A Cost-Effectiveness Analysis of Charcot Reconstruction, Transtibial Amputation and Lifetime Bracing for

Adults with Diabetes Rachel H. Albright, DPM, MPH

The Dartmouth Institute for Health Policy & Clinical Practice

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Contributing Authors

Dane Wukich, MD Adam Fleischer, DPM, MPH David Armstrong, DPM Robert Joseph, DPM, PhD

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Financial Disclosures

None

Background

• Charcot Foot prevalence: 0.8% - 7.5% • Increased interest in surgically

reconstructing non-ulcerated, non-plantigrade feet

• Value is poorly understood • There is no current widely adopted

treatment algorithm in existence for the neuropathic, non-plantigrade foot

• The decision to pursue CR in the U.S. is currently based almost entirely on surgeon preference

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What does the Literature Tell Us?

Crude Cost

Analysis

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Purpose

To compare the cost-effectiveness of three treatment strategies for adults suffering from Charcot arthropathy in the U.S. healthcare system: Charcot reconstruction (CR), primary transtibial amputation (TTA), and lifetime bracing.

Additionally, we aim to identify the optimal time for

reconstruction, from health system’s perspective

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• All available literature reporting on outcomes & costs for three strategies • A Markov model was used to compare the strategies in three clinical scenarios

(cohorts):

Methods

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Primary Outcomes: Quality adjusted life years (QALYs) and incremental health care costs – reported as ICER

Methods Base Case Scenario: 50 year old adult with moderate/severe midfoot Charcot Arthropathy

Costs reported in 2019 US Dollars Discount rate: 3%

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Relevant Costs

Index Surgery (TTA & CR)

Hardware Bracing

Postoperative Care

Prostheses Wound Care (New Ulcer)

Surgical Complications

Infection 9

• Patients cannot undergo multiple reconstructions • Co-morbidities were evenly distributed • Willingness-to-Pay: $100,000 for 1 additional QALY • Health Care System’s Perspective • Everyone in infected ulcer cohort underwent surgical

debridement to eradicate infection before undergoing their strategy – CR was done as a staged procedure (external fixation, followed

by internal fixation once infection cleared)

Assumptions

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Bracing Strategy Health States

Events occurring during a cycle, will determine the next health state transition:

• Development of New Ulcer • New Infection • Amputation

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Decision Tree – CR Strategy

Events: • Complications from surgery (major, minor, death, amputation)

These events are also true for the TTA strategy

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For patients with no ulcer, both bracing and CR are cost-effective

Strategy Lifetime Costs, 2019 $

QALYs Incremental Costs

Incremental QALYs

ICER

Transtibial Amputation

$48,181.97 2.41

Lifetime Bracing

$100,796.64 9.96 $52,614.77 7.55 $6,970.76

Charcot Reconstruction

$ 124,098.58 11.59 $23,301.95 1.63 $14,339.25

Willingness-to-Pay $100,000

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For patients with an ulcer, bracing and CR continue to be cost-

effective Strategy Lifetime Costs,

2019 $ QALYs Incremental

Costs Incremental

QALYs ICER

Transtibial Amputation

$48,181.97 2.41

Lifetime Bracing $102,808.99 9.05 $54,627.12 6.63 $8,234.41 Charcot

Reconstruction $ 129,969.96 10.08 $27,160.96 1.04 $26,217.08

Willingness-to-Pay $100,000 14

Sensitivity Analysis

• Non-Ulcerated and Ulcerated cohorts were robust to sensitivity analyses

• No plausible thresholds found • No re-ordering noted

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For patients with an infected ulcer, bracing is most cost-effective

Strategy Lifetime Costs, 2019 $

QALYs Incremental Costs

Incremental QALYs

ICER

Transtibial Amputation

$48,181.97 2.41

Lifetime Bracing $142,991.48 8.73 $94,807.62 6.32 $15,010.87 Charcot

Reconstruction $204,263.64 9.05 $61,272.16 0.32 $193,242.45

Willingness-to-Pay $100,000 16

Sensitivity Analysis – Infected Ulcer Cohort

Bracing VS. Charcot Reconstruction • Complication Rate after CR • Utility of Patients with Ulcer • Cost of Reconstruction

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Sensitivity Analysis – Infected Ulcer Cohort

• If complications rates after CR are less than 50%, then CR’s ICER is below the 100k threshold (current literature ranges 40%-70%)

• If the cost of CR is less than $40,000, then CR’s ICER is below the 100k threshold (current literature mean ~ $57,000)

• Other variations are not plausible • No re-ordering noted

• TTA was the cheapest strategy in every stage of disease, but also produced the least QALYs

• CR was the most effective strategy in the non-ulcerated and ulcerated patient

• For a patient with an infected ulcer, lifetime bracing after eradication of infection was the most cost-effective strategy compared to TTA

Key Takeaway Results

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Limitations Strengths Can only be interpreted from the healthcare system standpoint (societal costs not considered)

This analysis fills an important gap in the literature for a topic that has no current guidelines

Limited by current available literature This is the only cost-effectiveness analysis performed on this topic to our knowledge

Assumed co-morbidities were equally distributed

Included literature which included patients with all co-morbidities

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Bracing is a cost-effective option in all stages of disease, but offers less potential for increased quality of life opportunity for shared decision making

Conclusions

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Charcot Reconstruction is most cost-effective when performed early (i.e. in the non-ulcerated and ulcerated patient)

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