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Which Costs Matter? Costs Included in Economic Evaluation and their Impact on Decision Uncertainty for Stable Coronary Artery Disease.

ABSTRACT: BACKGROUND:Variation exists in the resource categories included in economic evaluations, and National Institute for Health and Care Excellence (NICE) guidance suggests the inclusion only of costs related to the index condition or intervention. However, there is a growing consensus that all healthcare costs should be included in economic evaluations for Health Technology Assessments (HTAs), particularly those related to extended years of life. OBJECTIVE AND METHODS:We aimed to quantify the impact of a range of cost categories on the adoption decision about a hypothetical intervention, and uncertainty around that decision, for stable coronary artery disease (SCAD) based on a dataset comprising 94,966 patients. Three costing scenarios were considered: coronary heart disease (CHD) costs only, cardiovascular disease (CVD) costs and all costs. The first two illustrate different interpretations of what might be regarded as related costs. RESULTS:Employing a 20-year time horizon, the highest mean expected incremental cost was when all costs were included (£2468) and the lowest when CVD costs only were included (£2377). The probability of the treatment being cost effective, estimating health opportunity costs using a ratio of £30,000 per quality-adjusted life-year (QALY), was different for each of the CHD (70%) costs, CVD costs (73%) and all costs (56%) scenarios. The results concern a hypothetical intervention and are illustrative only, as such they cannot necessarily be generalised to all interventions and diseases. CONCLUSIONS:Cost categories included in an economic evaluation of SCAD impact on estimates of both cost effectiveness and decision uncertainty. With an aging and co-morbid population, the inclusion of all healthcare costs may have important ramifications for the selection of healthcare provision on economic grounds.

SUBMITTER: Lomas J

PROVIDER: S-EPMC6249199 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Which Costs Matter? Costs Included in Economic Evaluation and their Impact on Decision Uncertainty for Stable Coronary Artery Disease.

Lomas James J Asaria Miqdad M Bojke Laura L Gale Chris P CP Richardson Gerry G Walker Simon S

PharmacoEconomics - open 20181201 4

<h4>Background</h4>Variation exists in the resource categories included in economic evaluations, and National Institute for Health and Care Excellence (NICE) guidance suggests the inclusion only of costs related to the index condition or intervention. However, there is a growing consensus that all healthcare costs should be included in economic evaluations for Health Technology Assessments (HTAs), particularly those related to extended years of life.<h4>Objective and methods</h4>We aimed to quan ...[more]

PMID: 29446055

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Project description:AimWe evaluated a decision algorithm for percutaneous coronary interventions (PCI) based on a no-stent strategy, corresponding to a combination of scoring balloon angioplasty (SCBA) and drug-coated balloon (DCB), as a first line approach. Stents were used only in unstable patients, or in case of mandatory bailout stenting (BO-stent).MethodsFrom April 2019 to March 2020, 984 consecutive patients, including 1922 lesions, underwent PCI. The 12-month primary end-point was a composite of major adverse cardiac events (MACE) defined as all-cause death, nonfatal myocardial infarction, nonfatal stroke, and target lesion revascularization. Patients were classified into conventional or no-stent strategy groups according to the PCI strategy. In the no-stent strategy group, they were further classified into BO-stent or DCB-only groups. Their metal index was calculated by stent length divided by the total lesion length.ResultsThe no-stent strategy was applied in 85% of the patients, and it was successful for 65% of them. MACE occurred in 7.1% of the study population, including 4.2% of all-cause death. Target lesion revascularization was required in 1.4%, 3.6%, and 1.5% of patients in the conventional DES, BO-stent, and DCB-only groups, respectively. MACE occurred more often in the elderly and in those treated with at least one stent (metal index greater than 0).ConclusionsThe no-stent strategy, i.e., revascularization of coronary lesions by SCBA followed by DCB and with DES bailout stenting, was effective and safe at 1 year. This PCI approach was applicable on a daily practice in our cath lab.Trial registrationThis study was registered with clinicaltrials.gov (NCT03893396, first posted on March 28, 2019). Feasibility, safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease. DES: drug eluting stent; SCBA: scoring balloon angioplasty; BO-stent: at least one stent; DCB: drug coated balloon; BMS: bare metal stent; Bailout (dash lines); MACE: major adverse cardiac event.

Project description:ObjectiveTo evaluate the cost-effectiveness of percutaneous coronary intervention (PCI) compared with placebo in patients with single-vessel coronary artery disease and angina despite anti-anginal therapy.DesignA cost-effectiveness analysis comparing PCI with placebo. A Markov model was used to measure incremental cost-effectiveness, in cost per quality-adjusted life-years (QALYs) gained, over 12 months. Health utility weights were estimated using responses to the EuroQol 5-level questionnaire, from the Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina trial and UK preference weights. Costs of procedures and follow-up consultations were derived from Healthcare Resource Group reference costs and drug costs from the National Health Service (NHS) drug tariff. Probabilistic sensitivity analysis was undertaken to test the robustness of results to parameter uncertainty. Scenario analyses were performed to test the effect on results of reduced pharmaceutical costs in patients undergoing PCI, and the effect of patients crossing over from placebo to PCI due to refractory angina within 12 months.SettingFive UK NHS hospitals.Participants200 adult patients with stable angina and angiographically severe single-vessel coronary artery disease on anti-anginal therapy.InterventionsAt recruitment, patients received 6 weeks of optimisation of medical therapy for angina after which they were randomised to PCI or a placebo procedure.Outcome measuresIncremental cost-effectiveness ratio (ICER) expressed as cost (in £) per QALY gained for PCI compared with placebo.ResultsThe estimated ICER is £90 218/QALY gained when using PCI compared with placebo in patients receiving medical treatment for angina due to single-vessel coronary artery disease. Results were robust under sensitivity analyses.ConclusionsThe ICER for PCI compared with placebo, in patients with single-vessel coronary artery disease and angina on anti-anginal medication, exceeds the threshold of £30?000 used by the National Institute of Health and Care Excellence when undertaking health technology assessment for the NHS context.Trial registration: The ORBITA study is registered with ClinicalTrials.gov, number NCT02062593.

Project description:AimsCoronary flow reserve (CFR) is an integrated measure of the entire coronary vasculature, and is a powerful prognostic marker in coronary artery disease (CAD). The extent to which coronary revascularization can improve CFR is unclear. This study aimed to evaluate the impact of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) on CFR in patients with stable CAD.Methods and resultsIn a prospective, multicentre observational study, CFR was measured by 15O-water positron emission tomography as the ratio of stress to rest myocardial blood flow at baseline and 6 months after optimal medical therapy (OMT) alone, PCI, or CABG. Changes in the SYNTAX and Leaman scores were angiographically evaluated as indicators of completeness of revascularization. Follow-up was completed by 75 (25 OMT alone, 28 PCI, and 22 CABG) out of 82 patients. The median SYNTAX and Leaman scores, and baseline CFR were 14.5 [interquartile range (IQR): 8-24.5], 5.5 (IQR: 2.5-12.5), and 1.94 (IQR: 1.67-2.66), respectively. Baseline CFR was negatively correlated with the SYNTAX (ρ = -0.40, P < 0.001) and Leaman scores (ρ = -0.33, P = 0.004). Overall, only CABG was associated with a significant increase in CFR [1.67 (IQR: 1.14-1.96) vs. 1.98 (IQR: 1.60-2.39), P < 0.001]. Among patients with CFR <2.0 (n = 41), CFR significantly increased in the PCI [1.70 (IQR: 1.42-1.79) vs. 2.21 (IQR: 1.78-2.49), P = 0.002, P < 0.001 for interaction between time and CFR] and CABG groups [1.28 (IQR: 1.13-1.80) vs. 1.86 (IQR: 1.57-2.22), P < 0.001]. The reduction in SYNTAX or Leaman scores after PCI or CABG was independently associated with the percent increase in CFR after adjusting for baseline characteristics (P = 0.012 and P = 0.011, respectively).ConclusionCoronary revascularization ameliorated reduced CFR in patients with obstructive CAD. The degree of improvement in angiographic CAD burden by revascularization was correlated with magnitude of improvement in CFR.

Project description:BACKGROUND:Remote ischaemic preconditioning (RIPC) is a cardioprotective intervention invoking intermittent periods of ischaemia in a tissue or organ remote from the heart. The mechanisms of this effect are incompletely understood. We hypothesised that RIPC might enhance coronary vasodilatation by an endothelium-dependent mechanism. METHODS:We performed a prospective, randomised, sham-controlled, blinded clinical trial. Patients with stable coronary artery disease (CAD) undergoing elective invasive management were prospectively enrolled, and randomised to RIPC or sham (1:1) prior to angiography. Endothelial-dependent vasodilator function was assessed in a non-target coronary artery with intracoronary infusion of incremental acetylcholine doses (10-6, 10-5, 10-4mol/l). Venous blood was sampled pre- and post-RIPC or sham, and analysed for circulating markers of endothelial function. Coronary luminal diameter was assessed by quantitative coronary angiography. The primary outcome was the between-group difference in the mean percentage change in coronary luminal diameter following the maximal acetylcholine dose (Clinicaltrials.gov identifier: NCT02666235). RESULTS:75 patients were enrolled. Following angiography, 60 patients (mean±SD age 57.5±8.5years; 80% male) were eligible and completed the protocol (n=30 RIPC, n=30 sham). The mean percentage change in coronary luminal diameter was -13.3±22.3% and -2.0±17.2% in the sham and RIPC groups respectively (difference 11.32%, 95%CI: 1.2- 21.4, p=0.032). This remained significant when age and sex were included as covariates (difference 11.01%, 95%CI: 1.01- 21.0, p=0.035). There were no between-group differences in endothelial-independent vasodilation, ECG parameters or circulating markers of endothelial function. CONCLUSIONS:RIPC attenuates the extent of vasoconstriction induced by intracoronary acetylcholine infusion. This endothelium-dependent mechanism may contribute to the cardioprotective effects of RIPC.

Project description:Cardiovascular disease is costly, and annual expenditures are projected to increase. Our objective was to examine the variation in patient-level costs and identify drivers of cost in patients with stable coronary artery disease.In this retrospective cohort study using administrative databases in Ontario, Canada, we identified all patients with stable coronary artery disease after index angiography between Oct. 1, 2008, and Sept. 30, 2011. We excluded patients with a myocardial infarction within 90 days before the index, with normal coronaries, or with mild coronary disease. We categorized hospitals into low, medium or high revascularization ratio centres. The primary outcome was cumulative 1-year health care costs. A hierarchical generalized linear model identified patient, physician and hospital characteristics associated with patient costs, with 2 main covariates of interest: treatment allocation (medical v. percutaneous coronary intervention v. coronary artery bypass grafting) and hospital revascularization ratio.A total of 183?630 angiography procedures were performed in Ontario during the study period. The final cohort included 39?126 patients with stable coronary artery disease, of which 15?138 received medical treatment and 23?988 received revascularization. The mean 1-year cost was $24 026 (interquartile range $8235-$30 511). The mean costs for medical management and revascularization were $18 069 and $27 786, respectively. The strongest predictor of costs was revascularization (percutaneous coronary intervention: cost ratio 1.27, 95% CI [confidence interval] 1.24-1.31; coronary artery bypass grafting: cost ratio 2.62, 95% CI 2.53-2.71). Hospital revascularization ratio did not significantly affect costs. There was no significant interaction between treatment and revascularization ratio.Most health care costs were due to acute care hospital admissions, and costs were higher for patients undergoing revascularization than medical therapy. This study suggests that treatment decision has a substantial impact on health care resources.

Dataset Information

Which Costs Matter? Costs Included in Economic Evaluation and their Impact on Decision Uncertainty for Stable Coronary Artery Disease.

Publications

Which Costs Matter? Costs Included in Economic Evaluation and their Impact on Decision Uncertainty for Stable Coronary Artery Disease.

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