scholarly journals Targeting screening and treatment for latent tuberculosis infection towards asylum seekers from high-incidence countries – a model-based cost-effectiveness analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Florian M. Marx ◽  
Barbara Hauer ◽  
Nicolas A. Menzies ◽  
Walter Haas ◽  
Nita Perumal
Keyword(s):  
Cost Effectiveness ◽  
Asylum Seekers ◽  
Country Of Origin ◽  
High Risk Group ◽  
Interferon Gamma Release Assay ◽  
Decision Analytic Model ◽  
Uncertainty Interval ◽  
Ltbi Screening ◽  
Life Years ◽  
High Incidence

Abstract Background Enhancing tuberculosis (TB) prevention and care in a post-COVID-19-pandemic phase will be essential to ensure progress towards global TB elimination. In low-burden countries, asylum seekers constitute an important high-risk group. TB frequently arises post-immigration due to the reactivation of latent TB infection (LTBI). Upon-entry screening for LTBI and TB preventive treatment (TPT) are considered worthwhile if targeted to asylum seekers from high-incidence countries who usually present with higher rates of LTBI. However, there is insufficient knowledge about optimal incidence thresholds above which introduction could be cost-effective. We aimed to estimate, among asylum seekers in Germany, the health impact and costs of upon-entry LTBI screening/TPT introduced at different thresholds of country-of-origin TB incidence. Methods We sampled hypothetical cohorts of 30–45 thousand asylum seekers aged 15 to 34 years expected to arrive in Germany in 2022 from cohorts of first-time applicants observed in 2017–2019. We modelled LTBI prevalence as a function of country-of-origin TB incidence fitted to data from observational studies. We then used a probabilistic decision-analytic model to estimate health-system costs and quality-adjusted life years (QALYs) under interferon gamma release assay (IGRA)-based screening for LTBI and rifampicin-based TPT (daily, 4 months). Incremental cost-effectiveness ratios (ICERs) were calculated for scenarios of introducing LTBI screening/TPT at different incidence thresholds. Results We estimated that among 15- to 34-year-old asylum seekers arriving in Germany in 2022, 17.5% (95% uncertainty interval: 14.2–21.6%) will be latently infected. Introducing LTBI screening/TPT above 250 per 100,000 country-of-origin TB incidence would gain 7.3 (2.7–14.8) QALYs at a cost of €51,000 (€18,000–€114,100) per QALY. Lowering the threshold to ≥200 would cost an incremental €53,300 (€19,100–€122,500) per additional QALY gained relative to the ≥250 threshold scenario; ICERs for the ≥150 and ≥ 100 thresholds were €55,900 (€20,200–€128,200) and €62,000 (€23,200–€142,000), respectively, using the next higher threshold as a reference, and considerably higher at thresholds below 100. Conclusions LTBI screening and TPT among 15- to 34-year-old asylum seekers arriving in Germany could produce health benefits at reasonable additional cost (with respect to international benchmarks) if introduced at incidence thresholds ≥100. Empirical trials are needed to investigate the feasibility and effectiveness of this approach.

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 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.

scholarly journals Cost-Effectiveness Analysis of Biomarker-Guided Treatment for Metastatic Gastric Cancer in the Second-Line Setting

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Brianna Lauren ◽  
Sassan Ostvar ◽  
Elisabeth Silver ◽  
Myles Ingram ◽  
Aaron Oh ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Cost Effectiveness ◽  
Targeted Therapies ◽  
Cost Effective ◽  
Metastatic Gastric Cancer ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
Effective Strategy ◽  
Second Line ◽  
Life Years

Background. The 5-year survival rate of patients with metastatic gastric cancer (GC) is only 5%. However, trials have demonstrated promising antitumor activity for targeted therapies/immunotherapies among chemorefractory metastatic GC patients. Pembrolizumab has shown particular efficacy among patients with programmed death ligand-1 (PD-L1) expression and high microsatellite instability (MSI-H). The aim of this study was to assess the effectiveness and cost-effectiveness of biomarker-guided second-line GC treatment. Methods. We constructed a Markov decision-analytic model using clinical trial data. Our model compared pembrolizumab monotherapy and ramucirumab/paclitaxel combination therapy for all patients and pembrolizumab for patients based on MSI status or PD-L1 expression. Paclitaxel monotherapy and best supportive care for all patients were additional comparators. Costs of drugs, treatment administration, follow-up, and management of adverse events were estimated from a US payer perspective. The primary outcomes were quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay threshold of $100,000/QALY over 60 months. Secondary outcomes were unadjusted life years (survival) and costs. Deterministic and probabilistic sensitivity analyses were performed to evaluate model uncertainty. Results. The most effective strategy was pembrolizumab for MSI-H patients and ramucirumab/paclitaxel for all other patients, adding 3.8 months or 2.0 quality-adjusted months compared to paclitaxel. However, this strategy resulted in a prohibitively high ICER of $1,074,620/QALY. The only cost-effective strategy was paclitaxel monotherapy for all patients, with an ICER of $53,705/QALY. Conclusion. Biomarker-based treatments with targeted therapies/immunotherapies for second-line metastatic GC patients substantially improve unadjusted and quality-adjusted survival but are not cost-effective at current drug prices.

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.

Metformin (Met): A cost-effective adjunct therapy with enzalutamide (Enza) for metastatic castrate-resistant prostate cancer (mCRPC)?

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 340-340
Author(s):  
Jordan Hill ◽  
Mike Paulden ◽  
Christopher McCabe ◽  
Peter Venner ◽  
Brita Lavender Danielson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cost Effectiveness ◽  
Large Population ◽  
Cost Effective ◽  
Expert Elicitation ◽  
Decision Analytic Model ◽  
Lifetime Horizon ◽  
Adjunct Therapy ◽  
Life Years ◽  
Effective Adjunct

340 Background: Several new therapies have changed the landscape of prostate cancer (PCa) treatment, primarily due to their effectiveness in treating patients with mCRPC. Enza has garnered much attention, but is relatively expensive (~$3175/month). Met is less expensive (~$8.00/month) and has been used for decades to treat patients with non-insulin dependent diabetes. Two recent large population-based studies of PCa have demonstrated that diabetics taking Met had improved PCa specific and overall survival compared to those not taking Met. As a result, we hypothesized that Met has the potential to be a cost-effective adjunct therapy to Enza, although it is not currently used as such. Methods: We constructed a Markov-based decision analytic model to compare the cost-effectiveness of Enza alone versus Enza combined with Met. Through expert elicitation, we assumed that adding Met to Enza increases its efficacy by 15%. All other costs, utilities, and transition probabilities were derived from existing literature or expert elicitation. Effectiveness was measured using quality-adjusted life years (QALYs). Costs and QALYs were considered over a lifetime horizon and discounted at 5% per annum. Cost-effectiveness was considered using a willingness to pay threshold of $50 000/QALY. Results: Adding Met to Enza increases expected lifetime costs per patient by $83 651, and improves the expected effectiveness of treatment by 3.74 QALYs, compared to Enza alone. The incremental cost-effectiveness ratio is $22 374/QALY. Accounting for parameter uncertainty, adding Met to Enza has a 72% probability of being cost-effective. Conclusions: Although Met is not currently used as an adjunct therapy to Enza, doing so would likely be cost-effective provided it is as effective as we have assumed in our model. Additionally, our results indicate that the combination of Enza and Met could be among the most cost effective interventions in oncology. However, given the uncertainty around the effectiveness of such an adjunct therapy, our results support the need for further clinical trials to provide more robust evidence of the effectiveness of such a combination therapy in clinical practice.

scholarly journals Cost-effectiveness of targeted screening for active pulmonary tuberculosis among asylum-seekers: A modelling study with screening data from a German federal state (2002-2015)

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0241852
Author(s):  
Katharina Wahedi ◽  
Louise Biddle ◽  
Kayvan Bozorgmehr
Keyword(s):  
Cost Effectiveness ◽  
Pulmonary Tuberculosis ◽  
Incremental Cost ◽  
Asylum Seekers ◽  
Country Of Origin ◽  
Federal State ◽  
Active Pulmonary Tuberculosis ◽  
Screening Measure ◽  
Targeted Screening ◽  
German Federal State

Screening asylum-seekers for active pulmonary tuberculosis is common practice among many European countries with low incidence of tuberculosis. The reported yields vary substantially, partly due to the heterogeneous and dynamic nature of asylum-seeking populations. Rather than screening all new arrivals (indiscriminate screening), a few countries apply targeted screening based on incidence of tuberculosis in asylum-seekers’ country of origin. However, evaluations of its cost-effectiveness have been scarce. The aim of this modelling study was to assess whether the introduction of a screening threshold based on the tuberculosis incidence in the country of origin is sensible from an economic perspective. To this end, we compare the current, indiscriminate screening policy for pulmonary tuberculosis in Germany with a hypothetical targeted screening programme using several potential screening thresholds based on WHO-reported incidence of tuberculosis in countries of origin. Screening data is taken from a large German federal state over 14 years (2002–2015). Incremental cost-effectiveness is measured as cost per case found and cost per case prevented. Our analysis shows that incremental cost-effectiveness ratios (ICERs) of screening asylum-seekers from countries with an incidence of 50 to 250/100,000 range between 15,000€ and 17,000€ per additional case found when compared to lower thresholds. The ICER for screening asylum-seekers from countries with an incidence <50/100,000 is 112,000€ per additional case found. Costs per case prevented show a similar increase in costs. The high cost per case found and per case prevented at the <50/100,000 threshold scenario suggests this threshold to be a sensible cut-off for targeted screening. Acknowledging that no screening measure can find all cases of tuberculosis, and that reactivation of latent infections makes up a large proportion of foreign-born cases, targeting asylum-seekers from countries with an incidence above 50/100,000 is likely to be a more reasonable screening measure for the prevention and control of tuberculosis than indiscriminate screening measures.

scholarly journals Cost-effectiveness analysis of screening for first-degree relatives of patients with bicuspid aortic valve

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
I Tessler ◽  
M Leshno ◽  
A Shmueli ◽  
S Shpitzen ◽  
R Durst ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Aortic Valve ◽  
Bicuspid Aortic Valve ◽  
Cost Effectiveness Analysis ◽  
Public Institution ◽  
Sensitivity Analyses ◽  
Decision Analytic Model ◽  
First Degree Relatives ◽  
Effectiveness Analysis ◽  
Life Years

Abstract Introduction Bicuspid aortic valve (BAV) is the commonest congenital heart valve defect, found in 1% to 2% of the general population and associated with life-threatening complications. Given the high heritability index of BAV, many experts recommend echocardiography for first-degree relatives (FDRs) of an index patient. However, the cost-effectiveness of such cascade screening for BAV has not been fully evaluated. Materials and methods Using a decision-analytic model, we performed a cost-effectiveness analysis of echocardiographic screening of FDRs of BAV index cases. Data on BAV probabilities and BAV complications among FDRs were derived from our institution's BAV familial cohort and from the relevant literature on population-based BAV cohorts with long-term follow-up. Health gain was measured as quality-adjusted life years (QALYs). Cost inputs were based on list prices and literature data. One-way and probabilistic sensitivity analyses were performed to account for uncertainty in the model's variables. Results and disscusion Screening of FDRs was found to be the dominant strategy, being more effective and less costly than no screening, with savings of €208 and gains of 1.6 QALYs. Results were sensitive to the full range of reported BAV rates among FDRs across the literature, with the benefit gradually decreasing from the screening age of 55 years, with trend shifting at the age of 69. Conclusions This economic evaluation model revealed that echocardiographic screening of FDRs of BAV index case is not only clinically important but also highly cost effective and cost-saving. Health gains could be achieved from initiating screening program, along with costs saving. Sensitivity analysis supported the model's robustness, suggesting its generalization. FUNDunding Acknowledgement Type of funding sources: Public Institution(s). Main funding source(s): Center for Interdisciplinary Data Science Research fellowships grant

scholarly journals Health benefits and costs of weight-loss dietary counselling by nurses in primary care: a cost-effectiveness analysis

2019 ◽  
Vol 23 (1) ◽  
pp. 83-93 ◽  
Author(s):  
Christine L Cleghorn ◽  
Nick Wilson ◽  
Nisha Nair ◽  
Giorgi Kvizhinadze ◽  
Nhung Nghiem ◽  
...  
Keyword(s):  
Primary Care ◽  
Weight Loss ◽  
Cost Effectiveness ◽  
Population Level ◽  
Cost Effective ◽  
Uncertainty Interval ◽  
Dietary Counselling ◽  
Life Years ◽  
Per Capita ◽  
The Impact

AbstractObjective:We aimed to estimate the cost-effectiveness of brief weight-loss counselling by dietitian-trained practice nurses, in a high-income-country case study.Design:A literature search of the impact of dietary counselling on BMI was performed to source the ‘best’ effect size for use in modelling. This was combined with multiple other input parameters (e.g. epidemiological and cost parameters for obesity-related diseases, likely uptake of counselling) in an established multistate life-table model with fourteen parallel BMI-related disease life tables using a 3 % discount rate.Setting:New Zealand (NZ).Participants:We calculated quality-adjusted life-years (QALY) gained and health-system costs over the remainder of the lifespan of the NZ population alive in 2011 (n 4·4 million).Results:Counselling was estimated to result in an increase of 250 QALY (95 % uncertainty interval −70, 560 QALY) over the population’s lifetime. The incremental cost-effectiveness ratio was 2011 $NZ 138 200 per QALY gained (2018 $US 102 700). Per capita QALY gains were higher for Māori (Indigenous population) than for non-Māori, but were still not cost-effective. If willingness-to-pay was set to the level of gross domestic product per capita per QALY gained (i.e. 2011 $NZ 45 000 or 2018 $US 33 400), the probability that the intervention would be cost-effective was 2 %.Conclusions:The study provides modelling-level evidence that brief dietary counselling for weight loss in primary care generates relatively small health gains at the population level and is unlikely to be cost-effective.

Cost-Effectiveness of Pharmacological Interventions for Smoking Cessation: A Literature Review and a Decision Analytic Analysis

2002 ◽  
Vol 22 (1_suppl) ◽  
pp. 26-37 ◽  
Author(s):  
Fujian Song ◽  
James Raftery ◽  
Paul Aveyard ◽  
Chris Hyde ◽  
Pelham Barton ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Cost Effectiveness ◽  
Cost Effective ◽  
Decision Analytic Model ◽  
Relative Cost ◽  
Pharmacological Interventions ◽  
Relative Cost Effectiveness ◽  
Life Years ◽  
The Uk ◽  
The Cost

To evaluate the relative cost-effectiveness of nicotine replacement therapy (NRT) and bupropion SR for smoking cessation, the authors reviewed published studies and developed a decision analytic model from the UK National Health Services perspective. Irrespective of the methods or assumptions involved, the results of published studies consistently indicated that NRT for smoking cessation is cost-effective. No published studies have evaluated the relative cost-effectiveness of bupropion SR for smoking cessation. The results of the decision analyses indicated that, as compared with advice or counseling alone, the incremental cost per life-years saved is about $1,441~$3,455 for NRT, $920~$2,150 for bupropion SR, and $1,282~$2,836 for NRT plus bupropion SR. The cost-effectiveness of adding NRT and bupropion SR to advice or counseling for smoking cessation is better than many other accepted health care interventions.

Cost-effectiveness of a two-gene urine biomarker assay in MRI strategies for the initial detection of prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 91-91 ◽  
Author(s):  
Tim Govers ◽  
Matthew J. Resnick ◽  
Geert Trooskens ◽  
Wim Van Criekinge ◽  
Jack A. Schalken
Keyword(s):  
Prostate Cancer ◽  
Cost Effectiveness ◽  
Health Gain ◽  
Cost Savings ◽  
Decision Analytic Model ◽  
Model Parameters ◽  
Life Years ◽  
Clinically Significant ◽  
Using Data ◽  
Systematic Biopsy

91 Background: MRI is increasingly used in men with a suspicion for prostate cancer (PCa) to target abnormal areas next to systematic biopsy. Although, MRI increases the detection of clinically significant PCa compared to systematic biopsy alone, overdiagnosis and overtreatment of insignificant disease still exists. The 2-gene mRNA PCR urine test combined with traditional risk factors SelectMDx (MDxhealth Irvine Ca) predicts clinically significant PCa, and can be used to reduce overdiagnosis and overtreatment. We assessed the cost-effectiveness of SelectMDx in a population of U.S. men who in the current situation undergo initial MRI and biopsies. Methods: We developed a decision-analytic model to simulate the downstream outcomes in the current MRI strategy, i.e. systematic biopsy plus targeted biopsy in case of a positive MRI. SelectMDx was assessed in two different diagnostic pathways: 1) before MRI to select patients for MRI and biopsy, 2) after a negative MRI to select patients for systematic biopsy. Outcomes were quality-adjusted life years (QALYs) and costs. Model parameters were informed by literature. Two scenarios regarding the mortality of missed PCa were used, using SPCG trial data and using data from the PIVOT trial. Results: Using SelectMDx before MRI (1) resulted in a health gain of 0.003 and 0.030 QALY per patient compared to the current MRI strategy, using the SPCG and PIVOT data, respectively. Cost savings were $1590 per patient and about $496 million for the yearly population of men at risk in the U.S. (n = 311,879). SelectMDx after negative MRI (2) resulted in a health gain of 0.008 and 0,011 QALY per patient using the SPCG and PIVOT data.. Cost savings were $436 per patient and about $136 million for the yearly population. Conclusions: The use of SelectMDx to guide prostate biopsy decision-making can improve health outcomes and lower costs. Cost savings were highest when SelectMDx was used before MRI to select patients for MRI and biopsy. With respect to health gain, the use of SelectMDx after negative MRI was most beneficial when assuming higher mortality for missed PCa (SPCG). When the mortality was assumed to be lower (PIVOT) SelectMDx should be used before MRI to result in the highest health gain.

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