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Objective: This study was undertaken to estimate the cost‐effectiveness of add‐on cenobamate in the UK when used to treat drug‐resistant focal seizures in adults who are not adequately controlled with at least two prior antiseizure medications, including at least one used adjunctively. Methods: We estimated the cost per quality‐adjusted life‐year (QALY) for cenobamate compared to brivaracetam, eslicarbazepine, lacosamide, and perampanel in the UK National Health Service over a lifetime time horizon. We used a Markov cohort structure to determine response to treatment, using pooled data from three long‐term studies of cenobamate. A network meta‐analysis informed the likelihood of response to therapy with brivaracetam, eslicarbazepine, lacosamide, and perampanel relative to cenobamate. Once individuals discontinued treatment, they transitioned to subsequent treatment health states, including other antiseizure medicines, surgery, and vagus nerve stimulation. Costs included treatment, administration, routine monitoring, event management, and adverse events. Published evidence and expert opinion informed the likelihood of response to subsequent treatments, associated adverse events, and costs. Utility data were based on Short‐Form six‐dimension form utility. Discounting was applied at 3.5% per annum as per National Institute for Health and Care Excellence guidance. Uncertainty was explored through deterministic and probabilistic sensitivity analyses. Results: In the base case, cenobamate led to cost savings of £51 967 (compared to brivaracetam), £21 080 (compared to eslicarbazepine), £33 619 (compared to lacosamide), and £28 296 (compared to perampanel) and increased QALYs of 1.047 (compared to brivaracetam), 0.598 (compared to eslicarbazepine), 0.776 (compared to lacosamide), and 0.703 (compared to perampanel) per individual over a lifetime time horizon. Cenobamate also dominated the four drugs across most sensitivity analyses. Differences were due to reduced seizure frequency with cenobamate relative to comparators. Significance: Cenobamate improved QALYs and was less costly than brivaracetam, eslicarbazepine, lacosamide, and perampanel. Therefore, cenobamate may be considered as a cost‐effective adjunctive antiseizure medication for people with drug‐resistant focal seizures. [ABSTRACT FROM AUTHOR]

Objectives: Amidst conflicting expectations about the benefits of personalized medicine (PM) and the potentially high implementation costs, we reviewed the available evidence on the cost-effectiveness of PM relative to non-PM.Methods: We conducted a systematic literature review of economic evaluations of PM and extracted data, including incremental quality-adjusted life-years (ΔQALYs) and incremental costs (Δcosts). ΔQALYs and Δcosts were combined with estimates of national cost-effectiveness thresholds to calculate incremental net monetary benefit (ΔNMB). Regression analyses were performed with these variables as dependent variables and PM intervention characteristics as independent variables. Random intercepts were used to cluster studies according to country.Results: Of 4774 studies reviewed, 128 were selected, providing cost-effectiveness data for 279 PM interventions. Most studies were set in the United States (48%) and the United Kingdom (16%) and adopted a healthcare perspective (82%). Cancer treatments (60%) and pharmaceutical interventions (72%) occurred frequently. Prognostic tests (19%) and tests to identify (non)responders (37%) were least and most common, respectively. Industry sponsorship occurred in 32%. Median ΔQALYs, Δcosts, and ΔNMB per individual were 0.03, Int$575, and Int$18, respectively. We found large heterogeneity in cost-effectiveness. Regression analysis showed that gene therapies were associated with higher ΔQALYs than other interventions. PM interventions for neoplasms brought higher ΔNMB than PM interventions for other conditions. Nonetheless, average ΔNMB in the 'neoplasm' group was found to be negative.Conclusions: PM brings improvements in health but often at a high cost, resulting in 0 to negative ΔNMB on average. Pricing policies may be needed to reduce the costs of interventions with negative ΔNMB. [ABSTRACT FROM AUTHOR]

Objectives: Cost-effectiveness analyses (CEA) are based on the value judgment that health outcomes (eg, quantified in quality-adjusted life-years; QALYs) are all equally valuable irrespective of their context. Whereas most published CEAs perform extensive sensitivity analysis on various parameters and assumptions, only rarely is the influence of the QALY-equivalence assumption on cost-effectiveness results investigated. We illustrate how the integration of alternative social value judgments in CEA can be a useful form of sensitivity analysis.Methods: Because varicella-zoster virus (VZV) vaccination affects 2 distinct diseases (varicella zoster and herpes zoster) and likely redistributes infections across different age groups, the program has an important equity dimension. We used a cost-effectiveness model and disentangled the share of direct protection and herd immunity within the total projected QALYs resulting from a 50-year childhood VZV program in the UK. We use the UK population's preferences for QALYs in the vaccine context to revalue QALYs accordingly.Results: Revaluing different types of QALYs for different age groups in line with public preferences leads to a 98% change in the projected net impact of the program. The QALYs gained among children through direct varicella protection become more important, whereas the QALYs lost indirectly through zoster in adults diminish in value. Weighting of vaccine-related side effects made a large difference.Conclusions: Our study shows that a sensitivity analysis in which alternative social value judgments about the value of health outcomes are integrated into CEA of vaccines is relatively straightforward and provides important additional information for decision makers to interpret cost-effectiveness results. [ABSTRACT FROM AUTHOR]

Quality-Adjusted Life-Years (QALYs) are central to healthcare decision-making in Britain and abroad, yet their history is poorly understood. In this paper, we argue that a more in-depth and political history of the QALY is needed to allow a critical evaluation of its current dominance. Exploiting rich data from archives and 44 semi-structured interviews conducted between 2015 and 2018, we employ Multiple Streams Analysis to construct a complex and dynamic picture of how the idea of QALYs emerged and was adopted within UK health policy. Through its historical and political approach, the paper illuminates the relative roles in the policy-making process of experts (especially economists) and politicians as ‘entrepreneurs’ in the development of new ideas; how these were influenced by negotiation within established and emerging institutional structures; and the role of serendipity and crisis. [ABSTRACT FROM AUTHOR]

Summary: The purpose of the study was to estimate the cost-effectiveness of balloon kyphoplasty compared to nonsurgical management and vertebroplasty for the treatment of hospitalised osteoporotic vertebral compression fractures in the UK. A cost-effectiveness model was constructed and used for analysis. Balloon kyphoplasty may be cost-effective compared to relevant alternatives. Introduction: The objective of this study was to estimate the cost-effectiveness of balloon kyphoplasty (BKP) for the treatment of patients hospitalised with acute osteoporotic vertebral compression fracture (OVCF) compared to percutaneous vertebroplasty (PVP) and nonsurgical management (NSM) in the UK. Methods: A Markov simulation model was developed to evaluate treatment with BKP, NSM and PVP in patients with symptomatic OVCF. Data on health-related quality of life (HRQoL) with acute OVCF were derived from the FREE and VERTOS II randomised clinical trials (RCTs) and normalised to the NSM arm in the FREE trial. Estimated differences in mortality among the treatments and costs for NSM were obtained from the literature whereas procedure costs for BKP and PVP were obtained from three National Health Service hospitals. It was assumed that BKP and PVP reduced hospital length of stay by 6 days compared to NSM. Results: The incremental cost-effectiveness ratio was estimated at Great Britain Pound Sterling (GBP) 2,706 per quality-adjusted life year (QALY) and GBP 15,982 per QALY compared to NSM and PVP, respectively. Sensitivity analysis showed that the cost-effectiveness of BKP vs. NSM was robust when mortality and HRQoL benefits with BKP were varied. The cost-effectiveness of BKP compared to PVP was particularly sensitive to changes in the mortality benefit. Conclusion: BKP may be a cost-effective strategy for the treatment of patients hospitalised with acute OVCF in the UK compared to NSM and PVP. Additional RCT data on the benefits of BKP and PVP compared to simulated sham surgery and further data on the mortality benefits with BKP compared to NSM and PVP would reduce uncertainty. [ABSTRACT FROM AUTHOR]

Appraisals by the UK's National Institute for Health and Clinical Excellence (NICE) examine clinical and cost-effectiveness to determine whether medical interventions should be publicly funded by the National Health Service (NHS). NICE's evaluations are attracting increasing debate about the tension between efficiency and equity. This article, using the case of renal cell cancer, argues that NICE is not only concerned with maximized aggregate welfare, but also with its social obligations to protect the less advantaged members of society. The English experience is likely to have international implications in terms of evaluating the benefits of new medical treatments. [ABSTRACT FROM AUTHOR]

Abstract: Background: One method suggested for creating preference-based tariffs for the new five-level EuroQol five-dimensional (EQ-5D) questionnaire is combining time trade-off (TTO) and discrete choice exercises. Rank values from previous valuation studies can be used as proxies for discrete choice exercises. This study examined rank and TTO data to determine whether the methods differ in sensitivity to the EQ-5D questionnaire dimensions. Methods: We used rank and TTO data for 42 EQ-5D questionnaire health states from the US and UK three-level EQ-5D questionnaire valuation studies, extracting overall ranks of mean TTO and mean rank values, ranging from 1 (best) to 42 (worst). We identified pairs of health states with reversed overall ranks between TTO and rank data and regressed overall rank differences (TTO – ranking) on dummy variables representing impairments on EQ-5D questionnaire dimensions. Results: Forty-three (US) and 41 (UK) health state pairs displayed reversed rank order. Both US and UK regression models on rank differences indicated that respondents rated impairments involving pain/discomfort and anxiety/depression as relatively worse in TTO than in the ranking task. Discussion: Different dimension sensitivity between TTO and ranking methods suggests that combining them could lead to inconsistent tariffs. Differences could be caused by respondents focusing on the first presented dimensions when ranking states or could be related to the longest endurable time for health states involving pain/discomfort or anxiety/depression. The observed differences call into question which method best represents the preferences of the population. [Copyright &y& Elsevier]

Abstract: This article provides an overview of economic methods to measure costs and benefits related to food safety issues. After an introduction on general economic principles, including the distinction between social and private costs and benefits, the article highlights the various methods for calculation of costs and benefits, including “willingness to pay”, amongst others. Particular attention is paid to the “quality-adjusted life years” (QALY) method for quantitatively expressing health impacts. The practice of Regulatory Impact Assessments as carried out by the UK authorities is explored in more detail as an example of cost–benefit analysis of regulatory measures. The applicability of the approaches to the various stages of the SAFE FOODS model is highlighted. [Copyright &y& Elsevier]

Balloon kyphoplasty (BKP) is a procedure used to treat vertebral compression fractures (VCFs). We developed a cost-effectiveness model to evaluate BKP in United Kingsdom patients with hospitalised VCFs and estimated the cost-effectiveness of BKP compared to non-surgical management. The results indicate that BKP provides a cost-effective alternative for treating these patients. VCFs of osteoporotic patients are associated with chronic pain, a reduction in health-related quality of life (QoL) and high healthcare costs. BKP is a minimally invasive procedure that has resulted in pain relief, vertebral body height-restoration, decreased kyphosis and improved physical functioning in patients with symptomatic VCFs. BKP was shown to improve health-related QoL in a 12-month interim analysis of a randomised phase-III trial. The objectives of this study were to develop a Markov cost-effectiveness model to evaluate BKP in patients with painful hospitalised VCFs and to estimate the cost-effectiveness of BKP compared with non-surgical management in a UK setting. It was assumed that QoL-benefits found at 12 months linearly approached zero during another 2 years, and that patients receiving BKP warranted six fewer hospital bed days compared with patients given non-surgical management. The procedure was associated with quality-adjusted life-years (QALY)-gains of 0.17 and cost/QALY-gains at £8,800. The results were sensitive to assumptions about avoided length of hospital-stay and persistence of kyphoplasty-related QoL-benefits. In conclusion, the results indicate that BKP provides a cost-effective alternative for treating patients with hospitalised VCFs in a UK-setting. [ABSTRACT FROM AUTHOR]

The study estimated the cost-effectiveness of risedronate compared to no treatment in UK women using the FRAX algorithm for fracture risk assessment. A Markov cohort model was used to estimate the cost-effectiveness. Risedronate was found cost-effective from the age of 65 years, assuming a willingness to pay for a QALY of £30,000. The aim of this study was to assess the cost-effectiveness of risedronate for the prevention and treatment in a UK setting using the FRAX® algorithm for fracture risk assessment. A further aim was to establish intervention thresholds with risedronate treatment. The cost-effectiveness of risedronate was compared to no treatment in post-menopausal women with clinical risk factors for fracture using a Markov cohort model populated with data relevant for the UK. The model incorporated the features of FRAX® (the WHO risk assessment tool). The analysis had a health care perspective and quality adjusted life years was used as the main outcome measure. Treatment was cost-effective from the age of 65 years, assuming a willingness to pay for a QALY of £30,000. Treatment was also cost-effective at all ages in women who had previously sustained a fragility fracture or in women with a parental history of hip fracture with a bone mineral density set at the threshold of osteoporosis. At the £30,000 threshold value for a QALY, risedronate was on average found to cost-effective below the 10-year probability of a major osteoporotic fractures of 13.0%. Risedronate is a cost-effective agent for the treatment of established osteoporosis (osteoporosis and a prior fragility fracture) in women from the age of 50 years and older and above 65 years in women with osteoporosis alone. The results support the treatment recommendations in recent UK guidelines for osteoporosis. [ABSTRACT FROM AUTHOR]

Carer quality of life is increasingly considered alongside patient quality of life in economic evaluation. Important questions remain about how to value carer and patient quality of life effects alongside one another. In this study, we estimated the relative social value of two conceptualisations of carer quality of life (health-related and care-related) compared to patient quality of life. Relative valuations were estimated using a person trade-off (PTO) study with 990 representative members of the UK public. Participants chose between hypothetical services that improved the quality of life of carers and patients, iterating to a point of indifference. Overall 84% of participants completing the task were willing to trade patient and carer quality of life effects. Relative to a reference point of 1 for patient health-related quality of life, we estimated a social value of 0.74 for carer health-related quality of life effects and 0.69 for carer care-related quality of life effects. In conclusion, public preferences appear to support the inclusion of carer quality of life effects within economic evaluation. The results provide a means to value different carer quality of life outcomes in economic evaluation, where such values are needed and deemed appropriate. • Person trade-off assessed relative value of carer and patient QoL. • 84% of participants trade-off carer and patient QoL. • Social value for health-related QoL for carers estimated to be 0.74. • Social value for care-related QoL for carers estimated to be 0.69. [ABSTRACT FROM AUTHOR]

Background: In the United Kingdom, approximately 10.8 million people suffer from asthma, placing an economic burden on the society of more than £2 billion per year. For allergic asthma, treatment options consist of allergen avoidance, symptomatic treatment and allergen-specific immunotherapy (SIT). Only SIT addresses the underlying cause of the disease, reducing symptoms and offering the potential for long-term improvement. Grazax – the first tablet-based SIT – is indicated for the treatment of patients with grass pollen-induced rhinoconjunctivitis, including those with co-existing asthma. Objective: To assess the cost-effectiveness of Grazax in patients with rhinoconjunctivitis and co-existing asthma. Methods: A prospective pharmacoeconomic analysis was carried out as part of a multinational clinical trial assessing the efficacy of Grazax ( n = 79) compared with placebo ( n = 72). Both groups had access to symptomatic medication; thus the placebo group represented current standard care. Pooled data on health resource use, productivity loss because of absence from work and quality of life (Quality Adjusted Life Years, QALYs) were collected in the trial. Reduced productivity at work was estimated from the literature. A societal perspective was adopted with a 9-year time horizon. The NHS price of Grazax of £2.25 per tablet was used. Results: The QALY gain was significantly higher for patients treated with Grazax than the placebo group receiving symptomatic medication alone (0.197 discounted QALYs gained 9 years into the future – equal to an extra 72 days of perfect health over 9 years). The levels of resource use and productivity loss were higher for the placebo group. As a result, the cost per QALY gained with Grazax was £4319, which is highly cost-effective. Price sensitivity analyses demonstrated that Grazax remained cost-effective up to a tablet price of £5.07. Conclusion: SIT with Grazax is a cost-effective strategy compared with standard management of patients with rhinoconjunctivitis and co-existing asthma. [ABSTRACT FROM AUTHOR]

Abstract: Context: Despite the substantive societal impact of prostate cancer, the medical community is currently divided on the balance between benefit and harm of screening for prostate cancer using prostate-specific antigen (PSA). Objective: To examine whether PSA-based screening for prostate cancer meets current guidelines on efficacy and effectiveness for screening, and how it compares with other currently implemented cancer-screening methods. Evidence acquisition: A literature search was conducted for reviews and individual studies that have examined the performance of screening for colorectal, cervical, breast, and prostate cancer. Each screening method was assessed using the United Kingdom National Screening Committee guidelines. Data on screening test performance (sensitivity, specificity, etc) were extracted from these articles for comparison. Evidence synthesis: In common with other cancers for which screening is conducted, prostate cancer represents a significant morbidity and mortality burden. The PSA test can be considered “simple” and “safe” within appropriate boundaries. The sensitivity/specificity profile of PSA is not optimal but has clinical validity: Cases missed at screening detected as interval cases do not have a poor outcome. Early prostate cancer intervention can be beneficial for long-term outcomes, although the benefits need to be weighed against the adverse effects of intervention. Early evidence from screening studies also suggests positive stage and grade shifts, although Level 1 mortality data are still awaited. Robust cost-effectiveness data are still lacking, although current evidence suggests that PSA screening may lie within acceptable limits. Conclusion: Until better markers become available, PSA can be regarded as an appropriate screening tool for prostate cancer at a population level. [Copyright &y& Elsevier]

Objective: To assess whether clozapine is likely to be more cost-effective than other second-generation antipsychotics (SGAs) in people with schizophrenia. Methods: An integrated clinical and economic multicenter, rater-blind, randomized controlled trial (RCT) compared clozapine to the class of other SGAs, using the perspectives of the National Health Service, social support services, and patients. The practice setting was secondary and primary care in the United Kingdom; patients were followed for 1 year. Incremental cost-effectiveness ratios (ICERs), net benefit statistics, and cost acceptability curves were estimated. Results: The ICER for clozapine was £33,240 per quality-adjusted life-year (QALY) (range £23,000–70,000 for the sensitivity analyses). The proportion of simulations when clozapine was more cost-effective than other SGAs reached 50% if decision-makers are prepared to pay £30,000 to £35,000 per QALY. This is at the top of the range of acceptable willingness-to-pay values per QALY implied by decisions taken by the National Institute for Health and Clinical Excellence (NICE). Conclusions: This study adds to a limited body of evidence comparing clozapine to other SGAs and is the first economic and clinical RCT to compare clozapine to the class of other SGAs using the lower cost of generic clozapine and a pragmatic trial design. Policy decisions by the NICE suggest that additional reasons would be needed to accept clozapine as effective and efficient if it had a high probability of having ICERs more than £35,000 per QALY. The results and limitations of the analysis suggest that there is still a need for further economic evaluation of clozapine. [ABSTRACT FROM AUTHOR]

Background The UK government has attempted to improve the quality of health care in the National Health Service and minimize geographical variations in quality by imposing targets in certain areas of health care. The measures taken by local health economies to achieve these targets have not before been subjected to cost-effectiveness analysis. We have assessed the cost effectiveness of an intervention designed to achieve thrombolysis time targets. [ABSTRACT FROM PUBLISHER]

New technologies, including pharmaceuticals and medical devices, can improve treatment options in healthcare but also bring concerns about rising healthcare costs. We undertake a narrative review of the United Kingdom's (UK) approach to appraising new health technologies. We find that the National Institute for Health and Care Excellence (NICE), Scottish Medicines Consortium (SMC) and All Wales Medicines Strategy Group (AWMSG) have contributed to the UK's robust and transparent approach towards the evaluation of new health technologies using the cost per QALY approach. However, there are limitations to this approach including several external benefits not captured, bias against less treatable diseases, and deciding the appropriate level of the threshold. NICE, SMC, and AWMSG have attempted to overcome some of these limitations by considering additional factors such as end-of-life criteria, highly specialised treatments, and populations that experience unmet need. Looking to the future, the advent of 'personalised' and 'genomic' medicine, will likely mean the UK has to accommodate an increasing number of 'step-change' and 'highly specialised' technologies as well as respond to changes in pharmaceutical licensing and increasing use of real-world evidence., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest relevant to this manuscript to declare., (Copyright © 2022. Published by Elsevier B.V.)

The impact case studies submitted by UK Higher Education Institutions to the Research Excellence Framework (REF) in 2014 provide a rich resource of text describing impact beyond academia and across all disciplines. Using text mining techniques and qualitative assessment, the 6,679 non-redacted case studies submitted were analysed and the impact described was found to be multidisciplinary, multi-impactful, and multinational. By digging deeper into the data, the health gains from health research in terms of Quality Adjusted Life Years was also estimated. Similar analyses are possible using these case studies, but will require the data to be 're-purposed' from the original intention (i.e., for assessment purposes) for robust analysis. [ABSTRACT FROM AUTHOR]

Aims: The aim of the Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) was to determine the optimal treatment for adults with a bicortical undisplaced or minimally displaced fracture of the waist of the scaphoid, comparing early surgical fixation with initial cast immobilization, with immediate fixation being offered to patients with nonunion., Methods: A cost-effectiveness analysis was conducted to assess the relative merits of these forms of treatment. The differences in costs to the healthcare system and quality-adjusted life years (QALYs) of the patients over the one-year follow-up of the trial in the two treatment arms were estimated using regression analysis., Results: Our base case analysis found that patients randomized to early surgical fixation had statistically significantly higher mean costs to the NHS of £1,295 more than for the cast immobilization arm (p < 0.001), primarily due to the cost of surgery. They also had a marginally better quality of life, over the period, of 0.0158 QALYs; however, this was not statistically significant (p = 0.379). The mean combined cost per additional QALY was £81,962, well above the accepted threshold for cost-effectiveness used in the UK and internationally. The probability of early surgery being cost-effective in this setting was only 5.6%., Conclusion: Consistent with the clinical findings of SWIFFT, these results indicate that initial cast immobilization of minimally displaced scaphoid fractures, with immediate fixation only offered to patients with nonunion, is the optimal form of treatment, resulting in comparable outcomes with less cost to the healthcare system. Cite this article: Bone Joint J  2021;103-B(7):1277-1283.

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., (Copyright © 2019 The Author(s). Published by Elsevier Inc. All rights reserved.)

Lay health workers have been utilized to deliver health promotion programmes in a variety of settings. However, few studies have sought to determine whether these programmes represent value for money, particularly in a UK context. The present study involved an economic evaluation of Wellbeing for Life, an integrated health and wellbeing service in northern England. The service combined one-to-one interventions delivered by lay health workers (known as health trainers), group wellbeing interventions, volunteering opportunities and other community development activities. Value for money was assessed using an established economic model developed with input from a panel of commissioners and providers, and the main data source was the national health trainer data collection and reporting system. Between June 2015 and January 2017, behaviour change outcomes (i.e. whether client goals in relation to diet, physical activity, smoking or other behaviours, had been achieved) were recorded for 2433 of the 3179 individuals who accessed one-to-one interventions. The level of achievement observed gave an estimated total health gain of 287.7 quality-adjusted life years (QALYs). In addition, there were 4669 health-promoting events, five asset mapping projects and 1595 occurrences of signposting to other services. Combining the value of individual behaviour change with the value of these additional activities gave an overall net cost per QALY gained of £3900 and a total estimated societal value of at least £3.45 for every £1 spent on the service. These results suggest that the Wellbeing for Life service offered good value for money. Further research is needed to systematically and comprehensively determine the societal value of similar holistic, asset-based and lay-led approaches., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Objective: Around one-third of patients with bipolar I disorder (BD-I) experience mixed episodes, characterized by both mania and depression, which tend to be more difficult and costly to treat. Atypical antipsychotics are recommended for the treatment of mixed episodes, although evidence of their efficacy, tolerability, and cost in these patients is limited. This study evaluates, from a UK National Health Service perspective, the cost-effectiveness of asenapine vs olanzapine in BD-I patients with mixed episodes., Methods: Cost-effectiveness was assessed using a Markov model. Efficacy was informed by a post-hoc analysis of two short-term clinical trials, with response measured as a composite Young Mania Rating Score and Montgomery-Åsberg Depression Rating Scale end-point. Probabilities of discontinuation and relapse to manic, mixed, and depressive episodes were sourced from published meta-analyses. Direct costs (2012-2013 values) included drug acquisition, monitoring, and resource use related to bipolar disorder as well as selected adverse events. Benefits were measured as quality-adjusted life years (QALYs)., Results: For treating mixed episodes, asenapine generated 0.0187 more QALYs for an additional cost of £24 compared to olanzapine over a 5-year period, corresponding to a £1302 incremental cost-effectiveness ratio. The higher acquisition cost of asenapine was roughly offset by the healthcare savings conferred through its greater efficacy in treating these patients. The model shows that benefits were driven by earlier response to asenapine during acute treatment and were maintained during longer-term follow-up. RESULTS were sensitive to changes in key parameters including short and longer-term efficacy, unit cost, and utilities, but conclusions remained relatively robust., Conclusions: RESULTS suggest that asenapine is a cost-effective alternative to olanzapine in mixed episode BD-I patients, and may have specific advantages in this population, potentially leading to healthcare sector savings and improved outcomes. Limitations of the analysis stem from gaps in clinical and economic evidence for these patients and should be addressed by future clinical trials.