Difference In Quality-adjusted Life-years Research Articles

Cost-effectiveness and cost-utility analysis of a work-place smoking cessation intervention with and without financial incentives.

AimsTo perform an economic evaluation of a work‐place smoking cessation group training programme with incentives compared with a training programme without incentives.DesignA trial‐based cost‐effectiveness analysis (CEA) and cost–utility analysis (CUA) from a societal perspective and an employer's perspective.SettingSixty‐one companies in the Netherlands.ParticipantsA total of 604 tobacco‐smoking employees.Intervention and comparatorA 7‐week work‐place smoking cessation group training programme. The intervention group earned gift vouchers of €350 for 12 months’ continuous abstinence. The comparator group received no incentives.MeasurementsOnline questionnaires were administered to assess quality of life (EQ‐5D‐5 L) and resource use during the 14‐month follow‐up period (2‐month training period plus 12‐month abstinence period). For the CEA the primary outcome measure was carbon monoxide (CO)‐validated continuous abstinence; for the CUA the primary outcome was quality‐adjusted life years (QALY). Bootstrapping and sensitivity analyses were performed to account for uncertainty. Incremental cost‐effectiveness ratio (ICER) tables were used to determine cost‐effectiveness from a life‐time perspective.FindingsOf the participants in the intervention group, 41.1% had quit smoking compared with 26.4% in the control group. From a societal perspective with a 14‐month follow‐up period, the ICER per quitter for an intervention with financial incentives compared with no incentives was €11 546. From an employer's perspective, the ICER was €5686. There was no significant difference in QALYs between the intervention and control group within the 14‐month follow‐up period. The intervention was dominated by the comparator in the primary analysis at a threshold of €20 000 per QALY. In the sensitivity analysis, these results were uncertain. A life‐time perspective showed an ICER of €1249 (95% confidence interval = €850–2387) per QALY.ConclusionsFinancial incentives may be cost‐effective in increasing quitting smoking, particularly from a life‐time perspective.

A Cost-Effectiveness Analysis of Isolated Meniscal Repair Versus Partial Meniscectomy for Red-Red Zone, Vertical Meniscal Tears in the Young Adult

To evaluate the cost-effectiveness of treating isolated red-red zone, vertical meniscal tears with either isolated meniscal repair (IMR) or partial meniscectomy (PM) in the young adult using conservative modeling. Adecision-analytic Markov disease progression model with a 40-year horizon was created simulating outcomes after IMR or PM for an isolated meniscal tear. Event probabilities, costs, and utilities were used for the index procedures, and the development of osteoarthritis (OA) and subsequent need for knee arthroplasty were calculated or selected from the published literature. Differences in cost, difference in quality-adjusted life years (QALYs), and the incremental cost effect ratio were calculated to determine which index procedure is most cost effective. Total direct costs from PM were modeled at $38,648, and the total direct costs of IMR were $23,948, resulting in a projected cost savings of $14,700 with IMR. There was a modeled gain in QALYs of 17 for PM and 21 for IMR, resulting in an increase in 4 QALYs for the IMR treatment group. This results in an incremental cost effect ratio of $3,935 per QALY, favoring IMR as the dominant procedure. Meniscal repair for isolated red-red zone, vertical meniscal tears was predicted to have lower direct costs and improve QALYs compared with partial meniscectomy over 40-year modeling, indicating isolated meniscal repair to be the cost-effective procedure in the treatment of an isolated meniscal tear in the young adult population. Level 3: economic and decision analysis.

Cost-Effectiveness of Sertraline in Primary Care According to Initial Severity and Duration of Depressive Symptoms: Findings from the PANDA RCT.

BackgroundAntidepressants are commonly prescribed for depression, but it is unclear whether treatment efficacy depends on severity and duration of symptoms and how prescribing might be targeted cost-effectively.ObjectivesWe investigated the cost-effectiveness of the antidepressant sertraline compared with placebo in subgroups defined by severity and duration of depressive symptoms.MethodsWe undertook a cost-effectiveness analysis from the perspective of the NHS and Personal and Social Services (PSS) in the UK alongside the PANDA (What are the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit?) randomised controlled trial (RCT), which compared sertraline with placebo over a 12-week period. Quality of life data were collected at baseline and at 2, 6, and 12 weeks post-randomisation using EQ-5D-5L, from which we calculated quality-adjusted life years (QALYs). Costs (in 2017/18£) were collected using patient records and from resource use questionnaires administered at each follow-up interval. Differences in mean costs and mean QALYs and net monetary benefits were estimated. Our primary analysis used net monetary benefit regressions to identify any interaction between the cost-effectiveness of sertraline and subgroups defined by baseline symptom severity (0–11; 12–19; 20+ on the Clinical Interview Schedule—Revised) and, separately, duration of symptoms (greater or less than 2 years duration). A secondary analysis estimated the cost-effectiveness of sertraline versus placebo, irrespective of duration or severity.ResultsThere was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline. Compared to patients with low symptom severity, the expected net benefits in patients with moderate symptoms were £24 (95% CI − £280 to £328; p value 0.876) and the expected net benefits in patients with high symptom severity were £37 (95% CI − £221 to £296; p value 0.776). Patients who had a longer history of depressive symptoms at baseline had lower expected net benefits from sertraline than those with a shorter history; however, the difference was uncertain (− £27 [95% CI − £258 to £204]; p value 0.817). In the secondary analysis, patients treated with sertraline had higher expected net benefits (£122 [95% CI £18 to £226]; p value 0.101) than those in the placebo group. Sertraline had a high probability (> 95%) of being cost-effective if the health system was willing to pay at least £20,000 per QALY gained.ConclusionsWe found insufficient evidence of a prespecified threshold based on severity or symptom duration that GPs could use to target prescribing to a subgroup of patients where sertraline is most cost-effective. Sertraline is probably a cost-effective treatment for depressive symptoms in UK primary care.Trial RegistrationControlled Trials ISRCTN Registry, ISRCTN84544741.Electronic supplementary materialThe online version of this article (10.1007/s41669-019-00188-5) contains supplementary material, which is available to authorized users.

Cost-Utility Analysis of Apixaban Compared to Usual Care for the Primary Thromboprophylaxis of Ambulatory Cancer Patients Initiating Chemotherapy

Introduction: Apixaban 2.5mg twice daily has been shown to significantly reduce the risk of venous thromboembolism (VTE) compared to placebo for the primary thromboprophylaxis of VTE in ambulatory cancer patients initiating chemotherapy, who are at intermediate-high risk of VTE, with a Khorana score of ≥2 (hazard ratio, 0.41; 95% confidence interval, 0.26 to 0.65; P<0.001). In this study, we estimated whether the health benefit gained from apixaban justified its costs. Method: We conducted a cost-utility analysis of apixaban (2.5mg twice daily) compared to usual care, whereby no apixaban is prescribed, from the perspective of Canada's healthcare system. Our target population was ambulatory cancer patients starting chemotherapy with an intermediate-high risk of VTE. We developed a Markov model with a cycle length of 1-week to simulate costs and quality-adjusted life years (QALYs) for patients receiving either apixaban or usual care over 6 months (Figure 1). To estimate the baseline time varying risk of VTE among ambulatory cancer patients undergoing chemotherapy, we created pseudo patient-level data from survival curves reported for patients in the placebo arm of the AVERT trial using 'WebPlotDigitizer'. We fitted parametric survival models to the patient-level data points to extrapolate VTE risk beyond the trial follow-up period (median follow-up 183 days). The best model was selected based on a visual inspection and the Akaike Information Criterion. The relative risk of VTE, clinically relevant non-major bleeding, and major bleeding (using the International Society of Thrombosis and Haemostasis criteria) as a result of apixaban was obtained from the AVERT trial using the on-treatment analysis. We conducted a targeted literature search to obtain the risk of complications among cancer patients receiving low-molecular-weight heparin for the initial treatment and secondary prevention of VTE using a meta-analysis technique. Hazard ratio for increased risk of death due to cancer was estimated as a weighted average of the age-standardized mortality rate by tumor type, based on the proportion of patients with each tumor type in the AVERT trial. Costs were obtained from published Canadian sources. Baseline health utility values for patients on chemotherapy and in remission were calculated as a weighted average of utility values by tumour type, also based on the proportion of patients with each tumour type in the AVERT trial. Utility values for chemotherapy and remission for each tumour type, as well as event specific disutility values, were obtained from the published literature. Both costs and QALYs were discounted using an annual rate of 1.5%, as recommended by the Canadian Agency for Drugs and Technologies in Health. We conducted deterministic and probabilistic sensitivity analyses to assess robustness of study findings. Results: Over a 6-month period, apixaban was associated with a lower health system cost (C$25,987 vs C$26,268) and a slight increase in QALYs (0.3339 vs 0.3337) compared to usual care (Table 1). The probability that apixaban was cost-saving compared to usual care was 90%; however, this probability decreased with the greater willingness to pay (WTP) values partly due to the high uncertainty in the difference in QALYs. At a WTP threshold of C$50,000/QALY, the probability of apixaban being cost effective was 57% (Figure 2). Over 1 year, apixaban reduced health care system costs by C$1,113 and improved QALYs by 0.0005 units compared to usual care. At a WTP threshold of C$50,000/QALY, the probability of apixaban being cost effective increased to 70%. Our results were robust to the change in time horizon; however, they were more sensitive to the relative risk of VTE, the relative risk of major bleeding, the costs amassed in the post-VTE period, and the treatment cost of acute VTE. Probabilistic sensitivity analysis indicated a high-level uncertainty around cost effectiveness estimates, which may be driven by the wide confidence intervals around estimates for relative risk of complications in patients receiving thromboprophylaxis with apixaban. Conclusion: From a publicly funded health system's perspective apixaban is a cost saving option for thromboprophylaxis among ambulatory cancer patients initiating chemotherapy. Disclosures Wells: BMS/Pfizer: Honoraria, Research Funding; Bayer: Honoraria; Sanofi: Honoraria; Daiichi Sankyo: Honoraria. Carrier:Servier: Honoraria; Bayer: Honoraria; Pfizer: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Leo Pharma: Honoraria, Research Funding. OffLabel Disclosure: Apixaban can be used as postoperative prophylaxis of DVT/PE and for treatment of DVT/PE. We performed a cost-utility analysis of apixaban 2.5mg BID for the primary thromboprophylaxis of ambulatory cancer patients initiating chemotherapy, at intermediate-high risk of venous thromboembolism.

Economic evaluation of fluoride varnish application of daily supervision versus daily supervision and additional six-monthly intervals in Scotland (Protecting Teeth @ 3): a randomised controlled trial

BackgroundEconomic evaluations of public health interventions aid decision makers in efficient resource allocation. Our aim was to do an economic evaluation of a subintake of the Protecting Teeth @ 3 Study (PT@3), a Scottish, 2 year, parallel group, randomised controlled trial, which explored the additional preventive value of fluoride varnish application at six-monthly intervals in nursery settings over and above daily supervised toothbrushing in nursery settings (treatment as usual). MethodsFrom Nov 21, 2012 to Aug 31, 2017, eligible children were randomly assigned to receive either fluoride varnish plus treatment as usual (fluoride varnish group) or treatment as usual in a 1:1 ratio. The economic evaluation was a within-trial, cost-utility analysis comparing the fluoride varnish group with the treatment as usual group. Cost-utility analysis was done from a National Health Service perspective. Within-trial costs included intervention and health-care resource use costs. Health outcomes were expressed in quality-adjusted life-years (QALYs) accrued over the 2 year period. The Child Health Utility 9 Dimensions questionnaire was used to obtain utility scores. Staff travel and labour costs were collected using a staff costs form. Information on other costs was requested from the trial coordinators. National reference costs were used, a discount rate of 1·5% for public health investments was adopted, multiple imputation methods for missing data were employed, sensitivity analyses done, and incremental cost-effectiveness ratios calculated. Ethical approval was from the West of Scotland Research Ethics Service. This trial is registered with EudraCT, 2012-002287-26. FindingsThe data for 534 participants from the 2014–15 intake were used in the analyses. Of these, 265 were assigned to fluoride varnish and assigned to 269 treatment as usual. The mean difference in costs between the fluoride varnish and treatment as usual group was GBP£36·64 (95% CI –48·51 to 111·47; p=0·64). The mean difference in QALYs was –0·0044 (95% CI –0·0168 to 0·0065; p=0·64). The fluoride varnish intervention had higher costs and resulted in less QALYs than that of the treatment as usual. The probability that the fluoride varnish intervention was cost-effective at the £30 000 threshold was 18·5%. InterpretationOur results indicate that there was no substantial difference in costs and QALYs between the two groups. Applying fluoride varnish in nursery settings in addition to daily supervised nursery toothbrushing seems not to be good value for money. We recommended that the funds could be used better on other more cost-effective oral health interventions. FundingPT@3 was funded by the Scottish Government.

PIH13 A COST-EFFECTIVENESS ANALYSIS OF ENTERAL LACTOFERRIN SUPPLEMENTATION FOR VERY PRETERM INFANTS: THE ELFIN TRIAL

This simulation-based economic evaluation aimed to assess the cost-effectiveness of lactoferrin in preventing late-onset infections (LOIs). 2,203 very preterm infants (<32 weeks’ gestation) from the United Kingdom (UK) were randomised to receive either lactoferrin or placebo. Generalised linear models were used to analyse data on LOI, mortality and cost of primary hospitalisation. Non-linear continuous variables (e.g. gestation age) were modelled using restricted cubic splines. Assuming that LOIs increase the risk of neurodevelopmental impairments (NDI), the cohort model calculated the proportion of infants developing NDI and, based on NDI severity, extrapolated the infants’ life-expectancy. These survival estimates were adjusted for quality of life utilities to obtain quality-adjusted life years (QALYs) and were used to estimate lifetime costs. Between groups differences in costs and QALYs were used to calculate Incremental cost-effectiveness ratios (ICERs) and a probabilistic sensitivity analysis determined the ICERs uncertainty. This uncertainty was presented as Value of Information (VOI) at UK-population level. A 1.5% annual discount rate and lifetime time horizon were used to capture long-term costs and consequences. The analyses were repeated for gestation age and feed-type subgroups, and under alternative assumptions on the discount rate and treatment effect. Missing data were multiple imputed assuming they were missing at random (MAR) or not MAR. On average, lactoferrin would provide an additional 0.05 QALYs at the cost of £1787. Apart from infants with 24 weeks’ gestation (ICER: £6,665 [1.5% discount] and £11,187 [3.5% discount]), lactoferrin was not cost-effective in any of the subgroups. The VOI for UK infants with 24 weeks’ gestation is approximately £15 million. Our results were robust to alternative assumptions. From the UK-NHS perspective, lactoferrin is not cost-effective based on conventional decision rules. More research in infants with 24 weeks’ gestation might be justifiable if the undergoing studies (e.g. LIFT trial) do not resolve these uncertainties.

Cost-effectiveness of telerehabilitation versus traditional care after total hip replacement: A trial-based economic evaluation

Introduction: Physical rehabilitation for total hip replacement patients following hospital discharge is beneficial; however, accessing rehabilitation is often challenging. Telerehabilitation helps negate access issues and is efficacious in total knee and hip replacement patients. This study aims to compare the cost-effectiveness of a telerehabilitation programme delivered remotely into patients’ homes versus traditional care for total hip replacement patients following hospital discharge. Methods: A cost-effectiveness (cost-utility) analysis was conducted from the perspective of a health service alongside a two-arm randomised controlled trial comparing telerehabilitation (n=35) with in-person care (n=35) following hospital discharge after total hip replacement. The primary analysis used an Incremental Cost-Effectiveness Ratio to compare the cost per Quality Adjusted Life Year (QALY) accrued in the telerehabilitation group versus in-person control using costs and effects data from the randomised trial. A secondary analysis was conducted whereby the time accrued by patients attending rehabilitation sessions (including travel time) was considered the “cost” (i.e. a time burden), rather than cost from the health service perspective. Results: Estimated mean differences in healthcare costs and QALYs gained were detected but were not significant. The estimated mean (95%CI) difference in cost of telerehabilitation versus in-person was –$28.90 (–$96.37 to $40.45), favouring the telerehabilitation group. The estimated mean (95%CI) difference in QALYs gained from telerehabilitation versus in-person was –0.0025 (–0.0227 to 0.0217). The estimated mean (95%CI) difference in time burden favoured less time burden for the telerehabilitation group (–4.21 (–4.69 to –3.74) hours). Discussion: Telerehabilitation in the total hip replacement population incurred similar costs and yielded similar effects to traditional in-person care. Telerehabilitation significantly reduced the time burden for patients and carers. These findings are valuable for healthcare providers seeking to implement accessible patient-centred rehabilitation services.

A national registry to assess the value of cardiovascular magnetic resonance imaging after primary percutaneous coronary intervention pathway activation: a feasibility cohort study

Background Cardiovascular magnetic resonance (CMR) is increasingly used in patients who activate the primary percutaneous coronary intervention (PPCI) pathway to assess heart function. It is uncertain whether having CMR influences patient management or the risk of major adverse cardiovascular events in these patients. Objective To determine whether or not it is feasible to set up a national registry, linking routinely collected data from hospital information systems (HISs), to investigate the role of CMR in patients who activate the PPCI pathway. Design A feasibility prospective cohort study. Setting Four 24/7 PPCI hospitals in England and Wales (two with and two without a dedicated CMR facility). Participants Patients who activated the PPCI pathway and underwent an emergency coronary angiogram. Interventions CMR either performed or not performed within 10 weeks of the index event. Main outcome measures A. Feasibility parameters – (1) patient consent implemented at all hospitals, (2) data extracted from more than one HIS and successfully linked for &gt; 90% of consented patients at all four hospitals, (3) HIS data successfully linked with Hospital Episode Statistics (HES) and Patient Episode Database Wales (PEDW) for &gt; 90% of consented patients at all four hospitals and (4) CMR requested and carried out for ≥ 10% of patients activating the PPCI pathway in CMR hospitals. B. Key drivers of cost-effectiveness for CMR (identified from simple cost-effectiveness models) in patients with (1) multivessel disease and (2) unobstructed coronary arteries. C. A change in clinical management arising from having CMR (defined using formal consensus and identified using HES follow-up data in the 12 months after the index event). Results A. (1) Consent was implemented (for all hospitals, consent rates were 59–74%) and 1670 participants were recruited. (2) Data submission was variable – clinical data available for ≥ 82% of patients across all hospitals, biochemistry and echocardiography (ECHO) data available for ≥ 98%, 34% and 87% of patients in three hospitals and medications data available for 97% of patients in one hospital. (3) HIS data were linked with hospital episode data for 99% of all consented patients. (4) At the two CMR hospitals, 14% and 20% of patients received CMR. B. In both (1) multivessel disease and (2) unobstructed coronary arteries, the difference in quality-adjusted life-years (QALYs) between CMR and no CMR [‘current’ comparator, stress ECHO and standard ECHO, respectively] was very small [0.0012, 95% confidence interval (CI) –0.0076 to 0.0093 and 0.0005, 95% CI –0.0050 to 0.0077, respectively]. The diagnostic accuracy of the ischaemia tests was the key driver of cost-effectiveness in sensitivity analyses for both patient subgroups. C. There was consensus that CMR leads to clinically important changes in management in five patient subgroups. Some changes in management were successfully identified in hospital episode data (e.g. new diagnoses/procedures, frequency of outpatient episodes related to cardiac events), others were not (e.g. changes in medications, new diagnostic tests). Conclusions A national registry is not currently feasible. Patients were consented successfully but conventional consent could not be implemented nationally. Linking HIS and hospital episode data was feasible but HIS data were not uniformly available. It is feasible to identify some, but not all, changes in management in the five patient subgroups using hospital episode data. The delay in obtaining hospital episode data influenced the relevance of some of our study objectives. Future work To test the feasibility of conducting the study using national data sets (e.g. HES, British Cardiovascular Intervention Society audit database, Diagnostic Imaging Dataset, Clinical Practice Research Datalink). Funding The National Institute for Health Research (NIHR) Health Services and Delivery Research programme. This study was designed and delivered in collaboration with the Clinical Trials and Evaluation Unit, a UK Clinical Research Collaboration-registered clinical trials unit that, as part of the Bristol Trials Centre, is in receipt of NIHR clinical trials unit support funding.

Radiation Therapy Without Hormone Therapy for Women Age 70 or Above with Low-Risk Early Breast Cancer: A Microsimulation

Hormone therapy without radiation therapy is considered appropriate for women age 70 or above with low-risk, hormone-positive breast cancer after partial mastectomy. However, some patients may prefer radiation without hormone therapy, for which there is minimal modern data. We modeled the comparative efficacy of aromatase inhibition alone without radiation versus radiation alone without hormone therapy. We constructed a patient-level Markov model and compared 5 years of anastrozole to a 15-fraction course of radiation without boost or anastrozole. The relative effectiveness between treatments was based on the National Surgical Adjuvant Breast and Bowel Project B-21 trial, which was further adjusted such that the endocrine-alone arm matched the Cancer and Leukemia Group B 9343 and PRIME II trials. Common or severe side effects were considered. Eight survival metrics were assessed and validated against clinical trial data. The cost-efficacy of each strategy was considered using the quality-adjusted life year and incremental cost-effectiveness ratio (ICER). The model's predicted outcomes matched those demonstrated by modern trials. Aromatase inhibitors were superior in preventing contralateral cancers, with a small impact on the risk of distant metastatic disease. Radiation was superior in preventing ipsilateral breast tumor recurrence with a small impact on regional failure. No clinically significant differences were seen in the other 4 oncologic endpoints. Differences in quality-adjusted life years were small, but radiation therapy was $3809 more expensive over the average lifetime. The ICER suggested anastrozole was cost-effective in 62% of probabilistic simulations. However, the ICER was unstable owing to a denominator that approached zero. Women age 70 or above with low-risk early breast cancer who are reluctant or unable to pursue adjuvant aromatase inhibition can safely pursue adjuvant radiation alone with limited differences in outcome and a modest increase in costs.

The Effects of Preventive Home Visits on Older People's Use of Health Care and Social Services and Related Costs.

We use data from a randomized controlled trial on preventive home visits exploring effectiveness on health-related quality of life. In this article, we examine the intervention's cost-effectiveness and effects on quality-adjusted life years in older home-dwelling adults. There were 422 independently home-dwelling participants in the randomized, controlled trial, all aged more than 75 years, with equal numbers in the control and intervention groups. The intervention took place in a municipality in Finland and consisted of multiprofessional preventive home visits. We gathered the data on health care and social services use from central registers and medical records during 1 year before the intervention and 2 years after the intervention. We analyzed the total health care and social services use and costs per person-years and the difference in change in health-related quality of life as measured using the 15D measure. We calculated quality-adjusted life years and incremental cost-effectiveness ratios. There was no significant difference in baseline use of services or in the total use and costs of health care and social services during the 2-year follow-up between the two groups. In the intervention group, health-related quality of life declined significantly more slowly compared with the control group (-0.015), but there was no significant difference in quality-adjusted life years gained between the groups. The cost-effectiveness plane showed 60% of incremental cost-effectiveness ratios lying in the dominant quadrant, representing additional effects with lower costs. This multiprofessional preventive home visit intervention appears to have positive effects on health-related quality of life without accruing additional costs. ACTRN12616001411437.

Quality-adjusted life years (QALYs) associated with limitations in activities of daily living (ADL) in a large longitudinal sample of the U.S. community-dwelling older population

BackgroundThe staging method for activities of daily living (ADLs) limitations developed by Stineman and colleagues that classifies people into five stages can reflect severity of activity limitations. ObjectiveTo assess the impact of stages of limitations in ADLs on quality-adjusted life years (QALYs) and the relative severity of each ADL limitation for a large, nationally-representative sample of the U.S. community-dwelling older population. MethodsData were obtained from the Limited Dataset of the Medicare Health Outcomes Survey Cohort 15 (2012 baseline survey, 2014 follow-up survey). We included respondents aged ≥65 years (n = 105,473). We estimated expected QALYs throughout the remaining lifetime of participants stratified by the ADL limitation status and stages of ADL limitations. ResultsOverall, the expected QALYs was 5.6 years. QALYs decreased with increasing stages of ADL limitations. The adjusted QALYs for Stage 0 (no limitation) participants were 6.8; for Stage I (mild) participants, 3.9; for Stage II (moderate) participants, 2.2; for Stage III (severe) participants, 1.8; and for Stage IV (complete limitations) participants, 1.5. Differences in QALYs occurred between individual ADL items within an ADL stage. In Stage I, for example, participants who reported only problems with getting in or out of chairs had 6.7 QALYs which was markedly higher than participants who reported only problems with walking (3.8 QALYs). ConclusionsOur findings provide additional evidence that Stineman's ADL stages serve as valid estimates of the overall health of elderly Americans. Self-reported ADL status should be routinely collected as a patient-reported outcome in the elderly population.

Comparing the Noncomparable: The Need for Equivalence Measures That Make Sense in Health-Economic Evaluations

BackgroundThe popularity of quality-adjusted life years (QALYs) has been resistant to concerns about validity and reliability. Utility-theoretic outcome equivalents are widely used in other areas of applied economics. Equivalence values can be derived for time, money, risk, and other metrics. These equivalence measures preserve all available information about individual preferences and are valid measures of individual welfare changes. ObjectiveThe objective of this study was to derive alternative generalized equivalence measures from first principles and illustrate their application in an empirical comparative-effectiveness example. MethodsWe specify a general-equilibrium model incorporating neoclassical utility functions, health production function, severity-duration preferences, and labor-market tradeoff function. The empirical implementation takes advantage of discrete-choice experiment methods that are widely accepted in other areas of applied economics and increasingly in health economics. We illustrate the practical significance of restrictive QALY assumptions using comparative-effectiveness results based on both QALYs and estimates of welfare-theoretic time-equivalent values for anti-tumor necrosis factor and prolonged corticosteroid treatments for Crohn’s disease in three distinct preference classes. ResultsThe QALY difference between the two treatments is 0.2 months, while time-equivalent values range between 0.5 and 1.3 months for aggregate and class-specific differences. Thus, the QALY-based analysis understates welfare-theoretic values by 60%-85%. ConclusionThese results suggest that using disease-specific equivalence values offer a meaningful alternative to QALYs to compare global outcomes across treatments. The equivalence values approach is consistent with principles of welfare economics and offers several features not represented in QALYs, including accounting for preference nonlinearities in disease severity and duration, inclusion of preference-relevant nonclinical healthcare factors, representing preferences of clinically-relevant patient subpopulations, and including utility losses related to risk aversion.

Cost effectiveness analysis of direct oral anticoagulant (DOAC) versus dalteparin for the treatment of cancer associated thrombosis (CAT) in the United States

IntroductionWhile trials have demonstrated non-inferiority of direct oral anticoagulant drugs (DOAC) to low-molecular-weight heparins (LMWH) for the treatment of cancer associated thrombosis (CAT), it is unclear if the newer intervention is cost-effective. MethodsWe performed a cost-utility analysis using a Markov state-transition model over a time horizon of 60 months in a hypothetical cohort of 65-year-old patients with active malignancy and first acute symptomatic CAT who were eligible to receive either rivaroxaban/edoxaban or dalteparin. We obtained transition probability, relative risk, cost, and utility inputs from the literature. We estimated the differential impact on costs and quality-adjusted life years (QALYs) per patient and performed one-way and probabilistic sensitivity analyses to test the robustness of results. ResultsUsing the base-case analysis over 60 months, DOAC versus dalteparin was associated with an incremental cost reduction of $24,129 with an incremental QALY reduction of 0.04. In the one-way sensitivity analysis, the cost of dalteparin contributed the most to the incremental cost difference; relative risk of death related to underlying cancer contributed the most of the incremental QALY difference. The probabilistic sensitivity analysis confirmed the base-case analysis, with a large reduction in cost but small reduction in QALYs. ConclusionRivaroxaban or edoxaban as compared to dalteparin is cost saving from a payer's perspective for the treatment of CAT. Professional organizations and healthcare systems may want to consider this analysis in future practice recommendations.

Implementing a thermal care bundle for inadvertent perioperative hypothermia: A cost-effectiveness analysis

BackgroundActive warming reduces risk of surgical complications. Implementation of a perioperative thermal care bundle increased use of active warming for surgical patients. ObjectiveThis study aimed to determine if implementing a thermal care bundle to prevent inadvertent perioperative hypothermia is cost-effective. DesignA model-based cost-effectiveness analysis was undertaken using Monte Carlo simulations from input distributions to estimate costs and effects. SettingHospitals undertaking between 5,000 and 40,000 surgeries per year, which either implemented or did not implement the thermal care bundle, were modelled. ParticipantsThe decision tree guiding the structure of the model was populated with clinical outcomes (surgical site infection, blood transfusion requirement and morbid cardiac events) of a hypothetical cohort of surgical patients. InterventionsImplementation or non-implementation of the thermal care bundle. Main outcome measuresNet monetary benefit was calculated by multiplying the health benefits (quality-adjusted life years) by the willingness-to-pay threshold minus the cost. We tested a range of values for willingness to pay per quality-adjusted life year thresholds and plotted results for expected incremental benefits and probability of cost-effectiveness. The incremental cost-effectiveness ratio was also calculated. ResultsThermal care bundle implementation simultaneously reduced costs and increased quality-adjusted life years in the majority of simulations (88.1%). The average cost reduction was $689,659 (95% credible intervals spanned from a $2,718,364 decrease in costs to $379,826 increase in costs) and average difference in quality-adjusted life years was 54 (95% CI = 0.4 less to 176 more). This equated to an incremental cost-effectiveness ratio of $12747 saved per quality-adjusted life year gained. ConclusionsIt is likely that increasing use of active warming by implementing the thermal care bundle would generate cost-savings and improve the quality of life for surgical patients. It would be good value for hospitals with similar characteristics to those included in our model to allocate the extra resources required for implementation.

PMH15 COST-EFFECTIVENESS OF THE MANAGING AGITATION AND RAISING QUALITY OF LIFE IN DEMENTIA (MARQUE) INTERVENTION FOR AGITATION SYMPTOMS IN PEOPLE WITH DEMENTIA IN CARE HOMES

Many people with dementia in care homes have distressing and costly agitation symptoms. This study assessed whether the MARQUE (Managing Agitation and Raising QUality of LifE) intervention was cost-effective (as measured with quality adjusted life years (QALYs)) compared to treatment as usual (TAU). This study was an eight-month cluster-randomised controlled trial that enrolled 404 residents (MARQUE=189; TAU=215) living in care homes. Data on healthcare service use and prescriptions were collected at baseline and 8 months asking about the previous 4 months. QALYs were calculated using the EQ-5D-5L adjusting for baseline differences over 8 months between groups. We used multivariate imputation by chained equation for missing data, generating 20 imputed data sets. For each data set we ran 1,000 bootstrap replications using non-parametric bootstrapping; results were combined to calculate the mean values for costs and utilities and the standard errors around the imputed values, used to calculate 95%CI around point estimates. Mean total cost per resident in the MARQUE group, including the cost of the intervention, was £1,379 (95%CI £1,041 to £1,718), compared with £1,175 (95%CI £917 to £1,433) in the TAU group, generating a mean difference of £204 (95%CI -£215 to £623; p-value=0.320). Non-parametric bootstrapping after multiple imputation produced 0.346 (95%CI 0.330 to 0.362) QALYs in the MARQUE group and 0.332 (95%CI 0.322 to 0.342) QALYs in the TAU group, generating a mean difference of 0.015 QALYs (95%CI -0.004 to 0.034; p-value=0.127). Combining the difference in costs and difference in QALYs, the mean incremental cost per QALY gained of the MARQUE compared to TAU was £14,064. This study showed that although the mean incremental cost per QALY gained is below the NICE threshold, it has a low probability (62%) of being cost-effective at a willingness-to-pay of £20,000 per QALY due to the wide confidence intervals for costs and QALYs.

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Primary care management of cardiovascular risk for people with severe mental illnesses: the Primrose research programme including cluster RCT

Negative pressure wound therapy for surgical wounds healing by primary closure.

Negative pressure wound therapy for surgical wounds healing by primary closure.

Cost-effectiveness of second-line atezolizumab in Canada for advanced non-small cell lung cancer (NSCLC)

Aim: To assess the cost-effectiveness in Canada of atezolizumab compared with docetaxel or nivolumab for the treatment of advanced NSCLC after first-line platinum-doublet chemotherapy.Materials and methods: A three-state partitioned-survival model was developed. Clinical inputs were obtained from the phase III OAK trial comparing atezolizumab with docetaxel in patients with advanced NSCLC who progressed after first-line platinum-doublet chemotherapy. Overall survival (OS) and progression-free survival (PFS) were extrapolated beyond the trial period using parametric models. A cure model assuming a 1% cure fraction was fitted to the OS data for atezolizumab. Outcomes for nivolumab were informed by a network meta-analysis (NMA) vs atezolizumab. Resource use and costs were informed by clinical expert opinion and published Canadian sources. Utility values were obtained from the OAK trial. The perspective of the analysis was that of the Canadian publicly-funded healthcare system. The base case time horizon was 10 years, and the discount rate was 1.5% annually for both costs and effects. Scenario analyses were performed to test the robustness of the results and all analyses were performed probabilistically.Results: Atezolizumab demonstrated a quality-adjusted life-year (QALY) gain of 0.60 compared with docetaxel at an incremental cost of $85,073, resulting in an incremental cost-effectiveness ratio (ICER) of $142,074/QALY. Atezolizumab dominated nivolumab (regardless of dosing regimen), based on modest differences in both QALYs and costs. Docetaxel was most likely to be cost effective at willingness-to-pay (WTP) thresholds below $125,000/QALY gained, while atezolizumab was most likely to be cost effective beyond this WTP threshold. In most scenario analyses, the results remained robust to changes in parameters. A reduced time horizon and alternative approaches to the NMA had the greatest impact on cost-effectiveness results.Conclusion: Atezolizumab represents a cost-effective therapeutic option in Canada for the treatment of patients with advanced NSCLC who progress after first-line platinum doublet chemotherapy.

Clinical and cost-effectiveness of the Managing Agitation and Raising Quality of Life (MARQUE) intervention for agitation in people with dementia in care homes: a single-blind, cluster-randomised controlled trial

Many people with dementia living in care homes have distressing and costly agitation symptoms. Interventions should be efficacious, scalable, and feasible. We did a parallel-group, cluster-randomised controlled trial in 20 care homes across England. Care homes were eligible if they had 17 residents or more with dementia, agreed to mandatory training for all eligible staff and the implementation of plans, and more than 60% of eligible staff agreed to participate. Staff were eligible if they worked during the day providing face-to-face care for residents with dementia. Residents were eligible if they had a known dementia diagnosis or scored positive on screening with the Noticeable Problems Checklist. A statistician independent of the study randomised care homes (1:1) to the Managing Agitation and Raising Quality of Life (MARQUE) intervention or treatment as usual (TAU) using computer-generated randomisation in blocks of two, stratified by type of home (residential or nursing). Care home staff were not masked to the intervention but were asked not to inform assessors. Residents with dementia, family carers, outcome assessors, statisticians, and health economists were masked to allocation until the data were analysed. MARQUE is an evidence-based manualised intervention, delivered by supervised graduate psychologists to staff in six interactive sessions. The primary outcome was agitation score at 8 months, measured using the Cohen-Mansfield Agitation Inventory (CMAI). Analysis of the primary outcome was done in the modified intention-to-treat population, which included all randomly assigned residents for whom CMAI data was available at 8 months. Mortality was assessed in all randomly assigned residents. This study is registered with the ISRCTN registry, number ISRCTN96745365. Between June 14, 2016, and July 4, 2017, we randomised ten care homes (189 residents) to the MARQUE intervention and ten care homes (215 residents) to TAU. At 8 months, primary outcome data were available for 155 residents in the MARQUE group and 163 residents in the TAU group. At 8 months, no significant differences in mean CMAI scores were identified between the MARQUE and TAU groups (adjusted difference -0·40 [95% CI -3·89 to 3·09; p=0·8226]). In the intervention care homes, 84% of all eligible staff completed all sessions. The mean difference in cost between the MARQUE and TAU groups was £204 (-215 to 623; p=0·320) and mean difference in quality-adjusted life-years was 0·015 (95% CI -0·004 to 0·034; p=0·127). At 8 months, 27 (14%) of 189 residents in the MARQUE group and 41 (19%) of 215 residents in the TAU group had died. The prescription of antipsychotic drugs was not significantly different between the MARQUE group and the TAU group (odds ratio 0·66; 95% CI 0·26 to 1·69, p=0·3880). The MARQUE intervention was not efficacious for agitation although feasible and cost-effective in terms of quality of life. Addressing agitation in care homes might require resourcing for delivery by professional staff of a more intensive intervention, implementing social and activity times, and a longer time to implement change. UK Economic and Social Research Council and the National Institute of Health Research.

Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial.

Minimally invasive video-assisted thoracic surgery (VATS) was first introduced in the early 1990s. For decades, numerous non-randomized studies demonstrated advantages of VATS over thoracotomy with lower morbidity and shorter hospital stay, but only recently did a randomized trial document that VATS results in lower pain scores and better quality of life. Opposing arguments for VATS have always been increased costs and concerns about oncological adequacy. In this paper, we aim to investigate the cost-effectiveness of VATS. The study was designed as a cost-utility analysis of the first 12 months following surgery and was performed together with a clinical randomized controlled trial of VATS versus thoracotomy for lobectomy of stage 1 lung cancer during a 6-year period (2008-2014). All health-related expenses were retrieved from a national database (Statistics Denmark) including hospital readmissions, outpatient clinic visits, prescription medication costs, consultations with general practitioners, specialists, physiotherapists, psychologists and chiropractors. One hundred and three VATS patients and 103 thoracotomy patients were randomized. Mean costs per patient operated by VATS were 103108 Danish Kroner (Dkr) (€13818) and 134945 Dkr (€18085) by thoracotomy, making the costs for VATS 31837 Dkr (€4267) lower than thoracotomy (P < 0.001). The difference in quality-adjusted life years gained over 52 weeks of follow-up was 0.021 (P = 0.048, 95% confidence interval -0.04 to -0.00015) in favour of VATS. The median duration of the surgical procedure was shorter after thoracotomy (79 vs 100 min; P < 0.001). The mean length of hospitalization was shorter following VATS (4.8 vs 6.7 days; P = 0.027). The use of other resources was not significantly different between groups. The costs of resources were lower in the VATS group. This difference was primarily due to reduced costs of readmissions (VATS 29247 Dkr vs thoracotomy 51734 Dkr; P < 0.001) and costs of outpatient visits (VATS 51412 Dkr vs thoracotomy 61575 Dkr; P = 0.012). VATS is a cost-effective alternative to thoracotomy following lobectomy for stage 1 lung cancer. Economical outcomes as measured by quality-adjusted life years were significantly better and overall costs were lower for VATS. NCT01278888.