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

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 cost-effectiveness 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.

A review of case studies evaluating economic incentives to promote occupational safety and health.

OBJECTIVES: In many European countries, external economic incentives are discussed as a policy instrument to promote occupational safety and health (OSH) in enterprises. This narrative case study review aims to support policy-makers in organizations providing such incentives by supplying information about different incentive schemes and their main characteristics such as effectiveness, efficiency, and feasibility. METHODS: The focal point and topic centre network of the European Agency for Safety and Health at Work were used to collect case studies about incentive schemes aimed at supporting the prevention of occupational accidents and diseases in enterprises. Such incentives are rarely described in the scientific literature. To be considered for this review, studies had to focus on external financial benefits that could be provided as part of an insurance-related incentive or a governmental subsidy scheme. RESULTS: In total, 14 cases were included in the review: 6 insurance premium- and 8 subsidy-based schemes. Of these, 13 contained an evaluation of the incentive scheme, of which 7 use quantitative criteria. Three cases provided sufficient data to conduct a cost-benefit analysis. Most qualitative evaluations related to the successful management of the program and the effectiveness of the promoted measures in the workplace. Regarding the latter, quantitative criteria covered accident rates, sick leave, and general improvement in working conditions. The cost-benefit analyses all resulted in a positive payout ratio, ranging from 1.01-4.81 euros return for every 1 euro invested. CONCLUSIONS: Generally, we found economic incentive schemes to be feasible and reasonably effective. However, analysis regarding the efficiency of such schemes is scarce and our evaluation of the cost-benefit analysis had to rely on few cases that, nevertheless, delivered positive results for large samples. Besides this finding, our study also revealed deficits in the quality of evaluations. In order to enable policy-makers to make well-informed decisions about public investments in OSH, better standards for reporting and evaluating incentive schemes are needed.