Publications by authors named "Mark Sculpher"

189 Publications

Authors' Response to: "Health Opportunity Costs and Expert Elicitation: A Comment on Soares et al." by Sampson, Firth, and Towse.

Med Decis Making 2021 Feb 25:272989X20987222. Epub 2021 Feb 25.

Centre for Health Economics, University of York, York, Yorkshire, UK.

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http://dx.doi.org/10.1177/0272989X20987222DOI Listing
February 2021

Ideas About Resourcing Health Care in the United States: Can Economic Evaluation Achieve Meaningful Use?

Ann Intern Med 2021 01 29;174(1):80-85. Epub 2020 Sep 29.

University of York, York, United Kingdom (M.J.S.).

The United States is one of the few high-income countries not to apply economic evaluation routinely to health care decision making on a national level, yet it excels at spending least efficiently on health care. In the interest of continuing to develop new solutions to curb spending on health care and reduce waste in the United States, perhaps now is an important moment to reconsider the benefits of economic evaluation and the barriers that must be overcome to have it emerge as a solution for health care institutions and the patients they serve. This article offers several distinct considerations to make economic evaluation methods (such as cost-effectiveness analysis) an effective component of value-based decision making in the United States. These considerations include overcoming the barriers presented by opportunity costs, spending on health care services versus biomedical technologies, phasing out low-value care, using value of information to prioritize resources, and determining what to do with the quality-adjusted life-year. These issues need to be addressed to achieve a collective purpose for economic evaluation at state and national levels.
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http://dx.doi.org/10.7326/M20-1234DOI Listing
January 2021

Yorkshire Lung Screening Trial (YLST): protocol for a randomised controlled trial to evaluate invitation to community-based low-dose CT screening for lung cancer versus usual care in a targeted population at risk.

BMJ Open 2020 09 10;10(9):e037075. Epub 2020 Sep 10.

Department of Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK

Introduction: Lung cancer is the world's leading cause of cancer death. Low-dose computed tomography (LDCT) screening reduced lung cancer mortality by 20% in the US National Lung Screening Trial. Here, we present the Yorkshire Lung Screening Trial (YLST), which will address key questions of relevance for screening implementation.

Methods And Analysis: Using a single-consent Zelen's design, ever-smokers aged 55-80 years registered with a general practice in Leeds will be randomised (1:1) to invitation to a telephone-based risk-assessment for a Lung Health Check or to usual care. The anticipated number randomised by household is 62 980 individuals. Responders at high risk will be invited for LDCT scanning for lung cancer on a mobile van in the community. There will be two rounds of screening at an interval of 2 years. Primary objectives are (1) measure participation rates, (2) compare the performance of PLCO (threshold ≥1.51%), Liverpool Lung Project (V.2) (threshold ≥5%) and US Preventive Services Task Force eligibility criteria for screening population selection and (3) assess lung cancer outcomes in the intervention and usual care arms. Secondary evaluations include health economics, quality of life, smoking rates according to intervention arm, screening programme performance with ancillary biomarker and smoking cessation studies.

Ethics And Dissemination: The study has been approved by the Greater Manchester West research ethics committee (18-NW-0012) and the Health Research Authority following review by the Confidentiality Advisory Group. The results will be disseminated through publication in peer-reviewed scientific journals, presentation at conferences and on the YLST website.

Trial Registration Numbers: ISRCTN42704678 and NCT03750110.
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http://dx.doi.org/10.1136/bmjopen-2020-037075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7485242PMC
September 2020

Cost-effectiveness of cardiovascular imaging for stable coronary heart disease.

Heart 2021 Mar 14;107(5):381-388. Epub 2020 Aug 14.

Centre for Health Economics, University of York, York, UK.

Objective: To assess the cost-effectiveness of management strategies for patients presenting with chest pain and suspected coronary heart disease (CHD): (1) cardiovascular magnetic resonance (CMR); (2) myocardial perfusion scintigraphy (MPS); and (3) UK National Institute for Health and Care Excellence (NICE) guideline-guided care.

Methods: Using UK data for 1202 patients from the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease 2 trial, we conducted an economic evaluation to assess the cost-effectiveness of CMR, MPS and NICE guidelines. Health outcomes were expressed as quality-adjusted life-years (QALYs), and costs reflected UK pound sterling in 2016-2017. Cost-effectiveness results were presented as incremental cost-effectiveness ratios and incremental net health benefits overall and for low, medium and high pretest likelihood of CHD subgroups.

Results: CMR had the highest estimated QALY gain overall (2.21 (95% credible interval 2.15, 2.26) compared with 2.07 (1.92, 2.20) for NICE and 2.11 (2.01, 2.22) for MPS) and incurred comparable costs (overall £1625 (£1431, £1824) compared with £1753 (£1473, £2032) for NICE and £1768 (£1572, £1989) for MPS). Overall, CMR was the cost-effective strategy, being the dominant strategy (more effective, less costly) with incremental net health benefits per patient of 0.146 QALYs (-0.18, 0.406) compared with NICE guidelines at a cost-effectiveness threshold of £15 000 per QALY (93% probability of cost-effectiveness). Results were similar in the pretest likelihood subgroups.

Conclusions: CMR-guided care is cost-effective overall and across all pretest likelihood subgroups, compared with MPS and NICE guidelines.
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http://dx.doi.org/10.1136/heartjnl-2020-316990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892375PMC
March 2021

Economic analysis of the prevalence and clinical and economic burden of medication error in England.

BMJ Qual Saf 2021 Feb 11;30(2):96-105. Epub 2020 Jun 11.

University of York, Centre for Health Economics, York, UK.

Objectives: To provide national estimates of the number and clinical and economic burden of medication errors in the National Health Service (NHS) in England.

Methods: We used UK-based prevalence of medication errors (in prescribing, dispensing, administration and monitoring) in primary care, secondary care and care home settings, and associated healthcare resource use, to estimate annual number and burden of errors to the NHS. Burden (healthcare resource use and deaths) was estimated from harm associated with avoidable adverse drug events (ADEs).

Results: We estimated that 237 million medication errors occur at some point in the medication process in England annually, 38.4% occurring in primary care; 72% have little/no potential for harm and 66 million are potentially clinically significant. Prescribing in primary care accounts for 34% of all potentially clinically significant errors. Definitely avoidable ADEs are estimated to cost the NHS £98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. This comprises primary care ADEs leading to hospital admission (£83.7 million; causing 627 deaths), and secondary care ADEs leading to longer hospital stay (£14.8 million; causing or contributing to 1081 deaths).

Conclusions: Ubiquitous medicines use in health care leads unsurprisingly to high numbers of medication errors, although most are not clinically important. There is significant uncertainty around estimates due to the assumption that avoidable ADEs correspond to medication errors, data quality, and lack of data around longer-term impacts of errors. Data linkage between errors and patient outcomes is essential to progress understanding in this area.
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http://dx.doi.org/10.1136/bmjqs-2019-010206DOI Listing
February 2021

Health Opportunity Costs: Assessing the Implications of Uncertainty Using Elicitation Methods with Experts.

Med Decis Making 2020 05 22;40(4):448-459. Epub 2020 May 22.

Centre for Health Economics and Department of Economics, University of York, York, Yorkshire, UK.

Well-established methods of economic evaluation are used in many countries to inform decisions about the funding of new medical interventions. To guide such decisions, it is important to consider what health gains would be expected from the same level of investment elsewhere in the health care system. Recent research in the United Kingdom has evaluated the evidence available and the methods required to estimate the health effects of changes in health care expenditure within the National Health Service. Because of the absence of sufficiently broad-ranging data, assumptions were required in the previously mentioned work to estimate health effects in terms of a broader measure of health (quality-adjusted life-years), which is more relevant for policy. These assumptions constitute important sources of uncertainty. This work presents an application of the structured elicitation of the judgments of key individuals about these uncertain quantities. This article describes the design and conduct of the exercise, including the quantities elicited, the individual (rather than consensus) approach used, how uncertainty in knowledge was elicited (mode and bounds of an 80% credible interval), and methods to generate group estimates. It also reports on a successful application involving 28 clinical experts and 25 individuals with policy responsibilities. Although, as expected, most experts found replying to the questions challenging, they were able to express their beliefs quantitatively. Consistent across the uncertainties elicited, experts' judgments suggest that the quality-adjusted life-year (QALY) impacts of changes in expenditure from earlier work using assumptions are likely to have been underestimated and the "central" estimate of health opportunity cost from that work (£12,936 per QALY) to have been overestimated.
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http://dx.doi.org/10.1177/0272989X20916450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7509606PMC
May 2020

The HOME Study: Statistical and economic analysis plan for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the  time spent in hospital by older acute hospital inpatients.

Trials 2020 May 4;21(1):373. Epub 2020 May 4.

Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.

Background: Prolonged acute hospital stays are a problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hospital stay. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards which is proactive, focussed, intensive and integrated with medical care. The primary aim of PPM is to reduce the time older people spend in hospital because of unmanaged psychological and social problems. The HOME Study will test the effectiveness and cost-effectiveness of PPM.

Methods/design: The study is a two-arm, parallel-group, randomised, controlled superiority trial with linked health economic analysis and an embedded process evaluation. The target population is people aged 65 years and older admitted to acute hospitals. Participants will be randomly allocated to either usual care plus PPM or usual care alone. The primary outcome is the number of days spent as an inpatient in a general hospital in the month following randomisation. Secondary outcomes include quality of life, cognitive function, independent functioning, symptoms of anxiety and depression, and experience of hospital stay. The cost-effectiveness of usual care plus PPM compared with usual care alone will be assessed using quality-adjusted life-years as an outcome as well as costs from the NHS perspective.

Discussion: This update to the published trial protocol gives a detailed plan of the statistical and economic analysis of The HOME Study.

Trial Registration: ISRCTN registry, ISRCTN86120296. Registered on 3 January 2018.
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http://dx.doi.org/10.1186/s13063-020-04256-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197124PMC
May 2020

Real-world data on the incidence, mortality, and cost of ischaemic stroke and major bleeding events among non-valvular atrial fibrillation patients in England.

J Eval Clin Pract 2021 Feb 21;27(1):119-133. Epub 2020 Apr 21.

Centre for Health Economics, University of York, York, UK.

Rationale, Aims, And Objectives: Several novel oral anticoagulants (NOACs) are licensed for atrial fibrillation (AF) treatment in the United Kingdom. We describe the incidence and mortality from ischaemic stroke and major bleeding in non-valvular atrial fibrillation (NVAF) patients in England, including treatment patterns before/following introduction of NOACs, healthcare resource utilization (HRU), and costs post-onset of these events.

Method: Data were extracted from the UK Clinical Practice Research Datalink linked to Hospital Episode Statistics secondary care and Office for National Statistics mortality data.

Results: Of 42 966 patients with a first AF record between 2011 and 2016, 9143 patients (21.3%) remained without AF (antiplatelets/antithrombotics) treatment post-index diagnosis. The proportion of patients receiving aspirin for ≥3 months post-index declined during the study (50.6%-5.5%), irrespective of CHA DS -VASc score, while the proportion prescribed NOACs increased (2.0%-70.1%). Rates of ischaemic stroke per 1000 patient-years (95% CI) were 9.4 (3.8-15.0) with NOACs, 10.4 (8.0-12.9) with warfarin, 20.1 (16.4-23.8) with aspirin, 21.3 (5.3-37.2) with other antiplatelets and 43.6 (39.3-47.8) in patients without AF prescription. Major bleeding occurred at a similar rate with different treatments. All-cause mortality rates were 42.8 (31.4-54.3) with NOACs, 46.3 (41.1-51.5) with warfarin, 56.5 (50.5-62.4) with aspirin, 102.2 (76.2-128.3) with other antiplatelets and 412.8 (399.6-426.0) with no AF prescription. Mean annual National Health Service healthcare costs up to 1 year post-index were lowest in patients receiving aspirin plus other antiplatelets without an event (£6152), and highest in patients with an event without AF prescriptions (£17 957). By extrapolation, national AF HRU in the United Kingdom in 2016 was estimated at £8-16 billion annually.

Conclusions: These data provide temporal insights into AF treatment patterns and outcomes for NVAF patients in England and highlight the need to review higher stroke risk AF patients not receiving antiplatelet/antithrombotic prescriptions.
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http://dx.doi.org/10.1111/jep.13400DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7891325PMC
February 2021

Effects of Bladder Cancer on UK Healthcare Costs and Patient Health-Related Quality of Life: Evidence From the BOXIT Trial.

Clin Genitourin Cancer 2020 08 14;18(4):e418-e442. Epub 2019 Dec 14.

Centre for Health Economics, University of York, York, United Kingdom.

Background: Limited evidence exists regarding the cost and health-related quality of life (HRQoL) effects of non-muscle-invasive bladder cancer (NMIBC) recurrence and progression to muscle-invasive bladder cancer (MIBC). We examined these effects using evidence from a recent randomized control trial.

Material And Methods: The costs and HRQoL associated with bladder cancer were assessed using data from the BOXIT trial (bladder COX-2 inhibition trial; n = 472). The cost and HRQoL effects from clinical events were estimated using generalized estimating equations. The costs were derived from the recorded resource usage and UK unit costs. HRQoL was assessed using the EQ-5D-3L and reported UK preference tariffs. The events were categorized using the TMN classification.

Results: Cases of grade 3 recurrence and progression were associated with statistically significant HRQoL decrements (-0.08; 95% confidence interval [CI], -0.13 to -0.03; and -0.10; 95% CI, -0.17 to -0.03, respectively). The 3-year average cost per NMIBC patient was estimated at £8735 (95% CI, 8325-9145). Cases of grade 1, 2, and 3 recurrence were associated with annual cost effects of £1218 (95% CI, 403-2033), £1677 (95% CI, 920-2433), and £3957 (95% CI, 2332-5583), respectively. Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).

Conclusion: Evidence from the BOXIT trial suggests that patients with NMIBC will both experience decrements in HRQoL and incur significant costs, especially in the event of a grade 3 recurrence or a progression to MIBC.
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http://dx.doi.org/10.1016/j.clgc.2019.12.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427321PMC
August 2020

Distributional cost effectiveness analysis of West Yorkshire low emission zone policies.

Health Econ 2020 05 30;29(5):567-579. Epub 2020 Jan 30.

Centre for Health Economics, University of York, York, UK.

Alternative strategies can reduce road vehicle emissions, with differential effects on exposure across population groups. We compare alternative strategies in West Yorkshire using a framework for economic evaluation that considers multiple perspectives and that takes account of the distribution of health outcomes. Exposure to pollutants by area is converted, via dose response relationships, into disease averted. Health benefits and National Health Service costs from diseases are estimated conditional on population demographics and index of multiple deprivation. The net health benefits from alternative strategies are expressed as distributions of quality-adjusted life expectancy (QALE), which are compared using dominance criteria and societal aversion to health inequality. Net production is estimated from intervention costs and the effects of health improvement on production and consumption. Social care outcomes are estimated from health improvement among care recipients and changes in care expenditure. A switch to less polluting private vehicles is dominant in terms of the distribution of QALE and social care outcomes but not consumption. Inclusion of health inequality aversion alters the rank order compared with prioritisation on health maximisation. The results were sensitive to the magnitude of health opportunity costs, the level of inequality aversion, and the proportion of intervention cost that generates health opportunity cost.
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http://dx.doi.org/10.1002/hec.4003DOI Listing
May 2020

After 20 Years of Using Economic Evaluation, Should NICE be Considered a Methods Innovator?

Pharmacoeconomics 2020 03;38(3):247-257

Centre for Health Economics, University of York, York, YO10 5DD, UK.

The National Institute for Health and Care Excellence (NICE) is only one of several organisations internationally that uses economic evaluation as part of decision making regarding funding and pricing of new medical technologies. However, it can be argued that NICE has developed a more prominent international profile than most in their use of economics. After 20 years of operation, it is timely to assess the extent of NICE's achievements, including the economic evaluation methods it has used and its willingness to adapt these as new evaluative approaches emerge and when NICE faces particular policy challenges. This paper considers some of the important policy and contextual developments in the UK over the last 20 years and how these may have shaped NICE's approach to economic evaluation. It then assesses key areas of NICE methods, including perspective, defining benefits, modelling and uncertainty. The paper concludes that NICE has provided important support for the development of new methods, in particular through its role in identifying priorities for methods research funding and its sponsorship of the NICE Decision Support Unit. However, potentially important developments in methods in a number of important areas have yet to be formally included in NICE's methods guidance and this should be addressed in the Institute's 2019/2020 methods review.
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http://dx.doi.org/10.1007/s40273-019-00882-6DOI Listing
March 2020

The HOME Study: study protocol for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients.

Trials 2019 Aug 7;20(1):483. Epub 2019 Aug 7.

Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.

Background: Prolonged acute hospital stays are a major problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hospital stays. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards. PPM is proactive, focussed, intensive and integrated with medical care. A major aim of PPM is to reduce the time older people spend in hospital because of unmanaged psychological and social problems. The HOME Study will test the effectiveness and cost-effectiveness of PPM.

Methods/design: A two-arm parallel-group randomised controlled superiority trial, with a linked health economic analysis and an embedded process evaluation, will be conducted at three sites. A total of 3588 participants will be recruited and randomised to usual care or usual care plus PPM. The primary outcome is the number of days spent as an inpatient in a general hospital in the month (30 days) post-randomisation. Secondary outcomes for each participant (measured at 1 and 3 months) include quality of life, independent functioning, symptoms of anxiety and depression, cognitive function, and their experience of the hospital stay.

Discussion: The trial has been designed to produce findings that are generalisable to all older medical inpatients (including those with cognitive impairment). It will provide information on the effectiveness and cost-effectiveness of PPM, which we hope will be of value to patients, clinicians, managers and service planners.

Trial Registration: ISRCTN86120296 . Registered on 3 January 2018.
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http://dx.doi.org/10.1186/s13063-019-3502-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686488PMC
August 2019

Cost-per-diagnosis as a metric for monitoring cost-effectiveness of HIV testing programmes in low-income settings in southern Africa: health economic and modelling analysis.

J Int AIDS Soc 2019 07;22(7):e25325

Centre for Health Economics, University of York, York, UK.

Introduction: As prevalence of undiagnosed HIV declines, it is unclear whether testing programmes will be cost-effective. To guide their HIV testing programmes, countries require appropriate metrics that can be measured. The cost-per-diagnosis is potentially a useful metric.

Methods: We simulated a series of setting-scenarios for adult HIV epidemics and ART programmes typical of settings in southern Africa using an individual-based model and projected forward from 2018 under two policies: (i) a minimum package of "core" testing (i.e. testing in pregnant women, for diagnosis of symptoms, in sex workers, and in men coming forward for circumcision) is conducted, and (ii) core-testing as above plus additional testing beyond this ("additional-testing"), for which we specify different rates of testing and various degrees to which those with HIV are more likely to test than those without HIV. We also considered a plausible range of unit test costs. The aim was to assess the relationship between cost-per-diagnosis and the incremental cost-effectiveness ratio (ICER) of the additional-testing policy. The discount rate used in the base case was 3% per annum (costs in 2018 U.S. dollars).

Results: There was a strong graded relationship between the cost-per-diagnosis and the ICER. Overall, the ICER was below $500 per-DALY-averted (the cost-effectiveness threshold used in primary analysis) so long as the cost-per-diagnosis was below $315. This threshold cost-per-diagnosis was similar according to epidemic and programmatic features including the prevalence of undiagnosed HIV, the HIV incidence and a measure of HIV programme quality (the proportion of HIV diagnosed people having a viral load <1000 copies/mL). However, restricting to women, additional-testing did not appear cost-effective even at a cost-per-diagnosis of below $50, while restricting to men additional-testing was cost-effective up to a cost-per-diagnosis of $585. The threshold cost per diagnosis for testing in men to be cost-effective fell to $256 when the cost-effectiveness threshold was $300 instead of $500, and to $81 when considering a discount rate of 10% per annum.

Conclusions: For testing programmes in low-income settings in southern African there is an extremely strong relationship between the cost-per-diagnosis and the cost-per-DALY averted, indicating that the cost-per-diagnosis can be used to monitor the cost-effectiveness of testing programmes.
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http://dx.doi.org/10.1002/jia2.25325DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6615491PMC
July 2019

Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE): Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness.

Eur Urol Oncol 2018 12 14;1(6):449-458. Epub 2018 Sep 14.

Centre for Health Economics, University of York, York, UK.

Background: Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with metastatic disease and prolongs failure-free survival for those without. To date there has been no formal assessment of whether funding docetaxel in this setting represents an appropriate use of UK National Health Service (NHS) resources.

Objective: To assess whether administering docetaxel to men with PC starting long-term hormone therapy is cost-effective in a UK setting.

Design, Setting, And Participants: We modelled health outcomes and costs in the UK NHS using data collected within the STAMPEDE trial, which enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy.

Intervention: SOC was hormone therapy for ≥2 yr and radiotherapy in some patients. Docetaxel (75mg/m) was administered alongside SOC for six three-weekly cycles.

Outcome Measurements And Statistical Analysis: The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs).

Results And Limitations: The model predicted that docetaxel would extend survival (discounted quality-adjusted survival) by 0.89 yr (0.51) for metastatic PC and 0.78 yr (0.39) for nonmetastatic PC, and would be cost-effective in metastatic PC (ICER £5514/QALY vs SOC) and nonmetastatic PC (higher QALYs, lower costs vs SOC). Docetaxel remained cost-effective in nonmetastatic PC when the assumption of no survival advantage was modelled.

Conclusions: Docetaxel is cost-effective among patients with nonmetastatic and metastatic PC in a UK setting. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in patients with nonmetastatic PC, as the opportunity to offer docetaxel at hormone therapy initiation will be missed for some patients by the time more mature survival data are available.

Patient Summary: Starting docetaxel chemotherapy alongside hormone therapy represents a good use of UK National Health Service resources for patients with prostate cancer that is high risk or has spread to other parts of the body.
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http://dx.doi.org/10.1016/j.euo.2018.06.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6692495PMC
December 2018

Striving for a Societal Perspective: A Framework for Economic Evaluations When Costs and Effects Fall on Multiple Sectors and Decision Makers.

Appl Health Econ Health Policy 2019 10;17(5):577-590

Centre for Health Economics, Alcuin a Block, University of York, York, YO10 5DD, UK.

In most societies, resources are distributed by individuals acting in markets and by governments through some form of collective decision-making process. Economic evaluation offers a set of tools to inform collective decisions by examining the resource requirements and outcomes of alternative policies. The 'societal perspective' has been advocated, but less consideration has been given to what this should include and its practical implementation. This paper presents a framework for economic evaluation of policies with costs and outcomes falling on different sectors (e.g. health, criminal justice, education) and involving different decision makers. It extends the 'impact inventory' developed by the Second Panel on Cost-Effectiveness in Health and Medicine by considering all affected individuals and reflecting how outcomes attributed to an intervention can be compared with outcomes forgone as a result of resources not being available for other purposes. The framework sets out the series of assessments to be made, distinguishing points at which value judgements feed into the evaluation, and the implications of alternative judgements. These assessments reflect the institutional arrangements of public bodies, for example, their funding, the outcomes they consider important and their relative valuations of these outcomes. By avoiding the use of an abstract 'societal perspective', the contribution of the framework is to inform multiple decision makers with different objectives and provide practical guidance on overall societal impact.
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http://dx.doi.org/10.1007/s40258-019-00481-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6748888PMC
October 2019

Adherence to the iDSI reference case among published cost-per-DALY averted studies.

PLoS One 2019 1;14(5):e0205633. Epub 2019 May 1.

Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, Boston, MA, United States of America.

Background: The iDSI reference case, originally published in 2014, aims to improve the quality and comparability of cost-effectiveness analyses (CEA). This study assesses whether the development of the guideline is associated with an improvement in methodological and reporting practices for CEAs using disability-adjusted life-years (DALYs).

Methods: We analyzed the Tufts Medical Center Global Health CEA Registry to identify cost-per-DALY averted studies published from 2011 to 2017. Among each of 11 principles in the iDSI reference case, we translated all methodological specifications and reporting standards into a series of binary questions (satisfied or not satisfied) and awarded articles one point for each item satisfied. We then calculated methodological and reporting adherence scores separately as a percentage of total possible points, measured as normalized adherence score (0% = no adherence; 100% = full adherence). Using the year 2014 as the dissemination period, we conducted a pre-post analysis. We also conducted sensitivity analyses using: 1) optional criteria in scoring, 2) alternate dissemination period (2014-2015), and 3) alternative comparator classification.

Results: Articles averaged 60% adherence to methodological specifications and 74% adherence to reporting standards. While methodological adherence scores did not significantly improve (59% pre-2014 vs. 60% post-2014, p = 0.53), reporting adherence scores increased slightly over time (72% pre-2014 vs. 75% post-2014, p<0.01). Overall, reporting adherence scores exceeded methodological adherence scores (74% vs. 60%, p<0.001). Articles seldom addressed budget impact (9% reporting, 10% methodological) or equity (7% reporting, 7% methodological).

Conclusions: The iDSI reference case has substantial potential to serve as a useful resource for researchers and policy-makers in global health settings, but greater effort to promote adherence and awareness is needed to achieve its potential.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0205633PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6493721PMC
January 2020

Future Directions for Cost-effectiveness Analyses in Health and Medicine.

Med Decis Making 2018 10;38(7):767-777

Duke Clinical Research Institute, Duke University, Durham, NC.

Objectives: In 2016, the Second Panel on Cost-effectiveness in Health and Medicine updated the seminal work of the original panel from 2 decades earlier. The Second Panel had an opportunity to reflect on the evolution of cost-effectiveness analysis (CEA) and to provide guidance for the next generation of practitioners and consumers. In this article, we present key topics for future research and policy.

Methods: During the course of its deliberations, the Second Panel discussed numerous topics for advancing methods and for improving the use of CEA in decision making. We identify and consider 7 areas for which the panel believes that future research would be particularly fruitful. In each of these areas, we highlight outstanding research needs. The list is not intended as an exhaustive inventory but rather a set of key items that surfaced repeatedly in the panel's discussions. In the online Appendix , we also list and expound briefly on 8 other important topics.

Results: We highlight 7 key areas: CEA and perspectives (determining, valuing, and summarizing elements for the analysis), modeling (comparative modeling and model transparency), health outcomes (valuing temporary health and path states, as well as health effects on caregivers), costing (a cost catalogue, valuing household production, and productivity effects), evidence synthesis (developing theory on learning across studies and combining data from clinical trials and observational studies), estimating and using cost-effectiveness thresholds (empirically representing 2 broad concepts: opportunity costs and public willingness to pay), and reporting and communicating CEAs (written protocols and a quality scoring system).

Conclusions: Cost-effectiveness analysis remains a flourishing and evolving field with many opportunities for research. More work is needed on many fronts to understand how best to incorporate CEA into policy and practice.
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http://dx.doi.org/10.1177/0272989X18798833DOI Listing
October 2018

Multiparametric MRI to improve detection of prostate cancer compared with transrectal ultrasound-guided prostate biopsy alone: the PROMIS study.

Health Technol Assess 2018 07;22(39):1-176

Division of Surgery and Interventional Science, Faculty of Medical Sciences, University College London, London, UK.

Background: Men with suspected prostate cancer usually undergo transrectal ultrasound (TRUS)-guided prostate biopsy. TRUS-guided biopsy can cause side effects and has relatively poor diagnostic accuracy. Multiparametric magnetic resonance imaging (mpMRI) used as a triage test might allow men to avoid unnecessary TRUS-guided biopsy and improve diagnostic accuracy.

Objectives: To (1) assess the ability of mpMRI to identify men who can safely avoid unnecessary biopsy, (2) assess the ability of the mpMRI-based pathway to improve the rate of detection of clinically significant (CS) cancer compared with TRUS-guided biopsy and (3) estimate the cost-effectiveness of a mpMRI-based diagnostic pathway.

Design: A validating paired-cohort study and an economic evaluation using a decision-analytic model.

Setting: Eleven NHS hospitals in England.

Participants: Men at risk of prostate cancer undergoing a first prostate biopsy.

Interventions: Participants underwent three tests: (1) mpMRI (the index test), (2) TRUS-guided biopsy (the current standard) and (3) template prostate mapping (TPM) biopsy (the reference test).

Main Outcome Measures: Diagnostic accuracy of mpMRI, TRUS-guided biopsy and TPM-biopsy measured by sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) using primary and secondary definitions of CS cancer. The percentage of negative magnetic resonance imaging (MRI) scans was used to identify men who might be able to avoid biopsy.

Results: Diagnostic study - a total of 740 men were registered and 576 underwent all three tests. According to TPM-biopsy, the prevalence of any cancer was 71% [95% confidence interval (CI) 67% to 75%]. The prevalence of CS cancer according to the primary definition (a Gleason score of ≥ 4 + 3 and/or cancer core length of ≥ 6 mm) was 40% (95% CI 36% to 44%). For CS cancer, TRUS-guided biopsy showed a sensitivity of 48% (95% CI 42% to 55%), specificity of 96% (95% CI 94% to 98%), PPV of 90% (95% CI 83% to 94%) and NPV of 74% (95% CI 69% to 78%). The sensitivity of mpMRI was 93% (95% CI 88% to 96%), specificity was 41% (95% CI 36% to 46%), PPV was 51% (95% CI 46% to 56%) and NPV was 89% (95% CI 83% to 94%). A negative mpMRI scan was recorded for 158 men (27%). Of these, 17 were found to have CS cancer on TPM-biopsy. Economic evaluation - the most cost-effective strategy involved testing all men with mpMRI, followed by MRI-guided TRUS-guided biopsy in those patients with suspected CS cancer, followed by rebiopsy if CS cancer was not detected. This strategy is cost-effective at the TRUS-guided biopsy definition 2 (any Gleason pattern of ≥ 4 and/or cancer core length of ≥ 4 mm), mpMRI definition 2 (lesion volume of ≥ 0.2 ml and/or Gleason score of ≥ 3 + 4) and cut-off point 2 (likely to be benign) and detects 95% (95% CI 92% to 98%) of CS cancers. The main drivers of cost-effectiveness were the unit costs of tests, the improvement in sensitivity of MRI-guided TRUS-guided biopsy compared with blind TRUS-guided biopsy and the longer-term costs and outcomes of men with cancer.

Limitations: The PROstate Magnetic resonance Imaging Study (PROMIS) was carried out in a selected group and excluded men with a prostate volume of > 100 ml, who are less likely to have cancer. The limitations in the economic modelling arise from the limited evidence on the long-term outcomes of men with prostate cancer and on the sensitivity of MRI-targeted repeat biopsy.

Conclusions: Incorporating mpMRI into the diagnostic pathway as an initial test prior to prostate biopsy may (1) reduce the proportion of men having unnecessary biopsies, (2) improve the detection of CS prostate cancer and (3) increase the cost-effectiveness of the prostate cancer diagnostic and therapeutic pathway. The PROMIS data set will be used for future research; this is likely to include modelling prognostic factors for CS cancer, optimising MRI scan sequencing and biomarker or translational research analyses using the blood and urine samples collected. Better-quality evidence on long-term outcomes in prostate cancer under the various management strategies is required to better assess cost-effectiveness. The value-of-information analysis should be developed further to assess new research to commission.

Trial Registration: Current Controlled Trials ISRCTN16082556 and NCT01292291.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 22, No. 39. See the NIHR Journals Library website for further project information. This project was also supported and partially funded by the NIHR Biomedical Research Centre at University College London (UCL) Hospitals NHS Foundation Trust and UCL and by The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research Biomedical Research Centre and was co-ordinated by the Medical Research Council's Clinical Trials Unit at UCL (grant code MC_UU_12023/28). It was sponsored by UCL. Funding for the additional collection of blood and urine samples for translational research was provided by Prostate Cancer UK.
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http://dx.doi.org/10.3310/hta22390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6077599PMC
July 2018

Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy.

JACC Heart Fail 2018 06;6(6):517-526

National Institute for Health Research Biomedical Research Centre and British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.

Objectives: Evaluate whether PCI in combination with optimal medical therapy (OMT) will reduce all-cause death and hospitalization for HF compared to a strategy of OMT alone.

Background: Ischemic cardiomyopathy (ICM) is the most common cause of heart failure (HF) and is associated with significant mortality and morbidity. Surgical revascularization has been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard. Percutaneous coronary intervention (PCI) may allow a better balance between risk and benefit.

Methods: REVIVED-BCIS2 is a prospective, multi-center, open-label, randomized controlled trial, funded by the National Institute for Health Research in the United Kingdom. Follow-up will be for at least 2 years from randomization. Secondary outcomes include left ventricular ejection fraction (LVEF), quality of life scores, appropriate implantable cardioverter defibrillator therapy and acute myocardial infarction. Patients with LVEF ≤35%, extensive coronary disease and demonstrable myocardial viability are eligible for inclusion and those with a myocardial infarction within 4 weeks, decompensated HF or sustained ventricular arrhythmias within 72 h are excluded. A trial of 700 patients has more than 85% power to detect a 30% relative reduction in hazard.

Results: A total of 400 patients have been enrolled to date.

Conclusions: International guidelines do not provide firm recommendations on the role of PCI in managing severe ICM, because of a lack of robust evidence. REVIVED-BCIS2 will provide the first randomized data on the efficacy and safety of PCI in ICM and has the potential to inform guidelines pertaining to both revascularization and HF. (Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure [REVIVED-BCIS2]; NCT01920048) (REVascularisation for Ischaemic VEntricular Dysfunction; ISRCTN45979711).
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http://dx.doi.org/10.1016/j.jchf.2018.01.024DOI Listing
June 2018

Decision uncertainty and value of further research: a case-study in fenestrated endovascular aneurysm repair for complex abdominal aortic aneurysms.

Cost Eff Resour Alloc 2018 16;16:15. Epub 2018 Apr 16.

3Centre for Health Economics, University of York, Heslington, Alcuin 'A' Block, York, YO10 5DD UK.

Background: Fenestrated endovascular aneurysm repair (fEVAR) is a new approach for complex abdominal aortic aneurysms, limited to a few specialist centers, with limited evidence base. We developed a cost-effectiveness decision model of fEVAR compared to open surgical repair (OSR) to investigate the likely direction of costs and benefits and inform further research projects on this technology.

Methods: A systematic review with meta-analysis and a four-state Markov model were used to estimate the cost-effectiveness of fEVAR versus OSR. We used a recent coverage with evidence development framework to characterize the main sources of uncertainty and inform decisions about the type of further research that would be most worthwhile and feasible.

Results: Seven observational comparative studies were identified, of which four presented odds ratios adjusted for confounders. The odds ratios for operative mortality varied widely between studies. Assuming a central estimate of the odds ratio of 0.54 (95% CI 0.05-6.24), the decision model estimated that the incremental cost per quality adjusted life year (QALY) was £74,580/QALY with a probability of 9 and 16% of being cost-effective at standard cost-effectiveness thresholds of £20,000/QALY and £30,000/QALY, respectively. The Expected Value of Perfect Information over 10 years at a threshold of £20,000/QALY was £11.2 million. Operative mortality contributed to most of the uncertainty in the decision model.

Conclusions: In the case of "maturing technologies", decision modelling indicates the likely direction of costs and benefits and guides the development of further research projects. In our analysis of fEVAR versus OSR, decision uncertainty, particularly around operative mortality, might be effectively resolved by a short-term RCT, or possibly a well-conducted comparative observational study. Decision makers may consider that a conditional coverage decision is warranted with assessments required to make this type of recommendation depending on local priorities and circumstances.
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http://dx.doi.org/10.1186/s12962-018-0098-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5902886PMC
April 2018

The Use of MCDA in HTA: Great Potential, but More Effort Needed.

Value Health 2018 04 22;21(4):394-397. Epub 2017 Nov 22.

Evidera, London, UK.

The potential for multi-criteria decision analysis (MCDA) to support health technology assessment (HTA) has been much discussed, and various HTA agencies are piloting or applying MCDA. Alongside these developments, good practice guidelines for the application of MCDA in health care have been developed. An assessment of current applications of MCDA to HTA in light of good practice guidelines reveals, however, that many have methodologic flaws that undermine their usefulness. Three challenges are considered: the use of additive models, a lack of connection between criteria scales and weights, and the use of MCDA in economic evaluation. More attention needs to be paid to MCDA good practice by researchers, journal editors, and decision makers and further methodologic developments are required if MCDA is to achieve its potential to support HTA.
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http://dx.doi.org/10.1016/j.jval.2017.10.001DOI Listing
April 2018

Supporting the development of a health benefits package in Malawi.

BMJ Glob Health 2018 9;3(2):e000607. Epub 2018 Apr 9.

Centre for Health Economics, University of York, York, UK.

Malawi, like many low-income and middle-income countries, has used health benefits packages (HBPs) to allocate scarce resources to key healthcare interventions. With no widely accepted method for their development, HBPs often promise more than can be delivered, given available resources. An analytical framework is developed to guide the design of HBPs that can identify the potential value of including and implementing different interventions. It provides a basis for informing meaningful discussions between governments, donors and other stakeholders around the trade-offs implicit in package design. Metrics of value, founded on an understanding of the health opportunity costs of the choices faced, are used to quantify the scale of the potential net health impact (net disability adjusted life years averted) or the amount of additional healthcare resources that would be required to deliver similar net health impacts with existing interventions (the financial value to the healthcare system). The framework can be applied to answer key questions around, for example: the appropriate scale of the HBP; which interventions represent 'best buys' and should be prioritised; where investments in scaling up interventions and health system strengthening should be made; whether the package should be expanded; costs of the conditionalities of donor funding and how objectives beyond improving population health can be considered. This is illustrated using data from Malawi. The framework was successfully applied to inform the HBP in Malawi, as a core component of the country's Health Sector Strategic Plan II 2017-2022.
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http://dx.doi.org/10.1136/bmjgh-2017-000607DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5898345PMC
April 2018

Quantifying patient centered outcomes associated with the use of bilateral endobronchial coil treatment in patients with severe emphysema.

Curr Med Res Opin 2018 11 8;34(11):1927-1932. Epub 2018 May 8.

n URCEco Ile de France Hôpital de l'Hotel Dieu , Paris , France.

Objective: To determine the impact of endobronchial coils on health-related quality-of-life (HRQoL). This paper utilizes trial data to identify the predictors of HRQoL in patients with severe emphysema, and subsequently estimates the impact of a new treatment on HRQoL (measured by utilities). These utility estimates are used to generate indicative long-term QALY estimates for a range of clinically plausible scenarios as a precursor to cost-effectiveness analyses.

Methods: Patient level HRQoL data from RENEW and the National Emphysema Treatment Trial (NETT) were combined and mapped to generic EuroQol 5-dimension health utility questionnaire (EQ-5D) values using a published algorithm. Multilevel statistical models were developed using treatment, time, response, and baseline characteristics (EQ-5D, age, gender, FEV1, lung RV) to predict EQ-5D over time. Lifetime QALY estimates were generated using published survival data from NETT (assuming no impact of treatment on mortality) and four clinically plausible response profiles. Each response profile was combined with assumptions around treatment impact (constant or time varying).

Results: After controlling for baseline characteristics, both treatment and response had a statistically significant impact (p < .001) on utility (+0.101 and +0.061, respectively). When combined with selected baseline characteristics and time, Coils and Standard of Care (SoC) generated more QALYs than SoC alone in all scenarios, with incremental lifetime benefit ranging from 0.29-0.55 QALYs.

Conclusions: Coils and SoC resulted in statistically significant improvements in HRQoL compared to SoC alone in patients with severe emphysema.
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http://dx.doi.org/10.1080/03007995.2018.1462784DOI Listing
November 2018

Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment.

Med Decis Making 2018 05 13;38(4):495-508. Epub 2018 Mar 13.

Centre for Health Economics, The University of York, York, Yorkshire, UK.

In recent years, Health Technology Assessment (HTA) processes specific to diagnostics and prognostic tests have been created in response to the increased pressure on health systems to decide not only which tests should be used in practice but also the best way to proceed, clinically, from the information they provide. These technologies differ in the way value is accrued to the population of users, depending critically on the value of downstream health care choices. This paper defines an analytical framework for establishing the value of diagnostic and prognostic tests for HTA in a way that is consistent with methods used for the evaluation of other health care technologies. It assumes a linked-evidence approach where modeling is required, and incorporates considerations regarding several different areas of policy, such as personalized medicine. We initially focus on diagnostic technologies with dichotomous results, and then extend the framework by considering diagnostic tests that provide more complex information, such as continuous measures (for example, blood glucose measurements) or multiple categories (such as tumor classification systems). We also consider how the methods of assessment differ for prognostic information or for diagnostics without a reference standard. Throughout, we propose innovative graphical ways of summarizing the results of such complex assessments of value.
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http://dx.doi.org/10.1177/0272989X17749829DOI Listing
May 2018

ISPOR's Initiative on US Value Assessment Frameworks: Seeking a Role for Health Economics.

Authors:
Mark Sculpher

Value Health 2018 02;21(2):171-172

Centre for Health Economics, University of York, York, UK. Electronic address:

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http://dx.doi.org/10.1016/j.jval.2017.12.003DOI Listing
February 2018

Impact of missed treatment opportunities on outcomes in hospitalised patients with heart failure.

Open Heart 2017;4(2):e000726. Epub 2017 Dec 22.

Centre for Health Economics, University of York, York, UK.

Objective: Many patients with heart failure (HF) do not receive recommended treatments, resulting in suboptimal outcomes. We aimed to investigate the impact of implementing recommended HF therapies on health outcomes, and the costs and effectiveness of interventions for improving adherence.

Methods: The health benefits of ACE inhibitor (ACEi), beta blockers and optimal therapy (ACEi and beta blockers if not contraindicated) following hospitalisation for HF were combined with evidence on uptake. The aim was to examine how much health was lost as a result of failure to follow guidelines, and how much could be gained using strategies to promote uptake.The net health benefits of different treatments (measured in quality-adjusted life-years (QALY)) were estimated using a decision-analytic model and treatment effectiveness from the literature. Data on the number of patients who would have benefitted from the additional treatments were estimated from 2010 to 2013 using the National Heart Failure Audit.

Results: Each recommended treatment was associated with positive net health benefit. In 2010, up to 4019 (38.3%) patients would have benefitted from additional treatments rising to 4886 patients in 2013 (although falling to 25.2% of patients). Failure to follow guidelines resulted in large health losses. In 2010, if all patients had received optimal therapy, 1569 QALYs would have been gained, implying a maximum justifiable investment in interventions to promote uptake of £31.4 million.

Conclusion: Current gaps in translation of evidence to practise in hospitals are associated with significant health losses. Strategies to encourage uptake of guidelines could be effective and cost-effective.
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http://dx.doi.org/10.1136/openhrt-2017-000726DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5743898PMC
December 2017

Reflecting the real value of health care resources in modelling and cost-effectiveness studies-The example of viral load informed differentiated care.

PLoS One 2018 2;13(1):e0190283. Epub 2018 Jan 2.

Centre for Health Economics, University of York, York, United Kingdom.

Background: The WHO HIV Treatment Guidelines suggest routine viral-load monitoring can be used to differentiate antiretroviral therapy (ART) delivery and reduce the frequency of clinic visits for patients stable on ART. This recommendation was informed by economic analysis that showed the approach is very likely to be cost-effective, even in the most resource constrained of settings. The health benefits were shown to be modest but the costs of introducing and scaling up viral load monitoring can be offset by anticipated reductions in the costs of clinic visits, due to these being less frequent for many patients.

Key Issues For Economic Evaluation: The cost-effectiveness of introducing viral-load informed differentiated care depends upon whether cost reductions are possible if the number of clinic visits is reduced and/or how freed clinic capacity is used for alternative priorities. Where freed resources, either physical or financial, generate large health gains (e.g. if committed to patients failing ART or to other high value health care interventions), the benefits of differentiated care are expected to be high; if however these freed physical resources are already under-utilized or financial resources are used less efficiently and would not be put to as beneficial an alternative use, the policy may not be cost-effective. The implication is that the use of conventional unit costs to value resources may not well reflect the latter's value in contributing to health improvement. Analyses intended to inform resource allocated decisions in a number of settings may therefore have to be interpreted with due consideration to local context. In this paper we present methods of how economic analyses can reflect the real value of health care resources rather than simply applying their unit costs. The analyses informing the WHO Guidelines are re-estimated by implementing scenarios using this framework, informing how differentiated care can be prioritized to generate greatest gains in population health.

Implications: The findings have important implications for how economic analyses should be undertaken and reported in HIV and other disease areas. Results provide guidance on conditions under which viral load informed differentiated care will more likely prove to be cost effective when implemented.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0190283PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5749768PMC
February 2018

Using Cost-Effectiveness Analysis to Quantify the Value of Genomic-Based Diagnostic Tests: Recommendations for Practice and Research.

Genet Test Mol Biomarkers 2017 Dec 13;21(12):705-716. Epub 2017 Oct 13.

2 Centre for Health Economics, University of York , York, United Kingdom .

Aims: New sequencing technologies allow increased opportunities to use genomic-based diagnostic tests (genomic tests) in routine clinical practice, which will impact healthcare budgets and patients' outcomes. This article aims to generate a list of recommendations on how the principles and methods of cost-effectiveness analysis (CEA) can be used to quantify the costs and benefits of genomic tests.

Methods: A systematic literature search identified publications describing the use of CEA to evaluate genomic tests. Data were extracted as key concepts to produce a thematic list of previously described challenges and solutions to using CEA to evaluate genomic tests. Defining features of evaluating genomic tests were categorized into a list of key recommendations for applying methods in practice and for research needs.

Results: Features producing challenges in the implementation of CEA to evaluate genomic tests were as follows: the ability of the tests to diagnose multiple disorders; potential consequences for future generations suggesting an infinite time horizon; and the potential need to consider nonhealth benefits.

Conclusions: CEA was identified as an appropriate evaluative framework for genomic tests, although standard methods may need modification and important method research questions remain. Key recommendations suggest a need for research to reflect: sharing genomic information across generations; genomic tests for multiple disorders; and health and nonhealth benefits.
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http://dx.doi.org/10.1089/gtmb.2017.0105DOI Listing
December 2017