Lifetime Quality-adjusted Life Years Research Articles

Cost-effectiveness of professional-mode flash glucose monitoring in general practice among adults with type 2 diabetes: Evidence from the GP-OSMOTIC trial.

To assess the cost-effectiveness of professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice compared with usual clinical care. An economic evaluation was conducted as a component of the GP-OSMOTIC trial, a pragmatic multicentre 12-month randomised controlled trial enrolling 299 adults with type 2 diabetes in Victoria, Australia. The economic evaluation was conducted from an Australian healthcare sector perspective with a lifetime horizon. Health-related quality of life (EQ-5D) and total healthcare costs were compared between the intervention and the usual care group within the trial period. The 'UKPDS Outcomes Model 2' was used to simulate post-trial lifetime costs, life expectancy and quality-adjusted life years (QALYs). No significant difference in health-related quality of life and costs was found between the two groups within the trial period. Professional-mode flash glucose monitoring yielded greater QALYs (0.03 [95% CI: 0.02, 0.04]) and a higher cost (A$3807 [95% CI: 3604, 4007]) compared with usual clinical care using a lifetime horizon under the trial-based monitoring frequency, considered not cost-effective (incremental cost-effectiveness ratio=A$120,228). The intervention becomes cost-effective if sensor price is reduced to lower than 50%, or monitoring frequency is decreased to once per year while maintaining the same treatment effect on HbA1c . Including professional-mode flash glucose monitoring every 3months as part of a management plan for people with type 2 diabetes in general practice is not cost-effective, but could be if the sensor price or monitoring frequency can be reduced.

Cost-Effectiveness Analysis of Camrelizumab Versus Chemotherapy as Second-Line Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Background: This study aimed to analyze the cost effectiveness of camrelizumab in the second-line treatment of advanced or metastatic esophageal squamous cell carcinoma in China. Methods: On the basis of the ESCORT clinical trial, a partitioned survival model was constructed to simulate the patient’s lifetime quality-adjusted life years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER). One-way sensitivity and probability sensitivity analyses were performed to test the stability of the model. Results: Treatment of esophageal squamous cell carcinoma with camrelizumab added 0.36 QALYs and resulted in an incremental cost of $1,439.64 compared with chemotherapy, which had an ICER of $3,999 per QALY gained. The ICER was far lower than the threshold of willingness to pay for one time the GDP per capita in China. Sensitivity analysis revealed that the ICERs were most sensitive to the cost of drugs, but the parameters did not have a major effect on the results of the model. Conclusion: Camrelizumab is likely to be a cost-effective option compared with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma. This informs patient selection and clinical path development.

Abstract 12120: Cost-Effectiveness of Earlier Initiation of Sodium-Glucose Cotransporter 2 Inhibitors in Patients With a History of Heart Failure

Background: Patients with heart failure (HF) are at increased risk after hospitalisations for HF (HHF). Timely initiation of medical therapy may reduce morbidity and mortality in these patients. The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial demonstrated that dapagliflozin reduced the risk of worsening HF and mortality when added to guideline-directed medical therapy (GDMT). Whilst previous economic evaluations have demonstrated that dapagliflozin is cost-effective; timing of initiation has not been considered. Objective: This study assessed whether early addition of dapagliflozin (D+GDMT) was cost-effective compared to a 12-month delay. Methods: A published lifetime Markov model was utilised with health states defined by Kansas City Cardiomyopathy (KCCQ) score, type 2 diabetes status and incidence of HF events. We analysed the DAPA-HF trial to estimate the incidence of HF events using a negative binomial regression model, and parametric survival analysis for all-cause death. Direct healthcare costs (2019 GBP) and utility values were sourced from the published literature and DAPA-HF, respectively. We estimated lifetime costs and quality adjusted life years (QALYs) for early initiation of D+GDMT compared to a 12-month delay. Results: Standard therapy was associated with lifetime costs of £12,641 and 4.11 QALYs. Treatment with D+GDMT with 12 months delay was associated with total discounted lifetime costs and QALYs of £15,966 and 4.71 respectively. Early initiation was associated with lifetime cost and QALYS; £16,518 and 4.78 respectively. Consequently, early initiation was associated with an additional cost of £552 and QALY gains of 0.08 resulting in an incremental cost effectiveness ratio of £8,515. Conclusion: Early or late initiation of D+GDMT is cost-effective. However, earlier initiation is associated with rapid improvement in patient symptoms leading to 10% greater QALY gains at a very attractive ICER.

Cost-effectiveness of anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation in mainland China.

With the high cost, the long-term persistence of new oral anticoagulants (NOACs) was lower than that of warfarin in Chinese patients with non-valvular atrial fibrillation (NVAF) for a long time. The prices of NOACs (apixaban, rivaroxaban and dabigatran) decreased significantly over the past year in mainland China. The objective of this study was to evaluate the cost-effectiveness of NOACs versus warfarin for preventing stroke in patients with NVAF from a Chinese healthcare system perspective. A decision tree and Markov model were used to assess the treatment strategies of four NOACs versus warfarin over a lifetime horizon. For each treatment strategy, the total lifetime cost, quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER) were calculated. The impact of parameter uncertainties on base-case analysis results was evaluated using sensitivity analyses. In the base-case analysis, compared with warfarin, apixaban had a decreased total lifetime cost of USD 389 and rivaroxaban of USD 1482, while low-dose dabigatran had an increased total lifetime cost of USD 925 and high-dose dabigatran of USD 6641, with QALY increasing by 0.53, 1.32, 0.92 and 1.83, respectively. The ICER of low-dose dabigatran versus warfarin was USD 1005 per QALY gain, while those of apixaban (-USD 734 per QALY gain) and rivaroxaban (-USD 1123 per QALY gain) were negative. One-way and probabilistic sensitivity analyses indicated that the base-case results were robust by applying certain varying parameters to the model. These four NOAC (apixaban, rivaroxaban, low-dose dabigatran and high-dose dabigatran) treatment strategies were cost-effective compared with warfarin and recommended as substitutes for warfarin treatment for preventing stroke in patients with NVAF in the healthcare system of China, which might be driven by large drug price reductions in the past year.

Timing of Antenatal Corticosteroids for Optimal Neonatal Outcomes: A Markov Decision Analysis Model

ObjectiveAntenatal corticosteroids (ACSs) are administered to pregnant individuals at high risk of preterm delivery to reduce neonatal morbidity and mortality. ACSs have a limited timeframe of effectiveness, and timing of administration can be difficult because of uncertainty surrounding the likelihood of preterm delivery. The objective of the current study was to design a decision analysis model to optimize the timing of ACS administration and identify important model variables that impact administration timing preference. MethodsWe created a Markov decision analysis model with a base case of a patient at 240 weeks gestation with antepartum hemorrhage. Decision strategies included immediate, delayed, and no ACS administration. Outcomes were based on the neonatal perspective and consisted of lifetime quality adjusted life years (QALYs). Data for model inputs were derived from current literature and clinical recommendations. ResultsOur base case analysis revealed a preferred strategy of delaying ACSs for 2 weeks, which maximized QALYs (39.18 lifetime discounted), driven by reduced neonatal morbidity at the expense of 0.1% more neonatal deaths, when compared with immediate ACS administration. Sensitivity analyses identified that, if the probability of delivery within the next week was >6.19%, then immediate steroids were preferred. Other important variables included gestational age, ACS effectiveness, and ACS adverse effects. ConclusionACS timing involves a trade-off between morbidity and mortality, and optimal timing depends on probability of delivery, gestational age, and risks and benefits of ACSs. Clinicians should carefully consider these factors prior to ACS administration.

Blinatumomab Is Cost-Effective Compared to Standard Chemotherapy for Children with High Risk Relapses of Acute Lymphoblastic Leukemia: A Cost-Effectiveness Analysis Using Population-Based Healthcare Data

▪Introduction: Though cure rates for childhood acute lymphoblastic leukemia (ALL) have improved significantly, outcomes for children with relapsed ALL remain poor. Novel immunotherapies have proved effective in relapsed disease. Blinatumomab, a bispecific T-cell engager targeting CD19, was recently shown to improve disease-free and overall survival among children with high-risk relapsed disease (Brown et al, 2021) prior to proceeding to stem cell transplant. Blinatumomab however also represents a significant cost burden to institutions and healthcare systems. Our objective was thus to determine the cost-effectiveness of blinatumomab vs. standard of care therapy among children with high-risk relapsed ALL.Methods: We used a childhood ALL-specific policy simulation model previously developed using real world clinical, healthcare utilization, and cost population-based data from Ontario, Canada, and restricted it to children with B-lineage ALL who relapsed with 18 months of their original diagnosis to capture a population of patients with high-risk relapse who survived their original month of re-induction chemotherapy. This model was combined with published data from the Children's Oncology Group randomized control study AALL1331 to estimate the long-term survival, healthcare costs and quality adjusted life years associated with two courses of blinatumomab vs. two courses of standard intensive chemotherapy, followed by stem cell transplant. Combining these two sources allowed for the creation of a multi-state survival model and the estimation of the impact of blinatumomab upon relapse and survival. Healthcare costs for the administration of blinatumomab or chemotherapy were sourced from administrative data, provincial formularies, and published sources. Lifetime costs and quality-adjusted life years were calculated while Monte Carlo simulation was used to propagate parameter uncertainty in the cost-effectiveness outcomes. All costs were calculated in Canadian dollars (CAD).Results: Blinatumomab was associated with on average higher life expectancy (43.4 years vs. 36.8 years) and a higher number of quality adjust life years [2.75 QALYs gained, 95 th confidence interval (95CI) -0.44 to 5.99] but higher costs (60,420 CAD, 95CI 26,794 - 94,047) compared to standard intensive chemotherapy. The incremental cost effectiveness ratio (ICER) associated with blinatumomab was 21,970 CAD/QALY gained. However, substantial uncertainty around model parameters resulted in wide confidence intervals around cost-effectiveness outcomes.Discussion: Initial evidence indicates that the use of blinatumomab in high-risk relapse of childhood ALL as compared to standard chemotherapy is associated with a cost-effectiveness ratio that is comparable to or lower than that associated with other interventions recently introduced in pediatric ALL, and represents a cost-effective intervention for this population. However, estimates are based on limited evidence; further research is necessary to better inform several model parameters and thereby decrease uncertainty in cost-effectiveness outcomes. DisclosuresGupta: Jazz Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees.

Cost-Effectiveness of Lipid-Lowering Treatments in Young Adults

BackgroundRaised low-density lipoprotein cholesterol (LDL-C) in young adulthood (aged 18-39 years) is associated with atherosclerotic cardiovascular disease (ASCVD) later in life. Most young adults with elevated LDL-C do not currently receive lipid-lowering treatment. ObjectivesThis study aimed to estimate the prevalence of elevated LDL-C in ASCVD-free U.S. young adults and the cost-effectiveness of lipid-lowering strategies for raised LDL-C in young adulthood compared with standard care. MethodsThe prevalence of raised LDL-C was examined in the U.S. National Health and Nutrition Examination Survey. The CVD Policy Model projected lifetime quality-adjusted life years (QALYs), health care costs, and incremental cost-effectiveness ratios (ICERs) for lipid-lowering strategies. Standard care was statin treatment for adults aged ≥40 years based on LDL-C, ASCVD risk, or diabetes plus young adults with LDL-C ≥190 mg/dL. Lipid lowering incremental to standard care with moderate-intensity statins or intensive lifestyle interventions was simulated starting when young adult LDL-C was either ≥160 mg/dL or ≥130 mg/dL. ResultsApproximately 27% of ASCVD-free young adults have LDL-C of ≥130 mg/dL, and 9% have LDL-C of ≥160 mg/dL. The model projected that young adult lipid lowering with statins or lifestyle interventions would prevent lifetime ASCVD events and increase QALYs compared with standard care. ICERs were US$31,000/QALY for statins in young adult men with LDL-C of ≥130 mg/dL and US$106,000/QALY for statins in young adult women with LDL-C of ≥130 mg/dL. Intensive lifestyle intervention was more costly and less effective than statin therapy. ConclusionsStatin treatment for LDL-C of ≥130 mg/dL is highly cost-effective in young adult men and intermediately cost-effective in young adult women.

Exploring the cost effectiveness of behavioural weight-management interventions based on the expected impact on mechanisms of action: a pre-trial health economic modelling study

BackgroundWhen designing behavioural interventions, it is recommended that the content of the intervention and the mechanisms of action (MoA) targeted are clearly described. Pre-trial health economic modelling is conducted to establish the likelihood of cost-effectiveness on the basis of the expected intervention effect. We aimed to explore the practical feasibility of conducting pre-trial health economic modelling based on the content of the intervention and the expected effect on MoA. MethodsThe School for Public Health Research (SPHR) microsimulation model was adapted to include three MoAs: dietary restraint, habit strength, and autonomous diet self-regulation. The SPHR model simulates individuals' metabolic trajectories, including body-mass index, and risk of health conditions including diabetes and cardiovascular disease. Lifetime costs and quality-adjusted life-years are calculated. In this study, treatment effect was based on demographic factors and change in the psychological MoAs. Pre-trial modelling was investigated by first exploring the feasibility of estimating intervention effect on a MoA on the basis of the behaviour change techniques used and, second, using hypothetical scenarios of small, medium, or large effect sizes on habit strength, dietary restraint, or autonomous self-regulation. FindingsEstimating change in a MoA on the basis of a behaviour change technique was restricted by the absence of quantitative evidence linking behaviour change techniques to MoA in the literature. Pre-trial modelling of 9 hypothetical interventions in which there were small, medium, and large effect size changes in of each of the MoA resulted in mean cost savings ranging from £425·89 (95% CI 98·34–892·01) for a small effect on autonomous motivation to £1700·27 (879·67–2812·13) for a large effect on habit strength. InterpretationPre-trial modelling based on changes in habit strength, dietary restraint, and autonomous diet self-regulation can be useful and has the potential to inform the design of cost-effective interventions, including the behaviour change techniques included and factors that affect budgeting. One limitation of this study is the absence of data on the impact of interventions on MoAs. Hypothetical intervention effect sizes were used, which might not reflect achievable intervention scenarios and the effect of potential interventions on inequalities was not explored. More research on the relationships between behaviour change techniques, MoAs, and outcomes is needed to support pre-trial modelling. FundingWellcome Trust.

Cost-Effectiveness Evaluation of Add-on Empagliflozin in Patients With Heart Failure and a Reduced Ejection Fraction From the Healthcare System's Perspective in the Asia-Pacific Region.

Background: EMPEROR-Reduced trial provides promising evidence on the efficacy of empagliflozin adding to the standard treatment in patients with heart failure and reduced ejection fraction (HFrEF). This study aimed to investigate the cost-effectiveness of add-on empagliflozin vs. standard therapy alone in HFrEF from the perspective of the Asia-Pacific healthcare systems.Methods: A Markov model was constructed to simulate HFrEF patients and to project the lifetime direct medical costs and quality-adjusted life years (QALY) of both therapies. Transitional probabilities were derived from the EMPEROR-Reduced trial. Country-specific costs and utilities were extracted from published resources. Incremental cost-effectiveness ratio (ICER) against willingness to pay (WTP) threshold was used to examine the cost-effectiveness. A series of sensitivity analyses was performed to ensure the robustness of the results.Results: The ICERs of add-on empagliflozin vs. standard therapy alone in HFrEF were US$20,508, US$24,046, US$8,846, US$53,791, US$21,543, and US$20,982 per QALY gained in Taiwan, Japan, South Korea, Singapore, Thailand, and Australia, respectively. Across these countries, the probabilities of being cost-effective for using add-on empagliflozin under the WTP threshold of 3-times country-specific gross domestic product per capita were 93.7% in Taiwan, 95.6% in Japan, 96.3% in South Korea, 94.2% Singapore, 51.9% in Thailand, and 95.9% in Australia. The probabilities were reduced when shortening the time horizon, assuming the same cardiovascular mortality for both treatments, and setting lower WTP thresholds.Conclusion: Adding empagliflozin to HFrEF treatment is expected to be a cost-effective option among the Asia-Pacific countries. The cost-effectiveness is influenced by the WTP thresholds of different countries.

Cost-Effectiveness of iGlarLixi in People with Type 2 Diabetes Mellitus Suboptimally Controlled on Basal Insulin Plus Metformin in the UK.

IntroductionA cost-effectiveness analysis was conducted comparing a fixed-ratio combination (FRC) of insulin glargine 100 units/mL plus lixisenatide (iGlarLixi) versus the FRC of insulin degludec plus liraglutide (iDegLira) and the free-combination comparators insulin glargine plus dulaglutide (iGlar plus Dula) and basal insulin plus liraglutide (BI plus Lira).MethodsThe IQVIA Core Diabetes Model was used to estimate lifetime costs and outcomes for a cohort of patients with type 2 diabetes mellitus (T2DM) from the UK healthcare perspective. Initial clinical data for iGlarLixi were based on the randomized, controlled LixiLan-L trial and the relative treatment effects for comparators were based on an indirect treatment comparison using data from the AWARD-9 (iGlar plus Dula), LIRA ADD2 BASAL (BI plus Lira), and DUAL V (iDegLira) trials. Costs were derived from publicly available sources. Lifetime costs (in British Pound Sterling [£]) and quality-adjusted life-years (QALYs) were predicted; net monetary benefit (NMB) for iGlarLixi versus comparators was derived using a willingness-to-pay threshold of £20,000. Extensive scenario and sensitivity analyses were conducted.ResultsEstimated costs were lowest with iGlarLixi (£31,295) compared with iGlar plus Dula (£38,790), iDegLira (£40,179), and BI plus Lira (£42,467). Total QALYs gained were identical with iGlarLixi and iDegLira (8.438), and comparable with iGlar plus Dula (8.439) and BI plus Lira (8.466). NMB for iGlarLixi was positive versus all comparators (£10,603.86 vs. BI plus Lira; £7,466.24 vs. iGlar plus Dula; £8.874.11 vs. iDegLira).ConclusionIn patients with T2DM with suboptimal glycemic control on basal insulin, iGlarLixi provides very similar outcomes and substantial cost savings, compared with other fixed and free combinations of insulins plus glucagon-like peptide-1 receptor agonists.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01159-y.

A Solution to Poorly Tolerated Lower Limb Amputations: Osseointegrated Prostheses Prove Cost-effective in the United States

PURPOSE: This study is the first cost–benefit analysis of osseointegrated implant (OI) prostheses compared with socket-suspended (SS) prostheses for lower limb amputees in the United States. The use of traditional SS prostheses for patients with transfemoral and transtibial amputations can be complicated by issues like poor fit, tissue damage, and pain at the socket-limb interface. These complications often require management by plastic surgeons. Osseointegration provides an alternative solution by anchoring the prosthesis directly to an implant in the user’s residual limb; this procedure involves both orthopedic and plastic surgery teams. The operation, materials, and maintenance associated with osseointegration can be expensive, but patient-reported data suggest that OI leads to better quality of life in patients who are dissatisfied with their SS prosthesis. METHODS: We used a Monte Carlo model to project costs and lifetime quality-adjusted life years (QALYs) for patients with OI and SS prostheses. Simulation parameters for the base-case scenario were derived from a cohort of 25 patients who underwent osseointegrated implantation following unilateral lower limb amputations at our institution between October 2017 and February 2020. An IRB-approved retrospective chart review was performed on each patient. CPT codes, material costs, length of surgery, and length of inpatient stay were collected for all encounters related to the amputation site. Utilities and SS prosthesis costs were derived from the literature. We calculated and compared incremental cost-effectiveness ratios (ICERs) for OI and SS prostheses. Parameters were varied individually in one-way sensitivity analyses to evaluate the sensitivity of the results to plausible variations in model inputs. RESULTS: Our patients had an average age of 49.6 years at implantation and were followed for 17 months on overage. In total, 84% of patients had traumatic amputations. We found the average cost of osseointegration surgery to be $54,503. An estimated 20% of patients required a pre-implantation residual limb revision surgery, averaging $49,191. Maintenance of a healthy OI prosthesis cost on average $2626 per year. Complication rates per year and average costs were as follows: soft tissue infection (29%, $435), bone/implant infection (11%, $11,721), painful neuroma (14%, $14,659), and mechanical failure (17%, $46,513). In the base-case scenario, the ICER of OI prostheses compared with SS prostheses was $44,660. A cost effectiveness acceptability curve showed that OI was favored over SS in 71% of cases at a willingness-to-pay of $50,000 per QALY. In one-way sensitivity analyses, the ICER was most sensitive to the mechanical failure rate, mechanical failure cost, and alternative yearly SS prosthesis cost. CONCLUSIONS: Our model suggests that osseointegrated implantation can provide a higher quality of life at affordable costs when compared with poorly tolerated SS prostheses in patients with lower limb amputations in the United States. Intraoperative reconstruction and postoperative management by a plastic surgeon is essential to minimize complications and thus improve cost-effectiveness and patient satisfaction. More follow-up must be done to understand the long-term benefits and risks of OI-based prostheses.

Cost-effectiveness evaluation of add-on dapagliflozin for heart failure with reduced ejection fraction from perspective of healthcare systems in Asia\u2013Pacific region

BackgroundWith emerging evidence on the efficacy of adding dapagliflozin to standard care for patients with heart failure with reduced ejection fraction (HFrEF), this study assessed the cost-effectiveness of add-on dapagliflozin to standard care versus standard care alone for HFrEF from the perspective of healthcare systems in the Asia–Pacific region.MethodsA Markov model was applied to project the outcomes of treatment in terms of lifetime medical cost and quality-adjusted life-years. The transition probabilities between health states in the model were obtained from the Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction trial. Country-specific costs and utilities were extracted for modeling. The incremental cost-effectiveness ratio against a country-specific willingness-to-pay threshold was applied to determine the cost-effectiveness of treatment. A series of sensitivity analyses were performed to ensure the robustness of the study results. Costs are presented in 2020 United States dollars.ResultsThe incremental cost-effectiveness ratios for add-on dapagliflozin versus standard care alone were $5277, $9980, $12,305, $16,705, and $23,227 per quality-adjusted life-year gained in Korea, Australia, Taiwan, Japan, and Singapore, respectively. When using add-on dapagliflozin to standard care versus standard care alone, ~ 100% of simulations were cost-effective at a willingness-to-pay threshold of one gross domestic product per capita of the given Asia–Pacific country; however, the probability of being cost-effective for using add-on dapagliflozin decreased when the time horizon for simulation was restricted to 18 months and when the cardiovascular mortality for the two treatments (43.8% and 33.0%, respectively) was assumed to be the same. The cost-effectiveness results were most sensitive to cardiovascular mortality of treatment.ConclusionsAdding dapagliflozin to standard care is cost-effective for HFrEF in healthcare systems in the Asia–Pacific region, which supports the rational use of dapagliflozin for HFrEF in this region.

Diagnosing newborns with suspected mitochondrial disorders: an economic evaluation comparing early exome sequencing to current typical care

PurposeTo determine the value of early exome sequencing (eES) relative to the current typical care (TC) in the diagnosis of newborns with suspected severe mitochondrial disorders (MitD). MethodsWe used a decision tree–Markov hybrid to model neonatal intensive care unit (NICU)–related outcomes and costs, lifetime costs and quality-adjusted life-years among patients with MitD. Probabilities, costs, and utilities were populated using published literature, expert opinion, and the Pediatric Health Information System database. Incremental cost-effectiveness ratios (ICER) and net monetary benefits (NMB) were calculated from lifetime costs and quality-adjusted life-years for singleton and trio eES, and TC. Robustness was assessed using univariate and probabilistic sensitivity analyses (PSA). Scenario analyses were also conducted. ResultsFindings indicate trio eES is a cost-minimizing and cost-effective alternative to current TC. Diagnostic probabilities and NICU length-of-stay were the most sensitive model parameters. Base case analysis demonstrates trio eES has the highest incremental NMB, and PSA demonstrates trio eES had the highest likelihood of being cost-effective at a willingness-to-pay (WTP) of $200,000 relative to TC, singleton eES, and no ES. ConclusionTrio and singleton eES are cost-effective and cost-minimizing alternatives to current TC in diagnosing newborns suspected of having a severe MitD.

Estimation of Lifetime QALYs Based on Lifestyle Behaviors.

Various lifestyle behaviors have been known to affect health-related quality of life (HRQL) and life expectancy. However, the impact on quality-adjusted life years (QALYs), which can be used for health economics, has not been clarified. The purpose of this study was to estimate the impact of lifestyle behaviors on lifetime QALYs. We first examined the relationship between lifestyle behaviors and HRQL as measured by the EQ-5D-5L among 4000 participants via a web-based survey. The results of multiple regression analysis showed that physical activity and sleep were significantly related to HRQL. Therefore, we used microsimulation to estimate QALYs from physical activity and sleep, which were determined to be significant in the regression analysis. The results showed that there was a difference of 3.6 QALYs between the recommended lifestyle scenario (23.4 QALYs; 95%CI 3.6 to 35.1) and the non-recommended lifestyle scenario (19.8 QALYs; 95%CI 3.1 to 31.6). This difference was greater in the younger age group than in the older age group. The results also indicated a large difference in QALYs between physical activity and sleep. These findings may provide a significant suggestion for future health promotion measures.

Cost-effectiveness and system-wide impact of using Hepatitis C-viremic donors for heart transplant

The advent of direct-acting antiviral therapy for Hepatitis C (HCV) has made using HCV-viremic donors a viable strategy to address the donor shortage in heart transplantation. We employed a large-scale simulation to evaluate the impact and cost-effectiveness of using HCV-viremic donors for heart transplant. We simulated detailed histories from time of listing until death for the real-world cohort of all adults listed for heart transplant in the United States from July 2014 to June 2019 (n=19,346). This population was imputed using historical data and captures "real-world" heterogeneity in geographic and clinical characteristics. We estimated the impact of an intervention in which all candidates accept HCV+ potential donors (n=472) on transplant volume, waitlist outcomes, and lifetime costs and quality-adjusted life years (QALYs). The intervention produced 232 more transplants, 132 fewer delistings due to deterioration, and 50 fewer waitlist deaths within this 5-year cohort and reduced wait times by 3% to 11% (varying by priority status). The intervention was cost-effective, adding an average of 0.08 QALYs per patient at a cost of $124 million ($81,892 per QALY). DAA therapy and HCV care combined account for 11% this cost, with the remainder due to higher costs of transplant procedures and routine post-transplant care. The impact on transplant volume varied by blood type and region and was correlated with donor-to-candidate ratio (ρ=0.71). Transplanting HCV+ donor hearts is likely to be cost-effective and improve waitlist outcomes, particularly in regions and subgroups experiencing high donor scarcity.

Cost-effectiveness of combination antiviral treatment with extended duration for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B in China.

BackgroundHepatitis B surface antigen clearance or seroconversion is rarely achieved for patients using nucleoside analogs or pegylated interferon alpha monotherapy approaches. Several recent studies have confirmed the benefit of a combination of these two approaches for selected chronic hepatitis B patients. However, few reports have investigated long-term outcomes or health economic evaluation for hepatitis B surface antigen clearance. The aim of this study was to perform a cost-effectiveness analysis of the long-term use of this combination strategy among selected hepatitis B e antigen-negative patients.MethodsDrawing on experience in China, we used a Markov model to simulate disease progression among a population of hepatitis B e antigen-negative chronic hepatitis B patients with surface antigen levels of ≤1,000 IU/mL through a discrete series of health states. We compared nucleoside analog monotherapy to the combination strategy over a prolonged period. We measured lifetime costs, quality-adjusted life-years and incremental cost-effectiveness ratios.ResultsThe combination therapy produced 15.8 quality-adjusted life-years, and cost US dollars (USD) 45,032 per patient. The monotherapy gave 13.9 quality-adjusted life-years, and had a cost of USD 52,064. The incremental cost-effectiveness ratio of the monotherapy (USD −3,755 per quality-adjusted life-year) did not obtain extended dominance over combination therapy. The most cost-effective option was combination therapy among patients with hepatitis B surface antigen levels of ≤10 IU/mL, which had the lowest calculated cost of USD 35,318 and most quality-adjusted life-years (16.7).ConclusionsA long-term combination treatment strategy for selected hepatitis B e antigen-negative chronic hepatitis B patients may prolong quality-adjusted life-years compared with nucleoside analog monotherapy. Chronic hepatitis B patients with a hepatitis B surface antigen level of ≤10 IU/mL were the most cost-effective population under this strategy.

Cost Effectiveness of a Cultural Physical Activity Intervention to Reduce Blood Pressure Among Native Hawaiians with Hypertension.

ObjectiveThe aim of this study was to calculate the costs and assess whether a culturally grounded physical activity intervention offered through community-based organizations is cost effective in reducing blood pressure among Native Hawaiian adults with hypertension.MethodsSix community-based organizations in Hawai‘i completed a randomized controlled trial between 2015 and 2019. Overall, 263 Native Hawaiian adults with uncontrolled hypertension (≥ 140 mmHg systolic, ≥ 90 mmHg diastolic) were randomized to either a 12-month intervention group of hula (traditional Hawaiian dance) lessons and self-regulation classes, or to an education-only waitlist control group. The primary outcome was change in systolic blood pressure collected at baseline and 3, 6, and 12 months for the intervention compared with the control group. Incremental cost-effectiveness ratios (ICERs) were calculated for primary and secondary outcomes. Non-parametric bootstrapping and sensitivity analyses evaluated uncertainty in parameters and outcomes.ResultsThe mean intervention cost was US$361/person, and the 6-month ICER was US$103/mmHg reduction in systolic blood pressure and US$95/mmHg in diastolic blood pressure. At 12 months, the intervention group maintained reductions in blood pressure, which exceeded reductions for usual care based on blood pressure outcomes. The change in blood pressure at 12 months resulted in ICERs of US$100/mmHg reduction in systolic blood pressure and US$93/mmHg in diastolic blood pressure. Sensitivity analyses suggested that at the estimated intervention cost, the probability that the program would lower systolic blood pressure by 5 mmHg was 67 and 2.5% at 6 and 12 months, respectively.ConclusionThe 6-month Ola Hou program may be cost effective for low-resource community-based organizations. Maintenance of blood pressure reductions at 6 and 12 months in the intervention group contributed to potential cost effectiveness. Future studies should further evaluate the cost effectiveness of indigenous physical activity programs in similar settings and by modeling lifetime costs and quality-adjusted life-years.Trial Registration NumberNCT02620709.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-021-00291-6.

A semi‐Markov model comparing the lifetime cost‐effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer

Parastomal hernia (PSH) is a common problem following colostomy. Using prophylactic mesh during end colostomy creation may reduce PSH incidence, but concerns exist regarding the optimal type of mesh, potential long-term complications, and cost-effectiveness of its use. We evaluated the cost-effectiveness of mesh prophylaxis to prevent PSH in patients undergoing end colostomy creation for rectal cancer. We developed a decision-analytical model, stratified by rectal cancer stages I-IV, to estimate the lifetime costs, quality-adjusted life-years (QALYs) and net monetary benefits (NMBs) of synthetic, biologic and no mesh from a UK NHS perspective. We pooled the mesh-related relative risks of PSH from 13 randomised controlled trials (RCTs) and superimposed these on the baseline (no mesh) risk from a population-based cohort. Uncertainty was assessed in sensitivity analyses. Synthetic mesh was less costly and more effective than biologic and no mesh to prevent PSH for all rectal cancer stages. At the willingness-to-pay threshold of £20,000/QALY, the incremental NMBs (95% CI) ranged between £1,706 (£1,692 to £1,720) (stage I) and £684 (£678 to £690) (stage IV) for synthetic versus no mesh, and £2,038 (£1,997 to £2,079) (stage I) and £1,671 (£1,653 to £1,689) (stage IV) for synthetic versus biologic mesh. Synthetic mesh was more cost-effective than no mesh unless the relative risk of PSH was ≥0.95 for stages I-III and ≥0.93 for stage IV. [Correction added on 05 October 2021 after first online publication: The estimation of health outcomes (QALYs) for all three interventions evaluated (synthetic mesh; biologic mesh; no mesh) have been corrected in this version.] CONCLUSIONS: Synthetic mesh was the most cost-effective strategy to prevent the formation of PSH in patients after end colostomy for any rectal cancer stage; however, conclusions are dependent on which subset of RCTs are considered to provide the most robust evidence.

210. Cost-utility analysis of bracing vs observation for adolescent idiopathic scoliosis

<h3>BACKGROUND CONTEXT</h3> High quality evidence has shown that bracing can prevent radiographic progression of spinal curvature in skeletally immature adolescent idiopathic scoliosis (AIS) patients with curves between 25° -45°. Despite popular use, the cost-utility of bracing has not been established. <h3>PURPOSE</h3> This study aimed to determine the cost-utility of bracing in AIS. <h3>STUDY DESIGN/SETTING</h3> Cost-utility analysis. <h3>PATIENT SAMPLE</h3> Hypothetical cohort of skeletally immature (Risser 1) AIS patient with a 35° right main thoracic curve. <h3>OUTCOME MEASURES</h3> Incremental cost utility ratio (ICUR) and incremental net monetary benefit were calculated. <h3>METHODS</h3> A decision-analysis model comparing bracing vs observation was developed for a hypothetical skeletally immature AIS patients. We estimated the probability, cost, and quality-adjusted life years (QALY) for each event based on comprehensive review of the AIS literature. Costs were adjusted for inflation based on Consumer Price Index and reported in terms of 2020 real dollars. QALYs were discounted at 3%. Incremental net monetary benefit (INMB) was calculated based on a probabilistic sensitivity analysis using Monte Carlo simulations of 1,000 hypothetical patients. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates. <h3>RESULTS</h3> Our decision-analysis model revealed that bracing was the dominant treatment choice over observation at $50,000/QALY willingness to pay threshold. The net lifetime costs were $57,908 ± $5,443 with bracing and $79,079 ± $4,281 with observation. The net lifetime QALYs were 24.1 ± 1.9 with bracing and 23.8 ± 1.8 with observation. Bracing was favored in 99.6% of the simulations with a median INMB of $32,854 (95% CI, $13,695 to $45,689). The model was most sensitive to the impact of bracing vs observation on the probability of requiring surgical treatment as an adolescent or adult spinal deformity treatment later in life. <h3>CONCLUSIONS</h3> Cost-utility analysis demonstrates that bracing for AIS is dominant over observation, with a positive INMB. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Cost-utility Analysis Comparing Bracing Versus Observation for Skeletally Immature Patients with Thoracic Scoliosis.

Cost-utility analysis. This study aimed to investigate the cost-utility of bracing versus observation in patients with thoracic scoliosis who would be indicated for bracing. There is high-quality evidence that bracing can prevent radiographic progression of spinal curvature in adolescent idiopathic scoliosis (AIS) patients with curves between 25° and 40° and Risser 0 to 2 skeletal maturity index. However, to our knowledge, the cost-utility of bracing in AIS has not been established. A decision-analysis model comparing bracing versus observation was developed for a hypothetical 10-year old girl (Risser 0, Sanders 3) with a 35° main thoracic curve. We estimated the probability, cost, and quality-adjusted life years (QALY) for each node based on comprehensive review of the literature. Costs were adjusted for inflation based on Consumer Price Index and reported in terms of 2020 real dollars. Incremental net monetary benefit (INMB) was calculated based on a probabilistic sensitivity analysis using Monte Carlo simulations of 1000 hypothetical patients. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates. Our decision-analysis model revealed that bracing was the dominant treatment choice over observation at $50,000/QALY willingness to pay threshold. In simulation analysis of a hypothetical patient cohort, bracing was associated with lower net lifetime costs ($60,377 ± $5,340 with bracing vs. $85,279 ± $4543 with observation) and higher net lifetime QALYs (24.1 ± 2.0 with bracing vs. 23.9 ± 1.8 with observation). Bracing was associated with an INMB of $36,093 (95% confidence interval $18,894-$55,963) over observation over the patient's lifetime. The model was most sensitive to the impact of bracing versus observation on altering the probability of requiring surgery, either as an adolescent or an adult. Cost-utility analysis supports scoliosis bracing as the preferred choice in management of appropriately indicated AIS patients with thoracic scoliosis.Level of Evidence: 5.