Microscopic examination of Gram-stained smears for anogenital gonorrhoea in men who have sex with men is cost-effective: evidence from a modelling study

2018 ◽  
Vol 95 (1) ◽  
pp. 13-20 ◽  
Author(s):  
Jolijn M Zwart ◽  
Marie-Josee J Mangen ◽  
Menne Bartelsman ◽  
Martijn S van Rooijen ◽  
Henry J C de Vries ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Nucleic Acid Amplification ◽  
Sensitivity Analyses ◽  
Transmission Model ◽  
Uncertainty Interval ◽  
Testing Strategies ◽  
Life Years ◽  
Additional Costs ◽  
Sex With Men

ObjectiveTo assess the cost-effectiveness of three testing strategies with or without light microscopic Gram-stained smear (GSS) evaluation for the detection of anogenital gonorrhoea among men who have sex with men (MSM) at the Amsterdam STI clinic using a healthcare payer perspective.MethodsThree testing strategies for MSM were compared: (1) GSS in symptomatic MSM only (currently practised strategy), (2) no GSS and (3) GSS in symptomatic and asymptomatic MSM. The three testing protocols include testing with nucleic acid amplification test to verify the GSS results in (1) and (3), or as the only test in (2). A transmission model was employed to calculate the influence of the testing strategies on the prevalence of anogenital gonorrhoea over 10 years. An economic model combined cost data on medical consultations, tests and treatment and utility data to estimate the number of epididymitis cases and quality-adjusted life years (QALY) associated with gonorrhoea. Incremental cost-effectiveness ratios (ICERs) for the testing scenarios were estimated. Uncertainty and sensitivity analyses were performed.ResultsNo GSS testing compared with GSS in symptomatic MSM only (current strategy) resulted in nine extra epididymitis cases (95% uncertainty interval (UI): 2–22), 72 QALYs lost (95% UI: 59–187) and €7300 additional costs (95% UI: −€185 000 (i.e.cost-saving) to €407 000) over 10 years. GSS testing in both symptomatic and asymptomatic MSM compared with GSS in symptomatic MSM only resulted in one prevented epididymitis case (95% UI: 0–2), 1.1 QALY gained (95% UI: 0.1–3.3), €148 000 additional costs (95% UI: €86 000 to–€217 000) and an ICER of €177 000 (95% UI: €67 000–to €705 000) per QALY gained over 10 years. The results were robust in sensitivity analyses.ConclusionsGSS for symptomatic MSM only is cost-effective compared with no GSS for MSM and with GSS for both symptomatic and asymptomatic MSM.

scholarly journals Cost-Effectiveness of Interventions to Improve HIV Pre-Exposure Prophylaxis Initiation, Adherence, and Persistence among Men Who Have Sex with Men

2021 ◽  
Author(s):  
Margo M Wheatley ◽  
Gregory Knowlton ◽  
Szu-Yu Kao ◽  
Samuel M Jenness ◽  
Eva Enns
Keyword(s):  
Cost Effectiveness ◽  
Scale Up ◽  
Cost Effective ◽  
Status Quo ◽  
Sensitivity Analyses ◽  
Transmission Model ◽  
Life Years ◽  
Sex With Men ◽  
Intervention Costs ◽  
Exposure Prophylaxis

Background: To help achieve Ending the HIV Epidemic (EHE) goals of reducing new HIV incidence, pre-exposure prophylaxis (PrEP) use and engagement must increase despite multidimensional barriers to scale-up and limitations in funding. We investigated the cost-effectiveness of interventions spanning the PrEP continuum of care for men who have sex with men (MSM) in Atlanta, Georgia, a focal jurisdiction for the EHE plan. Methods: Using a network-based HIV transmission model, we simulated lifetime costs, quality-adjusted life years (QALYs), and infections averted for eight intervention strategies using a health sector perspective. Strategies included a status quo (no interventions), three distinct interventions (targeting PrEP initiation, adherence, or persistence), and all possible intervention combinations. Cost-effectiveness was evaluated incrementally using a $100,000/QALY gained threshold. We performed sensitivity analyses on PrEP costs, intervention costs, and intervention coverage. Findings: Strategies averted 0.2-4.2% new infections and gained 0.0045%-0.24% QALYs compared to the status quo. Initiation strategies achieved 20%-23% PrEP coverage (up from 15% with no interventions) and moderate clinical benefits at a high cost, while adherence strategies were relatively low cost and low benefit. Under our assumptions, the adherence and initiation combination strategy was cost-effective with an incremental cost-effectiveness ratio of $86,927/QALY gained. Sensitivity analyses showed no strategies were cost-effective when intervention costs increased by 60% and the strategy combining all three interventions was cost-effective when PrEP costs decreased to $1,000/month. Interpretation: Under reasonable assumptions of intervention uptake and cost, PrEP initiation interventions achieved moderate public health gains and could be cost-effective. However, these analyses demonstrate that substantial financial resources will be needed to improve the PrEP care continuum towards meeting EHE goals.

scholarly journals COVID-19 vaccination in Sindh Province, Pakistan: A modelling study of health impact and cost-effectiveness

PLoS Medicine ◽  
2021 ◽  
Vol 18 (10) ◽  
pp. e1003815
Author(s):  
Carl A. B. Pearson ◽  
Fiammetta Bozzani ◽  
Simon R. Procter ◽  
Nicholas G. Davies ◽  
Maryam Huda ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Health Impact ◽  
High Income ◽  
World Health ◽  
Sensitivity Analyses ◽  
Transmission Model ◽  
System Perspective ◽  
Life Years ◽  
Sindh Province

Background Multiple Coronavirus Disease 2019 (COVID-19) vaccines appear to be safe and efficacious, but only high-income countries have the resources to procure sufficient vaccine doses for most of their eligible populations. The World Health Organization has published guidelines for vaccine prioritisation, but most vaccine impact projections have focused on high-income countries, and few incorporate economic considerations. To address this evidence gap, we projected the health and economic impact of different vaccination scenarios in Sindh Province, Pakistan (population: 48 million). Methods and findings We fitted a compartmental transmission model to COVID-19 cases and deaths in Sindh from 30 April to 15 September 2020. We then projected cases, deaths, and hospitalisation outcomes over 10 years under different vaccine scenarios. Finally, we combined these projections with a detailed economic model to estimate incremental costs (from healthcare and partial societal perspectives), disability-adjusted life years (DALYs), and incremental cost-effectiveness ratio (ICER) for each scenario. We project that 1 year of vaccine distribution, at delivery rates consistent with COVAX projections, using an infection-blocking vaccine at $3/dose with 70% efficacy and 2.5-year duration of protection is likely to avert around 0.9 (95% credible interval (CrI): 0.9, 1.0) million cases, 10.1 (95% CrI: 10.1, 10.3) thousand deaths, and 70.1 (95% CrI: 69.9, 70.6) thousand DALYs, with an ICER of $27.9 per DALY averted from the health system perspective. Under a broad range of alternative scenarios, we find that initially prioritising the older (65+) population generally prevents more deaths. However, unprioritised distribution has almost the same cost-effectiveness when considering all outcomes, and both prioritised and unprioritised programmes can be cost-effective for low per-dose costs. High vaccine prices ($10/dose), however, may not be cost-effective, depending on the specifics of vaccine performance, distribution programme, and future pandemic trends. The principal drivers of the health outcomes are the fitted values for the overall transmission scaling parameter and disease natural history parameters from other studies, particularly age-specific probabilities of infection and symptomatic disease, as well as social contact rates. Other parameters are investigated in sensitivity analyses. This study is limited by model approximations, available data, and future uncertainty. Because the model is a single-population compartmental model, detailed impacts of nonpharmaceutical interventions (NPIs) such as household isolation cannot be practically represented or evaluated in combination with vaccine programmes. Similarly, the model cannot consider prioritising groups like healthcare or other essential workers. The model is only fitted to the reported case and death data, which are incomplete and not disaggregated by, e.g., age. Finally, because the future impact and implementation cost of NPIs are uncertain, how these would interact with vaccination remains an open question. Conclusions COVID-19 vaccination can have a considerable health impact and is likely to be cost-effective if more optimistic vaccine scenarios apply. Preventing severe disease is an important contributor to this impact. However, the advantage of prioritising older, high-risk populations is smaller in generally younger populations. This reduction is especially true in populations with more past transmission, and if the vaccine is likely to further impede transmission rather than just disease. Those conditions are typical of many low- and middle-income countries.

Ixazomib (IXA), carfilzomib (CAR), elotuzumab (ELO) or daratumumab (DAR) with lenalidomide and dexamethasone (LEN+DEX) versus LEN+DEX only in relapsed/refractory multiple myeloma (R/R MM): A comparative cost-effectiveness analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8043-8043
Author(s):  
Mavis Obeng-Kusi ◽  
Daniel Arku ◽  
Neda Alrawashdh ◽  
Briana Choi ◽  
Nimer S. Alkhatib ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Cost Utility ◽  
Cost Effectiveness Analysis ◽  
The Other ◽  
Sensitivity Analyses ◽  
Treatment Comparison ◽  
Comparative Cost ◽  
Effectiveness Analysis ◽  
Life Years

8043 Background: IXA, CAR, ELO and DARin combination with LEN+DEXhave been found superior in efficacy compared to LEN+DEX in the management of R/R MM. Applying indirect treatment comparisons from a network meta-analysis (NMA), this economic evaluation aimed to estimate the comparative cost-effectiveness and cost-utility of these four triplet regimens in terms of progression-free survival (PFS). Methods: In the absence of direct treatment comparison from a single clinical trial, NMA was used to indirectly estimate the comparative PFS benefit of each regimen. A 2-state Markov model simulating the health outcomes and costs was used to evaluate PFS life years (LY) and quality-adjusted life years (QALY) with the triplet regimens over LEN+DEX and expressed as the incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR). Probability sensitivity analyses were conducted to assess the influence of parameter uncertainty on the model. Results: The NMA revealed that DAR+LEN+DEX was superior to the other triplet therapies, which did not differ statistically amongst them. As detailed in the Table, in our cost-effectiveness analysis, all 4 triplet regimens were associated with increased PFSLY and PFSQALY gained (g) over LEN+DEX at an additional cost. DAR+LEN+DEX emerged the most cost-effective with ICER and ICUR of $667,652/PFSLYg and $813,322/PFSQALYg, respectively. The highest probability of cost-effectiveness occurred at a willingness-to-pay threshold of $1,040,000/QALYg. Conclusions: Our economic analysis shows that all the triplet regimens were more expensive than LEN +DEX only but were also more effective with respect to PFSLY and PFSQALY gained. Relative to the other regimens, the daratumumab regimen was the most cost-effective.[Table: see text]

scholarly journals Cost-utility Analysis of Second-generation Direct-acting Antivirals for Hepatitis C

2021 ◽  
Vol 21 (8) ◽  
Author(s):  
Abdollah Poursamad ◽  
Zahra Goudarzi ◽  
Iman Karimzadeh ◽  
Nahid Jallaly ◽  
Khosro Keshavarz ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Hepatitis C ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Genotype 1 ◽  
Medication Regimen ◽  
Lifetime Horizon ◽  
Medication Therapy ◽  
Life Years ◽  
Study Results

Background: Hepatitis C virus (HCV) can lead to increased mortality, disability, and liver transplantation if left untreated, and it is associated with a possible increase in disease burden in the future, all of which would surely have a significant impact on the health system. New antiviral regimens are effective in the treatment of the disease yet expensive. Objectives: The purpose of the present study was to assess the cost-effectiveness of three medication regimens, namely, ledipasvir/sofosbuvir (LDV/SOF), velpatasvir/sofosbuvir, and daclatasvir/sofosbuvir (DCV/SOF) for HCV patients with genotype 1 in Iran. Methods: A Markov model with a lifetime horizon was developed to predict the costs and outcomes of the three mentioned medication therapy strategies. The final outcome of the study was quality-adjusted life-years (QALYs), which was obtained using the previously published studies. The study was conducted from the perspective of the Health Ministry; therefore, only direct medical costs were estimated. The results were provided as the incremental cost-effectiveness ratio (ICER) per QALY. Ultimately, the one-way and probabilistic sensitivity analyses were used to measure the strength of study results. Results: The results showed that the QALYs for LDV/SOF, DCV/SOF, and VEL/SOF were 13.25, 13.94, and 14.61, and the costs were 4,807, 7,716, and 4,546$, respectively. The VEL/SOF regimen had lower costs and higher effectiveness than the LDV/SOF and DCV/SOF regimens, making it a dominant strategy. The tornado diagram results showed that the study results had the highest sensitivity to chronic hepatitis C (CHC) and compensated cirrhosis (CC) state costs. Moreover, the scatter plots showed that the VEL/SOF was the dominant therapeutic strategy in 73% of the simulations compared to LDV/SOF and 66% of the simulations compared to DCV/SOF; moreover, it was in the acceptable region in 92% of the simulations and below the threshold. Therefore, it was considered the most cost-effective strategy. Moreover, the results showed that DCV/SOF was in the acceptable region below the threshold in 69% of the simulations compared to LDV/SOF. Therefore, the DCV/SOF regimen was more cost-effective than LDV/SOF. Conclusions: According to the present study results, it is suggested that the VEL/SOF regimen be used as the first line of therapy in patients with HCV genotype 1. Moreover, DCV/SOF can be the second-line medication regimen.

scholarly journals Cladribine tablets are a cost-effective strategy in high-disease activity relapsing multiple sclerosis patients in Iran

2021 ◽  
Author(s):  
Nayyereh Ayati ◽  
Lora Fleifel ◽  
Mohammad Ali Sahraian ◽  
Shekoufeh Nikfar
Keyword(s):  
Multiple Sclerosis ◽  
Cost Effectiveness ◽  
Disease Activity ◽  
Cost Effective ◽  
High Disease Activity ◽  
Sensitivity Analyses ◽  
Life Years ◽  
Multiple Sclerosis Patients ◽  
The Cost ◽  
Relapsing Multiple Sclerosis

Background: Cladribine tablets are the foremost oral immune-reconstitution therapy for high disease activity relapsing multiple sclerosis (HDA-RMS). We aimed to assess the cost-effectiveness of cladribine tablets compared to natalizumab in patients with HDA-RMS in Iran. Methods: A 5-year cohort-based Markov model was developed with 11 expanded disability status score (EDSS) health states, including patients with HDA-RMS as on and off-treatment. All costs were identified from the literature and expert opinion and were measured in Iranian Rial rates, changed to the 2020 USD rate and were discounted by 7.2%. Quality adjusted life years (QALY), discounted by 3.5%, and life years gained (LYG) were adopted to measure efficacy. The final results were presented as incremental cost-effectiveness ratio that was compared to a national willingness to pay (WTP) threshold of 1 to 3 gross domestic product (GDP) per capita. Deterministic and probabilistic sensitivity analyses (D/PSA) were employed to evaluate uncertainty. Results: Cladribine tablets dominated natalizumab and yielded 6,607 USD cost-saving and 0.003 additional QALYs per patient. LYG was comparable. The main cost component was drug acquisition cost in both arms. DSA indicated the sensitivity of the results to the cost discount rates and also the patients’ body weight; while they were less sensitive to the main clinical variables. PSA indicated that cladribine tablets were cost-effective in Iran, with a probability of 57.5% and 58.6% at lower and higher limits of threshold, respectively. Conclusion: Cladribine tablets yielded higher QALYs and lower costs compared to natalizumab, in patients with HDA-RMS in Iran.

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.

scholarly journals A Cost-Effectiveness Analysis of Newborn Screening for Severe Combined Immunodeficiency in the UK

2019 ◽  
Vol 5 (3) ◽  
pp. 28 ◽  
Author(s):  
Alice Bessey ◽  
James Chilcott ◽  
Joanna Leaviss ◽  
Carmen de la Cruz ◽  
Ruth Wong
Keyword(s):  
Cost Effectiveness ◽  
Severe Combined Immunodeficiency ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Combined Immunodeficiency ◽  
Tree Model ◽  
Life Years ◽  
The Uk ◽  
The Cost ◽  
The Impact

Severe combined immunodeficiency (SCID) can be detected through newborn bloodspot screening. In the UK, the National Screening Committee (NSC) requires screening programmes to be cost-effective at standard UK thresholds. To assess the cost-effectiveness of SCID screening for the NSC, a decision-tree model with lifetable estimates of outcomes was built. Model structure and parameterisation were informed by systematic review and expert clinical judgment. A public service perspective was used and lifetime costs and quality-adjusted life years (QALYs) were discounted at 3.5%. Probabilistic, one-way sensitivity analyses and an exploratory disbenefit analysis for the identification of non-SCID patients were conducted. Screening for SCID was estimated to result in an incremental cost-effectiveness ratio (ICER) of £18,222 with a reduction in SCID mortality from 8.1 (5–12) to 1.7 (0.6–4.0) cases per year of screening. Results were sensitive to a number of parameters, including the cost of the screening test, the incidence of SCID and the disbenefit to the healthy at birth and false-positive cases. Screening for SCID is likely to be cost-effective at £20,000 per QALY, key uncertainties relate to the impact on false positives and the impact on the identification of children with non-SCID T Cell lymphopenia.

scholarly journals Milk Powder Fortified with Potassium and Phytosterols to Decrease the Risk of Cardiovascular Events among the Adult Population in Malaysia: A Cost-Effectiveness Analysis

Nutrients ◽  
2019 ◽  
Vol 11 (6) ◽  
pp. 1235
Author(s):  
Anita E. Gandola ◽  
Livia Dainelli ◽  
Diane Zimmermann ◽  
Maznah Dahlui ◽  
Patrick Detzel
Keyword(s):  
Cost Effectiveness ◽  
Adult Population ◽  
Grey Literature ◽  
Milk Powder ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Discounted Cost ◽  
Life Years ◽  
The Impact

This study evaluated the cost-effectiveness of the consumption of a milk powder product fortified with potassium (+1050.28 mg/day) and phytosterols (+1200 mg/day) to lower systolic blood pressure and low-density lipoprotein cholesterol, respectively, and, therefore, the risk of myocardial infarction (MI) and stroke among the 35–75-year-old population in Malaysia. A Markov model was created against a do-nothing option, from a governmental perspective, and with a time horizon of 40 years. Different data sources, encompassing clinical studies, practice guidelines, grey literature, and statistical yearbooks, were used. Sensitivity analyses were performed to evaluate the impact of uncertainty on the base case estimates. With an incremental cost-effectiveness ratio equal to international dollars (int$) 22,518.03 per quality-adjusted life-years gained, the intervention can be classified as very cost-effective. If adopted nationwide, it would help prevent at least 13,400 MIs, 30,500 strokes, and more than 10,600 and 17,100 MI- and stroke-related deaths. The discounted cost savings generated for the health care system by those who consume the fortified milk powder would amount to int$8.1 per person, corresponding to 0.7% of the total yearly health expenditure per capita. Sensitivity analyses confirmed the robustness of the results. Together with other preventive interventions, the consumption of milk powder fortified with potassium and phytosterols represents a cost-effective strategy to attenuate the rapid increase in cardiovascular burden in Malaysia.

scholarly journals Pharmacist prescribing and care improves cardiovascular risk, but is it cost-effective? A cost-effectiveness analysis of the RxEACH study

2019 ◽  
Vol 152 (4) ◽  
pp. 257-266 ◽  
Author(s):  
Yazid N. Al Hamarneh ◽  
Karissa Johnston ◽  
Carlo A. Marra ◽  
Ross T. Tsuyuki
Keyword(s):  
Cost Effectiveness ◽  
Health Outcomes ◽  
Usual Care ◽  
Population Level ◽  
Cost Effective ◽  
Pharmacist Intervention ◽  
Sensitivity Analyses ◽  
Pharmacist Prescribing ◽  
Canadian Health Care System ◽  
Life Years

Background: The RxEACH randomized trial demonstrated that community pharmacist prescribing and care reduced the risk for cardiovascular (CV) events by 21% compared to usual care. Objective: To evaluate the economic impact of pharmacist prescribing and care for CV risk reduction in a Canadian setting. Methods: A Markov cost-effectiveness model was developed to extrapolate potential differences in long-term CV outcomes, using different risk assessment equations. The mean change in CV risk for the 2 groups of RxEACH was extrapolated over 30 years, with costs and health outcomes discounted at 1.5% per year. The model incorporated health outcomes, costs and quality of life to estimate overall cost-effectiveness. It was assumed that the intervention would be 50% effective after 10 years. Individual-level results were scaled up to population level based on published statistics (29.2% of Canadian adults are at high risk for CV events). Costs considered included direct medical costs as well as the costs associated with implementing the pharmacist intervention. Uncertainty was explored via probabilistic sensitivity analysis. Results: It is estimated that the Canadian health care system would save more than $4.4 billion over 30 years if the pharmacist intervention were delivered to 15% of the eligible population. Pharmacist care would be associated with a gain of 576,689 quality-adjusted life years and avoid more than 8.9 million CV events. The intervention is economically dominant (i.e., it is both more effective and reduces costs when compared to usual care). Conclusion: Across a range of 1-way and probabilistic sensitivity analyses of key parameters and assumptions, pharmacist prescribing and care are both more effective and cost-saving compared to usual care. Canadians need and deserve such care.

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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