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author:("sculpted, M.")
1.  What is the Quality of Economic Evaluations of Non-Drug Therapies? A Systematic Review and Critical Appraisal of Economic Evaluations of Radiotherapy for Cancer 
Background
Breast, cervical and colorectal cancers are the three most frequent cancers in women, while lung, prostate and colorectal cancers are the most frequent in men. Much attention has been given to the economic evaluation of pharmaceuticals for treatment of cancer by the National Institute for Health and Care Excellence (NICE) in the UK and similar authorities internationally, while economic analysis developed for other types of anti-cancer interventions, including radiotherapy and surgery, are less common.
Objectives
Our objective was to review methods used in published cost-effectiveness studies evaluating radiotherapy for breast, cervical, colorectal, head and neck and prostate cancer, and to compare the economic evaluation methods applied with those defined in the guidelines used by the NICE technology appraisal programme.
Methods
A systematic search of seven databases (MEDLINE, EMBASE, CDSR, NHSEED, HTA, DARE, EconLit) as well as research registers, the NICE website and conference proceedings was conducted in July 2012. Only economic evaluations of radiotherapy interventions in individuals diagnosed with cancer that included quality-adjusted life-years (QALYs) or life-years (LYs) were included. Included studies were appraised on the basis of satisfying essential, preferred and UK-specific methods requirements, building on the NICE Reference Case for economic evaluations and on other methods guidelines.
Results
A total of 29 studies satisfied the inclusion criteria (breast 14, colorectal 2, prostate 10, cervical 0, head and neck 3). Only two studies were conducted in the UK (13 in the USA). Among essential methods criteria, the main issue was that only three (10 %) of the studies used clinical-effectiveness estimates identified through systematic review of the literature. Similarly, only eight (28 %) studies sourced health-related quality-of-life data directly from patients with the condition of interest. Other essential criteria (e.g. clear description of comparators, patient group indication and appropriate time horizon) were generally fulfilled, while most of the UK-specific requirements were not met.
Conclusion
Based on this review there is a dearth of up-to-date, robust evidence on the cost effectiveness of radiotherapy in cancer suitable to support decision making in the UK. Studies selected did not fully satisfy essential method standards currently recommended by NICE.
doi:10.1007/s40258-014-0115-8
PMCID: PMC4175431  PMID: 25060829
2.  Sugammadex compared with neostigmine/glycopyrrolate for routine reversal of neuromuscular block: a systematic review and economic evaluation† 
BJA: British Journal of Anaesthesia  2010;105(5):558-567.
Summary
The cost-effectiveness of sugammadex for the routine reversal of muscle relaxation produced by rocuronium or vecuronium in UK practice is uncertain. We performed a systematic review of randomized controlled trials of sugammadex compared with neostigmine/glycopyrrolate and an economic assessment of sugammadex for the reversal of moderate or profound neuromuscular block (NMB) produced by rocuronium or vecuronium. The economic assessment aimed to establish the reduction in recovery time and the ‘value of time saved’ which would be necessary for sugammadex to be potentially cost-effective compared with existing practice. Three trials indicated that sugammadex 2 mg kg−1 (4 mg kg−1) produces more rapid recovery from moderate (profound) NMB than neostigmine/glycopyrrolate. The economic assessment indicated that if the reductions in recovery time associated with sugammadex in the trials are replicated in routine practice, sugammadex would be cost-effective if those reductions are achieved in the operating theatre (assumed value of staff time, £4.44 per minute), but not if they are achieved in the recovery room (assumed value of staff time, £0.33 per minute). However, there is considerable uncertainty in these results. Sugammadex has the potential to be cost-effective compared with neostigmine/glycopyrrolate for the reversal of rocuronium-induced moderate or profound NMB, provided that the time savings observed in trials can be achieved and put to productive use in clinical practice. Further research is required to evaluate the effects of sugammadex on patient safety, predictability of recovery from NMB, patient outcomes, and efficient use of resources.
doi:10.1093/bja/aeq269
PMCID: PMC2955536  PMID: 20935005
clinical trials; neuromuscular block, recovery; neuromuscular block, rocuronium
3.  Sugammadex for reversal of neuromuscular block after rapid sequence intubation: a systematic review and economic assessment† 
BJA: British Journal of Anaesthesia  2010;105(5):568-575.
Summary
Sugammadex 16 mg kg−1 can be used for the immediate reversal of neuromuscular block 3 min after administration of rocuronium and could be used in place of succinylcholine for emergency intubation. We have systematically reviewed the efficacy and cost-effectiveness and made an economic assessment of sugammadex for immediate reversal. The economic assessment investigated whether sugammadex appears cost-effective under various assumptions about the value of any reduction in recovery time with sugammadex, the likelihood of a ‘can't intubate, can't ventilate’ (CICV) event, the age of the patient, and the length of the procedure. Three trials were included in the efficacy review. Sugammadex administered 3 or 5 min after rocuronium produced markedly faster recovery than placebo or spontaneous recovery from succinylcholine-induced block. No published economic evaluations were found. Our economic analyses showed that sugammadex appears more cost-effective, where the value of any reduction in recovery time is greater, where the reduction in mortality compared with succinylcholine is greater, and where the patient is younger, for lower probabilities of a CICV event and for long procedures which do not require profound block throughout. Because of the lack of evidence, the value of some parameters remains unknown, which makes it difficult to provide a definitive assessment of the cost-effectiveness of sugammadex in practice. The use of sugammadex in combination with high-dose rocuronium is efficacious. Further research is needed to clarify key parameters in the analysis and to allow a fuller economic assessment.
doi:10.1093/bja/aeq270
PMCID: PMC2955537  PMID: 20937718
complications, intubation tracheal; neuromuscular block, recovery; neuromuscular block, rocuronium; neuromuscular block, succinylcholine
4.  Cost-effectiveness of shared pharmaceutical care for older patients: RESPECT trial findings 
Background
Pharmaceutical care serves as a collaborative model for medication review. Its use is advocated for older patients, although its cost-effectiveness is unknown. Although the accompanying article on clinical effectiveness from the RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) trial finds no statistically significant impact on prescribing for older patients undergoing pharmaceutical care, economic evaluations are based on an estimation, rather than hypothesis testing.
Aim
To evaluate the cost-effectiveness of pharmaceutical care for older people compared with usual care, according to National Institute for Health and Clinical Excellence (NICE) reference case standards.
Methods
An economic evaluation was undertaken in which NICE reference case standards were applied to data collected in the RESPECT trial.
Results
On average, pharmaceutical care is estimated to cost an incremental £10 000 per additional quality-adjusted life year (QALY). If the NHS's cost-effectiveness threshold is between £20 000 and £30 000 per extra QALY, then the results indicate that pharmaceutical care is cost-effective despite a lack of statistical significance to this effect. However, the statistical uncertainty surrounding the estimates implies that the probability that pharmaceutical care is not cost-effective lies between 0.22 and 0.19. Although results are not sensitive to assumptions about costs, they differ between subgroups: in patients aged >75 years pharmaceutical care appears more cost-effective for those who are younger or on fewer repeat medications.
Conclusion
Although pharmaceutical care is estimated to be cost-effective in the UK, the results are uncertain and further research into its long-term benefits may be worthwhile.
doi:10.3399/bjgp09X482312
PMCID: PMC2801802  PMID: 20040164
cost-effectiveness; health services for the aged; medication therapy management; pharmaceutical care
5.  A randomised controlled trial to assess the effectiveness and cost of a patient orientated self management approach to chronic inflammatory bowel disease 
Gut  2004;53(11):1639-1645.
Objectives: We developed a patient centred approach to chronic disease self management by providing information designed to promote patient choice. We then conducted a randomised controlled trial of the approach in inflammatory bowel disease (IBD) to assess whether it could alter clinical outcome and affect health service use.
Design: A multicentre cluster randomised controlled trial.
Setting: The trial was conducted in the outpatient departments of 19 hospitals with randomisation by treatment centre, 10 control sites, and nine intervention sites. For patients at intervention sites, an individual self management plan was negotiated and written information provided.
Participants: A total of 700 patients with established inflammatory bowel disease were recruited.
Main outcome measures: Main outcome measures recorded at one year were: quality of life, health service resource use, and patient satisfaction. Secondary outcomes included measures of enablement—confidence to cope with the condition.
Results: One year following the intervention, self managing patients had made fewer hospital visits (difference −1.04 (95% confidence interval (CI) −1.43 to −0.65); p<0.001) without increase in the number of primary care visits, and quality of life was maintained without evidence of anxiety about the programme. The two groups were similar with respect to satisfaction with consultations. Immediately after the initial consultation, those who had undergone self management training reported greater confidence in being able to cope with their condition (difference 0.90 (95% CI 0.12–1.68); p<0.03).
Conclusions: Adoption of this approach for the management of chronic disease such as IBD in the NHS and other managed health care organisations would considerably reduce health provision costs and benefit disease control.
doi:10.1136/gut.2003.034256
PMCID: PMC1774266  PMID: 15479685
randomised controlled trial; inflammatory bowel disease; self management
6.  Cost effectiveness of clinically appropriate decisions on alternative treatments for angina pectoris: prospective observational study 
BMJ : British Medical Journal  2007;334(7594):624.
Objective To assess whether revascularisation that is considered to be clinically appropriate is also cost effective.
Design Prospective observational study comparing cost effectiveness of coronary artery bypass grafting, percutaneous coronary intervention, or medical management within groups of patients rated as appropriate for revascularisation.
Setting Three tertiary care centres in London.
Participants Consecutive, unselected patients rated as clinically appropriate (using a nine member Delphi panel) to receive coronary artery bypass grafting only (n=815); percutaneous coronary intervention only (n=385); or both revascularisation procedures (n=520).
Main outcome measure Cost per quality adjusted life year gained over six year follow-up, calculated with a National Health Service cost perspective and discounted at 3.5%/year.
Results Coronary artery bypass grafting cost £22 000 (€33 000; $43 000) per quality adjusted life year gained compared with percutaneous coronary intervention among patients appropriate for coronary artery bypass grafting only (59% probability of being cost effective at a cost effectiveness threshold of £30 000 per quality adjusted life year) and £19 000 per quality adjusted life year gained compared with medical management among those appropriate for both types of revascularisation (probability of being cost effective 63%). In none of the three appropriateness groups was percutaneous coronary intervention cost effective at a threshold of £30 000 per quality adjusted life year. Among patients rated appropriate for percutaneous coronary intervention only, the cost per quality adjusted life year gained for percutaneous coronary intervention compared with medical management was £47 000, exceeding usual cost effectiveness thresholds; in these patients, medical management was most likely to be cost effective (probability 54%).
Conclusions Among patients judged clinically appropriate for coronary revascularisation, coronary artery bypass grafting seemed cost effective but percutaneous coronary intervention did not. Cost effectiveness analysis based on observational data suggests that the clinical benefit of percutaneous coronary intervention may not be sufficient to justify its cost.
doi:10.1136/bmj.39129.442164.55
PMCID: PMC1832000  PMID: 17339236
7.  The "Let's Get Alarmed!" initiative: a smoke alarm giveaway programme 
Injury Prevention  1999;5(3):177-182.
Objectives—To reduce fires and fire related injuries by increasing the prevalence of functioning smoke alarms in high risk households.
Setting—The programme was delivered in an inner London area with above average material deprivation and below average smoke alarm ownership. The target population included low income and rental households and households with elderly persons or young children.
Methods—Forty wards, averaging 4000 households each, were randomised to intervention or control status. Free smoke alarms and fire safety information were distributed in intervention wards by community groups and workers as part of routine activities and by paid workers who visited target neighbourhoods. Recipients provided data on household age distribution and housing tenure. Programme costs were documented from a societal perspective. Data are being collected on smoke alarm ownership and function, and on fires and related injuries and their costs.
Results—Community and paid workers distributed 20 050 smoke alarms, potentially sufficient to increase smoke alarm ownership by 50% in intervention wards. Compared with the total study population, recipients included greater proportions of low income and rental households and households including children under 5 years or adults aged 65 and older. Total programme costs were £145 087.
Conclusions—It is possible to implement a large scale smoke alarm giveaway programme targeted to high risk households in a densely populated, multicultural, materially deprived community. The programme's effects on the prevalence of installed and functioning alarms and the incidence of fires and fire related injuries, and its cost effectiveness, are being evaluated as a randomised controlled trial.
PMCID: PMC1730526  PMID: 10518263
8.  Screening for Down's syndrome: effects, safety, and cost effectiveness of first and second trimester strategies 
BMJ : British Medical Journal  2001;323(7310):423.
Objective
To compare the effects, safety, and cost effectiveness of antenatal screening strategies for Down's syndrome.
Design
Analysis of incremental cost effectiveness.
Setting
United Kingdom.
Main outcome measures
Number of liveborn babies with Down's syndrome, miscarriages due to chorionic villus sampling or amniocentesis, healthcare costs of screening programme, and additional costs and additional miscarriages per additional affected live birth prevented by adopting a more effective strategy.
Results
Compared with no screening, the additional cost per additional liveborn baby with Down's syndrome prevented was £22 000 for measurement of nuchal translucency. The cost of the integrated test was £51 000 compared with measurement of nuchal translucency. All other strategies were more costly and less effective, or cost more per additional affected baby prevented. Depending on the cost of the screening test, the first trimester combined test and the quadruple test would also be cost effective options.
Conclusions
The choice of screening strategy should be between the integrated test, first trimester combined test, quadruple test, or nuchal translucency measurement depending on how much service providers are willing to pay, the total budget available, and values on safety. Screening based on maternal age, the second trimester double test, and the first trimester serum test was less effective, less safe, and more costly than these four options.
What is already known on this topicScreening strategies that combine nuchal translucency measurement with serum testing perform better than either of these tests used aloneSerum testing in the second trimester using the triple test is cost effective compared with screening based on maternal ageWhat this study addsThe integrated test is the most effective, safest, and most expensive strategyThe choice of screening strategy should be between the integrated test, first trimester combined test, quadruple test, or measurement of nuchal translucencyScreening based on maternal age, the second trimester double test, and the first trimester serum test is less effective, less safe, and more costly than the above options
PMCID: PMC37550  PMID: 11520837
11.  Cost effectiveness analysis of antenatal HIV screening in United Kingdom 
BMJ : British Medical Journal  1999;319(7219):1230-1234.
Objective
To assess the cost effectiveness of universal antenatal HIV screening compared with selective screening in the United Kingdom.
Design
Incremental cost effectiveness analysis relating additional costs of screening to life years gained. Maternal and paediatric costs and life years were combined.
Setting
United Kingdom.
Main outcome measures
Number of districts for which universal screening would be cost effective compared with selective screening under various conditions.
Results
On base case assumptions, a new diagnosis of a pregnant woman with HIV results in a gain of 6.392 life years and additional expenditure of £14 833. If decision makers are prepared to pay up to £10 000 for an additional life year, this would imply a net benefit of £49 090 (range £12 300-£59 000), which would be available to detect each additional infected woman in an antenatal screening programme. In London, universal antenatal screening would be cost effective compared with a selective screening under any reasonable assumptions about screening costs. Outside London, universal screening with uptake above 90% would be cost effective with a £0.60 HIV antibody test cost and up to 3.5 minutes for pretest discussion. Cost effectiveness of universal testing is lower if selective testing can achieve high uptake among those at higher risk. A universal strategy with only 50% uptake may not be less cost effective in low prevalence districts and may cost more and be less effective than a well run selective strategy.
Conclusions
Universal screening with pretest discussion should be adopted throughout the United Kingdom as part of routine antenatal care as long as test costs can be kept low and uptake high.
Key messagesIn 1997 only 13% of undiagnosed HIV infection in pregnant women was picked up on antenatal testing, resulting in many preventable paediatric infectionsAssuming NHS willingness to pay £10 000 per life year gained, universal testing would be much more cost effective than selective testing throughout London on any reasonable assumptions on costs, prevalence, and uptake of testingOutside London, universal testing would also be cost effective, even allowing 2-4 minutes for pretest discussion, provided that test costs were no more than £0.60 and uptake exceeded 90%Low cost tests could be achieved by pooling antenatal sera or centralisation of testingUniversal testing with uptake of 50% may be less cost effective than a well run selective programme
PMCID: PMC28271  PMID: 10550083
12.  Commentary: Markov models of medical prognosis. 
BMJ : British Medical Journal  1997;314(7077):354-355.
PMCID: PMC2125826  PMID: 9040334
13.  Cost effectiveness of screening for and eradication of Helicobacter pylori in management of dyspeptic patients under 45 years of age. 
BMJ : British Medical Journal  1996;312(7042):1321-1325.
OBJECTIVE--To assess the cost effectiveness of screening for and eradicating Helicobacter pylori in patients under 45 years of age presenting with dyspepsia. DESIGN--A decision analytic model composed of a decision tree to represent the epidemiology of dyspepsia and a Markov process to model the outcomes of treatment. PATIENTS--Patients under the age of 45 years presenting to their general practitioner with (peptic type) dyspepsia. INTERVENTIONS--Conventional empirical treatment with healing and maintenance doses of cimetidine v eradication treatment solely in patients with confirmed peptic ulcer; and conventional empirical treatment for all dyspeptic patients compared with the use of a serology test to identify patients with H pylori, who then receive endoscopy to investigate the presence of peptic ulcer disease and, when disease is found, are given eradication treatment with a breath test to confirm successful eradication. MAIN OUTCOME MEASURES--Expected cumulative costs over a period of 10 years. The proportion of time patients spend without a recurrent ulcer. RESULTS--After receiving eradication treatment, patients with confirmed ulcer spend an average of 99% of their time free from recurrent ulcer disease compared with 95% after treatment with cimetidine. Eradication treatment costs less than that with cimetidine. When the initial cost of identifying appropriate patients to receive eradication treatment is added to the analysis, however, these cost savings take almost eight years to accrue. CONCLUSIONS--Enthusiasm for introducing testing for and eradication of H pylori for dyspeptic patients in general practice should be tempered by an awareness that cost savings may take many years to realise.
PMCID: PMC2350996  PMID: 8646042
14.  Managing menorrhagia. 
Quality in Health Care  1995;4(3):218-226.
PMCID: PMC1055321  PMID: 10153434
15.  The cost effectiveness of ivabradine in the treatment of chronic heart failure from the UK National Health Service perspective 
Heart  2014;100(13):1031-1036.
Objective
Ivabradine, a specific heart rate lowering therapy, has been shown in a randomised placebo-controlled study, Systolic HF Treatment with the If Inhibitor Ivabradine Trial (SHIfT), to significantly reduce the composite end point of cardiovascular death and hospitalisation for worsening heart failure (HF) in patients with systolic HF who are in sinus rhythm and with a heart rate ≥70 bpm, when added to optimised medical therapy (HR: 0.82, 95% CI 0.75 to 0.90, p<0.0001). We assessed the cost effectiveness of ivabradine, from a UK National Health Service perspective, based on the results of SHIfT.
Methods
A Markov model estimated the cost effectiveness of ivabradine compared with standard care for two cohorts of patients with HF (heart rate ≥75 bpm in line with the EU labelled indication; and heart rate ≥70 bpm in line with the SHIfT study population). Modelled outcomes included death, hospitalisation, quality of life and New York Heart Association class. Total costs and quality adjusted life years (QALYs) for ivabradine and standard care were estimated over a lifetime horizon.
Results
The incremental cost per additional QALY for ivabradine plus standard care versus standard care has been estimated as £8498 for heart rate ≥75 bpm and £13 764 for heart rate ≥70 bpm. Ivabradine is expected to have a 95% chance of being cost-effective in the EU licensed population using the current National Institute for Health and Care Excellence cost effectiveness threshold of £20 000 per QALY. These results were robust in sensitivity analyses.
Conclusions
This economic evaluation suggests that the use of ivabradine is likely to be cost-effective in eligible patients with HF from a UK National Health Service perspective.
doi:10.1136/heartjnl-2013-304598
PMCID: PMC4078716  PMID: 24634022

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