Cost-effectiveness and budget impact of the microprocessor-controlled knee C-Leg in transfemoral amputees with and without diabetes mellitus

Abstract

Background The safe use of a prosthesis in activities of daily living is key for transfemoral amputees. However, the number of falls varies significantly between different prosthetic device types. This study aims to compare medical and economic consequences of falls in transfemoral amputees who use the microprocessor-controlled knee joint C-Leg with patients who use non-microprocessor-controlled (mechanical) knee joints (NMPK). The main objectives of the analysis are to investigate the costeffectiveness and budget impact of C-Legs in transfemoral amputees with diabetes mellitus (DM) and without DM in Germany. Methods A decision-analytic model was developed that took into account the effects of prosthesis type on the risk of falling and fall-related medical events. Cost-effectiveness and budget impact analyses were performed separately for transfemoral amputees with and without DM. The study took the perspective of the statutory health insurance (SHI). Input parameters were derived from the published literature. Univariate and probabilistic sensitivity analyses (PSA) were performed to investigate the impact of changes in individual input parameter values on model outcomes and to explore parameter uncertainty. Results C-Legs reduced the rate of fall-related hospitalizations from 134 to 20 per 1000 person years (PY) in amputees without DM and from 146 to 23 per 1000 PY in amputees with DM. In addition, the C-Leg prevented 15 or 14 fall-related death per 1000 PY. Over a time horizon of 25 years, the incremental cost-effectiveness ratio (ICER) was 16,123 Euro per quality-adjusted life years gained (QALY) for amputees without DM and 20,332 Euro per QALY gained for amputees with DM. For the period of 2020-2024, the model predicted an increase in SHI expenditures of 98 Mio Euro (53 Mio Euro in prosthesis users without DM and 45 Mio Euro in prosthesis users with DM) when all new prosthesis users received C-Legs instead of NMPKs and 50% of NMPK user whose prosthesis wore out switched to C-Legs. Results of the PSA showed moderate uncertainty and a probability of 97-99% that C-Legs are cost-effective at an ICER threshold of 40,000 Euro (≈ German GDP per capita in 2018) per QALY gained. Conclusion Results of the study suggest that the C-Leg provides substantial additional health benefits compared with NMPKs and is likely to be cost-effective in transfemoral amputees with DM as well as in amputees without DM at an ICER threshold of 40,000 Euro per QALY gained.

Degree of Safety Against Falls Provided by 4 Different Prosthetic Knee Types in People With Transfemoral Amputation: A Retrospective Observational Study

“…Although falls in people with lower-limb amputations are considered major health events and receive the attention of public health researchers, current health technology assessments rely on a limited knowledge base. 55–57 The present study assessed the safety of prosthetic knees grouped into 4 categories. The evidence was based on more than 30 different knee models ( Suppl.…”

The Economics of Innovation in the Prosthetic and Orthotics Industry

“…Cost-effectiveness analyses, which compare treatments and their relative costs and outcomes, enable funders, governments and health care professionals and institutions, to make informed decisions about the care that is provided within funding constrained health care systems. 7 Unfortunately, the clinical evidence relating to most P&O interventions is lacking or is not of high quality. The highest evidence comes from meta-analyses of RCTs (Level 1), followed by at least one RCT (Level 2), quasi experimental designs (Level 3) and so on, and the majority of clinical research studies involving P&O interventions fall in the latter categories.…”

The Kenevo microprocessor-controlled prosthetic knee compared with non–microprocessor-controlled knees in individuals older than 65 years in Sweden: A cost-effectiveness and budget-impact analysis

“…Interestingly, neither the effects of mortality nor the costs and health consequences due to falls were included in cost-effectiveness analyses until recently. 12 , 13 …”

“…They found that the clinical and economic benefits of MPKs were comparable with other reimbursed technologies in the United States. 12 Kuhlmann et al 13 extended this modeling strategy to apply both a cost-efficacy and budget-impact analysis on the use of MPKs in patients with or without diabetes mellitus (DM) in a German context. The predicted reduction in fall-related hospitalizations and deaths in individuals older than 40 years, who received an MPK, indicated health and economic benefits for individuals both with and without DM.…”

“…The predicted reduction in fall-related hospitalizations and deaths in individuals older than 40 years, who received an MPK, indicated health and economic benefits for individuals both with and without DM. 13 To date, no health economic study of MPKs has specifically focused on older prosthesis users who represent the largest proportion of this patient population.…”