Our results based on nationwide long-term epidemiologic data suggest that palivizumab is cost-effective in prevention of RSV disease in high-risk infants.
Health economic evaluations of pharmaceuticals and subsequently medical devices were introduced in the early 1990s and have since developed into a standard decision-making tool for payers to appraise the value of new health technologies. To the prosthetic and orthotic industry, health economics is still a new concept that may help overcome the limitations and restrictions of the current reimbursement system by driving the discussion with payers and their coverage decisions from a purely price-based to a value-based perspective. However, to move the industry in that direction, manufacturers would have to make substantial investments in qualified staff and research funding. This article gives an overview on how iterative health economic modeling could be implemented and how it would transform current research and development processes of prosthetic manufacturers. It would add another aspect to decision making, allowing to identify the most cost-effective option among several potential development projects, or even to terminate development of devices that have no chance to ever be cost-effective. The adoption of health economic methods would probably also have a dramatic impact on the manufacturer community and the marketplace as a whole. Bigger companies that are able and willing to afford the cost to generate clinical evidence and health technology assessments would probably introduce fewer innovations that are supported by better evidence than today. Smaller companies that are unable to absorb the cost would likely have to cooperate or focus on products that fit in the limitations of the current reimbursement system. As a result, we would probably see fewer innovations and many more me-too products. However, that situation would underscore a challenge that innovative manufacturers are already facing today. Payers demand high-quality evidence for new devices but tend to extrapolate the benefits demonstrated for the predicate device to similar, yet-unstudied components. That puts innovative manufacturers that invest in clinical and health economic research at a business disadvantage against technology followers. Therefore, policy makers are advised to hold individual components to comparable standards of demonstrated performance when making decisions on coverage and reimbursement.
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.
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: andreas.kannenberg@ottobock.comORCID ID: https://orcid.org/0000-0001-7983-1744
Background: Safety and efficacy of paricalcitol in hemodialysis patients with secondary hyperparathyroidism (sHPT) was investigated under routine clinical practice in German and Austrian dialysis centers. Methods: Hemodialysis patients with sHPT initiating intravenous paricalcitol were enrolled in this noninterventional study regardless of concomitant sHPT treatment. Prior active vitamin D therapy was discontinued. Clinical laboratory values, including intact parathyroid hormone (iPTH), total serum calcium (Ca), phosphorus (P), Ca × P product, and alkaline phosphatase (AP), were recorded for 6 months following initiation of paricalcitol treatment. Results: 1,313 patients (Austria, n = 280; Germany, n = 1,033) from 169 dialysis centers were enrolled. Most patients (n = 932; 79.1%) had received dialysis for ≥1 year. Median iPTH fell from 518.9 pg/ml [55.0 pmol/l] at baseline to 264.0 pg/ml [28.0 pmol/l] after 6 months (p < 0.0001). After 6 months of treatment, ≥30 and ≥60% reductions in iPTH were observed in 63.0 and 35.9% of patients, respectively. At 6 months, 27.2% of patients achieved iPTH levels between 150 and <300 pg/ml [15.9 and <31.8 pmol/l] compared with 9.7% at baseline. Ca, P, and Ca × P levels remained stable in the majority of patients. AP levels declined from a median of 98 U/l at baseline to 83 U/l (p < 0.0001) at 6 months. Monitoring of adverse events and clinical laboratory assessments identified no unexpected safety signals for paricalcitol. Conclusions: Paricalcitol is an effective and well-tolerated treatment option for the control of iPTH levels in hemodialysis patients with sHPT. The results of this study support the results of previous trials under real-time clinical practice conditions in Austria and Germany.
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