Step 3A) 

Ideally, actual labor and parts costs of prosthetic care with 

usual intervention and the innovation, can be extracted from 

financial systems for the largest possible cohort of 

participants. However, only partial information on the 

primary post-treatment costs over the time horizon might be 

available (Steps 1C, B).  

I advise considering generic costs organized in schedules 

of allowable expenses.14,20 These schedules can be used, 

in part or whole, to estimate the most probable costs for 

prosthetic care without or with the innovation.7,8,14 A 

schedule is a matrix that presents costs at the intersection 

list of tasks in rows and the timeline of interventions 

between the columns.3 The type of tasks and frequency of 

interventions should be based on the standard of care 

recommended by clinicians and government 

agencies.20,54,55 The actual costs of labor and parts should 

be consistent with allowable expenses supported by 

reimbursement schemes (e.g., L-Codes), particularly when 

analyzing from the healthcare perspective. Examples of 

schedules of allowable expenses used for preliminary CUAs 

of lower limb bone-anchored prostheses can be used as a 

template.7,8,14  

Healthcare organizations tend to provide support for 

categories of components depending on functional levels 

(e.g., K-Levels).56 Here, prosthetists are free to prescribe a 

model and brand according to the patients’ specific needs. 

Thus, allocating lump sums rather than price tags for 

specific prosthetic components may be more acceptable. In 

all cases, I recommend presenting the source and analysis 

of datasets (e.g., actual vs. estimated). The series of 

assumptions made to estimate costs must be justified (e.g., 

hours of labor for socket fittings, frequency of replacement 

of prosthetic components).14,20   

    
New 

    K0 K1 K2 K3 K4 

U
s
u
a
l 

K0 
Scenario 

1 
Scenario 

2 
Scenario 

3 
Scenario 

4 
Scenario 

5 

K1 - 
Scenario 

6 
Scenario 

7 
Scenario 

8 
Scenario 

9 

K2 - - 
Scenario 

10 
Scenario 

11 
Scenario 

12 

K3 - - - 
Scenario 

13 
Scenario 

14 

K4 - - - - 
Scenario 

15 

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ISSN: 2561-987X 
COST-UTILITY ANALYSIS OF THE PROSTHETIC CARE INNOVATIONS 

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Table 2: Overview of manageable barriers and transferrable facilitators of basic framework of preliminary cost-utility analysis (CUA) 

comparing usual intervention (e.g., socket-based, socket-free using osseointegration) and a prosthetic care innovation susceptible to 

improve prosthetic fittings. ICUR: Incremental cost-utility ratio, K-level: Medicare Functional Classification Level, QALY: Quality-adjusted 

life-year, $: Australian Dollar.   

Barriers Facilitators 

1. Determine feasibility 

Investigate product (Step 1A) 

1. Understand the technical description of the 

..treatment (e.g., identify parts) 
1. Find technical information provided by the supplier of the innovation (e.g., website, flyer)  

2. Understand the surgical, medical, rehabilitation 

.and prosthetic care procedures (e.g., Understand 

.clinical indications and contraindications) 

2. Find clinical guidelines for the prescription of the innovation provided by the supplier  

3. Seek opinion of expert clinicians about indications and contraindications 

3. Understand unique added value of the innovation 

.compared to other interventions 

4. Extract information provided in publications about innovation 

5. Identify uniqueness of the treatment after cross-comparison with other interventions 

6. Establish if the potential benefits of the innovation justified investigating safety 

Search evidence of safety (Step 1B) 

4. Foresee indications of safety of the innovation 
7. Sass out potential harms of innovation  

8. Compare potential risks with other interventions 

5. Find early evidence of safety of the innovation 
9. Search literature focusing on safety of the innovation 

10. Review level of evidence of adverse events (i.e., Level I-VII, registered clinical trial)  

6. Identify evidence gaps about safety of the  

.innovation 

11. Acknowledge evidence gaps about safety of the innovation 

12. Establish if evidence of safety of the innovation justified investigating efficacy 

Search evidence of efficacy (Step 1C) 

7. Foresee indications of efficacy of the innovation 
13. Sass out potential benefits of innovation  

14. Compare potential benefits with other interventions 

8. Find evidence of the efficacy of the innovation 

15. Search literature focusing on efficacy of the innovation 

16. Review level of evidence of satisfaction, function (e.g., performance of physical tasks) and    

.health-related quality of life (i.e., Level I-VII, registered clinical trial)  

9. Identify evidence gaps about efficacy of the 

.innovation 

17. Acknowledge evidence gaps about efficacy of the innovation 

18. Establish if health-related quality of life data of the innovation is sufficient to justified continuing 

.CUA 

2. Outline constructs  

Define perspective (Step 2A) 

10. Choose healthcare perspective considering 

surgical, medical and prosthetic care expenses 

19. Accept that considering whole care expenses together might have little relevance, in fine, 

because of the separation between primary, secondary, and tertiary services in typical 

healthcare systems 

20. Simplify analysis be considering only a prosthetic care perspective 

Define time horizon (Step 2B) 

11.  Find the time horizon that is long enough to 

provide realistic outcomes but the least 

subjected to large approximation errors 

21. Understand that prediction of costs of prosthetic components over the long period of time is 

.more likely to be grossly inaccurate 

22. Acknowledge studies suggesting that a rather short time horizon would be indicated for the 

.preliminary analysis  

23. Consider that six-year time horizon might be a suitable compromise because of the predictability 

.of costs and lifetime of components  

Identify scenarios (Step 2C) 

12. Identify a small series of plausible scenarios  

24. Consider 15 scenarios for all possible progressions across K-levels  

25. Select up to five realistic scenarios most likely to represent expected clinical outcomes with the 

innovation including worse, best and base cases   

Set discount (Step 2D) 

13. Ascertain to which extent typical discounting 

rate should apply  

26. Consider applying no discount when time horizon is short enough to predict costs  

27. Consider applying no discount when most important costs might occur at the beginning of the  

.cycle 

Assess uncertainty (Step 2E) 

14. Find ways to determine the uncertainty  

28. Make the conservative assumption that the innovation would minimally improve prosthetic 

.fittings  

29. Consider that looking at multiple events or health states is beyond the scope of this analysis  

15. Find ways to present the sensibility  
30. Choose to report sensibility analysis using only basic descriptive statistics including coefficient of 

.variation 

 

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A conservative method to estimate costs is to assume that 

full allowable expenses are claimed, although some users 

might choose to keep components even after the warranty 

period or discard cosmetic covers. Alternatively, I consider 

that all prosthetic tasks are performed by qualified 

prosthetists even if some tasks might be undertaken by a 

technician working at a lower hourly rate. However, these 

suggestions could be discarded, particularly when the 

analyses focus on innovations improving service delivery.57  

Estimate utilities (Step 3B) 

Primary utilities measured for groups of participants without 

and with the innovation are preferable, depending on the 

relevant healthcare organization. However, like costs, 

Table 2: Continued.   

Barriers Facilitators 

3. Conduct analysis  

Estimate costs (Step 3A) 

16. Estimate costs for the provision of prosthetic 

.care without and with the innovation 

31. Acknowledge that primary costs with the innovation might not be available in relevant healthcare 

system 

32. Create schedules of allowable expenses for labour and parts for the provision of prosthetic care 

.without and with innovation 

33. Apply costings recommended by the healthcare system 

Estimate utilities (Step 3B) 

17. Estimates utilities experienced by users without 

.and with the innovation 

34. Acknowledge that primary utility data with the innovation might not be available for groups of 

users involved in relevant healthcare system 

35. Search utility information with the innovation in the literature  

36. Consider utility information published and convert data to create baseline utility reported in 

QALY  

37. Assume that users experience a small increase of utilities with the innovation compare to 

.baseline 

38. Assume that utilities experienced without and with the innovation remain steady during the time 

horizon 

Calculate ICURs (Step 3C) 

18.Determine which scenario could provide a 

tentative ICUR 
39. Assume that the base-case scenario should be correspond to the indicative ICUR 

Compare with WTP (Step 3D) 

19.Identify the sensible WTP commonly accepted 

in the relevant health care 

40. Consider that a conservative WTP is $40,000 per QALY that is significantly lower that oft-cited 

WTP 

20.Identify thresholds most likely to motivate 

promoters to continue the developments of the 

innovation 

41. Consider that an indicative ICUR costing less than $20,000 per QALY is most likely to motivate 

.promoters to continue the developments of the innovation 

4. Interpret outcomes  

Consider limitations (Step 4A) 

21. Understand the effects of the series of 

.assumptions 

42. Concede that analysis is noticeably limited by a series of assumptions 

43. Look at how costs might have been over-estimated  

44. Look at how utilities might have been under-estimated  

45. Acknowledge when ICURs aggregates mismatched data  

Interpret outcomes (Step 4B) 

22. Assess how the treatment compared to other 

.interventions  

46. Estimate the range of costs and utilities that might be required to make the innovation cost-

.effective and below WTP  

47. Determine if the innovation has the potential to be more cost-effectiveness than competing 

.interventions  

23. Assess limitations to generalization of the 

.outcomes  
48. Concede that generalization of outcomes might be limited 

Outline implementation strategy (Step 4C) 

24. Gauge the worthiness of data to justify 

.introducing of the innovation in healthcare 

49. Establish how the indicative ICUR with the innovation stacks up against other interventions  

50. Decide if the analysis provided sufficient evidence to motivate promoters to encourage clinical 

.adoption in relevant healthcare 

25. Identify how information gathered during this 

.analysis could inform the design subsequent 

.full CUA of the innovation 

51. Acknowledge that outline pathways for the clinical introduction of the innovation is beyond the               

;scope of this analysis 

52. Detail how this information provided can inform subsequent primary and modelling CUAs of the 

.innovation  

 

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primary utilities collected at the outset of the preliminary 

CUA are likely to be unattainable.  

Alternatively, I suggest using health-related quality of life 

data identified in Step 1C to estimate baseline and 

incremental utilities published together or separately. For 

instance, the dataset from SF36 can be converted into 

QALY applying the Ara and Brazier regression model used 

by Frossard et al. (2018).7,8,43 Plausible estimates of 

incremental utilities could be based on the assumption that 

users of the innovation are likely to experience a gradual 

gain of QALY between the worse, base, and best cases 

scenarios.7,8  

I recommend describing the sources and processing of 

datasets, including the criteria to select publications and 

summarize the study designs used to measure original 

primary utilities. Gain of utilities should also be justified.  

Calculate incremental cost-utility ratios (Step 3C) 

This preliminary CUA comes together when ICURs are 

calculated using the formula ICUR = (Costs with innovation 

– Costs with usual intervention) / (Utility with innovation – 

Utility with usual intervention).4-6 ICUR should be calculated 

for each scenario and plotted on a conventional four-

quadrant cost-utility plane diagram indicating if the provision 

of the prosthetic care with innovation is more costly and 

more effective (Quadrant A: Consider ICUR), more costly 

and less effective (Quadrant B: Dominated), less costly and 

less effective (Quadrant C: Consider ICUR), and less costly 

and more effective (Quadrant D: Dominant) than usual 

intervention.4-6 I advise considering an indicative ICUR 

corresponding to the base-case scenario.7,8 

Compare with the willingness-to-pay threshold (Step 

3D) 

Typically, understanding outcomes of a CUA involved 

comparing ICUR and WTP. The oft-cited WTP is 

approximately $50,000 per QALY, depending on healthcare 

organizations.6 Based on figures frequently considered to 

determine the likelihood of adoption of an intervention, an 

indicative ICUR costing less than $20,000, between 

$20,000 and $100,000, and more than $100,000 per QALY 

could make the innovation most likely, likely, and unlikely, 

respectively, to motivate promoters to continue further 

product development and clinical introduction of the 

innovation.6 I advise a conservative WTP threshold of up to 

20% lower than the recommended WTP (e.g., $40,000 per 

QALY).7,8 

Interpret outcomes 

This four-step phase ascertains the extent to which the 

understanding of the outcomes of this preliminary CUA is 

sufficient to facilitate or curtail further product development 

and clinical introduction of the innovation (Figure 1.4).  

Consider limitations (Step 4A) 

This step recognizes the impacts of assumptions on the 

overall outcomes of the analysis. The typical and specific 

limitations of calculations of ICURs are discussed (e.g., 

mismatching datasets).  

I suggest exploring possible causes of cost overestimation 

(e.g., claiming full allowable expenses, tasks only 

performed by qualified prosthetist) and utilities 

underestimations (e.g., low incremental gains, consider 

utilities gained post-treatment consistent over time). I 

recommend acknowledging the extent to which the 

aggregate ICURs mismatched data (e.g., sources, 

jurisdictions, onset, post-operative timeline).7,8  

Interpret outcomes (Step 4B) 

This step considers the cost-effective conditions for the 

innovation. It ascertains by how much the QALY must be 

increased to offset its costs, and the requirements to make 

the indicative ICUR below WTP.  

I advise interpreting the analysis outcomes after comparing 

the costs, utilities, and ICURs with other competing 

interventions that could improve prosthetic fittings. Potential 

generalization of the outcomes should be investigated, 

considering the limitations. Finally, I advise basing the 

recommendations for wider clinical usage and likelihood of 

adoption of the innovation on the figures presented in Step 

3D.  

Outline implementation strategy (Step 4C) 

This last step examines the innovation against other 

interventions and relevant healthcare cost-utility standards. 

Decision-makers should comprehensively gauge whether 

the outcomes produced were robust enough to justify 

pursuing subsequent implementation strategy. Weak or 

unfavorable outcomes might encourage innovators to 

rethink product development and revisit opportunities for 

preliminary CUAs at a later stage. Strong and favorable 

outcomes might warrant continuing further product 

development and clinical promotion of the innovation.  

I suggest highlighting the elements of the preliminary CUA 

that could facilitate the design of the potential primary or 

modelling CUAs of the innovation (e.g., within-trial and 

beyond-trial horizon studies).47 Regardless of the 

recommendations, I advise outlining subsequent 

implementation strategies that could be deemed outside the 

scope of the analysis and the purpose of another process. 

APPRAISAL OF BASIC FRAMEWORK  

Strengths and weaknesses 

The proposed basic framework will provide timely 

information. This preliminary CUA will generate sufficient 

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evidence to identify gaps in evidence and improvement, 

educate about the design of primary or modeling studies, 

and fast-track approval of innovation from governing bodies.  

This framework carries the intrinsic limitations of the usual 

preliminary CUAs mentioned in Frossard (2021).3 The 

inherent limitations to the analysis include narrow 

perspective, plausible scenarios, and mid-term time 

horizon. The cost and utility estimates are built around best-

known evidence and substantial assumptions. ICURs would 

be based on mismatched costs and utilities. Reporting of 

the uncertainty and sensibility data will likely lack definition.  

Altogether, I predicted that the analysis might have a weak, 

moderate, and strong capacity to address 9 (33%), 8 (30%), 

and 10 (37%) of the items in the CHEERS checklist, 

including 7 (44%), 6 (38%) and 3 (19%) of the items in the 

Methods, and 2 (40%), 2 (40%), and 1 (20%) of the items in 

the Results sections, respectively.23,24 The proposed 

preliminary CUA might be capable and incapable of 

addressing items 11 (58%) and 8 (42%) in the CHEC-

extended checklists, respectively.24,25 

Barriers and facilitators 

As outlined in Table 2, I identified a total of 25 barriers that 

could be overcome by 52 facilitators likely to be transferable 

across preliminary CUAs of prosthetic care innovations. I 

believe these key but not comprehensive recommendations 

can be included:  

• Choosing abided constructs. The preliminary CUA 

design (Step 2), particularly the time horizon, emanated 

from educated choices integrating various basic and 

applied CUA methodological approaches presented in 

guidelines and recent publications.48 I recommended 

considering constructs that are consistent with recent 

preliminary CUA socket-free solutions.7,8,14 Choosing 

similar constructs would significantly streamline 

decision-making in all Steps 2A, B, C, and D. This 

should greatly facilitate the interpretation of the 

outcomes (Step 4B) and the gauging of the value 

proposition of the innovation compared to other 

interventions (Step 4C). This difference in outcomes 

between analyses could be minimally attributed to 

confounding constructs. 

• Building on prior schedules of expenses. The cost 

estimates (Step 3A) could be largely guided by an initial 

template of schedules considering the prosthetic care 

provision costs for lower limb socket-suspended and 

bone-anchored prostheses.7,8,14 Some generic tasks 

and timeline of interventions could be transferable. 

Other costs specific to each innovation must be 

tabulated into the new schedules recommended by 

clinicians and government agencies.  

• Capitalizing on benchmark baseline and incremental 

utilities. The utility estimates (Step 3B) could be 

educated by benchmark baseline and incremental 

utilities provided in the health economic literature 

focusing on socket-based or socket-fee prostheses.10-

13,15-19,57  

Returns on investment  

Questions might be raised about the returns on investment 

of the proposed preliminary CUA. Although some 

safeguards were embedded into the initial feasibility phase 

to curtail unnecessary work, the entire preliminary CUA 

requires noticeable efforts depending on the source of data 

(e.g., design schedules, extract costs, map utility).  

The returns might be unclear because of the important 

structural uncertainty, medium grade of evidence, and 

tentative recommendations.1  

However, policymakers in the healthcare sector might see 

some benefits of systematically embedding such 

preliminary CUA into their horizon scanning process.1 It can 

contribute to deciding whether a new prosthetic care 

intervention shows early signs of cost-utility. Promoters of 

new interventions might deem this preliminary CUA a 

worthwhile investment to support applications for healthcare 

approval.2  

CONCLUSIONS  

This study was an initial effort to standardize a basic 

framework of preliminary CUA comparing the prosthetic 

care provisions with and without innovation suitable to 

improve prosthetic fittings. This new approach to 

preliminary CUA has the potential to simplify the selection 

of methods, standardize outcomes, ease comparisons 

between innovations and streamline pathways for adoption 

while facilitating the production of a body of literature on 

prosthetic health economics. Insights into the next phase of 

development of this method might come from Masaaki Imai, 

a Japanese organizational theorist, and management 

consultant. He stated that it is impossible to improve any 

process until it is standardized. He added that if the process 

is shifting from here to there, then any improvement will just 

be one more variation that is occasionally used and mostly 

ignored. One must standardize, and thus stabilize the 

process, before continuous improvement can be made. 

Therefore, I welcome further experiments of this proposed 

analysis with emerging prosthetic care innovations. This will 

refine and validate the standard basic framework of 

preliminary CUA. Hopefully, this collegial effort will facilitate 

the adoption of economic prosthetic care innovations that 

could improve the lives of individuals suffering from limb 

loss worldwide. 

 

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CALL TO ACTION 

• Continue the discussion between promoters of 

prosthetic care innovations around the use and 

validation of preliminary CUAs framework. 

• Inspire authors of health economic evaluations to road-

test the proposed framework with a series of emerging 

prosthetic care innovations susceptible to improve 

prosthetic fittings.  

• Encourage authors of health economic evaluations of 

prosthetic care innovations to capitalize on the benefits 

of early and preliminary CUAs during development of 

the innovations. 

ACKNOWLEDGEMENTS 

The author wishes to express his gratitude to Debra Berg and 

Gregory Merlo for their support. 

DECLARATION OF CONFLICTING 

INTERESTS 

The author is in the view that these competing interests do not 

conflict with the content of this manuscript. Laurent Frossard, 

Director and Chief Scientist Officer of YourResearchProject Pty Ltd, 

has worked as consultant for several organisations on non-related 

educational programs and projects of research focusing on 

recording loading data, developing of database to record clinical 

outcomes as well as drafting grants and manuscripts for Cognitive 

Institute, Exercise & Sports Science Australia, Griffith University, 

iPug Pty Ltd, Middlesex University, New Zealand Artificial Limb 

Service, Osseointegration Group of Australia Pty Ltd, OSSUR, 

Poly-Orthodox International, Queensland Artificial Limb Service, 

Queensland University of Technology, Return to Work-South 

Australia, South Australia Health, Tequir S.L, University of the New 

South Whales, University of the Sunshine Coast. 

SOURCES OF SUPPORT 

This study was funded by YourResearchProject Pty Ltd. 

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AUTHOR SCIENTIFIC BIOGRAPHY 

Dr Laurent Frossard is a 

bionic limbs scientist who is 

passionate about developing 

ground-breaking prosthetic 

solutions to improve the lives 

of individuals suffering from 

limb loss. He is internationally 

recognized as a researcher 

and an independent expert for 

his unique expertise in bionic 

limbs. He approaches bionic 

solutions from a holistic 

perspective, by integrating the 

prosthetic biomechanics, 

clinical benefits, service delivery, and health economics. Dr 

Frossard has over 25 years of experience, both in academia and in 

private industries in Australia, Canada, and Europe. He has 

collaborated with over 100 organizations worldwide. He is currently 

a Professor of bionics at the Griffith University, the Director and 

Chief Scientist Officer at YourResearchProject Pty Ltd, and Adjunct 

Professor at the Queensland University of Technology and the 

University of Sunshine Coast in Australia.   

https://doi.org/10.33137/cpoj.v4i2.36365
https://www.who.int/choice/publications/p_2003_generalised_cea.pdf?ua=1DFID
https://www.who.int/choice/publications/p_2003_generalised_cea.pdf?ua=1DFID

