Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with non-psychotic mental health problems: a pragmatic randomized controlled trial.

Narratives describing first-hand experiences of recovery from mental health problems are widely available. Emerging evidence suggests that engaging with mental health recovery narratives can benefit people experiencing mental health problems, but no randomized controlled trial has been conducted as yet. We developed the Narrative Experiences Online (NEON) Intervention, a web application providing self-guided and recommender systems access to a collection of recorded mental health recovery narratives (n=659). We investigated whether NEON Intervention access benefited adults experiencing non-psychotic mental health problems by conducting a pragmatic parallel-group randomized trial, with usual care as control condition. The primary endpoint was quality of life at week 52 assessed by the Manchester Short Assessment (MANSA). Secondary outcomes were psychological distress, hope, self-efficacy, and meaning in life at week 52. Between March 9, 2020 and March 26, 2021, we recruited 1,023 participants from across England (the target based on power analysis was 994), of whom 827 (80.8%) identified as White British, 811 (79.3%) were female, 586 (57.3%) were employed, and 272 (26.6%) were unemployed. Their mean age was 38.4±13.6 years. Mood and/or anxiety disorders (N=626, 61.2%) and stress-related disorders (N=152, 14.9%) were the most common mental health problems. At week 52, our intention-to-treat analysis found a significant baseline-adjusted difference of 0.13 (95% CI: 0.01-0.26, p=0.041) in the MANSA score between the intervention and control groups, corresponding to a mean change of 1.56 scale points per participant, which indicates that the intervention increased quality of life. We also detected a significant baseline-adjusted difference of 0.22 (95% CI: 0.05-0.40, p=0.014) between the groups in the score on the "presence of meaning" subscale of the Meaning in Life Questionnaire, corresponding to a mean change of 1.1 scale points per participant. We found an incremental gain of 0.0142 quality-adjusted life years (QALYs) (95% credible interval: 0.0059 to 0.0226) and a £178 incremental increase in cost (95% credible interval: -£154 to £455) per participant, generating an incremental cost-effectiveness ratio of £12,526 per QALY compared with usual care. This was lower than the £20,000 per QALY threshold used by the National Health Service in England, indicating that the intervention would be a cost-effective use of health service resources. In the subgroup analysis including participants who had used specialist mental health services at baseline, the intervention both reduced cost (-£98, 95% credible interval: -£606 to £309) and improved QALYs (0.0165, 95% credible interval: 0.0057 to 0.0273) per participant as compared to usual care. We conclude that the NEON Intervention is an effective and cost-effective new intervention for people experiencing non-psychotic mental health problems.

Estimating the cost-effectiveness of intermittently scanned continuous glucose monitoring in adults with type 1 diabetes in England.

OBJECTIVE: We previously showed that intermittently scanned continuous glucose monitoring (isCGM) reduces HbA1c at 24 weeks compared with self-monitoring of blood glucose with finger pricking (SMBG) in adults with type 1 diabetes and high HbA1c levels (58-97 mmol/mol [7.5%-11%]). We aim to assess the economic impact of isCGM compared with SMBG. METHODS: Participant-level baseline and follow-up health status (EQ-5D-5L) and within-trial healthcare resource-use data were collected. Quality-adjusted life-years (QALYs) were derived at 24 weeks, adjusting for baseline EQ-5D-5L. Participant-level costs were generated. Using the IQVIA CORE Diabetes Model, economic analysis was performed from the National Health Service perspective over a lifetime horizon, discounted at 3.5%. RESULTS: Within-trial EQ-5D-5L showed non-significant adjusted incremental QALY gain of 0.006 (95% CI: -0.007 to 0.019) for isCGM compared with SMBG and an adjusted cost increase of £548 (95% CI: 381-714) per participant. The lifetime projected incremental cost (95% CI) of isCGM was £1954 (-5108 to 8904) with an incremental QALY (95% CI) gain of 0.436 (0.195-0.652) resulting in an incremental cost-per-QALY of £4477. In all subgroups, isCGM had an incremental cost-per-QALY better than £20,000 compared with SMBG; for people with baseline HbA1c >75 mmol/mol (9.0%), it was cost-saving. Sensitivity analysis suggested that isCGM remains cost-effective if its effectiveness lasts for at least 7 years. CONCLUSION: While isCGM is associated with increased short-term costs, compared with SMBG, its benefits in lowering HbA1c will lead to sufficient long-term health-gains and cost-savings to justify costs, so long as the effect lasts into the medium term.

Organisational and student characteristics, fidelity, funding models, and unit costs of recovery colleges in 28 countries: a cross-sectional survey.

BACKGROUND: Recovery colleges were developed in England to support the recovery of individuals who have mental health symptoms or mental illness. They have been founded in many countries but there has been little international research on recovery colleges and no studies investigating their staffing, fidelity, or costs. We aimed to characterise recovery colleges internationally, to understand organisational and student characteristics, fidelity, and budget. METHODS: In this cross-sectional study, we identified all countries in which recovery colleges exist. We repeated a cross-sectional survey done in England for recovery colleges in 28 countries. In both surveys, recovery colleges were defined as services that supported personal recovery, that were coproduced with students and staff, and where students learned collaboratively with trainers. Recovery college managers completed the survey. The survey included questions about organisational and student characteristics, fidelity to the RECOLLECT Fidelity Measure, funding models, and unit costs. Recovery colleges were grouped by country and continent and presented descriptively. We used regression models to explore continental differences in fidelity, using England as the reference group. FINDINGS: We identified 221 recovery colleges operating across 28 countries, in five continents. Overall, 174 (79%) of 221 recovery colleges participated. Most recovery colleges scored highly on fidelity. Overall scores for fidelity (ß=-2·88, 95% CI 4·44 to -1·32; p=0·0001), coproduction (odds ratio [OR] 0·10, 95% CI 0·03 to 0·33; p<0·0001), and being tailored to the student (OR 0·10, 0·02 to 0·39; p=0·0010), were lower for recovery colleges in Asia than in England. No other significant differences were identified between recovery colleges in England, and those in other continents where recovery colleges were present. 133 recovery colleges provided data on annual budgets, which ranged from €0 to €2 550 000, varying extensively within and between continents. From included data, all annual budgets reported by the college added up to €30 million, providing 19 864 courses for 55 161 students. INTERPRETATION: Recovery colleges exist in many countries. There is an international consensus on key operating principles, especially equality and a commitment to recovery, and most recovery colleges achieve moderate to high fidelity to the original model, irrespective of the income band of their country. Cultural differences need to be considered in assessing coproduction and approaches to individualising support. FUNDING: National Institute for Health and Care Research.

Statistical analysis plans for two randomised controlled trials of the Narrative Experiences Online (NEON) Intervention: impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis (NEON) and people experiencing non-psychosis mental health problems (NEON-O).

BACKGROUND: Mental health recovery narratives are a first-hand account of an individual's recovery from mental health distress, access to narratives can aid recovery. The NEON Intervention is a web-application providing access to a managed collection of narratives. We present the statistical analysis plan for assessing the effectiveness of the NEON Intervention in improving quality of life at 1-year post-randomisation. We pay particular focus on the statistical challenges encountered due to the online nature of this trial. METHODS AND DESIGN: The NEON Intervention is assessed in two trial populations, one for people with experience of psychosis in the last 5 years, and mental health distress in the last six months (NEON Trial) and one for people with experience of non-psychosis mental health problems (NEON-O Trial). Both NEON trials are two-arm randomised controlled superiority trials comparing the effectiveness of the NEON Intervention with usual care. The target sample size is 684 randomised participants for NEON and 994 for NEON-O. Participants were randomised centrally in a 1:1 ratio. RESULTS: The primary outcome is the mean score of subjective items on the Manchester Short Assessment of Quality-of-Life questionnaire (MANSA) at 52 weeks. Secondary outcomes are scores from the Herth Hope Index, Mental Health Confidence Scale, Meaning of Life questionnaire, CORE-10 questionnaire and Euroqol 5-Dimension 5-Level (EQ-5D-5L). CONCLUSION: This manuscript is the statistical analysis plan (SAP) for the NEON trials. Any post hoc analysis, such as those requested by journal reviewers will be clearly labelled as such in the final trial reporting. Trial registration Both trials were prospectively registered. NEON Trial: ISRCTN11152837, registered on 13 August 2018. NEON-O Trial: ISRCTN63197153, registered on 9 January 2020.

Development and delivery cost of digital health technologies for mental health: Application to the Narrative Experiences Online Intervention.

Background: The increasing development and use of digital health interventions requires good quality costing information to inform development and commissioning choices about resource allocation decisions. The Narrative Experiences Online (NEON) Intervention is a web-application that delivers recorded mental health recovery narratives to its users. Two randomized controlled trials are testing the NEON Intervention in people with experience of psychosis (NEON) and people experiencing non-psychosis mental health problems (NEON-O). Aim: This study describes and estimates the cost components and total cost of developing and delivering the NEON Intervention. Materials and methods: Total costs for the NEON Trial (739 participants) and NEON-O Trial (1,024 participants) were estimated by: identifying resource use categories involved in intervention development and delivery; accurate measurement or estimation of resource use; and a valuation of resource use to generate overall costs, using relevant unit costs. Resource use categories were identified through consultation with literature, costing reporting standards and iterative consultation with health researchers involved in NEON Intervention development and delivery. Sensitivity analysis was used to test assumptions made. Results: The total cost of developing the NEON Intervention was £182,851. The largest cost components were software development (27%); Lived Experience Advisory Panel workshops (23%); coding the narratives (9%); and researchers' time to source narratives (9%). The total cost of NEON Intervention delivery during the NEON Trial was £118,663 (£349 per NEON Intervention user). In the NEON-O Trial, the total delivery cost of the NEON Intervention was £123,444 (£241 per NEON Intervention user). The largest cost components include updating the narrative collection (50%); advertising (19%); administration (14%); and software maintenance (11%). Uncertainty in the cost of administration had the largest effect on delivery cost estimates. Conclusion: Our work shows that developing and delivering a digital health intervention requires expertise and time commitment from a range of personnel. Teams developing digital narrative interventions need to allocate substantial resources to curating narrative collections. Implications for practice: This study identifies the development and delivery resource use categories of a digital health intervention to promote the consistent reporting of costs and informs future decision-making about the costs of delivering the NEON Intervention at scale. Trial registration: NEON Trial: ISRCTN11152837, registered 13 August 2018, http://www.isrctn.com/ISRCTN11152837. NEON-O Trial: ISRCTN63197153, registered 9 January 2020, http://www.isrctn.com/ISRCTN63197153.

Cost-effectiveness of pain management services for chronic low back pain: a systematic review of published studies.

BACKGROUND: Chronic low back pain (CLBP) is a highly prevalent condition that has substantial impact on patients, the healthcare system and society. Pain management services (PMS), which aim to address the complex nature of back pain, are recommended in clinical practice guidelines to manage CLBP. Although the effectiveness of such services has been widely investigated in relation to CLBP, the quality of evidence underpinning the use of these services remains moderate. Therefore the aim is to summarize and critically appraise the current evidence for the cost effectiveness of pain management services for managing chronic back pain. METHODS: Electronic searches were conducted in MEDLINE, EMBASE and PsycINFO from their inception to February 2019. Full economic evaluations undertaken from any perspective conducted alongside randomized clinical trials (RCTs) or based on decision analysis models were included. Cochrane Back Review Group (CBRG) risk assessment and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist were used to assess the methodological quality of eligible studies. RESULTS: Five studies fulfilled eligibility criteria. The interventions varied significantly between studies in terms of the number and types of treatment modalities, intensity and the duration of the program. Interventions were compared with either standard care, which varied according to the country and the setting; or to surgical interventions. Three studies showed that pain management services are cost effective, while two studies showed that these services are not cost effective. In this review, three out of five studies had a high risk of bias based on the design of the randomised controlled trials (RCTs). In addition, there were limitations in the statistical and sensitivity analyses in the economic evaluations. Therefore, the results from these studies need to be interpreted with caution. CONCLUSION: Pain management services may be cost effective for the management of low back pain. However, this systematic review highlights the variability of evidence supporting pain management services for patients with back pain. This is due to the quality of the published studies and the variability of the setting, interventions, comparators and outcomes.

Clinical and economic implications of therapeutic switching of angiotensin receptor blockers to angiotensin-converting enzyme inhibitors: a population-based study.

OBJECTIVE: To evaluate the clinical and cost impact of switching angiotensin receptor blockers (ARBs) to angiotensin-converting enzyme inhibitors (ACEIs) in patients with hypertension. METHODS: This study used the UK Clinical Practice Research Datalink, linking with the Hospital Episode Statistics (April 2006 to March 2012). Adults with hypertension (n = 470) were followed from the first ARB prescription date to the switching date (preswitching period); then from the switching date to the date when study ended, patient left the dataset or died (postswitching period). Patients were divided into ACEIs-combined (n = 369) and ACEIs-monotherapy (n = 101) groups by whether additional antihypertensive drugs were prescribed with ACEIs in the postswitching period. Proportion of days covered (PDC), clinical outcomes and costs were compared between the preswitching and postswitching periods using a multilevel regression. RESULTS: Overall, in the postswitching period, there was a significant increase in the proportion of nonadherence (PDC < 80%) (OR: 2.4; 95% CI: 1.6-3.7), but a significant reduction in mean SBP (mean difference: -2.3; 95 CI: -3.4 to 1.2 mmHg) and mean DBP (mean difference: -1.9; 95% CI: -2.6 to -1.2 mmHg). However, these results were only observed in the ACEIs-combined group. There was no postswitching significant difference in either the incidence of individual or composite hypertension-related complications (OR: 0.9; 95% CI: 0.4-2.0). There was a significant reduction in the overall annual medical cost per patient by £329 (95% CI: -534 to -205). CONCLUSION: Switching of ARBs to ACEIs monotherapy appeared to be clinically effective and a cost-saving strategy. The observed changes in the ACEIs-combined group are assumed to be related to factors other than the ARBs switching.

'I expected just to walk in, get my tablets and then walk out': on framing new community pharmacy services in the English healthcare system.

Reconfiguration of the healthcare division of labour is becoming increasingly attractive in the context of increased patient demand and resource constraints. One example is the introduction of extended roles for pharmacists to provide patients additional support to manage their medicines, while also reducing work pressures experienced by other health professionals. Understanding how such policies are framed by those delivering and receiving care has been under-theorised. Using Goffman's frame theory, we examine one newly introduced community pharmacy service (New Medicines Service (NMS)) to illustrate how a policy intended to support patient medicine-taking through the extended roles of pharmacists is framed and where this deviates from its proposed aims. Three themes emerged: (i) the spatial-material artefacts; (ii) existing discursive culture and practice around medicine-taking; and (iii) the NMS interactions that shape and govern framing and subsequent interpretation of the NMS. Our study offers an explanatory and dynamic view of the framing process with important lessons for reconfiguring medicine management policy and practice. As well as illustrating framing as being variegated, complementary or conflicting, it also shows how this plurality and fragility had consequences for patient engagement and sense-making. The consequences for engagement and recommendations for implementing future initiatives are discussed.

Cost Effectiveness of Support for People Starting a New Medication for a Long-Term Condition Through Community Pharmacies: An Economic Evaluation of the New Medicine Service (NMS) Compared with Normal Practice.

BACKGROUND: The English community pharmacy New Medicine Service (NMS) significantly increases patient adherence to medicines, compared with normal practice. We examined the cost effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs. METHODS: We developed Markov models for diseases targeted by the NMS (hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma and antiplatelet regimens) to assess the impact of patients' non-adherence. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. Incremental costs and outcomes associated with each disease were incorporated additively into a composite probabilistic model and combined with adherence rates and intervention costs from the trial. Costs per extra quality-adjusted life-year (QALY) were calculated from the perspective of NHS England, using a lifetime horizon. RESULTS: NMS generated a mean of 0.05 (95% CI 0.00-0.13) more QALYs per patient, at a mean reduced cost of -£144 (95% CI -769 to 73). The NMS dominates normal practice with a probability of 0.78 [incremental cost-effectiveness ratio (ICER) -£3166 per QALY]. NMS has a 96.7% probability of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. Sensitivity analysis demonstrated that targeting each disease with NMS has a probability over 0.90 of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. CONCLUSIONS: Our study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost. TRIAL REGISTRATION: ClinicalTrials.gov Trial reference number NCT01635361 ( http://clinicaltrials.gov/ct2/show/NCT01635361 ). Current Controlled trials: Trial reference number ISRCTN 23560818 ( http://www.controlled-trials.com/ISRCTN23560818/ ; DOI 10.1186/ISRCTN23560818 ). UK Clinical Research Network (UKCRN) study 12494 ( http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494 ). FUNDING: Department of Health Policy Research Programme.

Economic evaluation of a community-based diagnostic pathway to stratify adults for non-alcoholic fatty liver disease: a Markov model informed by a feasibility study.

OBJECTIVES: To assess the long-term cost-effectiveness of a risk stratification pathway, compared with standard care, for detecting non-alcoholic fatty liver disease (NAFLD) in primary care. SETTING: Primary care general practices in England. PARTICIPANTS: Adults who have been identified in primary care to have a risk factor for developing NAFLD, that is, type 2 diabetes without a history of excessive alcohol use. INTERVENTION: A community-based pathway, which uses transient elastography and hepatologists to stratify patients at risk of NAFLD, has been implemented and demonstrated to be feasible (NCT02037867). Earlier identification could mean earlier treatments, referral to specialist and enrolment into surveillance programmes. DESIGN: The impact of earlier detection and treatment with the risk stratification pathway on progression to later stages of liver disease was examined using decision modelling with Markov chains to estimate lifetime health and economic effects of the two comparators. DATA SOURCES: Data from a prospective cross-sectional feasibility study indicating risk stratification pathway and standard care diagnostic accuracies were combined with a Markov model that comprised the following states: no/mild liver disease, significant liver disease, compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, liver transplant and death. The model data were chosen from up-to-date UK sources, published literature and an expert panel. OUTCOME MEASURE: An incremental cost-effectiveness ratio (ICER) indicating cost per quality-adjusted life year (QALY) of the risk stratification pathway compared with standard care was estimated. RESULTS: The risk stratification pathway was more effective than standard care and costs £2138 per QALY gained. The ICER was most sensitive to estimates of the rate of fibrosis progression and the effect of treatment on reducing this, and ranged from -£1895 to £7032/QALY. The risk stratification pathway demonstrated an 85% probability of cost-effectiveness at the UK willingness-to-pay threshold of £20 000/QALY. CONCLUSIONS: Implementation of a community-based risk stratification pathway is likely to be cost-effective. TRIAL REGISTRATION NUMBER: NCT02037867, ClinicalTrials.gov.

Describing the characteristics, treatment pathways, outcomes, and costs of people with persistent noncancer pain managed by community pain clinics and generating an indicative estimate of cost-effectiveness: feasibility study protocol.

BACKGROUND: Low back pain (LBP) and fibromyalgia (FM), also known as chronic widespread pain (CWP), are highly prevalent chronic painful conditions that have substantial impact on patients, health care systems, and society. Diagnosis is complex and management strategies are associated with various levels of evidence for effectiveness and cost-effectiveness. Multidisciplinary pain services have been shown to be effective in some settings and therefore are recommended by clinical practice guidelines as a rational treatment option to manage these patients. Knowing that these services are resource intensive, evidence is needed to demonstrate their cost-effectiveness. This study aims to describe the management of patients with LBP and FM in two community pain clinics to derive an indicative estimate of cost-effectiveness compared with standard practice. METHODS: This is a prospective observational multicenter study, using patient-level data. The data from this study will be combined with modelling of the long-term economic impact of community pain clinics in treating people with LBP and FM. Newly referred patients with LBP and FM who provide written consent will be included. We will collect data on functional disability, pain intensity, quality of life, and health resource utilization. Follow-up data at the 3- and 6-month points will be collected by patient-completed questionnaires and health care contact diaries. Health care resource use from diaries will be compared with patient electronic records to assess the agreement between these recording methods. Patient cohort characteristics, treatment pathways, resource use, and outcomes derived from this study will be integrated in a decision analysis model to assess the cost-effectiveness of community pain clinics compared with standard care. This feasibility study will address key methodological issues such as sample estimates and retention rate to inform the design of a future randomized controlled trial.

Economic Evaluation of a General Hospital Unit for Older People with Delirium and Dementia (TEAM Randomised Controlled Trial).

BACKGROUND: One in three hospital acute medical admissions is of an older person with cognitive impairment. Their outcomes are poor and the quality of their care in hospital has been criticised. A specialist unit to care for older people with delirium and dementia (the Medical and Mental Health Unit, MMHU) was developed and then tested in a randomised controlled trial where it delivered significantly higher quality of, and satisfaction with, care, but no significant benefits in terms of health status outcomes at three months. OBJECTIVE: To examine the cost-effectiveness of the MMHU for older people with delirium and dementia in general hospitals, compared with standard care. METHODS: Six hundred participants aged over 65 admitted for acute medical care, identified on admission as cognitively impaired, were randomised to the MMHU or to standard care on acute geriatric or general medical wards. Cost per quality adjusted life year (QALY) gained, at 3-month follow-up, was assessed in trial-based economic evaluation (599/600 participants, intervention: 309). Multiple imputation and complete-case sample analyses were employed to deal with missing QALY data (55%). RESULTS: The total adjusted health and social care costs, including direct costs of the intervention, at 3 months was £7714 and £7862 for MMHU and standard care groups, respectively (difference -£149 (95% confidence interval [CI]: -298, 4)). The difference in QALYs gained was 0.001 (95% CI: -0.006, 0.008). The probability that the intervention was dominant was 58%, and the probability that it was cost-saving with QALY loss was 39%. At £20,000/QALY threshold, the probability of cost-effectiveness was 94%, falling to 59% when cost-saving QALY loss cases were excluded. CONCLUSIONS: The MMHU was strongly cost-effective using usual criteria, although considerably less so when the less acceptable situation with QALY loss and cost savings were excluded. Nevertheless, this model of care is worthy of further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01136148.

The impact of the 'Better Care Better Value' prescribing policy on the utilisation of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for treating hypertension in the UK primary care setting: longitudinal quasi-experimental design.

BACKGROUND: In April/2009, the UK National Health Service initiated four Better Care Better Value (BCBV) prescribing indicators, one of which encouraged the prescribing of cheaper angiotensin-converting enzyme inhibitors (ACEIs) instead of expensive angiotensin receptor blockers (ARBs), with 80 % ACEIs/20 % ARBs as a proposed, and achievable target. The policy was intended to save costs without affecting patient outcomes. However, little is known about the actual impact of the BCBV indicator on ACEIs/ARBs utilisation and cost-savings. Therefore, this study aimed to evaluate the impact of BCBV policy on ACEIs/ARBs utilisation and cost-savings, including exploration of regional variations of the policy's impact. METHODS: This cross-sectional study used data from the UK Clinical Practice Research Datalink. Segmented time-series analysis was applied to monthly ACEIs prescription proportion, adjusted number of ACEIs/ARBs prescriptions and costs. RESULTS: Overall, the proportion of ACEIs prescription decreased during the study period from 71.2% in April/2006 to 70.7% in March/2012, with a small but a statistically significant pre-policy reduction in its monthly trend of 0.02% (p < 0.001). Instantly after its initiation, the policy was associated with a sudden reduction in the proportion of ACEIs prescription; however, it resulted in a statistically significant increase in the post-policy monthly trend of ACEIs prescription proportion of 0.013% (p < 0.001), resulting in an overall post-policy slope of -0.007%. Despite this post-policy induced increment, the policy failed to achieve the 80% target, which resulted in missing a potential cost-saving opportunity. The pre-policy trend of the adjusted number of ACEIs/ARBs prescriptions was increasing; however, their trends declined after the policy implementation. The policy affected neither total ACEIs/ARBs cost nor individual ACEIs or ARBs costs. CONCLUSIONS: ACEIs/ARBs utilisation was not affected by the BCBV policy. The small increase in post-policy ACEIs prescription proportion was not associated with any savings. This study represents a case study of a failed or ineffective policy and thus provides key learning lessons for other healthcare authorities. Given the existing opportunity of potential cost-savings from achieving the 80 % target, specific measures would be needed to enhance the policy implementation and uptake; however, this must be balanced against other cost-saving policies in other high-priority areas.

Cost-Effectiveness of a Specialist Geriatric Medical Intervention for Frail Older People Discharged from Acute Medical Units: Economic Evaluation in a Two-Centre Randomised Controlled Trial (AMIGOS).

BACKGROUND: Poor outcomes and high resource-use are observed for frail older people discharged from acute medical units. A specialist geriatric medical intervention, to facilitate Comprehensive Geriatric Assessment, was developed to reduce the incidence of adverse outcomes and associated high resource-use in this group in the post-discharge period. OBJECTIVE: To examine the costs and cost-effectiveness of a specialist geriatric medical intervention for frail older people in the 90 days following discharge from an acute medical unit, compared with standard care. METHODS: Economic evaluation was conducted alongside a two-centre randomised controlled trial (AMIGOS). 433 patients (aged 70 or over) at risk of future health problems, discharged from acute medical units within 72 hours of attending hospital, were recruited in two general hospitals in Nottingham and Leicester, UK. Participants were randomised to the intervention, comprising geriatrician assessment in acute units and further specialist management, or to control where patients received no additional intervention over and above standard care. Primary outcome was incremental cost per quality adjusted life year (QALY) gained. RESULTS: We undertook cost-effectiveness analysis for 417 patients (intervention: 205). The difference in mean adjusted QALYs gained between groups at 3 months was -0.001 (95% confidence interval [CI]: -0.009, 0.007). Total adjusted secondary and social care costs, including direct costs of the intervention, at 3 months were £4412 (€5624, $6878) and £4110 (€5239, $6408) for the intervention and standard care groups, the incremental cost was £302 (95% CI: 193, 410) [€385, $471]. The intervention was dominated by standard care with probability of 62%, and with 0% probability of cost-effectiveness (at £20,000/QALY threshold). CONCLUSIONS: The specialist geriatric medical intervention for frail older people discharged from acute medical unit was not cost-effective. Further research on designing effective and cost-effective specialist service for frail older people discharged from acute medical units is needed. TRIAL REGISTRATION: ISRCTN registry ISRCTN21800480 http://www.isrctn.com/ISRCTN21800480.

The economics of medicines optimization: policy developments, remaining challenges and research priorities.

BACKGROUND: This review scopes the evidence on the effectiveness and cost-effectiveness of interventions to improve suboptimal use of medicines in order to determine the evidence gaps and help inform research priorities. SOURCES OF DATA: Systematic searches of the National Health Service (NHS) Economic Evaluation Database, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects. AREAS OF AGREEMENT: The majority of the studies evaluated interventions to improve adherence, inappropriate prescribing and prescribing errors. AREAS OF CONTROVERSY: Interventions tend to be specific to a particular stage of the pathway and/or to a particular disease and have mostly been evaluated for their effect on intermediate or process outcomes. GROWING POINTS: Medicines optimization offers an opportunity to improve health outcomes and efficiency of healthcare. AREAS TIMELY FOR DEVELOPING RESEARCH: The available evidence is insufficient to assess the effectiveness and cost-effectiveness of interventions to address suboptimal medicine use in the UK NHS. Decision modelling, evidence synthesis and elicitation have the potential to address the evidence gaps and help prioritize research.

A review of the methodological challenges in assessing the cost effectiveness of pharmacist interventions.

Pharmacists' roles are shifting away from medicines supply and the provision of patient education involving acute medications towards consultation-type services for chronic medications. Determining the cost effectiveness of pharmacist interventions has been complicated by methodological challenges. A critique of 31 economic evaluations carried out alongside comparative studies of pharmacist interventions published between 2003 and 2013 (12 from the UK, six from the USA) found a range of disease-specific and cross-therapeutic interventions targeting both patients and prescribers in a range of settings evaluated through a variety of study designs. Only ten were full economic evaluations, five of which were based on randomized controlled trials (RCTs). The intervention was usually quite well described, but the comparator was not always clearly described, and some interventions are very context specific due to the variability in pharmacist services available in different countries and practice settings. Complex multidirectional aims of most pharmacist interventions have led to many process, intermediate and longer-term outcomes being included in any one study. Quality of resource use and cost data varied. Most incremental cost-effectiveness ratios (ICERs) were generated from process indicators such as errors and adherence, with only four studies reporting cost per quality-adjusted life-year (QALY). Very few studies examined the effect of uncertainty, and methods used were not very clear in some cases. The principal finding from our critique is that poor RCT study design or analysis precludes many studies from finding pharmacist interventions effective or cost effective. We conclude with a set of recommendations for future study design.

Identifying patient-level health and social care costs for older adults discharged from acute medical units in England.

BACKGROUND: acute medical units allow for those who need admission to be correctly identified, and for those who could be managed in ambulatory settings to be discharged. However, re-admission rates for older people following discharge from acute medical units are high and may be associated with substantial health and social care costs. OBJECTIVE: identifying patient-level health and social care costs for older people discharged from acute medical units in England. DESIGN: a prospective cohort study of health and social care resource use. SETTING: an acute medical unit in Nottingham, England. PARTICIPANTS: four hundred and fifty-six people aged over 70 who were discharged from an acute medical unit within 72 h of admission. METHODS: hospitalisation and social care data were collected for 3 months post-recruitment. In Nottingham, further approvals were gained to obtain data from general practices, ambulance services, intermediate care and mental healthcare. Resource use was combined with national unit costs. RESULTS: costs from all sectors were available for 250 participants. The mean (95% CI, median, range) total cost was £1926 (1579-2383, 659, 0-23,612). Contribution was: secondary care (76.1%), primary care (10.9%), ambulance service (0.7%), intermediate care (0.2%), mental healthcare (2.1%) and social care (10.0%). The costliest 10% of participants accounted for 50% of the cost. CONCLUSIONS: this study highlights the costs accrued by older people discharged from acute medical units (AMUs): they are mainly (76%) in secondary care and half of all costs were incurred by a minority of participants (10%).

Cost effectiveness of a pharmacist-led information technology intervention for reducing rates of clinically important errors in medicines management in general practices (PINCER).

BACKGROUND AND OBJECTIVE: We recently showed that a pharmacist-led information technology-based intervention (PINCER) was significantly more effective in reducing medication errors in general practices than providing simple feedback on errors, with cost per error avoided at £79 (US$131). We aimed to estimate cost effectiveness of the PINCER intervention by combining effectiveness in error reduction and intervention costs with the effect of the individual errors on patient outcomes and healthcare costs, to estimate the effect on costs and QALYs. METHODS: We developed Markov models for each of six medication errors targeted by PINCER. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. A composite probabilistic model combined patient-level error models with practice-level error rates and intervention costs from the trial. Cost per extra QALY and cost-effectiveness acceptability curves were generated from the perspective of NHS England, with a 5-year time horizon. RESULTS: The PINCER intervention generated £2,679 less cost and 0.81 more QALYs per practice [incremental cost-effectiveness ratio (ICER): -£3,037 per QALY] in the deterministic analysis. In the probabilistic analysis, PINCER generated 0.001 extra QALYs per practice compared with simple feedback, at £4.20 less per practice. Despite this extremely small set of differences in costs and outcomes, PINCER dominated simple feedback with a mean ICER of -£3,936 (standard error £2,970). At a ceiling 'willingness-to-pay' of £20,000/QALY, PINCER reaches 59 % probability of being cost effective. CONCLUSIONS: PINCER produced marginal health gain at slightly reduced overall cost. Results are uncertain due to the poor quality of data to inform the effect of avoiding errors.

The cost-effectiveness of a pharmacogenetic test: a trial-based evaluation of TPMT genotyping for azathioprine.

BACKGROUND: Thiopurine-methyl transferase (TPMT) testing prior to the prescription of azathioprine in autoimmune diseases is one of the few examples of a pharmacogenetic test that has made the transition from research into clinical practice. TPMT testing could lead to improved prescribing of azathioprine resulting in a reduction in adverse drug reactions as well as an improvement in effectiveness. When allocating scarce resources robust evidence on cost-effectiveness is required. OBJECTIVE: This study aimed to evaluate the cost-effectiveness of a TPMT genotyping test to inform azathioprine prescribing in autoimmune diseases. The secondary aim of this study was to demonstrate the complexity of undertaking a trial-based evaluation of a pharmacogenetic test. METHODS: A prospective economic evaluation was conducted alongside the TARGET (TPMT: Azathioprine Response to Genotype and Enzyme Testing) study, a pragmatic controlled trial that randomized (1:1) patients to undergo TPMT genotyping before azathioprine (n = 167) or current practice (n = 166). Assuming the UK health service perspective and a time horizon of 4 months, resource-use and health status data were collected prospectively for all recruited patients. RESULTS: The mean incremental cost for TPMT genotyping and subsequent care pathways compared with current practice for the 4-month follow-up was -£421.06 (95% confidence interval -£925.15 to £89.75). Mean incremental quality-adjusted life-years were close to zero but negative: -0.008 (95% confidence interval -0.017 to 0.0002). Assuming a threshold of £20,000 per quality-adjusted life-year, the expected incremental net benefit of introducing the test is £256.89 (95% CI -£425.94 to £932.86). CONCLUSIONS: TPMT genotyping potentially offers a less expensive alternative than current practice, but it may also have a small but negative effect on health status. These findings are associated with significant uncertainty, and the causal effect of TPMT genotyping on changes in health status and health care resource use remains uncertain. The results from this study therefore pose a difficult challenge to decision makers.

The direct medical costs of epilepsy in children and young people: a population-based study of health resource utilisation.

We described the health resource utilisation (HRU) and associated direct medical costs of managing epilepsy in children and young people (CYP) using population-level data from the United Kingdom. The study cohort were CYP born between 1988 and 2004 who were newly diagnosed with epilepsy and identified using a nationally representative primary care database from the United Kingdom. Reference unit costs were applied to each element of HRU to calculate annual direct medical costs per child. We assessed whether HRU and costs differed by time from diagnosis, age, sex and socioeconomic deprivation. Of 798 CYP newly diagnosed with epilepsy, 56% were male and the mean age at diagnosis was 5.6 years. The highest burden of HRU was in the first year following diagnosis with a mean annual cost of £930 (95% confidence interval (CI) £839-1022) per child in this first year. This decreased to £461 (95%CI 368-551) in the second year which remained fairly constant each subsequent year (£413 (95% CI 282-540) in the 8th year). The highest contribution to the annual medical costs was from inpatient hospital admissions followed by the costs of AEDs. Mean annual medical costs were significantly higher in children under 6 years of age compared with older children (p<0.01), but were similar across socioeconomic groups (p=0.62). The direct medical costs of HRU in CYP with epilepsy are higher in the first year after diagnosis compared to subsequent years, reflecting HRU related to the diagnostic process in the first year. Medical costs did not vary substantially by sex or socioeconomic deprivation indicating a similar level of consultation and care across these groups.