scholarly journals Cost-effectiveness analysis of genomic profiling in early breast cancer in Colombia

2021 ◽  
Author(s):  
Leonardo Rojas ◽  
María Rojas-Reyes ◽  
Diego Rosselli ◽  
Andres F. Cardona
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Adjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
National Health System ◽  
Cost Effective ◽  
Decision Analytic Model ◽  
United States Dollar ◽  
Life Years

Abstract BackgroundThe best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) in Colombia is unknown. This study aimed to identify the cost-effectiveness of various strategies to establish the necessity of adjuvant chemotherapy.MethodsThis study used an adapted decision-analytic model to compare cost and outcomes of care that includes Oncotype DX™ (ODX) or Mammaprint™ (MMP) test with routine care without ODX or MMP tests (application of adjuvant chemotherapy for all patients) over a 5-year time horizon, and the from the perspective of the Colombian National Health System (NHS) perspective (payer). Data were obtained from published literature and clinical trial database. The study population was composed of women with EBC, hormone-receptor positive (HR+), Her2-negative, lymph-node negative (LN0), with high-risk clinical criteria for recurrence. The outcome measures were incremental cost-effectiveness ratio (ICER; 2019 United States Dollar [USD] per quality-adjusted life years [QALY] gained) and net monetary benefit (NMB).ResultsODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2,445 and $570 compared with the standard strategy, respectively. The ICER for ODX was −$41,857 and that for MMP was −$18,253 per QALY; NMB was $2,821 and $771, respectively. Both tests were cost effective under defined threshold. When the two tests were compared, ODX was more cost effective than MMP. Sensitivity analysis revealed that, with a threshold of 1 GDP per capita, ODX will be cost effective in 95.5% of the cases compared with 70.2% of MMP. Probabilistic sensitivity analysis revealed that ODX was a consistently superior strategy.ConclusionsGenomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and Her2 − EBC is a cost-effective strategy that allows Colombian NHS saving money.

scholarly journals Cost-Effectiveness Analysis of Genomic Profiling in Early Breast Cancer in Colombia

2021 ◽  
Author(s):  
Leonardo Rojas ◽  
María Rojas-Reyes ◽  
Diego Rosselli ◽  
Andres F. Cardona
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Adjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
National Health System ◽  
Cost Effective ◽  
Decision Analytic Model ◽  
Genomic Profiling ◽  
United States Dollar

Abstract Background: In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-effectiveness of various strategies to establish the necessity of adjuvant chemotherapy.Methods: This study used an adapted decision-analytic model to compare cost and outcomes of care that includes Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests with routine care without ODX or MMP tests (adjuvant chemotherapy for all patients) over a 5-year time horizon from the perspective of the Colombian National Health System (NHS; payer). Data were obtained from published literature and clinical trial database. The study population comprised women with hormone-receptor-positive (HR+), HER2-negative, lymph-node-negative (LN0) EBC with high-risk clinical criteria for recurrence. The outcome measures were incremental cost-effectiveness ratio (ICER; 2019 United States dollar per quality-adjusted life-year [QALY] gained) and net monetary benefit (NMB).Results: ODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2,445 and $570 compared with the standard strategy, respectively. ICER for ODX was −$41,857 and that for MMP was −$18,253 per QALY; NMB was $2,821 and $771, respectively. Both tests were cost-effective under the defined threshold. When the two tests were compared, ODX was more cost-effective than MMP. Sensitivity analysis revealed that with a threshold of 1 gross domestic product per capita, ODX will be cost-effective in 95.5% of the cases compared with 70.2% cases involving MMP. Probabilistic sensitivity analysis revealed that ODX was a consistently superior strategy.Conclusions: Genomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR+ and HER2− EBC is a cost-effective strategy that allows Colombian NHS to maintain budget.

Cost Effectiveness of Molecular Profiling for Adjuvant Decision Making in Patients With Node-Negative Breast Cancer

2014 ◽  
Vol 32 (31) ◽  
pp. 3513-3519 ◽  
Author(s):  
Julia Bonastre ◽  
Sophie Marguet ◽  
Beranger Lueza ◽  
Stefan Michiels ◽  
Suzette Delaloge ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Cost Effectiveness ◽  
Adjuvant Chemotherapy ◽  
Cost Effective ◽  
Gene Signature ◽  
Node Negative ◽  
Node Negative Breast Cancer ◽  
Life Years ◽  
Er Positive

Purpose To conduct an economic evaluation of the 70-gene signature used to guide adjuvant chemotherapy decision making both in patients with node-negative breast cancer (NNBC) and in the subgroup of estrogen receptor (ER) –positive patients. Patients and Methods We used a mixed approach combining patient-level data from a multicenter validation study of the 70-gene signature (untreated patients) and secondary sources for chemotherapy efficacy, unit costs, and utility values. Three strategies on which to base the decision to administer adjuvant chemotherapy were compared: the 70-gene signature, Adjuvant! Online, and chemotherapy in all patients. In the base-case analysis, costs from the French National Insurance Scheme, life-years (LYs), and quality-adjusted life-years (QALYs) were computed for the three strategies over a 10-year period. Cost-effectiveness acceptability curves using the net monetary benefit were computed, combining bootstrap and probabilistic sensitivity analyses. Results The mean differences in LYs and QALYs were similar between the three strategies. The 70-gene signature strategy was associated with a higher cost, with a mean difference of €2,037 (range, €1,472 to €2,515) compared with Adjuvant! Online and of €657 (95% CI, −€642 to €3,130) compared with systematic chemotherapy. For a €50,000 per QALY willingness-to-pay threshold, the probability of being the most cost-effective strategy was 92% (76% in ER-positive patients) for the Adjuvant! Online strategy, 6% (4% in ER-positive patients) for the systematic chemotherapy strategy, and 2% (20% in ER-positive patients) for the 70-gene strategy. Conclusion Optimizing adjuvant chemotherapy decision making based on the 70-gene signature is unlikely to be cost effective in patients with NNBC.

scholarly journals Cost-Effectiveness of Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer

2016 ◽  
Vol 34 (9) ◽  
pp. 902-909 ◽  
Author(s):  
Ben Y. Durkee ◽  
Yushen Qian ◽  
Erqi L. Pollom ◽  
Martin T. King ◽  
Sara A. Dudley ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Sensitivity Analysis ◽  
Epidermal Growth Factor Receptor ◽  
Metastatic Breast Cancer ◽  
Cost Effectiveness ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Cost Effective ◽  
Life Years ◽  
Epidermal Growth

Purpose The Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study showed a 15.7-month survival benefit with the addition of pertuzumab to docetaxel and trastuzumab (THP) as first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) –overexpressing metastatic breast cancer. We performed a cost-effectiveness analysis to assess the value of adding pertuzumab. Patient and Methods We developed a decision-analytic Markov model to evaluate the cost effectiveness of docetaxel plus trastuzumab (TH) with or without pertuzumab in US patients with metastatic breast cancer. The model followed patients weekly over their remaining lifetimes. Health states included stable disease, progressing disease, hospice, and death. Transition probabilities were based on the CLEOPATRA study. Costs reflected the 2014 Medicare rates. Health state utilities were the same as those used in other recent cost-effectiveness studies of trastuzumab and pertuzumab. Outcomes included health benefits expressed as discounted quality-adjusted life-years (QALYs), costs in US dollars, and cost effectiveness expressed as an incremental cost-effectiveness ratio. One- and multiway deterministic and probabilistic sensitivity analyses explored the effects of specific assumptions. Results Modeled median survival was 39.4 months for TH and 56.9 months for THP. The addition of pertuzumab resulted in an additional 1.81 life-years gained, or 0.62 QALYs, at a cost of $472,668 per QALY gained. Deterministic sensitivity analysis showed that THP is unlikely to be cost effective even under the most favorable assumptions, and probabilistic sensitivity analysis predicted 0% chance of cost effectiveness at a willingness to pay of $100,000 per QALY gained. Conclusion THP in patients with metastatic HER2-positive breast cancer is unlikely to be cost effective in the United States.

HBV screening before adjuvant chemotherapy in patients with early breast cancer: A cost-effectiveness analysis.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 11-11
Author(s):  
William W. L. Wong ◽  
Lisa K. Hicks ◽  
Hong-Anh Tu ◽  
Murray Krahn ◽  
Kathleen I. Pritchard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Adjuvant Chemotherapy ◽  
Cost Effective ◽  
Economic Effects ◽  
Decompensated Cirrhosis ◽  
Health States ◽  
Antiviral Therapies ◽  
Life Years ◽  
Hbv Screening

11 Background: The seroprevalence of hepatitis B virus (HBV) infection among Canadian was 0.4%, and 1.6% among immigrants. Most infected individuals have clinically silent disease. Cytotoxic chemotherapy causes reactivation in 30% of the HBV infected patients. This can be severe and fatal, may also lead to interruption of chemotherapy. HBV screening before adjuvant chemotherapy (ADJ) for breast cancer (BC) seems to be a plausible strategy. Our objective is to estimate the health and economic effects of HBV screening strategies. Methods: We developed a state transition microsimulation model to examine the cost effectiveness of 3 strategies for 55 year old BC patients undergoing ADJ: (1) No screen; (2) Screen Imm: Screen immigrant only and treat; (3) Screen all: Screen all and treat; with antiviral therapies. In the model, health states were constructed to reflect the natural history of BC and HBV. Model data were obtained from published literature. We used a payer perspective, a lifetime time horizon, and used a 5% discount rate. Results: Screen all would prevent 43 severe reactivations (SR), 9 deaths from reactivation (DR), 22 chemotherapy interruptions (CI), 36 decompensated cirrhosis (DC), 48 HCCs, and 67 HBV deaths per 100,000 persons screened over the lifetime of the cohort. Screen Imm would prevent 34 SR, 4 DR, 20 CI, 30 DC, 41 HCCs, and 52 HBV deaths. Screen all was associated with an increase of at least 0.00368 quality adjusted life years (QALY) and cost C$116 more per person, translating to an incremental cost effectiveness ratio (ICER) of C$31,518-51,276/QALY gained compared with No screen, depends on different antiviral therapies. Screen all was the most cost effective, while Screen Imm was ruled out due to extended dominance (ED) by No Screen and Screen all. Conclusions: HBV screening before ADJ for BC patients would prevent a significant number of reactivations, and is likely be cost effective. [Table: see text]

scholarly journals Initiation of Somatostatin analogues for neuroendocrine tumor patients: a cost-effectiveness analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sheila D. Rustgi ◽  
Aaron Oh ◽  
Jeong Yun Yang ◽  
Dasol Kang ◽  
Edward Wolin ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Treatment Strategies ◽  
Stage Iv ◽  
Cost Effective ◽  
Somatostatin Analogues ◽  
Optimal Timing ◽  
Decision Analytic Model ◽  
Gastroenteropancreatic Neuroendocrine Tumors ◽  
Life Years

Abstract Background & Aims Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are heterogeneous neoplasms. Although some have a relatively benign and indolent natural history, others can be aggressive and ultimately fatal. Somatostatin analogues (SSAs) improve both quality of life and survival for these patients once they develop metastatic disease. However, these drugs are costly and their cost-effectiveness is not known. Methods A decision-analytic model was developed and analyzed to compare two treatment strategies for patients with Stage IV GEP-NETs. The first strategy had all patients start SSA immediately while the second strategy waited, reserving SSA initiation until the patient showed signs of progression. Sensitivity analysis was performed to explore model parameter uncertainty. Results Our model of patients age 60 with metastatic GEP-NETs suggests empiric initiation of SSA led to an increase 0.62 unadjusted life-years and incremental increase in quality-adjusted life years (QALYs) of 0.44. The incremental costs were $388,966 per QALY and not cost-effective at a willingness-to-pay threshold of $100,000. Death was attributed to GEP-NETs for 94.1% of patients in the SSA arm vs. 94.9% of patients in the DELAY SSA arm. Sensitivity analysis found that the model was most sensitive to costs of SSAs. Using probabilistic sensitivity analysis, the SSA strategy was only cost-effective 1.4% of the time at a WTP threshold of $100,000 per QALY. Conclusions Our modeling study finds it is not cost-effective to initiate SSAs at time of presentation for patients with metastatic GEP-NETs. Further clinical studies are needed to identify the optimal timing to initiate these drugs.

Cost-effectiveness analysis of oncotype DX-guided treatment in early breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11536-e11536 ◽  
Author(s):  
D. T. Tsoi ◽  
M. Inoue ◽  
C. M. Kelly ◽  
S. Verma ◽  
K. Pritchard
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Cost Effectiveness ◽  
Adjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
Lifetime Cost ◽  
Oncotype Dx ◽  
Lifetime Horizon ◽  
Life Years ◽  
The Cost

e11536 Background: Some early breast cancer patients with hormone receptor positive (HR+) disease may benefit from adjuvant chemotherapy in addition to hormonal therapy. Most guidelines recommend the addition of adjuvant chemotherapy for majority of women, leading to overtreatment causing considerable morbidity and cost. There has been recent incorporation of gene expression analysis to help aid in adjuvant chemotherapy decision making. We evaluated the cost-effectiveness of Oncotype DX-guided treatment as compared to treatment guided by Adjuvant! Online program. Methods: A Markov model was developed to compare the cost- effectiveness of treatment guided by either Oncotype DX or Adjuvant! Online in a cohort of 50-year-old women with HR+, lymph node negative breast cancer over a lifetime horizon. We assumed women assessed to be high risk all received chemotherapy followed by tamoxifen, and that those assessed to be low risk received tamoxifen only. The model took a health care payer's perspective with results reported in 2008 Canadian dollars ($). Event rates, costs and utilities were derived from the literature. Both costs and benefits were discounted at 5%. Sensitivity analysis for key parameters in the model was conducted. Outcome measures were life year gained, quality- adjusted life years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs). Results: For a 50-year-old woman, Oncotype DX-guided treatment was associated with an incremental lifetime cost of $4,200 and a gain in 0.067 QALY, with an ICER of $61,800/QALY compared with treatment guided by Adjuvant! ICER was positively correlated to the cost of Oncotype DX and the age of patients. Results were most sensitive to probabilities relating to risk categorization and recurrence rate. Conclusions: Relative to Adjuvant!-guided treatment, Oncotype DX-guided treatment appears cost-effective with an ICER of $61,800/QALY from a Canadian health care perspective. [Table: see text]

Cost-effectiveness of subcutaneous pertuzumab, trastuzumab, and hyaluronidase-zzxf for the treatment of high-risk HER2+ early breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18846-e18846
Author(s):  
Jesse Sussell ◽  
Joshua A. Roth ◽  
Svenn Hansen ◽  
Craig S. Meyer ◽  
Anita M. Fung
Keyword(s):  
Breast Cancer ◽  
Targeted Therapy ◽  
Cost Effectiveness ◽  
High Risk ◽  
Neoadjuvant Therapy ◽  
Early Breast Cancer ◽  
Standard Therapy ◽  
Healthcare Sector ◽  
Base Case ◽  
Life Years

e18846 Background: Standard therapy for high-risk HER2+ early breast cancer (EBC) begins with neoadjuvant dual targeted therapy with pertuzumab (P) + trastuzumab (T) + chemotherapy (CTX). After surgery, patients who achieve pathological complete response (pCR) should complete one year of dual targeted therapy, while patients with residual disease should receive ado-trastuzumab emtansine (T-DM1). Recently, a subcutaneously administered formulation of P, T, and hyaluronidase-zzxf (Phesgo) was approved for use in the U.S. This study assesses the value of this new formulation in EBC patients vs. a strategy in which patients initiate standard therapy, but discontinue P following ascertainment of pCR. Methods: We developed a six-state Markov model to assess EBC costs and quality-adjusted life years (QALYs) from a healthcare sector perspective over a lifetime time horizon. Two strategies were modeled: 1) Neoadjuvant therapy with subcutaneous P, T, and hyaluronidase-zzxf + CTX with adjuvant continuation if pCR is achieved, and T-DM1 if not (“intervention”), and 2) neoadjuvant therapy with infused P, T + CTX with adjuvant infused T if pCR is achieved, and T-DM1 if not (“comparator”). Event-free and invasive-disease free survival were derived from the PEONY and KATHERINE/APHINITY trials, respectively. Utility values, drug prices, and procedure costs were derived from KATHERINE EQ-5D data, Wholesale Acquisition Costs, and claims analyses, respectively. We assessed comparator costs using both biosimilar and branded T pricing. The primary outcome was the incremental cost-effectiveness ratio (ICER). Outcomes were discounted at 3%/year and costs are presented in 2020 U.S. dollars. Uncertainty in outcomes was assessed through Monte Carlo simulation (1,000 replicates). Results: The table shows key results. The intervention resulted in a gain of 0.092 QALYs. With biosimilar T pricing in the comparator (base case), the intervention increased costs by $7,575 (ICER = $81,793). With branded T pricing in the comparator (scenario analysis), the intervention increased costs by $982 (ICER = $10,602). In probabilistic analyses, the intervention was favored in 52% and 81% of simulations at a willingness-to-pay of $100,000/QALY with biosimilar and branded T pricing, respectively. Conclusions: This study provides additional evidence to support adjuvant continuation of P+T among patients achieving pCR. Neoadjuvant P, T, and hyaluronidase-zzxf + CTX (with adjuvant continuation of dual targeted therapy) is expected to be cost-effective ( < $100,000/QALY) vs. neoadjuvant P and T + CTX (with adjuvant T continuation) for patients with high-risk HER2+ EBC irrespective of whether the comparator uses biosimilar or branded T.[Table: see text]

Cost-effectiveness of mobile health-based integrated care for atrial fibrillation: Model development and data analysis (Preprint)

2021 ◽  
Author(s):  
Xueyan Luo ◽  
Wei Xu ◽  
Quan Yuan ◽  
Han Lai ◽  
Chunji Huang
Keyword(s):  
Atrial Fibrillation ◽  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Integrated Care ◽  
Mobile Health ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Life Years ◽  
Mhealth Technology

BACKGROUND Mobile health (mhealth) technology is increasingly used in disease management. Using mhealth tools to integrate and streamline care was found to improve atrial fibrillation (AF) patients’ clinical outcomes. OBJECTIVE This study aimed to investigate the potential clinical and health economic outcomes of mhealth-based integrated care for AF from the perspective of a public healthcare provider in China. METHODS A Markov model was designed to compare outcomes of mhealth-based care and usual care in a hypothetical cohort of AF patients in China. The time horizon was 30 years with monthly cycles. Model outcomes measured were direct medical cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were conducted to examine the robustness of base-case results. RESULTS In the base-case analysis, mhealth-based care gained higher QALYs of 0.0818 with an incurred cost of USD1,778. Using USD33,438 per QALY (three times gross domestic product) as the willingness-to-pay threshold, mhealth-based care was cost-effective, with an ICER of USD21,739 per QALY. The one-way sensitivity analysis found compliance to mhealth-based care had the greatest impact on the ICER. In probabilistic sensitivity analysis, mhealth-based care was accepted as cost-effective in 80.91% of 10,000 iterations. CONCLUSIONS This study suggested that the use of mhealth technology in streamlining and integrating care for AF patients was cost-effective in China.

Is Banning Texturized Implants to Prevent Breast Implant-Associated Anaplastic Large Cell Lymphoma a Rational Decision? A Meta-Analysis and Cost-Effectiveness Study

2019 ◽  
Vol 40 (7) ◽  
pp. 721-731 ◽  
Author(s):  
Stefan V Danilla ◽  
Rocio P Jara ◽  
Felipe Miranda ◽  
Francisco Bencina ◽  
Marcela Aguirre ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Cost Effectiveness ◽  
Cell Lymphoma ◽  
Meta Analysis ◽  
Breast Implant ◽  
Cost Effective ◽  
Large Cell ◽  
Life Years ◽  
Large Cell Lymphoma ◽  
The Cost

Abstract Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emergent disease that threatens patients with texturized breast implants. Major concerns about the safety of these implants are leading to global changes to restrict the utilization of this product. The principal alternative is to perform breast augmentation utilizing smooth implants, given the lack of association with BIA-ALCL. The implications and costs of this intervention are unknown. Objectives The authors of this study determined the cost-effectiveness of smooth implants compared with texturized implants for breast augmentation surgery. Methods A tree decision model was utilized to analyze the cost-effectiveness. Model input parameters were derived from published sources. The capsular contracture (CC) rate was calculated from a meta-analysis. Effectiveness measures were life years, avoided BIA-ALCL, avoided deaths, and avoided reoperations. A sensitivity analysis was performed to test the robustness of the model. Results For avoided BIA-ALCL, the incremental cost was $18,562,003 for smooth implants over texturized implants. The incremental cost-effectiveness ratio was negative for life years, and avoided death and avoided reoperations were negative. The sensitivity analysis revealed that to avoid 1 case of BIA-ALCL, the utilization of smooth implants would be cost-effective for a risk of developing BIA-ALCL equal to or greater than 1:196, and there is a probability of CC with smooth implants equal to or less than 0.096. Conclusions The utilization of smooth implants to prevent BIA-ALCL is not cost-effective. Banning texturized implants to prevent BIA-ALCL may involve additional consequences, which should be considered in light of higher CC rates and more reoperations associated with smooth implants than with texturized implants.

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

2020 ◽  
Vol 21 (3) ◽  
pp. 437-449 ◽  
Author(s):  
Alexander Kuhlmann ◽  
Henning Krüger ◽  
Susanne Seidinger ◽  
Andreas Hahn
Keyword(s):  
Diabetes Mellitus ◽  
Cost Effectiveness ◽  
Budget Impact ◽  
Input Parameter ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
Life Years ◽  
Transfemoral Amputees ◽  
The Impact

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 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.

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