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. © 2020, The Author(s)

HEALTH ECONOMICS IN THE FIELD OF PROSTHETICS AND ORTHOTICS: A GLOBAL PERSPECTIVE

The rapid advancement of prosthetic and orthotic (P&O) technology raises the question how the industry can ensure that patients have access to the benefits and providers get paid properly and fairly by healthcare payers. This is a challenge that not only P&O but all areas of health technology face. In many areas of medicine and health products, such as drugs and medical devices, health-technology assessments (HTA) have become a standard procedure in the coverage and reimbursement process. In most countries, P&O is lagging behind that development, although some countries have already formalized HTA for prosthetic and orthotic products and may even use cost-effectiveness analyses to determine pricing and payment amounts. This article gives an overview on the coverage and reimbursement processes in the United States, Canada, Germany, France, Sweden, the United Kingdom, Poland, Japan, and China. This selection reflects the variety and diversity of coverage and reimbursement processes that the P&O industry faces globally. The paper continues with an overview on the necessary research and investment efforts that manufacturers will have to make in the future, and contemplates the likely consequences for the manufacturer community in the market place. Health economics may help support the transition from price-based to value-based coverage and reimbursement but will come at considerable costs to the industry. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/35298/28317 How To Cite: Kannenberg A, Seidinger S. Health economics in the field of prosthetics and orthotics: A global perspective. Canadian Prosthetics & Orthotics Journal. 2021; Volume 4, Issue 2, No.6. https://doi.org/10.33137/cpoj.v4i2.35298 Corresponding Author: Andreas Kannenberg, MD (GER), PhDExecutive Medical Director North America, Otto Bock Healthcare LP, 11501 Alterra Parkway, Suite 600, Austin, Texas, USA.E-Mail: [email protected] ID: https://orcid.org/0000-0001-7983-174

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

Background:Growing evidence suggests that individuals with transfemoral amputation or knee disarticulation using a prosthesis equipped with a microprocessor-controlled knee (MPK) benefit from enhanced mobility and safety, including less falls. In elderly individuals, high mortality rates are assumed to reduce the expected useful life of MPKs, and this raises concerns regarding their economic effectiveness.Objective:To investigate the cost-effectiveness and budget impact of the Kenevo/MPK (Ottobock, Germany) compared with non-microprocessor-controlled knees (NMPKs) in people older than 65 years at the time of transfemoral amputation/knee disarticulation, from a Swedish payer's perspective.Methods:A decision-analytic model was developed to conduct the economic analysis of the Kenevo/MPK. Model parameters were derived from Swedish databases and published literature. Univariate and probabilistic sensitivity analyses were performed to explore parameter uncertainty.Results:Compared with NMPKs, the Kenevo/MPK reduced the frequency of hospitalizations by 137 per 1,000 person years while the frequency of fatal falls was reduced by 19 per 1,000 person-years in the simulation. Over a 25-year time horizon, the incremental cost-effectiveness ratio was EUR11,369 per quality-adjusted life year. The probability of the MPK being cost-effective at a threshold of EUR40,000 per quality-adjusted life year was 99%. The 5-year budget impact model predicted an increase in payer expenditure of EUR1.76 million if all new patients received a Kenevo/MPK, and 50% of current NMPK users switched to the MPK.Conclusions:Results of the modeling suggest that the Kenevo/MPK is likely to be cost-effective for elderly individuals, primarily because of a reduction in falls