Quality-adjusted Life Year Gain Research Articles

IMMEDIATE WEIGHT BEARING FOLLOWING ANKLE FRACTURE FIXATION IS LESS COSTLY AND MORE EFFECTIVE THAN NON-WEIGHT BEARING: INWN TRIAL RESULT

Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility.IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm.We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime.IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation.

Cost-Effectiveness of Bariatric Surgery in Tunisia.

Obesity is a growing global issue with evidence linking it to an increase in loss of disease-free years, reduced quality of life, increased mortality, and additional economic burden. This study sought to establish the cost-effectiveness of gastric bypass and sleeve gastrectomy, compared to conventional therapy in patients with obesity, from a Tunisian healthcare payor perspective. A Markov model compared lifetime costs and outcomes of bariatric surgery with conventional treatment among patients with body mass index (BMI) ≥ 40 kg/m2, BMI ≥ 35 kg/m2 with obesity-related co-morbidities (Group 1), or BMI ≥ 35 kg/m2 with type 2 diabetes mellitus (T2DM) (Group 2). Inputs were sourced from the Tunisian Health Examination Survey, local clinician data and literature sources. Health states were associated with different cost and utility decrements. Changes in body mass index, systolic blood pressure, lipid ratio and diabetes remission rates were modelled on a yearly basis. The incremental cost-effectiveness ratio (ICER), quality-adjusted life years (QALYs) and net monetary benefit (NMB) were key outcomes. Sensitivity and scenario analyses were performed to test the model's robustness. The model showed that the benefits of bariatric surgery were favorable compared to conventional treatment, with an ICER of 1844 TND/QALY in Group 1 patients and 2413 TND/QALY in Group 2 patients. Bariatric surgery resulted in a QALY gain of 3.26 per patient in Group 1 and a gain of 1.77 per patient in Group 2. At a willingness to pay threshold of 31,379 TND/QALY, the incremental NMB was 96,251 TND and 51,123 TND for Group 1 and Group 2, respectively. From the Tunisian healthcare payor perspective, bariatric surgery is cost-effective for patients with obesity and those with T2DM and obesity-related comorbidities. These findings may have impact on future decision-making on funding and reimbursement of bariatric surgery in Tunisia.

Cost Effectiveness of CDK4/6 Inhibitors in the First-Line Treatment of HR+/HER2- Metastatic Breast Cancer in Postmenopausal Women in the USA.

Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors improve progression-free survival when combined with endocrine therapies in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. However, the comparative cost effectiveness of utilizing three US Food and Drug Administration-approved CDK4/6 inhibitors is unknown. Therefore, we aimed to evaluate the cost effectiveness of individual CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) with letrozole versus letrozole monotherapy in the first-line treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in the USA. We constructed a Markov-based decision-analytic model to evaluate the cost effectiveness of CDK4/6 inhibitors plus endocrine therapies over a 40-year lifetime from a third-party payer perspective. The model incorporated health states (progression-free disease, progressive disease, and death), major adverse events (neutropenia), and cancer-specific and all-cause mortality. Using clinical efficacy and quality-of-life scores (utility) data from clinical trials, we estimated quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios using Medicare charges reported in US dollars per 2022 valuation and a discount rate of 3% applied to costs and outcomes. We performed deterministic and probabilistic sensitivity analyses to evaluate parametric and decision uncertainty. Compared to letrozole, the model estimated an increase of 5.72, 5.87, and 6.39 in QALYs and costs of $799,178, $788,168, and $741,102 in combining palbociclib, ribociclib, and abemaciclib plus letrozole, respectively. Palbociclib or ribociclib plus letrozole were dominated by abemaciclib plus letrozole. Compared with letrozole, abemaciclib plus letrozole resulted in an incremental cost-effectiveness ratio of $457,538 per QALY with an incremental cost of $553,621 and an incremental QALY gain of 1.21. The results were sensitive to the cost of abemaciclib, disease progression utility, and patients' age. At a willingness to pay of $100,000/QALY gained, our model predicts that combining CDK4/6 inhibitors plus letrozole is not cost effective with a marginal increase in QALYs at a high cost. Lowering the cost of these drugs or identifying patients who can receive maximal benefit from CDK4/6 inhibitors would improve the value of this regimen in patients.

Cost-Effectiveness of Brentuximab Vedotin Versus Physician's Choice of Methotrexate or Bexarotene for the Treatment of Cutaneous T-cell Lymphoma in Canada.

Brentuximab vedotin versus physician's choice of methotrexate (MTX) or bexarotene (BEX) significantly improved progression-free survival (PFS) (median PFS, 16.7 vs. 3.5months) and delayed time to subsequent treatment (8.4 vs. 3.7months), with similar overall survival in patients with CD30-expressing mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL), two types of cutaneous T-cell lymphomas. We assessed the cost-effectiveness of brentuximab vedotin versus MTX or BEX from a Canadian healthcare payer perspective in the indicated population. A 5-state partitioned survival model [pre-progression, non-stem cell transplant (SCT) post-progression, SCT, SCT relapse, death] with a weekly cycle length and 45-year lifetime horizon has been developed. Health-state occupancies, utility estimates, and treatment duration were informed by ALCANZA. Other inputs and costs came from the literature or clinician experts. Scenario analyses varied key parameters and tested assumptions. Brentuximab vedotin versus MTX or BEX was cost-effective; the incremental cost-effectiveness ratio was CAN$43,790 per quality-adjusted life year (QALY) gained. Brentuximab vedotin was more effective (incremental life years: 0.15; QALYs: 0.25) and total treatment costs were slightly higher (incremental costs: $11,105) than MTX or BEX. Key model drivers included end-stage care duration, SCT eligibility, and brentuximab vedotin retreatment rates. Brentuximab vedotin compared with MTX or BEX was cost-effective for CD30-expressing MF and pcALCL. Brentuximab vedotin's higher drug costs versus MTX or BEX were offset by decreased post-progression and end-stage management costs, and showed a 0.25 QALY gain versus MTX or BEX, and increased the proportion of patients eligible for potentially curative SCT.

Risk-Stratified Screening for Colorectal Cancer Using Genetic and Environmental Risk Factors: A Cost-Effectiveness Analysis Based on Real-World Data

Previous studies on the cost-effectiveness of personalized colorectal cancer (CRC) screening were based on hypothetical performance of CRC risk prediction and did not consider the association with competing causes of death. In this study, we estimated the cost-effectiveness of risk-stratified screening using real-world data for CRC risk and competing causes of death. Risk predictions for CRC and competing causes of death from a large community-based cohort were used to stratify individuals into risk groups. A microsimulation model was used to optimize colonoscopy screening for each risk group by varying the start age (40-60 years), end age (70-85 years), and screening interval (5-15 years). The outcomes included personalized screening ages and intervals and cost-effectiveness compared with uniform colonoscopy screening (ages 45-75, every 10 years). Key assumptions were varied in sensitivity analyses. Risk-stratified screening resulted in substantially different screening recommendations, ranging from a one-time colonoscopy at age 60 for low-risk individuals to a colonoscopy every 5 years from ages 40 to 85 for high-risk individuals. Nevertheless, on a population level, risk-stratified screening would increase net quality-adjusted life years gained (QALYG) by only 0.7% at equal costs to uniform screening or reduce average costs by 1.2% for equal QALYG. The benefit of risk-stratified screening improved when it was assumed to increase participation or costs less per genetic test. Personalized screening for CRC, accounting for competing causes of death risk, could result in highly tailored individual screening programs. However, average improvements across the population in QALYG and cost-effectiveness compared with uniform screening are small.

Cost-effectiveness analysis of vaccination against COVID-19 in China.

Since September 2020, Chinese populations aged > 3 years have been encouraged to receive a two-dose inoculation with vaccines against coronavirus disease 2019 (COVID-19). This study aims to evaluate the cost-effectiveness of the current vaccination strategy amongst the general population in mainland China from a societal perspective. In this study, we construct a decision tree with Markov models to compare the economic and health consequences of the current vaccination strategy versus a no-vaccination scenario, over a time horizon of one year and an annual discount rate of 5%. Transition probabilities, health utilities, healthcare costs, and productivity losses are estimated from literature. Outcome measures include infection rates, death rates, quality-adjusted life years (QALYs), and costs. The incremental cost-effectiveness ratio (ICER) is then calculated to evaluate the cost-effectiveness of the current vaccination strategy, and both one-way deterministic sensitivity analysis and probabilistic sensitivity analysis (PSA) are applied to assess the impact of uncertainties on results. Our simulation indicates that compared with a no-vaccination scenario, vaccination amongst the general population in mainland China would reduce the infection rate from 100% to 45.3% and decrease the death rate from 6.8% to 3.1%. Consequently, the strategy will lead to a saving of 37,664.77 CNY (US$5,256.70) and a gain of 0.50 QALYs per person per year on average (lifetime QALY and productivity loss due to immature death are included). The cost-saving for each QALY gain is 74,895.69 CNY (US$10,452.85). Result of the PSA indicates that vaccination is the dominating strategy with a probability of 97.9%, and the strategy is cost-effective with a probability of 98.5% when the willingness-to-pay (WTP) is 72,000 CNY (US$10,048.71) per QALY. Compared with a no-vaccination scenario, vaccination among the general population in mainland China is the dominating strategy from a societal perspective. The conclusion is considered robust in the sensitivity analyses.

Effect of workers' compensation status on pain, disability, quality of life, and return to work after lumbar spine surgery: a 1-year propensity-matched analysis.

Workers' compensation (WC) and litigation have been shown to adversely impact prognoses in a vast range of health conditions. Low-back pain is currently the most frequent reason for WC claims. The objective of this study was to conduct the largest propensity-matched comparison of outcomes between patients with WC and non-WC status who underwent lumbar spinal decompression with and without fusion. Complete data sets for patients who underwent 1- to 4-level lumbar spinal fusion or decompression alone were retrospectively retrieved from the Quality Outcomes Database (QOD), which included 1-year patient-reported outcomes from more than 200 hospital systems collected from 2012 to 2021. Population demographics, perioperative safety, facility utilization, patient satisfaction, disability, pain, EQ-5D quality of life, and return to work (RTW) rates were compared between cohorts for both subgroups. Statistical significance was set at p < 0.05. There were 29,652 patients included in the study. Laminectomy was performed in 16,939 with non-WC status and in 615 with WC, whereas fusion was performed in 11,767 with non-WC status and in 331 with WC. WC patients were more frequently male, a minority race, younger, less educated, more frequently a smoker, had a healthier American Society of Anesthesiologists grade, and with greater baseline visual analog scale (VAS) and Oswestry Disability Index (ODI) scores (p < 0.001). One-year postoperative improvements in VAS, ODI, quality-adjusted life years (QALYs), RTW rates, and satisfaction were all significantly worse for WC versus non-WC patients for both procedures. After adjusting for baseline differences via propensity matching, WC versus non-WC patients continued to demonstrate worse 3- and 12-month VAS and ODI scores, reduced 12-month QALY gain, and delayed RTW after both procedure types. WC status was associated with significantly greater residual disability and pain postoperatively, a lower quality of life, and delayed RTW. Utilizing resources to identify the negative influences on outcomes for WC patients may be valuable in preoperative optimization and could yield better outcomes in these patients.

Cost-Effectiveness of Robot-Assisted Total Knee Arthroplasty: A Markov Decision Analysis

BackgroundRobot-assisted total knee arthroplasty (rTKA) may improve clinical outcomes for patients who have end-stage osteoarthritis of the knee. However, the costs of rTKA are high, and there is a paucity of data evaluating the cost-effectiveness of rTKA. We aimed to analyze the cost per quality-adjusted life-year (QALY) of rTKA relative to manual TKA. MethodsA Markov decision analysis was performed using known parameters for costs, outcomes, implant survivorships, and mortalities. The cost-effectiveness of rTKA relative to manual TKA was assessed for end-stage knee osteoarthritis patients who had a mean age of 65 years (range, 27 to 94 years). The rTKA costs were calculated for a pay-per-use contract robot. ResultsUsing the Markov Model with an annual case volume of 500 patients and a mean age of 65 years, the overall health gain per patient was 13.34 QALYs after rTKA and 13.31 QALYs after manual TKA. This resulted in an overall gain in QALYs of 0.03 for each patient undergoing an rTKA compared with manual TKA and an incremental cost of $128,526 Singapore Dollars per QALY. ConclusionRobotic TKA is not a cost-effective alternative to conventional TKA using a pay-per-use contract robot.

Cost-effectiveness of immediate initiation of dapagliflozin in patients with a history of heart failure.

To compare the cost-effectiveness of immediate and 12-month delayed initiation of dapagliflozin treatment in patients with a history of hospitalization for heart failure (HHF) from the UK, Canadian, German, and Spanish healthcare perspectives. A cost-utility analysis was conducted using a decision-analytic Markov model with health states defined by Kansas City Cardiomyopathy Questionnaire scores, type 2 diabetes mellitus status and incidence of heart failure (HF) events. Patient-level data for patients with prior HHF from the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial were used to inform the model inputs on clinical events and utility values. Healthcare costs were sourced from the relevant national reference databases and the published literature. Compared to standard therapy, immediate initiation of dapagliflozin decreased HHF (187 events), urgent HF visits (32 events) and cardiovascular mortality (18 events). Standard therapy was associated with lifetime costs of £13 224 and 4.02 quality-adjusted life years (QALYs). Twelve-month delayed initiation of dapagliflozin was associated with total discounted lifetime costs and QALYs of £16 660 and 4.61, respectively, compared to £16 912 and 4.66, respectively, for immediate initiation. Compared to standard therapy, immediate and 12-month delayed initiation of dapagliflozin yielded an incremental cost-effectiveness ratio (ICER) of £5779 and £5821, respectively. Compared to 12-month delayed initiation, immediate initiation of dapagliflozin had an ICER of £5263. Results were similar from the Canadian, German, and Spanish healthcare perspectives. Both immediate and 12-month delayed initiation of dapagliflozin are cost-effective. However, immediate initiation provides greater clinical benefits, with almost 10% additional QALYs gain, compared to 12-month delayed initiation of dapagliflozin and should be considered standard of care.

Cost-Effectiveness of Vonoprazan Compared With Proton Pump Inhibitors in Patients Taking Low-Dose Aspirin for Secondary Prevention of Cardiovascular Events in Japan.

Low-dose aspirin (LDA) is used to prevent recurrent cardiovascular (CV) events, but is associated with upper gastrointestinal (GI) bleeding; concomitant use of a proton pump inhibitor (PPI) reduces this risk. This study aimed to assess the cost-effectiveness of vonoprazan compared with PPIs (lansoprazole and esomeprazole) in patients taking LDA for secondary prevention of CV events. A Markov simulation model was developed to predict the number of GI bleeding and acute CV events using 3 strategies (vonoprazan+LDA, esomeprazole+LDA, and lansoprazole+LDA), which were translated into quality-adjusted life-years (QALYs) and costs. Transition probabilities and utilities were derived from the results of published literature, and medical costs were based on the Japanese National Health Insurance fee table and claims databases in 2020. Outcomes were projected over 30 years starting at age 65 years and discounted at 2% annually. Expected costs with esomeprazole 20 mg, lansoprazole 15 mg and vonoprazan 10 mg were JPY 1,225,657, JPY 943,930, and JPY 1,059,510, respectively. The QALY gain for vonoprazan vs. esomeprazole was 0.35, thus vonoprazan was dominant against esomeprazole. The QALY gain for vonoprazan vs. lansoprazole was 0.29 and the incremental cost-effectiveness ratio (ICER) was JPY 398,551, thus, vonoprazan was more cost-effective than lansoprazole. Vonoprazan is dominant or cost-effective compared with esomeprazole and lansoprazole in patients taking LDA for secondary prevention of CV events.

Cost effectiveness analysis of the East of England stroke telemedicine service

IntroductionStroke is the fourth single leading cause of death in the UK with more than 100,000 people diagnosed with stroke annually. Timely access to urgent care and treatments, such as thrombolysis, is crucial for survival and recovery but there are national variations in care access. Materials and methodsWe explore the cost-effectiveness of an integrated telemedicine service for rapid access to stroke Consultant support in the East of England acute stroke care pathway compared to usual care during out-of-hour periods. The Sentinel Stroke National Audit Programme (SSNAP) health economics thrombolysis tool enabled us to compare the service with usual acute stroke care pathway. The tool was used to estimate costs and cost per quality-adjusted life year (QALY) gain associated with improved thrombolysis rates from a health and social care perspective. ResultsBased on SSNAP data, an average of 1,861 stroke patients were admitted out-of-hours in the participating centres annually between 2014 and 2019. Average thrombolysis rate was 9.7% when using a telemedicine service across the centres relative to the total stroke patients that presented out-of-hours. The total NHS cost savings compared to usual care were estimated at £482k and £471k while social care cost savings were £1.7m and £536k at the end of 1-year and 5-years respectively. ConclusionIntegrating a telemedicine service improves thrombolysis rates in out-of-hours acute stroke care and is associated with NHS and social care savings and QALY gains. Telemedicine is a cost-effective approach to delivering stroke care to remote communities with limited access to stroke specialists.

An economic evaluation of vagus nerve stimulation as an adjunctive treatment to anti-seizure medications for the treatment of drug resistant epilepsy in the United States

IntroductionPeople with recurrent epileptic seizures are typically treated with anti-seizure medications (ASMs). Around a third of epilepsy patients fail to achieve an adequate response to ASMs and may be eligible to receive vagus nerve stimulation (VNS) therapy for their drug-resistant epilepsy (DRE) if they are unsuited to surgery. VNS received approval from the United States (US) Food and Drug Administration agency. However, there has to date been no comprehensive cost effectiveness evaluation of VNS within the US setting. This study was designed, using a US Medicare perspective, to estimate costs and quality-adjusted life years (QALYs) associated with VNS as an adjunct to ongoing ASM therapy, compared to ASMs alone.MethodsWe developed a cohort state transition model in Microsoft Excel, with four health states defined by different percentage reductions in seizure frequency, with a 3-month cycle and transition probabilities derived from published clinical trials and registry data. Sensitivity analyses were conducted to understand the impact of parameter uncertainty. Costs included the VNS device, placement, programming, battery changes, and removal; ASM therapy; adverse events associated with VNS (dyspnea, hoarseness, and cough); and costs associated with seizure burden (i.e. hospitalizations, emergency department visits, neurologist visits).ResultsUnder base case assumptions, treatment with VNS was associated with a 0.385 QALY gain and a $109,678 saving per patient, when compared with ASM therapy alone. The incremental net monetary benefit (iNMB) was $128,903 at a threshold of $50,000 per QALY, with the positive iNMB indicating that VNS is a highly cost effective treatment. This result is explained by the modeled reduction in relative seizure frequency and associated reduction in healthcare resource use that the VNS group experienced. Sensitivity analyses supported this conclusion.ConclusionsVNS was evaluated as a cost effective addition to the current standard of care in the treatment of DRE in the US Medicare context.

Cost-effectiveness of ravulizumab compared with eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria in the Netherlands.

The aim of this study was to evaluate the cost-effectiveness of ravulizumab compared with eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) in the Netherlands. A cost-effectiveness analysis was conducted based on a Markov cohort model simulating the course of patients with PNH with clinical symptom(s) indicative of high disease activity, or who are clinically stable after having been treated with eculizumab for at least the past sixmonths. Costs, quality of life, and the incremental cost-effectiveness ratio (ICER) were estimated over a lifetime horizon from a Dutch societal perspective. Several additional analyses were performed, including a one-way sensitivity analysis, a probabilistic sensitivity analysis, and scenario analysis. When compared with eculizumab, ravulizumab saves €266,833 and 1.57 quality adjusted life years (QALYs) are gained, resulting in a dominant ICER. Drug costs account for the majority of the total costs in both intervention groups. Cost savings were driven by the difference in total treatment costs of ravulizumab compared with eculizumab caused by the reduced administration frequency, accounting for 98% of the total cost savings. The QALY gain with ravulizumab is largely attributable to the improved quality of life associated with less frequent infusions and BTH events. At a willingness-to-pay threshold of €20,000/QALY, there is a 76.6% probability that ravulizumab would be cost-effective. The cost reduction and QALY gain associated with the lower rates of BTH and less frequent administration make ravulizumab a cost-saving and clinically beneficial substitute for eculizumab for adults with PNH in the Netherlands.

Cost-effectiveness Analysis of a Personalized, Teleretinal-Inclusive Screening Policy for Diabetic Retinopathy via Markov Modeling

Although teleretinal imaging has proved effective in increasing population-level screening for diabetic retinopathy (DR), there is a lack of quantitative understanding of how to incorporate teleretinal imaging into existing screening guidelines. We develop a mathematical model to determine personalized DR screening recommendations that utilize teleretinal imaging and evaluate the cost-effectiveness of the personalized screening policy. A partially observable Markov decision process is employed to determine personalized screening recommendations based on patient compliance, willingness to pay, and A1C level. Deterministic sensitivity analysis was conducted to evaluate the impact of patient-specific factors on personalized screening policy. The cost-effectiveness of identified screening policies was evaluated via hidden-Markov chain Monte Carlo simulation on a data-based hypothetical cohort. Screening policies were simulated for a hypothetical cohort of 500 000 patients with parameters based on the literature and electronic medical records of 2457 patients who received teleretinal imaging from 2013 to 2020 from the Harris Health System. Population-based mathematical modeling study. Interventions included dilated fundus examinations referred to as clinical screening, teleretinal imaging, and wait and watch recommendations. Personalized screening recommendations based on patient-specific factors. Accumulated quality-adjusted life-years (QALYs) and cost (USD) per patient under different screening policies. Incremental cost-effectiveness ratio to compare different policies. For the base cohort, on average, teleretinal imaging was recommended 86.7% of the time over each patient's lifetime. The model-based personalized policy dominated other standardized policies, generating more QALY gains and cost savings for at least 57% of the base cohort. Similar outcomes were observed in sensitivity analyses of the base cohort and the Harris Health-specific cohort and rural population scenario analysis. A mathematical model was developed as a decision support tool to identify a personalized screening policy that incorporates both teleretinal imaging and clinical screening and adapts to patient characteristics. Compared with current standardized policies, the model-based policy significantly reduces costs, whereas it is performing comparably, if not better, in terms of QALY gain. A personalized approach to DR screening has significant potential benefits that warrant further exploration. Proprietary or commercial disclosure may be found after the references.

Cost-effectiveness of hyperthermic intraperitoneal chemotherapy following interval cytoreductive surgery for stage III-IV ovarian cancer from a randomized controlled phase III trial in Korea (KOV-HIPEC-01)

BackgroundTo evaluate the cost-effectiveness of the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) following interval cytoreductive surgery (ICS) for stage III-IV ovarian cancer from a randomized controlled phase III trial. MethodsA comparative cost-effective analysis was performed using a Markov health-state transition model derived from the current trial cohort (ClinicalTrials.gov Identifier: NCT01091636). The incremental cost-effectiveness ratio (ICER) was evaluated by dividing the incremental costs by incremental quality-adjusted life-years (QALYs) with a time horizon of 10 years. Costs were calculated from the perspective of Korean healthcare, and health utility values were extracted from published sources. ResultsBased on data from the trial, the mean QALY in the ICS group was 7.16 compared to 10.8 in ICS followed by the HIPEC group. With an incremental QALY of 3.64, the ICS followed by HIPEC, was estimated to obtain an ICER of KRW 954,598 (USD 708.3) per QALY. ConclusionThe findings of the study suggest that ICS followed by HIPEC, is cost-effective with a significant gain in QALYs. These results may support the current reimbursement of HIPEC from Korean insurance services and the management of long-term conditions.

Cost-effectiveness of neuromuscular electrical stimulation for the treatment of mild obstructive sleep apnea: an exploratory analysis.

To assess the potential cost-effectiveness of neuromuscular electrical stimulation (NMES) for treatment of mild obstructive sleep apnea (OSA). A decision-analytic Markov model was developed to estimate health state progression, incremental cost, and quality-adjusted life year (QALY) gain of NMES compared to no treatment, continuous airway pressure (CPAP), or oral appliance (OA) treatment. The base case assumed no cardiovascular (CV) benefit for any of the interventions, while potential CV benefit was considered in scenario analyses. Therapy effectiveness was based on a recent multi-center trial for NMES, and on the TOMADO and MERGE studies for OA and CPAP. Costs, considered from a United States payer perspective, were projected over lifetime for a 48-year-old cohort, 68% of whom were male. An incremental cost-effectiveness ratio (ICER) threshold of USD150,000 per QALY gained was applied. From a baseline AHI of 10.2 events/hour, NMES, OA and CPAP reduced the AHI to 6.9, 7.0 and 1.4 events/hour respectively. Long-term therapy adherence was estimated at 65-75% for NMES and 55% for both OA and CPAP. Compared to no treatment, NMES added between 0.268 and 0.536 QALYs and between USD7,481 and USD17,445 in cost, resulting in ICERs between USD15,436 and USD57,844 per QALY gained. Depending on long-term adherence assumptions, either NMES or CPAP were found to be the preferred treatment option, with NMES becoming more attractive with younger age and assuming CPAP was not used for the full night in all patients. NMES might be a cost-effective treatment option for patients with mild OSA.

A pulmonary rehabilitation program reduces hospitalizations in chronic obstructive pulmonary disease patients: A cost-effectiveness study.

Although pulmonary rehabilitation (PR) is recommended in patients with chronic obstructive pulmonary disease (COPD), there is a scarcity of data demonstrating the cost-effectiveness and effectiveness of PR in reducing exacerbations. A quasi-experimental study in 200 patients with COPD was conducted to determine the number of exacerbations 1 year before and after their participation in a PR program. Quality of life was measured using the COPD assessment test and EuroQol-5D. The costs of the program and exacerbations were assessed the year before and after participation in the PR program. The incremental cost-effectiveness ratio (ICER) was estimated in terms of quality-adjusted life years (QALYs). The number of admissions, length of hospital stay, and admissions to the emergency department decreased after participation in the PR program by 48.2%, 46.6%, and 42.5%, respectively (P < 0.001 for all). Results on quality of life tests improved significantly (P < 0.001 for the two tests). The cost of PR per patient and the cost of pre-PR and post-PR exacerbations were €1867.7 and €7895.2 and €4201.9, respectively. The PR resulted in a cost saving of €1826 (total, €365,200) per patient/year, and the gain in QALYs was+0.107. ICER was -€17,056. The total cost was <€20,000/QALY in 78% of patients. PR contributes to reducing the number of exacerbations in patients with COPD, thereby slowing clinical deterioration. In addition, it is cost-effective in terms of QALYs.

COVID-19 and the forgone health benefits of elective operations

Background and aimThe first SARS-CoV-2 pandemic wave in Germany involved a tradeoff between saving the lives of COVID-19 patients by providing sufficient intensive care unit (ICU) capacity and foregoing the health benefits of elective procedures. This study aims to quantify this tradeoff.MethodsThe analysis is conducted at both the individual and population levels. The analysis calculates quality-adjusted life years (QALYs) to facilitate a comparison between the health gains from saving the lives of COVID-19 patients in the ICU and the health losses associated with postponing operative procedures. The QALYs gained from saving the lives of COVID-19 patients are calculated based on both the real-world ICU admissions and deaths averted from flattening the first wave. Scenario analysis was used to account for variation in input factors.ResultsAt the individual level, the resource-adjusted QALY gain of saving one COVID-19 life is predicted to be 3 to 15 times larger than the QALY loss of deferring one operation (the average multiplier is 9). The real-world QALY gain at the population level is estimated to fall within the range of the QALY loss due to delayed procedures. The modeled QALY gain by flattening the first wave is 3 to 31 times larger than the QALY loss due to delayed procedures (the average multiplier is 17).ConclusionDuring the first wave of the pandemic, the resource-adjusted health gain from treating one COVID-19 patient in the ICU was found to be much larger than the health loss from deferring one operation. At the population level, flattening the first wave led to a much larger health gain than the health loss from delaying operative procedures.

A group-based exercise and behavioural maintenance intervention for adults over 65 years with mobility limitations: the REACT RCT

Background Mobility limitation in older age reduces quality of life, generates substantial health- and social-care costs, and increases mortality. Objective The REtirement in ACTion (REACT) trial aimed to establish whether or not a community-based active ageing intervention could prevent decline in physical functioning in older adults already at increased risk of mobility limitation. Design A multicentre, pragmatic, two-arm, parallel-group randomised controlled trial with parallel process and health economic evaluations. Setting Urban and semi-rural locations across three sites in England. Participants Physically frail or pre-frail older adults (aged ≥ 65 years; Short Physical Performance Battery score of 4–9). Recruitment was primarily via 35 primary care practices. Interventions Participants were randomly assigned to receive brief advice (three healthy ageing education sessions) or a 12-month, group-based, multimodal exercise and behavioural maintenance programme delivered in fitness and community centres. Randomisation was stratified by site and used a minimisation algorithm to balance age, sex and Short Physical Performance Battery score. Data collection and analyses were blinded. Main outcome measures The primary outcome was change in lower limb physical function (Short Physical Performance Battery score) at 24 months, analysed using an intention-to-treat analysis. The economic evaluation adopted the NHS and Personal Social Services perspective. Results Between June 2016 and October 2017, 777 participants (mean age 77.6 years, standard deviation 6.8 years; 66% female; mean Short Physical Performance Battery score 7.37, standard deviation 1.56) were randomised to the intervention arm (n = 410) or the control arm (n = 367). Data collection was completed in October 2019. Primary outcome data at 24 months were provided by 628 (80.8%) participants. At the 24-month follow-up, the Short Physical Performance Battery score was significantly greater in the intervention arm (mean 8.08, standard deviation 2.87) than in the control arm (mean 7.59, standard deviation 2.61), with an adjusted mean difference of 0.49 (95% confidence interval 0.06 to 0.92). The difference in lower limb function between intervention and control participants was clinically meaningful at both 12 and 24 months. Self-reported physical activity significantly increased in the intervention arm compared with the control arm, but this change was not observed in device-based physical activity data collected during the trial. One adverse event was related to the intervention. Attrition rates were low (19% at 24 months) and adherence was high. Engagement with the REACT intervention was associated with positive changes in exercise competence, relatedness and enjoyment and perceived physical, social and mental well-being benefits. The intervention plus usual care was cost-effective compared with care alone over the 2 years of REACT; the price year was 2019. In the base-case scenario, the intervention saved £103 per participant, with a quality-adjusted life-year gain of 0.04 (95% confidence interval 0.006 to 0.074) within the 2-year trial window. Lifetime horizon modelling estimated that further cost savings and quality-adjusted life-year gains were accrued up to 15 years post randomisation. Conclusion A relatively low-resource, 1-year multimodal exercise and behavioural maintenance intervention can help older adults to retain physical functioning over a 24-month period. The results indicate that the well-established trajectory of declining physical functioning in older age is modifiable. Limitations Participants were not blinded to study arm allocation. However, the primary outcome was independently assessed by blinded data collectors. The secondary outcome analyses were exploratory, with no adjustment for multiple testing, and should be interpreted accordingly. Future work Following refinements guided by the process evaluation findings, the REACT intervention is suitable for large-scale implementation. Further research will optimise implementation of REACT at scale. Trial registration This trial is registered as ISRCTN45627165. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 10, No. 14. See the NIHR Journals Library website for further project information.

P10 Modelling Spillover Effects on Informal Carers: The 'Carer QALY Trap'

Caring for patients can impose significant ‘spillover effects’ on the health of informal carers. A review of National Institute for Health and Care Excellence technology appraisals found that carer health-related quality of life (HRQOL) is rarely included in appraisals, and when it is, modelling approaches have been inconsistent. Furthermore, when modelling carer HRQOL, situations can occur whereby a life extension for patients results in an overall reduction in net quality-adjusted life years (QALYs). In other words, for some life-extending treatments, a gain in patient QALYs may be outweighed by a loss in carer QALYs, which may be inconsistent with societal values. The objective of this study was to explore the circumstances through which this issue occurs and consider potential approaches for addressing it.