scholarly journals Cost-effectiveness of ablation of ventricular tachycardia in ischaemic cardiomyopathy: limitations in the trial evidence base

Open Heart ◽  
2020 ◽  
Vol 7 (1) ◽  
pp. e001155 ◽  
Author(s):  
Yang Chen ◽  
Manuel Gomes ◽  
Jason V Garcia ◽  
Ross J Hunter ◽  
Anthony W Chow ◽  
...  

ObjectiveCatheter ablation is an important treatment for ventricular tachycardia (VT) that reduces the frequency of episodes of VT. We sought to evaluate the cost-effectiveness of catheter ablation versus antiarrhythmic drug (AAD) therapy.MethodsA decision-analytic Markov model was used to calculate the costs and health outcomes of catheter ablation or AAD treatment of VT for a hypothetical cohort of patients with ischaemic cardiomyopathy and an implantable cardioverter-defibrillator. The health states and input parameters of the model were informed by patient-reported health-related quality of life (HRQL) data using randomised clinical trial (RCT)-level evidence wherever possible. Costs were calculated from a 2018 UK perspective.ResultsCatheter ablation versus AAD therapy had an incremental cost-effectiveness ratio (ICER) of £144 150 (€161 448) per quality-adjusted life-year gained, over a 5-year time horizon. This ICER was driven by small differences in patient-reported HRQL between AAD therapy and catheter ablation. However, only three of six RCTs had measured patient-reported HRQL, and when this was done, it was assessed infrequently. Using probabilistic sensitivity analyses, the likelihood of catheter ablation being cost-effective was only 11%, assuming a willingness-to-pay threshold of £30 000 used by the UK’s National Institute for Health and Care Excellence.ConclusionCatheter ablation of VT is unlikely to be cost-effective compared with AAD therapy based on the current randomised trial evidence. However, better designed studies incorporating detailed and more frequent quality of life assessments are needed to provide more robust and informed cost-effectiveness analyses.

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Chen ◽  
M Gomes ◽  
J V Garcia ◽  
P D Lambiase

Abstract Introduction Randomised clinical trials (RCTs) have suffered from criticisms including a lack of generalisability as well as a lack of cost-effectiveness analysis of the different interventions being studied. Such analyses are used by organisations including the UK's National institute for Health and Care Excellence (NICE) to inform system-level decisions regarding which treatments are funded. There is the potential for a growing chasm to exist between what is the latest innovation in cardiology and what can be afforded. Purpose To evaluate the cost-effectiveness of ventricular tachycardia (VT) catheter ablation versus anti-arrhythmic drug (AAD) therapy in ischemic heart disease. Methods A decision-analytic Markov model was used to calculate the costs and health outcomes of catheter ablation or AAD treatment of VT for a hypothetical cohort of patients with ischaemic cardiomyopathy andan implantable cardioverter defibrillator (ICD). Model inputs where informed using RCT-level evidence [Table 1] wherever possible. Costs were calculated from a UK perspective. Results Catheter ablation vs. AAD therapy had an incremental cost-effectiveness ratio (ICER) of £144,150 (€161,448) per quality adjusted life year (QALY) gained, over a five-year time horizon. The ICER for a ten-year time horizon was £75,074 (€84,083) and £69,986 (€78,384) over the cohort's lifetime. Using probabilistic sensitivity analyses to account for model parameter uncertainty, the likelihood of catheter ablation being cost-effective was only 11%, assuming a willingness to pay threshold of £30,000 used by the NICE [Figure 1]. Table 1. Summary of RCT level source data used to inform Markov model inputs Name of trial SMASH VT VTACH SMS CALYPSO VANISH VISTA Sample size 128 110 111 27 259 118 Mean age 67 66 67 64 68 66 Control AAD AAD AAD AAD AAD Clinical ablation Intervention Ablation Ablation Ablation Ablation Ablation Substrate ablation Length of follow up 22 months 24 months 28 months 6 months 28 months 12 months Mortality (%) 11% [AAD] 7% [AAD] 19% [AAD] 14% [AAD] 28% [AAD] 15% [C-ablation] vs. vs. vs. vs. vs. vs. 9% [Ablation] 10% [Ablation] 17% [Ablation] 15% [Ablation] 27% [Ablation] 9% [S-Ablation] Readmission (%) 19% [AAD] 55% [AAD] 44% [AAD] 50% [AAD] 31% [AAD] 32% [C-ablation] vs. vs. vs. vs. vs. vs. 12% [S-ablation] 6% [Ablation] 33% [Ablation] 39% [Ablation] 38% [Ablation] 25% [Ablation] Cost-effectiveness acceptability curve Conclusion Catheter ablation of VT is unlikely to be cost-effective compared with AAD therapy alone in patients with ischaemic cardiomyopathy implanted with an ICD based on pooled trial evidence. However, better designed studies incorporating detailed and more frequent quality of life assessment are needed to advise health policy in this field and to provide more informed cost-effectiveness analyses. Acknowledgement/Funding NIHR Academic Clinical Fellowship


Author(s):  
Danielle M. Gillard ◽  
Jeffrey D. Sharon

Abstract Purpose of Review To summarize and critically review recent literature on the relative cost-effectiveness of hearing augmentation versus stapes surgery for the treatment of otosclerosis. Recent Findings Otosclerosis leads to reduced patient quality of life, which can be ameliorated by either stapes surgery, or hearing aid usage. The success of stapes surgery is high, and the risks of serious postoperative complications are low. Hearing aids don’t have the complications of surgery but are associated with long-term costs. Cost-effectiveness models have shown that stapes surgery is a cost-effective method for treating otosclerosis. Summary Both stapes surgery and hearing aids can improve patient-reported quality of life in otosclerosis. Stapes surgery has larger upfront costs and surgical risks, but hearing aids are associated with longer lifetime costs. Stapes surgery is cost-effective for the treatment of otosclerosis.


2015 ◽  
Vol 33 (26) ◽  
pp. 2885-2892 ◽  
Author(s):  
Isabelle Borget ◽  
Julia Bonastre ◽  
Bogdan Catargi ◽  
Désirée Déandréis ◽  
Slimane Zerdoud ◽  
...  

Purpose In the ESTIMABL phase III trial, the thyroid ablation rate was equivalent for the two thyroid-stimulating hormone (TSH) stimulation methods (thyroid hormone withdrawal [THW] and recombinant human TSH [rhTSH]) and the two iodine-131 (131I) activities (1.1 or 3.7 GBq). The objectives of this article were to present health-related quality-of-life (HRQoL) results and a cost-effectiveness evaluation performed alongside this trial. Patients and Methods HRQoL and utility were longitudinally assessed, from random assignment to the follow-up visit at 8 ± 2 months for the 752 patients with thyroid cancer, using the Short Form-36 and the EuroQoL-5D questionnaires, respectively. A cost-effectiveness analysis was performed from the societal perspective in the French context. Resource use (hospitalization for 131I administration, rhTSH, sick leaves, and transportation) was collected prospectively. We used the net monetary benefit approach and computed cost-effectiveness acceptability curves for both TSH stimulation methods and 131I activities. Sensitivity analyses of the costs of rhTSH were performed. Results At 131I administration, THW caused a clinically significant deterioration of HRQoL, whereas HRQoL remained stable with rhTSH. This deterioration was transient with no difference 3 months later. rhTSH was more effective than THW in terms of quality-adjusted life-years (QALYs; +0.013 QALY/patient) but more expensive (+€474/patient). The probability that rhTSH would be cost effective at a €50,000/QALY threshold was 47% in France. The use of 1.1 GBq of 131I instead of 3.7 GBq reduced per-patient costs by €955 (US$1,018) but with slightly decreased efficacy (−0.007 QALY/patient). Conclusion rhTSH avoids the transient THW-induced deterioration of HRQoL but is unlikely to be cost effective at its current price.


2014 ◽  
Vol 18 (68) ◽  
pp. 1-206 ◽  
Author(s):  
Geoff Frampton ◽  
Petra Harris ◽  
Keith Cooper ◽  
Andrew Lotery ◽  
Jonathan Shepherd

BackgroundElective cataract surgery is the most commonly performed surgical procedure in the NHS. In bilateral cataracts, the eye with greatest vision impairment from cataract is operated on first. First-eye surgery can improve vision and quality of life. However, it is unclear whether or not cataract surgery on the second eye provides enough incremental benefit to be considered clinically effective and cost-effective.ObjectiveTo conduct a systematic review of clinical effectiveness and analysis of cost-effectiveness of second-eye cataract surgery in England and Wales, based on an economic model informed by systematic reviews of cost-effectiveness and quality of life.Data sourcesTwelve electronic bibliographic databases, including MEDLINE, EMBASE, Web of Science, The Cochrane Library and the Centre for Reviews and Dissemination databases were searched from database inception to April 2013, with searches updated in July 2013. Reference lists of relevant publications were also checked and experts consulted.Review methodsTwo reviewers independently screened references, extracted and checked data from the included studies and appraised their risk of bias. Based on the review of cost-effectiveness, a de novo economic model was developed to estimate the cost-effectiveness of second-eye surgery in bilateral cataract patients. The model is based on changes in quality of life following second-eye surgery and includes post-surgical complications.ResultsThree randomised controlled trials (RCTs) of clinical effectiveness, three studies of cost-effectiveness and 10 studies of health-related quality of life (HRQoL) met the inclusion criteria for the systematic reviews and, where possible, were used to inform the economic analysis. Heterogeneity of studies precluded meta-analyses, and instead data were synthesised narratively. The RCTs assessed visual acuity, contrast sensitivity, stereopsis and several measures of HRQoL. Improvements in binocular visual acuity and contrast sensitivity were small and unlikely to be of clinical significance, but stereopsis was improved to a clinically meaningful extent following second-eye surgery. Studies did not provide evidence that second-eye surgery significantly affected HRQoL, apart from an improvement in the mental health component of HRQoL in one RCT. In the model, second-eye surgery generated 0.68 incremental quality-adjusted life-years with an incremental cost-effectiveness ratio of £1964. Model results were most sensitive to changes in the utility gain associated with second-eye surgery, but otherwise robust to changes in parameter values. The probability that second-eye surgery is cost-effective at willingness-to-pay thresholds of £10,000 and £20,000 is 100%.LimitationsClinical effectiveness studies were all conducted more than 9 years ago. Patients had good vision pre surgery which may not represent all patients eligible for second-eye surgery. For some vision-related patient-reported outcomes and HRQoL measures, thresholds for determining important clinical effects are either unclear or have not been determined.ConclusionsSecond-eye cataract surgery is generally cost-effective based on the best available data and under most assumptions. However, more up-to-date data are needed. A well-conducted RCT that reflects current populations and enables the estimation of health state utility values would be appropriate. Guidance is required on which vision-related, patient-reported outcomes are suitable for assessing effects of cataract surgery in the NHS and how these measures should be interpreted clinically.Study registrationThis project is registered as PROSPERO CRD42013004211.FundingThis project was funded by the National Institute for Health Research Health Technology Assessment programme.


2016 ◽  
Vol 6 (1) ◽  
Author(s):  
Wen-Wen Yue ◽  
Shu-Rong Wang ◽  
Feng Lu ◽  
Xiao-Long Li ◽  
Hui-Xiong Xu ◽  
...  

Abstract This study is to compare the health-related quality of life (HRQoL) and cost-effectiveness of radiofrequency ablation (RFA) and open thyroidectomy (OT) for benign thyroid nodules (BTNs) treatment. HRQoL and utility were assessed for 404 BTN patients immediately before treatments (RFA:OT = 137:267) and at 6-month visit. A cost-effectiveness analysis was performed from societal perspective in the China context. Resource use (hospitalization, sick leaves) was collected. We used the net monetary benefit approach and computed cost-effectiveness acceptability curves for RFA and OT. Sensitivity analyses of costs of RFA were performed. At 6-month visit, patients treated with RFA had significantly better HRQoL than patients treated with OT on general health (68.5 versus 66.7, P = 0.029), vitality (71.3 versus 67.5, P < 0.001) and mental health (80.9 versus 79.3, P = 0.038). RFA was more effective than OT in terms of quality-adjusted life-years (QALYs; 0.01QALY/patient) but more expensive (US$823/patient). The probability that RFA would be cost effective at a US$50,000/QALY threshold was 15.5% in China, and it would be increased to 88.4% when price of the RFA device was lowered by 30%. RFA exhibited a significant improvement of HRQoL relative to OT, but is unlikely to be cost effective at its current price in short time.


BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023881 ◽  
Author(s):  
Filipa Sampaio ◽  
Marianne Bonnert ◽  
Ola Olén ◽  
Erik Hedman ◽  
Maria Lalouni ◽  
...  

ObjectiveTo assess whether exposure-based internet-delivered cognitive–behavioural therapy (internet-CBT) is a cost-effective treatment for adolescents with irritable bowel syndrome (IBS) compared with a waitlist control, from a societal perspective, based on data from a randomised trial.DesignWithin-trial cost-effectiveness analysis.SettingParticipants were recruited from the whole of Sweden via primary, secondary and tertiary care clinics reached through news media and advertising.ParticipantsAdolescents (aged 13–17) with a diagnosis of IBS.InterventionsParticipants were randomised to either an exposure-based internet-CBT, including 10 weekly modules for adolescents and five modules for parents, or a waitlist.Outcome measuresThe main health outcome was the quality-adjusted life-year (QALY) estimated by mapping Pediatric Quality-of-Life Inventory (PedsQL) scores onto EQ-5D-3L utilities. The secondary outcome was the point improvement on the PedsQL scale. Data on health outcomes and resource use were collected at baseline and 10 weeks post-treatment. Resource use was measured using the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) . Incremental cost-effectiveness ratios (ICER) were calculated as the difference in average costs by the difference in average outcomes between groups.ResultsThe base-case results showed that internet-CBT costs were on average US$170.24 (95% CI 63.14 to 315.04) more per participant than the waitlist. Adolescents in the internet-CBT group showed small QALY gains (0.0031; 95% CI 0.0003 to 0.0061), and an average improvement of 5.647 points (95% CI 1.82 to 9.46) on the PedsQL compared with the waitlist. Internet-CBT yielded an ICER of $54 916/QALY gained and a probability of cost-effectiveness of 74% given the Swedish willingness-to-pay threshold. The ICER for the outcome PedsQL was US$85.29/point improvement.ConclusionsOffering internet-CBT to adolescents with IBS improves health-related quality of life and generates small QALY gains at a higher cost than a waitlist control. Internet-CBT is thus likely to be cost-effective given the strong efficacy evidence, small QALY gains and low cost.Trial registration numberNCT02306369; Results.


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20573-e20573 ◽  
Author(s):  
G. Bernardo ◽  
R. Palumbo ◽  
M. Frascaroli ◽  
A. Bernardo ◽  
A. Losurdo ◽  
...  

e20573 Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life. No significant financial relationships to disclose.


2015 ◽  
Vol 19 (40) ◽  
pp. 1-188 ◽  
Author(s):  
Alison McMillan ◽  
Daniel J Bratton ◽  
Rita Faria ◽  
Magda Laskawiec-Szkonter ◽  
Susan Griffin ◽  
...  

BackgroundThe therapeutic and economic benefits of continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnoea syndrome (OSAS) have been established in middle-aged people. In older people there is a lack of evidence.ObjectiveTo determine the clinical efficacy of CPAP in older people with OSAS and to establish its cost-effectiveness.DesignA randomised, parallel, investigator-blinded multicentre trial with within-trial and model-based cost-effectiveness analysis.MethodsTwo hundred and seventy-eight patients, aged ≥ 65 years with newly diagnosed OSAS [defined as oxygen desaturation index at ≥ 4% desaturation threshold level for > 7.5 events/hour and Epworth Sleepiness Scale (ESS) score of ≥ 9] recruited from 14 hospital-based sleep services across the UK.InterventionsCPAP with best supportive care (BSC) or BSC alone. Autotitrating CPAP was initiated using standard clinical practice. BSC was structured advice on minimising sleepiness.Coprimary outcomesSubjective sleepiness at 3 months, as measured by the ESS (ESS mean score: months 3 and 4) and cost-effectiveness over 12 months, as measured in quality-adjusted life-years (QALYs) calculated using the European Quality of Life-5 Dimensions (EQ-5D) and health-care resource use, information on which was collected monthly from patient diaries.Secondary outcomesSubjective sleepiness at 12 months (ESS mean score: months 10, 11 and 12) and objective sleepiness, disease-specific and generic quality of life, mood, functionality, nocturia, mobility, accidents, cognitive function, cardiovascular risk factors and events at 3 and 12 months.ResultsTwo hundred and seventy-eight patients were randomised to CPAP (n = 140) or BSC (n = 138) over 27 months and 231 (83%) patients completed the trial. Baseline ESS score was similar in both groups [mean (standard deviation; SD) CPAP 11.5 (3.3), BSC 11.4 (4.2)]; groups were well balanced for other characteristics. The mean (SD) in ESS score at 3 months was –3.8 (0.4) in the CPAP group and –1.6 (0.3) in the BSC group. The adjusted treatment effect of CPAP compared with BSC was –2.1 points [95% confidence interval (CI) –3.0 to –1.3 points;p < 0.001]. At 12 months the effect was –2.0 points (95% CI –2.8 to –1.2 points;p < 0.001). The effect was greater in patients with increased CPAP use or higher baseline ESS score. The number of QALYs calculated using the EQ-5D was marginally (0.005) higher with CPAP than with BSC (95% CI –0.034 to 0.044). The average cost per patient was £1363 (95% CI £1121 to £1606) for those allocated to CPAP and £1389 (95% CI £1116 to £1662) for those allocated to BSC. On average, costs were lower in the CPAP group (mean –£35; 95% CI –£390 to £321). The probability that CPAP was cost-effective at thresholds conventionally used by the NHS (£20,000 per QALY gained) was 0.61. QALYs calculated using the Short Form questionnaire-6 Dimensions were 0.018 higher in the CPAP group (95% CI 0.003 to 0.034 QALYs) and the probability that CPAP was cost-effective was 0.96. CPAP decreased objective sleepiness (p = 0.02), increased mobility (p = 0.03) and reduced total and low-density lipoprotein cholesterol (p = 0.05,p = 0.04, respectively) at 3 months but not at 12 months. In the BSC group, there was a fall in systolic blood pressure of 3.7 mmHg at 12 months, which was not seen in the CPAP group (p = 0.04). Mood, functionality, nocturia, accidents, cognitive function and cardiovascular events were unchanged. There were no medically significant harms attributable to CPAP.ConclusionIn older people with OSAS, CPAP reduces sleepiness and is marginally more cost-effective than BSC over 12 months. Further work is required in the identification of potential biomarkers of sleepiness and those patients at increased risk of cognitive impairment. Early detection of which could be used to inform the clinician when in the disease cycle treatment is needed to avert central nervous system sequelae and to assist patients decision-making regarding treatment and compliance. Treatment adherence is also a challenge in clinical trials generally, and adherence to CPAP therapy in particular is a recognised concern in both research studies and clinical practice. Suggested research priorities would include a focus on optimisation of CPAP delivery or support and embracing the technological advances currently available. Finally, the improvements in quality of life in trials do not appear to reflect the dramatic changes noted in clinical practice. There should be a greater focus on patient centred outcomes which would better capture the symptomatic improvement with CPAP treatment and translate these improvements into outcomes which could be used in health economic analysis.Trial registrationCurrent Controlled Trials ISRCTN90464927.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 40. See the NIHR Journals Library website for further project information.


2010 ◽  
Vol 196 (5) ◽  
pp. 377-382 ◽  
Author(s):  
Paul McCrone ◽  
Tom K. J. Craig ◽  
Paddy Power ◽  
Philippa A. Garety

BackgroundThere is concern that delaying treatment for psychosis may have a negative impact on its long-term course. A number of countries have developed early intervention teams but there is limited evidence regarding their cost-effectiveness.AimsTo compare the costs and cost-effectiveness of an early intervention service in London with standard care.MethodIndividuals in their first episode of psychosis (or those who had previously discontinued treatment) were recruited to the study. Clinical variables and costs were measured at baseline and then at 6- and 18-month follow-up. Information on quality of life and vocational outcomes were combined with costs to assess cost-effectiveness.ResultsA total of 144 people were randomised. Total mean costs were £11 685 in the early intervention group and £14 062 in the standard care group, with the difference not being significant (95% CI –£8128 to £3326). When costs were combined with improved vocational and quality of life outcomes it was shown that early intervention would have a very high likelihood of being cost-effective.ConclusionsEarly intervention did not increase costs and was highly likely to be cost-effective when compared with standard care.


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