1-way Sensitivity Analyses Research Articles

Cost-Effectiveness of First-Line Pembrolizumab Monotherapy Versus Chemotherapy in High Programmed Death-Ligand 1 Advanced Non–Small Cell Lung Cancer in the Irish Healthcare Setting

ObjectivesThis study aimed to assess the cost-effectiveness of pembrolizumab monotherapy in the first-line treatment of advanced non–small cell lung cancer (NSCLC) in adults whose tumors expressed programmed death-ligand 1 (PD-L1) with a tumor proportion score (TPS) ≥ 50% in the Irish healthcare setting. MethodsEffectiveness inputs were derived from the 5-year analysis of KEYNOTE-024 phase III clinical trial. The intervention was pembrolizumab monotherapy; the comparator was a weighted average of the 5 chemotherapy regimens from the trial. The population included those with previously untreated advanced PD-L1 TPS ≥ 50% NSCLC. A de novo partitioned survival model was developed. Survival modeling was done using Bayesian model averaging on fitted parametric functions. Costs included drug acquisition, treatment initiation, administration and monitoring, adverse events, subsequent treatments, and terminal care. Costs and health state utilities were sourced from the literature and Irish sources. The model had a 20-year time horizon. The perspective taken was the Health Service Executive. A 4% discount rate was applied. Outcomes were expressed as an incremental cost-effectiveness ratio (ICER), measured in terms of incremental costs per quality-adjusted life-year (QALY). Probabilistic sensitivity analysis and 1-way sensitivity analyses were conducted. ResultsThe model estimated a base case ICER of €54 237 per QALY. The probabilistic sensitivity analysis estimated an average ICER of €54 568 per QALY and a 11% probability of cost-effectiveness at the Irish cost-effectiveness threshold of €45 000 per QALY. ConclusionAt the current list price, first-line pembrolizumab monotherapy is not considered cost-effective for the treatment of advanced PD-L1 TPS ≥ 50% NSCLC in the Irish healthcare setting.

If the price is right: Cost-effectiveness of radiofrequency ablation versus thyroidectomy in the treatment of benign thyroid nodules

BackgroundRadiofrequency ablation is an emerging technology in the United States to treat benign thyroid nodules. The cost-effectiveness of radiofrequency ablation in comparison with traditional thyroidectomy is unknown. MethodsA patient-level state transition microsimulation decision model was constructed comparing radiofrequency ablation with lobectomy in the management of benign thyroid nodules. Our base case was a 45-year-old woman with a solitary 30-cm3 nodule. Estimates of health utilities, complications, and mortality were obtained from the literature, and costs were estimated using Medicare reimbursement data. The primary outcomes of interest included total cost, quality-adjusted life years, and incremental cost-effectiveness ratios. All model estimates were subjected to 1-way sensitivity analyses to identify factors that strongly influence cost-effectiveness. A probabilistic sensitivity analysis was run across 1 million simulations to gauge outcome confidence with a willingness-to-pay threshold set at $100,000/quality-adjusted life year. ResultsRadiofrequency ablation was assumed to cost $5,000, with an initial success rate of 78%. Patients with volume reduction ratio <50% underwent a second treatment of radiofrequency ablation. Radiofrequency ablation represented the dominant strategy, yielding 21.31 quality-adjusted life years for a total cost of $16,563 in comparison to lobectomy, which yielded 21.13 quality-adjusted life years for a total cost of $19,262. In a 1-way sensitivity analysis varying the cost of radiofrequency ablation across of range of values, the radiofrequency ablation strategy remained cost-effective until the cost of radiofrequency ablation exceeded $12,330 at willingness-to-pay $50,000 or $17,950 at willingness-to-pay $100,000. ConclusionRadiofrequency ablation is a cost-effective strategy in the treatment of benign thyroid nodules but is most sensitive to the cost of radiofrequency ablation.

Cost-Effectiveness of PET Directed Versus Combined Modality Therapy for Early-Stage Favorable Hodgkin's Lymphoma.

The standard of care for early-stage Hodgkin Lymphoma (HL) is combined modality therapy (CMT) consisting of chemotherapy and involved site radiation therapy (ISRT). Recent treatment de-escalation trials have assessed the impact of omitting radiation with the use of positron emission tomography (PET) and have suggested a detriment in progression free survival (PFS) for patients who do not receive radiation therapy (RT) but similar overall survival. The purpose of this study was to compare the cost-effectiveness of PET-directed therapy versus standard of care CMT. This study used a cost-effectiveness Markov model simulating 5 year outcomes for 1 million patients with early-stage HL treated with either PET-directed therapy consisting of 2 cycles of ABVD chemotherapy ± ISRT or CMT consisting of 2 cycles of ABVD+ISRT. Patients progressed to no evidence of disease, progression of disease (PD), or death. Patients with PD underwent salvage therapy with high dose chemotherapy and stem cell transplant (HDC-SCT). The primary outcome measured was the incremental cost-effectiveness ratio. Deterministic sensitivity analyses were performed. We found that PET-directed therapy and CMT strategies were associated with costs of $47,362 and $41,167, respectively. The CMT strategy was equally as effective as the PET-directed therapy strategy with QALYs of 3.4. On 1-way sensitivity analyses, the model was most sensitive to CMT and HDC-SCT costs. Two-way sensitivity analyses showed the model was sensitive to the relative costs of these treatments. For patients with early-stage HL, CMT is the cost-effective strategy as compared with PET-directed therapy.

Cost-effectiveness of universal iron supplementation and iron-containing micronutrient powders for anemia among young children in rural Bangladesh: analysis of a randomized, placebo-controlled trial

Universal provision of iron supplements or iron-containing multiple micronutrient powders (MNPs) is widely used to prevent anemia in young children in low- and middle-income countries. The BRISC (Benefits and Risks of Iron Interventions in Children) trial compared iron supplements and MNPs with placebo in children <2 y old in rural Bangladesh. We aimed to assess the cost-effectiveness of iron supplements or iron-containing MNPs among young children in rural Bangladesh. We did a cost-effectiveness analysis of MNPs and iron supplements using the BRISC trial outcomes and resource use data, and programmatic data from the literature. Health care costs were assessed from a health system perspective. We calculated incremental cost-effectiveness ratios (ICERs) in terms of US$ per disability-adjusted life-year (DALY) averted. To explore uncertainty, we constructed cost-effectiveness acceptability curves using bootstrapped data over a range of cost-effectiveness thresholds. One- and 2-way sensitivity analyses tested the impact of varying key parameter values on our results. Provision of MNPs was estimated to avert 0.0031 (95% CI: 0.0022, 0.0041) DALYs/child, whereas iron supplements averted 0.0039 (95% CI: 0.0030, 0.0048) DALYs/child, over 1 y compared with no intervention. Incremental mean costs were $0.75 (95% CI: 0.73, 0.77) for MNPs compared with no intervention and $0.64 ($0.62, $0.67) for iron supplements compared with no intervention. Iron supplementation dominated MNPs because it was cheaper and averted more DALYs. Iron supplementation had an ICER of $1645 ($1333, $2153) per DALY averted compared with no intervention, and had a 0% probability of being the optimal strategy at cost-effectiveness thresholds of $200 (reflecting health opportunity costs in Bangladesh) and $985 [half of gross domestic product (GDP) per capita] per DALY averted. Scenario and sensitivity analyses supported the base case findings. These findings do not support universal iron supplementation or micronutrient powders as a cost-effective intervention for young children in rural Bangladesh. This trial was registered at anzctr.org.au as ACTRN1261700066038 and trialsearch.who.int as U1111-1196-1125.

Total thyroidectomy is more cost-effective than radioactive iodine as an alternative to antithyroid medication for Graves’ disease

BackgroundPatients with Graves’ disease treated with radioactive iodine report worse quality of life than those treated by thyroidectomy. However, radioactive iodine is often selected due to lower risk of complications and lower cost. The objective of this study was to estimate the cost-effectiveness of radioactive iodine versus total thyroidectomy for treatment of Graves’ disease. MethodsA Markov decision-analytic model was created to simulate clinical outcomes and costs of medication-refractory Graves’ disease treated with radioactive iodine or total thyroidectomy. Complication rates and utilities were derived from published data. Costs were extracted from national Medicare reimbursement rates. We conducted 1-way, 2-way, and probabilistic sensitivity analyses to identify factors that influence cost-effectiveness and reflect uncertainty in model parameters. The willingness-to-pay threshold was set at $100,000/quality-adjusted life-years. ResultsTotal thyroidectomy yielded 23.6 quality-adjusted life-years versus 20.9 quality-adjusted life-years for radioactive iodine. The incremental cost-effectiveness ratio was $2,982 per quality-adjusted life-years, indicating that surgery is highly cost-effective relative to radioactive iodine. Surgery was more cost effective than radioactive iodine in 88.2% of model simulations. Sensitivity analyses indicate that the model outcomes are driven predominantly by posttreatment quality of life, with contributing effects from rates of treatment complications and the impact of these complications on quality of life. ConclusionFor patients with Graves’ disease who either cannot tolerate or are refractory to antithyroid drugs, thyroidectomy is more cost-effective than radioactive iodine. Future research should validate reported differences in quality of life between these 2 treatment modalities.

Cost-Effectiveness of Screening for Open Angle Glaucoma Compared With Opportunistic Case Finding.

The manuscript evaluates cost-effectiveness of glaucoma screening with imaging devices and telemedicine based on a screening campaign performed in Spain. The screening strategy implemented in our analysis was cost-effective compared with opportunistic case finding. Open angle glaucoma is an asymptomatic ocular disease that represents one of the first causes of blindness. Diagnosis is currently made by opportunistic case finding, usually by community optometrists or general ophthalmologists. The aim of this study was to assess the cost-effectiveness of a screening strategy based on optical coherence tomography and fundus photographs in glaucoma detection. A cost-effectiveness analysis was carried out to compare 2 alternative strategies: opportunistic finding versus screening. A Markov tree model was carried out with 10 health states according to disease progression. Quality-adjusted life years (QALYs) were used as a measure of effectiveness. We included short-term and long-term direct health costs and a discount rate of 3%. We performed a probabilistic sensitivity analysis and several 1-way sensitivity analyses. The cohort in the screening program entailed an increase in 0.097 QALYs and additional costs of €1187 versus opportunistic finding, with an incremental cost-effectiveness ratio of about €12.214/QALY. The 1-way sensitivity analysis showed that inputs related to age and screening program (cost and detection rate) were those most strongly influencing the results of the analysis. Probabilistic sensitivity analyses showed that the model was robust to significant changes in the main variables of the analysis. The screening strategy implemented in our analysis was cost-effective compared with opportunistic finding in patients with glaucoma in this Spanish setting.

S1446 Cost-Effectiveness Analysis of Endoscopic Sleeve Gastroplasty

Introduction: Obesity continues to increase at an alarming rate. Endoscopic sleeve gastroplasty (ESG), a minimally invasive endoscopic weight loss procedure, has been shown to produce effective weight loss and improvement in obesity-related disease; however, it is unclear whether ESG is cost-effective. This study was created to assess the cost-effectiveness of endoscopic sleeve gastroplasty for weight loss in patients with obesity with or without type 2 diabetes (T2DM). Methods: A decision analytic model with time horizon of 5 years and lifetime, respectively, from a health system’s perspective was constructed to compare ESG to no weight loss intervention (no ESG) in obese patients aged 35-45 years with a body mass index (BMI) ≥30 kg/m2 with or without T2DM. Parameters including probabilities and utility weights were obtained based on published meta-analyses and retrospective studies (Table). Costs were taken from institutional data and were evaluated in 2022 U.S. dollars (2022$). Life expectancy with or without T2DM was obtained from a prospective cohort study. One-way and 2-way sensitivity analyses were performed to evaluate the impact of variations in the probability of T2DM resolution following ESG as well as variations of the cost of ESG. Results: Quality-adjusted life-years (QALYs), cost (in 2022$), and incremental cost-effectiveness ratios (ICERs) were calculated. For the 5-year time horizon in patients with T2DM, ESG produced 4.28 QALYs and incurred a total cost of $77,874, compared to 3.99 QALYs and a total cost of $73,738 for no ESG, resulting in an ICER of $13,922 per QALY gained. For the lifetime horizon, ESG produced 29.57 QALYs and incurred a lifetime cost of $451,261, compared to 26.69 QALYs and incurred a lifetime cost of $493,806 for no ESG, resulting in a negative ICER (i.e., cost-saving). The 5-year time horizon in patients without T2DM demonstrated that ESG produced 4.42 QALYs, compared to 4.08 QALYs with no ESG, resulting in an ICER of $39,116 per QALY gained. For the lifetime horizon ESG produced 34.21 QALYs, compared to 31.60 QALYs for no ESG, resulting in an ICER of $4,752. Conclusion: This cost-effectiveness analysis suggests that ESG is cost-effective in 5 years and cost-saving over a lifetime for patients with obesity and type 2 diabetes (Figure). ESG remains cost-effective at 5 years and over a lifetime in patients without T2DM.Figure 1.: Decision Analytic Model Table 1. - Parameters and data sources Parameters Source Endoscopic Sleeve Gastroplasty Cost of ESG (2022$) $12,999 (Institutional data) Cost of Complication of ESG (2022$) $13,851.96 AHRQ (Avg hospital stay) Rate of Complication of ESG 2.2% Hedjoudje et al Annual Medical Costs (2022$) Obese with T2DM, age 40 $14,767.52 Chang et al Obese w/o T2DM age 40 Chang et al Probability of T2DM improvement after ESG 0.19 Wing et al Life expectancies Obese with no T2DM, age 40 38.7 years Leung et al Obese with T2DM, age 40 33.48 years Leung et al, Chang et al Utility weight Obese with T2DM 0.797 Boye et al Obese w/o T2DM 0.817 Boye et al Obese with T2DM, 15% weight loss 0.850 Boye et al Obese w/o T2DM, 15% weight loss 0.884 Boye et al

Economic Analysis of Exclusionary EGFR Test Versus Up-Front NGS for Lung Adenocarcinoma in High EGFR Mutation Prevalence Areas.

This study sought to determine whether exclusionary EGFR mutation testing followed by next-generation sequencing (NGS) is a cost-efficient and timely strategy in areas with high prevalence rates of EGFR mutation. We developed a decision tree model to compare exclusionary EGFR testing followed by NGS and up-front NGS. Patients entered the model upon diagnosis of metastatic lung adenocarcinoma. Gene alterations with FDA-approved targeted therapies included EGFR, ALK, ROS1, BRAF, RET, MET, NTRK, and KRAS. Model outcomes were testing-related costs; time-to-test results; monetary loss, taking both costs and time into consideration; and percentage of patients who could be treated by FDA-approved therapies. Stacked 1-way and 3-way sensitivity analyses were performed. Exclusionary EGFR testing incurred testing-related costs of US $1,387 per patient, a savings of US $1,091 compared with the costs of up-front NGS. The time-to-test results for exclusionary EGFR testing and up-front NGS were 13.0 and 13.6 days, respectively. Exclusionary EGFR testing resulted in a savings of US $1,116 in terms of net monetary loss, without a reduction of patients identified with FDA-approved therapies. The EGFR mutation rate and NGS cost had the greatest impact on minimizing monetary loss. Given that the tissue-based NGS turnaround time was shortened to 7 days, up-front NGS testing would become the best strategy if its price could be reduced to US $568 in Taiwan. In areas with high prevalence rates of EGFR mutation, exclusionary EGFR testing followed by NGS, rather than up-front NGS, is currently a cost-efficient strategy for metastatic lung adenocarcinoma.

Cost-effectiveness of Pulmonary Rehabilitation Among US Adults With Chronic Obstructive Pulmonary Disease

Pulmonary rehabilitation (PR) after exacerbation of chronic obstructive pulmonary disease (COPD) is effective in reducing COPD hospitalizations and mortality while improving health-related quality of life, yet use of PR remains low. Estimates of the cost-effectiveness of PR in this setting could inform policies to improve uptake. To estimate the cost-effectiveness of participation in PR after hospitalization for COPD. This economic evaluation estimated the cost-effectiveness of participation in PR compared with no PR after COPD hospitalization in the US using a societal perspective analysis. A Markov microsimulation model was developed to estimate the cost-effectiveness in the US health care system with a lifetime horizon, 1-year cycle length, and a discounted rate of 3% per year for both costs and outcomes. Data sources included published literature from October 1, 2001, to April 1, 2021, with the primary source being an analysis of Medicare beneficiaries living with COPD between January 1, 2014, and December 31, 2015. The analysis was designed and conducted from October 1, 2019, to December 15, 2021. A base case microsimulation, univariate analyses, and a probabilistic sensitivity analysis were performed. Pulmonary rehabilitation compared with no PR after COPD hospitalization. Net cost in US dollars, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Among the hypothetical cohort with a mean age of 76.9 (age range, 60-92) years and 58.6% women, the base case microsimulation from a societal perspective demonstrated that PR resulted in net cost savings per patient of $5721 (95% prediction interval, $3307-$8388) and improved quality-adjusted life expectancy (QALE) (gain of 0.53 [95% prediction interval, 0.43-0.63] years). The findings of net cost savings and improved QALE with PR did not change in univariate analyses of patient age, the Global Initiative for Obstructive Lung Disease stage, or number of PR sessions. In a probabilistic sensitivity analysis, PR resulted in net cost savings and improved QALE in every one of 1000 samples and was the dominant strategy in 100% of simulations at any willingness-to-pay threshold. In a 1-way sensitivity analysis of total cost, assuming completion of 36 sessions, a single PR session would remain cost saving to $171 per session and had an incremental cost-effectiveness ratio of $884 per session for $50 000/QALY and $1597 per session for $100 000/QALY. In this economic evaluation, PR after COPD hospitalization appeared to result in net cost savings along with improvement in QALE. These findings suggest that stakeholders should identify policies to increase access and adherence to PR for patients with COPD.

Universal first-trimester cytomegalovirus screening and valaciclovir prophylaxis in pregnant persons: a cost-effectiveness analysis

BACKGROUNDRecent studies have suggested a possible benefit of valaciclovir prophylaxis to prevent vertical transmission after a positive serologic screen for primary maternal cytomegalovirus infection during pregnancy, although its cost-effectiveness remains uncertain. OBJECTIVEThis study aimed to determine the circumstances under which universal first-trimester maternal serologic screening for maternal cytomegalovirus infection, with valaciclovir prophylaxis to prevent congenital cytomegalovirus, is cost-effective. STUDY DESIGNThis study was a decision analysis from the perspective of the pregnant person to assess whether universal maternal screening in the first trimester of pregnancy, with subsequent valaciclovir prophylaxis (8 g/day from the time of positive serologic screen for primary maternal cytomegalovirus infection to 21 weeks of gestation) for those who are acutely infected, is cost-effective compared with usual care (ie, no routine serologic screening but with amniocentesis if midtrimester sonographic findings suggest cytomegalovirus). For baseline estimates, this study assumed a 35% risk of congenital cytomegalovirus after primary maternal infection and a 71% risk reduction with valaciclovir. This study varied valaciclovir's efficacy to identify whether and at what threshold universal screening would be estimated to be cost-effective, compared with usual care. Monte Carlo analyses were performed. A willingness-to-pay threshold of $100,000/quality-adjusted life year was used to define cost-effectiveness. RESULTSUnder base case estimates, first-trimester universal screening and valaciclovir prophylaxis for seropositive pregnant persons with acute cytomegalovirus infection were not cost-effective, with a cost of $137,854 per maternal quality-adjusted life year but resulted in 14 fewer children affected with cytomegalovirus per 100,000 pregnancies compared with usual care. In 1-way sensitivity analysis, universal screening and treatment were estimated to be the cost-effective strategy if the incidence of primary maternal cytomegalovirus infection exceeds 2.6%, the baseline risk of vertical transmission of cytomegalovirus without prophylaxis is greater than 36.8%, and the risk reduction of vertical transmission of cytomegalovirus with valaciclovir prophylaxis exceeds 75.9%. In Monte Carlo analyses, first-trimester universal serologic screening with valaciclovir prophylaxis was estimated to be the cost-effective strategy in 46.8% of runs. CONCLUSIONUniversal first-trimester serologic screening with valaciclovir prophylaxis is not the cost-effective strategy for antenatal management of cytomegalovirus under the base case estimates. Although universal screening is cost-effective in certain circumstances when the efficacy of valaciclovir exceeds the base case, that result was not robust to variation of estimates across their reasonable ranges. These data can inform future studies to evaluate screening and treatment to prevent congenital cytomegalovirus.

Analysis of the Budget Impact of Fractional Exhaled Nitric Oxide Monitoring in the Management of Childhood Asthma: The Colombian National Health System Perspective.

Fractional exhaled nitric oxide (FeNO) testing is a simple, noninvasive approach to assessing airway inflammation with minimal discomfort that provides results within a few minutes. For policy makers, the economic impact of this technology is the main concern, especially in developing countries. We evaluated the budget impact of asthma management using FeNO monitoring in patients aged between 4 and 18 years in Colombia. A budget impact analysis was performed to evaluate the potential cost of FeNO monitoring. The analysis was based on a 5-year time horizon and performed from the perspective of the Colombian National Health System. The incremental budget impact was calculated by subtracting the cost of the new treatment, in which FeNO is reimbursed, from the cost of conventional treatment without FeNO (management based on clinical symptoms [with or without spirometry/peak flow] or asthma guidelines [or both] for asthma-related cases). Univariate 1-way sensitivity analyses were performed. In the base case analysis the 5-year costs associated with FeNO and non-FeNO were estimated to be €469 904 130 and €480 485 149, respectively, indicating savings for the Colombian National Health System of €10 581 019 if FeNO is adopted for the routine management of patients with persistent asthma. This result proved to be robust in the univariate 1-way sensitivity analysis. FeNO monitoring generated cost savings in emergency settings for infants with persistent asthma. This evidence can be used by decision makers in Colombia to improve clinical practice guidelines and should be replicated to validate the results in other middle-income countries.

Comparative Cost-effectiveness of Trabeculectomy versus MicroShunt in the US Medicare System

To assess the societal cost-utility of the MicroShunt compared with trabeculectomy for the surgical management of glaucoma in the US Medicare system. Cost-utility analysis using efficacy and safety results of a randomized controlled trial and other pivotal clinical trials. Markov model cohort of patients with open-angle glaucoma. Open-angle glaucoma treatment costs and effects were analyzed with a deterministic model over a 1-year horizon using TreeAge software. Health states included the Hodapp-Parrish-Anderson glaucoma stages (mild, moderate, advanced, blind) and death. Both treatment arms received additional ocular hypotensive agents to control intraocular pressure (IOP). Treatment effect was measured as mean number of ocular hypotensive medications and reduction in IOP, which had a direct impact on transition probabilities between health states. Analyses of scenarios were performed with longer time horizons. One-way sensitivity and probabilistic sensitivity analyses were conducted to assess the impact of alternative model inputs. Both treatment arms were subject to reported complication rates, which were factored in the model. Incremental cost per quality-adjusted life-year (QALY) gained. At 1 year, the MicroShunt had an expected cost of US dollars (USD) 6318 compared with USD 4260 for trabeculectomy. MicroShunt patients gained 0.85 QALYs compared with 0.86 QALYs for trabeculectomy, resulting in a dominated incremental cost-utility ratio of USD 187 680. Dominance is a health economic term used to describe a treatment option that is both more costly and less effective than the alternative. The MicroShunt remained dominant in 1-way sensitivity analyses using best-case input parameters (including a device fee of USD 0). At a willingness-to-pay threshold of USD 50 000, the likelihood of the MicroShunt being cost-effective was 6.4%. Dominance continued in longer time horizons, up to 20 years. Trabeculectomy appears to be a dominant treatment strategy over the MicroShunt in the surgical management of glaucoma. More independent, long-term studies are required for the MicroShunt and other subconjunctival microstent devices to evaluate their use in clinical practice.

Cost-effectiveness of prophylactic retropubic sling at the time of vaginal prolapse surgery

Prophylactic midurethral sling placement at the time of prolapse repair significantly reduces the risk for de novo stress urinary incontinence, but it is associated with some small but significant morbidities. Because there has not been a standardized approach to midurethral sling utilization, decision analysis provides a method to evaluate the cost and effectiveness associated with varying midurethral sling placement strategies in addressing the risk for de novo stress urinary incontinence. We aimed to compare the cost effectiveness of the 3 midurethral sling utilization strategies in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. The 3 approaches are (1) staged strategy in which prolapse repair is done without prophylactic midurethral sling placement, (2) universal sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement, and (3) selective sling placement in which prolapse repair is accompanied by prophylactic midurethral sling placement only in patients with a positive prolapse-reduced cough stress test. We created a decision analysis model to compare staged strategy, universal sling placement, and selective sling placement. We modeled probabilities of de novo stress urinary incontinence, patients choosing subsequent midurethral sling surgery for de novo stress urinary incontinence, and outcomes related to midurethral sling placement. De novo stress urinary incontinence rates were determined for each strategy from published data. The likelihood of patients with de novo stress urinary incontinence choosing midurethral sling surgery as their first-line treatment was also determined from the literature, and this scenario was only applied to patients without prophylactic midurethral sling placement at their index prolapse repair. Finally, outcomes related to midurethral sling placement, including recurrent or persistent stress urinary incontinence, voiding dysfunction requiring sling lysis, mesh exposure requiring excision, and de novo overactive bladder requiring medications, were all derived from publicly available data. All midurethral sling placement procedures were assumed to be retropubic. The costs for each procedure were obtained from the 2020 Centers for Medicare & Medicaid Services Physician Fee Schedule or from previous literature with convertion to 2020 equivalent US dollar prices using the Consumer Price Index. The primary outcome was modeled as the incremental cost-effectiveness ratio. We performed multiple 1-way sensitivity analyses to assess model robustness. The lowest-cost strategy was the staged strategy, which cost $1051.70 per patient, followed by $1093.75 for selective sling placement and $1125.54 for universal sling placement. The selective sling approach, however, had the highest health utility value; therefore, universal sling placement was dominated by selective sling placement because it is both less costly and more effective. When compared with the staged strategy, selective sling placement was cost effective with an incremental cost-effectiveness ratio of $2664 per quality adjusted life-years, meeting the predetermined threshold. In multiple 1-way sensitivity analyses, the variable with the largest effect was the percentage of patients electing to undergo subsequent midurethral sling surgery for de novo stress urinary incontinence after the index surgery. Only when this proportion exceeded 62% did universal sling placement become the cost-effective option because selective sling placement surpassed the predetermined incremental cost-effectiveness ratio threshold and became dominated. Selective sling placement was the preferred and cost-effective strategy in treating de novo stress urinary incontinence 1 year after vaginal prolapse repair. Surgeons should counsel their patients preoperatively regarding the possibility of de novo stress urinary incontinence after prolapse repair, as well as on the benefits and risks of prophylactic midurethral sling placement surgery.

Cost-effectiveness of DPYD Genotyping Prior to Fluoropyrimidine-based Adjuvant Chemotherapy for Colon Cancer

BackgroundAdjuvant fluoropyrimidine-based chemotherapy substantially reduces recurrence and mortality after resection of stage 3 colon cancer. While standard doses of 5-fluorouracil and capecitabine are safe for most patients, the risk of severe toxicity is increased for the approximately 6% of patients with dihydropyimidine dehydrogenase (DPD) deficiency caused by pathogenic DPYD gene variants. Pre-treatment screening for pathogenic DPYD gene variants reduces severe toxicity but has not been widely adopted in the United States. MethodsWe conducted a cost-effectiveness analysis of DPYD genotyping prior to fluoropyrimidine-based adjuvant chemotherapy for stage 3 colon cancer, covering the c.1129-5923C>G (HapB3), c.1679T>G (*13), c.1905+1G>A (*2A), and c.2846A>T gene variants. We used a Markov model with a 5-year horizon, taking a United States healthcare perspective. Simulated patients with pathogenic DPYD gene variants received reduced-dose fluoropyrimidine chemotherapy. The primary outcome was the incremental cost-effectiveness ratio (ICER) for DPYD genotyping. ResultsCompared with no screening for DPD deficiency, DPYD genotyping increased per-patient costs by $78 and improved survival by 0.0038 quality-adjusted life years (QALYs), leading to an ICER of $20,506/QALY. In 1-way sensitivity analyses, The ICER exceeded $50,000 per QALY when the cost of the DPYD genotyping assay was greater than $286. In probabilistic sensitivity analysis using a willingness-to-pay threshold of $50,000/QALY DPYD genotyping was preferred to no screening in 96.2% of iterations. ConclusionAmong patients receiving adjuvant chemotherapy for stage 3 colon cancer, screening for DPD deficiency with DPYD genotyping is a cost-effective strategy for preventing infrequent but severe and sometimes fatal toxicities of fluoropyrimidine chemotherapy.

A Cost-Benefit Analysis of Osseointegrated Prostheses for Lower Limb Amputees in the US Health Care System.

Patients with transfemoral and transtibial amputations generally rely on socket-suspended (SS) prostheses for ambulation. The use of these aids can be complicated by poor fit, leading to tissue damage, pain at the socket-limb interface, and inability to ambulate. Osseointegrated implants (OIs) directly anchor a prosthesis to the patient's residual limb, eliminating these issues. However, they require customized components and additional surgeries. The purpose of this study was to conduct the first cost-benefit analysis of OI prostheses compared to SS prostheses for lower limb amputees in the United States. A retrospective chart review was performed on all patients who received unilateral lower limb OI prostheses at our institution. Costs were calculated in a bottom-up approach using Current Procedural Terminology codes. Utilities and SS prosthesis costs were derived from previous studies. A Monte Carlo model was used to project costs and lifetime quality-adjusted life years for OI and SS prostheses, and the incremental cost-effectiveness ratio (ICER) of OI compared SS prostheses was determined. Twenty-five patients (12 female) were included in the study. The mean follow-up was 17 months postimplantation. The average cost of OI surgery was $54,463. Twenty percent of patients required preimplantation soft tissue revision surgery ($49,191). Complication rates per year and average costs were as follows: soft tissue infection (29%, $435), bone/implant infection (11%, $11,721), neuroma development (14%, $14,659), and mechanical failure (17%, $46,513). The ICER was $44,660. A cost-effectiveness acceptability curve demonstrated that OI was favored over SS in 78% of cases at a willingness-to-pay of $100,000 per quality-adjusted life year. In a 1-way sensitivity analysis, the ICER was most sensitive to the mechanical failure rate, mechanical failure cost, and prior SS prosthesis costs. The model shows that OI prostheses provide a higher quality of life at affordable costs when compared to poorly tolerated SS prostheses in patients with lower limb amputations in the United States. The cost-effectiveness is largely determined by the patient's previous SS prosthesis costs and is limited by the frequency and costs of OI mechanical failure. More research must be done to understand the long-term benefits and risks of OI prostheses.

Salpingo-oophorectomy or surveillance for ovarian endometrioma in asymptomatic premenopausal women: a cost-effectiveness analysis

The lifetime risk of ovarian cancer is 1.9% among women with endometriosis compared with 1.3% among the general population. When an asymptomatic endometrioma is incidentally discovered on imaging, gynecologists must weigh the procedural complications and the potential for subsequent surgical menopause against future ovarian pathology or cancer. We aimed to determine if performing unilateral salpingo-oophorectomy is a more cost-effective strategy for the prevention of death than surveillance for asymptomatic endometriomas. We created a cost-effectiveness model using TreeAge Pro (TreeAge Software Inc; Williamstown, MA) with a lifetime horizon. Our hypothetical cohort included premenopausal patients with 2 ovaries who did not desire fertility. Those diagnosed with asymptomatic endometrioma underwent either unilateral salpingo-oophorectomy or surveillance (ultrasound 6-12 weeks after diagnosis, then annually). Our primary effectiveness outcome was mortality, including death from ovarian cancer or surgery and all-cause mortality related to surgical menopause (± hormone replacement therapy) if the contralateral ovary is removed. We modeled the probabilities of surgical complications, occult malignancy, development of contralateral adnexal pathology, surgical menopause, use of hormone replacement therapy, and development of ovarian cancer. The costs included surgical procedures, complications, ultrasound surveillance, hormone therapy, and treatment of ovarian cancer, with information gathered from Medicare reimbursement data and published literature. Cost-effectiveness was determined using the incremental cost-effectiveness ratio of Δ costs / Δ deaths with a willingness-to-pay threshold of $11.6 million as the value of a statistical life. Multiple 1-way sensitivity analyses were performed to evaluate model robustness. Our model demonstrated that unilateral salpingo-oophorectomy is associated with improved outcomes compared with surveillance, with fewer deaths (0.28% vs 1.50%) and fewer cases of ovarian cancer (0.42% vs 2.96%). However, it costs more than sonographic surveillance at $6403.43 vs $5381.39 per case of incidental endometrioma. The incremental cost-effectiveness ratio showed that unilateral salpingo-oophorectomy costs $83,773.77 per death prevented and $40,237.80 per case of ovarian cancer prevented. As both values were well below the willingness-to-pay threshold, unilateral salpingo-oophorectomy is cost-effective and is the preferred strategy. If unilateral salpingo-oophorectomy were chosen over surveillance for premenopausal patients with incidental endometriomas, 1 diagnosis of ovarian cancer would be prevented in every 40 patients and 1 death averted in every 82 patients. We performed 1-way sensitivity analyses for all input variables and determined that there were no reasonable inputs that would alter our conclusions. Unilateral salpingo-oophorectomy is cost-effective and is the preferred strategy compared with surveillance for the management of incidental endometrioma in a premenopausal patient not desiring fertility. It incurs fewer deaths and fewer cases of ovarian cancer with costs below the national willingness-to-pay thresholds.

Microwave Ablation versus Stereotactic Body Radiotherapy for Stage I Non–Small Cell Lung Cancer: A Cost-Effectiveness Analysis

PurposeTo assess the cost effectiveness of microwave ablation (MWA) and stereotactic body radiotherapy (SBRT) for patients with inoperable stage I non–small cell lung cancer (NSCLC). Materials and MethodsA literature search was performed in MEDLINE with broad search clusters. A decision-analytic model was constructed over a 5-year period. The model incorporated treatment-related complications and long-term recurrence. All clinical parameters were derived from the literature with preference to long-term prospective trials. A healthcare payers’ perspective was adopted. Outcomes were measured in quality-adjusted life years (QALYs) extracted from prior studies and U.S. dollars from Medicare reimbursements and prior studies. Base case calculations, probabilistic sensitivity analysis with 10,000 Monte Carlo simulations, and multiple 1- and 2-way sensitivity analyses were performed. ResultsMWA yielded a health benefit of 2.31 QALYs at a cost of $195,331, whereas SBRT yielded a health benefit of 2.33 QALYs at a cost of $225,271. The incremental cost-effectiveness ratio was $1,480,597/QALY, indicating that MWA is the more cost-effective strategy. The conclusion remains unchanged in probabilistic sensitivity analysis with MWA being the optimal cost strategy in 99.84% simulations. One-way sensitivity analyses revealed that MWA remains cost effective when its annual recurrence risk is <18.4% averaged over 5 years, when the SBRT annual recurrence risk is >1.44% averaged over 5 years, or when MWA is at least $7,500 cheaper than SBRT. ConclusionsMWA appears to be more cost effective than SBRT for patients with inoperable stage I NSCLC.

Economic Evaluation of Screening for Polyomavirus Infection in Kidney Transplant Recipients: A Cost-Utility Analysis.

Background:Screening for polyomavirus infection after kidney transplantation is recommended by clinical practice guidelines, but cost-effectiveness of this strategy is uncertain. The aim of this study was to estimate the incremental costs and benefits of routine screening for polyomavirus infection compared with no screening in kidney transplant recipients.Methods:Probabilistic Markov models were constructed to compare the health and economic benefits of routine screening for polyomavirus infection using real-time polymerase chain reaction assay. A series of 1-way and probabilistic sensitivity analyses were conducted to define the most influential variables in the model.Results:Monthly screening for 6 mo followed by 3 monthly screenings until 12 mo after transplant was dominant (lower costs and improved outcomes). Compared with no screening, the incremental benefits of screening were 0.294 life-years saved and 0.232 quality-adjusted life-years saved. Total savings from screening were $6986 Australian dollars ($5057 US dollars). The cost-effectiveness ratios were most sensitive to the costs of transplantation and dialysis, age of transplantation, prevalence of viremia, and probability of death in patients with a history of polyomavirus-associated nephropathy. Probabilistic sensitivity analysis indicated that screening (compared with no screening) was the dominant strategy across all plausible ranges of transition probabilities.Conclusions:Screening for polyomavirus infections 1 year following transplantation appears to save money, improves survival, and improves quality of life in kidney transplant recipients.

Cost-effectiveness of Choosing Wisely guidelines for axillary observation in women older than age 70 years with hormone receptor-positive, clinically node-negative, operable breast tumors.

The Society for Surgical Oncology's Choosing Wisely guidelines recommend against sentinel lymph node biopsy (SLNB) in favor of observation in this population. Recent analyses reveal that this has not been widely adopted. The purpose of this cost-effectiveness analysis is to compare the costs and benefits associated with observation or SLNB in women >70 years old with hormone receptor-positive, clinically node-negative, operable breast cancer. A decision tree with Markov modeling was created to compare treatment strategies using long-term follow-up data from clinical trials in this population. Costs were estimated from published literature and publicly available databases. Breast cancer-specific health-state utilities were derived from the literature and expert opinion. One-way, 2-way, and probabilistic sensitivity analyses were conducted. A structural sensitivity analysis was performed to assess the effect of functional status and anxiety from nonevaluation of the axilla on cost-effectiveness. Costs and benefits, measured in life-years (LYs) and quality-adjusted life-years (QALYs), were tabulated across 10, 15, and 20 years and compared using incremental cost-effectiveness ratios (ICERs). SLNB is not cost-effective from the payer or societal perspectives with ICERs of $138,374/LY and $131,900/LY, respectively. When QALYs were considered, SLNB provided fewer QALYs (SLNB, 10.33 QALYs; observation, 10.53 QALYs) at a higher cost (SLNB, $15,845; observation, $4020). Structural sensitivity analysis revealed that SLNB was cost-effective in certain patients with significant anxiety related to axillary observation (ICER, $39,417/QALY). Routine SLNB in this population is not cost-effective. The cost-effectiveness of SLNB, however, is dependent on individual patient factors, including functional status as well as patient preference.

Dasiglucagon demonstrates reduced costs in the treatment of severe hypoglycemia in a budget impact model.

BACKGROUND: Approximately 7.3 million people with type 1 or type 2 diabetes (T1D/T2D) are treated with insulin, placing them at higher risk of severe hypoglycemia (SH). SH requires assistance of another individual and often necessitates the prompt administration of intravenous glucose, injectable glucagon, or both. Untreated, SH can progress to unconsciousness, seizures, coma, or death. Before 2018, all glucagon rescue treatments required reconstitution. The complexity of reconstitution is often a barrier to successful administration during a severe hypoglycemic event. Studies suggest successful administration of glucagon emergency kits range from 6%-56% of the time. Second-generation glucagon treatments and glucagon analogs do not require reconstitution and have caregiver administration success rates ranging from 94%-100%. Dasiglucagon is a glucagon analog administered via autoinjector or prefilled syringe and has been shown to result in rapid hypoglycemia recovery. Moreover, the autoinjector can be administered successfully 94% of the time by trained caregivers. Previous evaluation of costs in budget impact models (BIMs) demonstrated the potential for second-generation glucagon treatments to reduce the cost of SH events (SHEs). The current model expands on those findings with a treatment pathway and accompanying assumptions reflecting important aspects of real-world SHE treatment. OBJECTIVE: To evaluate the economic impact of dasiglucagon compared with available glucagon treatments for SHE management, considering direct cost of treatment and health care resource utilization. METHODS: A 1-year BIM with a hypothetical US commercial health plan of 1 million lives was developed with a target population of individuals with diabetes at risk of SHE. The treatment pathway model included initial and secondary treatment attempts, treatment administration success and failure, plasma glucose (PG) recovery within 15 minutes, emergency medical services, emergency department (ED) visits, and hospitalizations. A 1-way sensitivity analysis was conducted to assess the sensitivity of the model to changes in parameter values. RESULTS: In a 1 million-covered lives population, it was estimated that 12,006 SHEs would occur annually. The higher rate of initial treatment success and PG recovery within 15 minutes associated with dasiglucagon treatment resulted in lower total health care costs. Total SHE treatment costs with dasiglucagon were estimated at $13.4 million, compared with $16.7 million for injectable native glucagon, $20.7 million for nasal glucagon, $35.3 million for reconstituted glucagon, and $43.8 million for untreated individuals. Compared with untreated people, the number needed to treat (NNT) with dasiglucagon was 6 individuals to avoid 1 hospitalization. NNT for this same comparison was 59 for injectable native glucagon and 27 for nasal glucagon. CONCLUSIONS: Treatment of SH with dasiglucagon decreased total direct medical costs by reducing health care resource utilization (emergency calls, emergency transports, ED visits, and hospitalizations) and accompanying costs associated with the treatment of SH. DISCLOSURES: This research was funded by Zealand Pharma. Bromley, Hinahara, and Goss are employed by Boston Healthcare Associates, Inc., which received funding from Zealand Pharma for development of the health economic model and the manuscript. Kendall and Hammer are employed by Zealand Pharma. Weinzimer has received consulting fees from Zealand Pharma.