UK Unit Costs Research Articles

Variations in the costs of atrial fibrillation: a longitudinal study across 27 European and Central Asian countries

Abstract Background/Introduction For many conditions, disease complications are the main driver of care costs. Atrial fibrillation (AF) – the commonest manifestation of cardiac arrhythmia – increases the risk of stroke and coronary heart disease, both of which are costly. Although the clinical burden of AF is widely documented, it is unknown to what extent AF-related complications contribute to healthcare costs and if these costs vary across countries. Purpose To assess the individual patient healthcare costs associated with AF-related complications and their variation across 27 European and Central Asian countries. Methods We used data from the European Society of Cardiology’s Atrial Fibrillation General Registry, a prospective, multinational registry of 10,249 atrial fibrillation patients from 27 countries with two-years of annual follow-up. Information on patients’ clinical characteristics, healthcare visits, as well as diagnostic and interventional procedures were collected at each visit. Atrial fibrillation related complications were angina, non-ST-elevation myocardial infarction (NSTEMI), ST-elevation myocardial infarction (STEMI), thromboembolic events, haemorrhagic events, and new onset or worsening heart failure. All healthcare resource use (inpatient stays, outpatient visits, and medications) were costed using 2019 UK unit costs to better assess variations in overall resource use across countries. We used panel data methods to assess the association of AF-related complications and healthcare costs and resource use. The models were adjusted for patients’ clinical and sociodemographic characteristics, prior medication use and geographical location. Results Over the follow-up period, 745 (8%) patients had an AF-related complication at 12-months and 477 (6%) at 24-months. Of the total 1,222 complications, the most common AF-related complication was new onset or worsening heart failure which occurred in 567 (3%) patients with complications. Overall, angina (£2,629, 95% CI: 1869 to 3361) and haemorrhagic events (£2,549, £2,199 to £2,900) incurred the highest cost, whereas non-stable myocardial infarction (£1,367, £687 to £2,048) incurred the least additional cost. We found significant regional variation. Costs of angina in Eastern EU and in non-EU former Soviet republics were, respectively, £1,362 (-£2,262 to -£461) and £1,416 (-£2,571 to -£261) lower than in Western Europe. Whereas costs in Southern EU and Northern EU countries were £721 (-£2,629 to £1,186) and £344 (-£1,460 to £ 674) lower than in Western Europe. Conclusions Although disease complications are costly in all countries, notable differences were observed across countries. These differences were driven by fewer investigations, clinic visits, and ER admissions. Our results, therefore, highlight the regional variations in resource use patterns across countries, limiting the generalisability of country-specific economic evaluations to other jurisdictions.

Cost-Effectiveness of Single-Inhaler Triple Therapy (FF/UMEC/VI) versus Tiotropium Monotherapy in Patients with Symptomatic Moderate-to-Very Severe COPD in the UK.

For patients with chronic obstructive pulmonary disease (COPD) who remain symptomatic despite maintenance treatment, clinical management guidelines recommend a stepwise escalation from monotherapy to dual therapy, and from dual therapy to triple therapy. However, in clinical practice, patients are often escalated directly from monotherapy to triple therapy based on disease severity. This study evaluated the cost-effectiveness of once-daily, single-inhaler fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) triple therapy compared with long-acting muscarinic antagonist monotherapy with once-daily tiotropium (TIO) in patients with symptomatic moderate-to-very severe COPD, from a UK National Health Service perspective. The validated GALAXY-COPD disease progression model was populated with patient baseline characteristics and treatment effect data from the 12-week GSK Study 207626 comparing FF/UMEC/VI with TIO in patients with moderate-to-very severe COPD. UK unit costs and drug costs (British Pound, 2021) were applied to healthcare resource utilization and treatments. The base case analysis was conducted over a lifetime horizon, and costs and health outcomes (except for life years [LYs]) were discounted at 3.5% per year. Model outputs included exacerbation rates, healthcare costs, LYs, quality-adjusted LYs (QALYs), and incremental cost-effectiveness ratios. Overall, treatment with FF/UMEC/VI resulted in increased clinical benefit (reduction in total exacerbations and increased overall survival and QALYs), coupled with cost savings (derived from lower maintenance and exacerbation healthcare costs) compared with TIO monotherapy. In the base case analysis, FF/UMEC/VI provided an additional 0.393 LYs (95% range: 0.176, 0.655) and 0.443 QALYs (0.246, 0.648), at a cost saving of £880 (£54, £1608) versus TIO. FF/UMEC/VI remained the cost-effective (dominant) treatment option across sensitivity and scenario analyses. FF/UMEC/VI offers greater clinical benefits and is a cost-effective treatment option compared with TIO for the treatment of adult patients with COPD with persistent symptoms and/or who are at risk of exacerbation in the UK.

Healthcare costs associated with short-acting β2-agonists in asthma: observational UK SABINA study.

Poor asthma control is associated with high short-acting β2-agonist (SABA) use. To assess asthma-related healthcare resource utilisation (HCRU) and medication costs associated with high versus low SABA prescriptions in the UK. Analysis of SABINA I (SABA use IN Asthma I), a retrospective longitudinal study using UK electronic health records (Clinical Practice Research Datalink GOLD 2008-2019 and Hospital Episode Statistics database). Eligible patients were ≥12 years old with SABA prescriptions in the past year. SABA prescriptions (number of canisters per year) were defined as high (≥3) or low (1-2). Association of SABA prescriptions with HCRU was assessed by negative binominal model adjusted for covariates. The UK unit costs from the NHS were applied to estimate total healthcare costs (2020). Medication costs were based on the annual average number of canisters per year per patient. Overall, 186 061 patients with SABA prescriptions were included, of whom 51% were prescribed high SABA. Total annual average costs (HCRU and medication) were 52% higher in the high SABA group versus the low SABA group (£2 256 091 per 1000 patients/year versus £1 480 640 per 1000 patients/year). Medication costs accounted for the majority of asthma-related costs. Across both groups, most HCRU costs were for non-exacerbation-related primary care or hospital outpatient visits. The annual average HCRU cost difference for high SABA versus low SABA was the greatest for hospitalisations (+230%; £15 521 per 1000 patients/year versus £4697 per 1000 patients/year) and exacerbation-related primary care visits (+162%; £18 770 per 1000 patients/year versus £7160 per 1000 patients/year). Asthma-related HCRU extrapolated to the broader UK asthma population was £108.5 million per year higher with high SABA versus low SABA. High SABA versus low SABA prescriptions are associated with higher asthma-related HCRU costs.

Cost-Utility Analysis of Discontinuing Antidepressants in England Primary Care Patients Compared with Long-Term Maintenance: The ANTLER Study.

BackgroundDepression is a common mental health condition with considerable negative impact on health and well-being. Although antidepressants are recommended as first-line treatment, there is limited evidence regarding the cost effectiveness of long-term maintenance antidepressants for preventing relapse.ObjectivesOur objective was to calculate the mean incremental costs and quality-adjusted life-years (QALYs) over 12 months of discontinuing long-term antidepressant medication in well patients compared with maintenance, using patient-level trial data.MethodsWe conducted a cost-utility analysis of 478 participants from 150 UK general practices recruited to a randomised, double-blind trial (ANTLER). QALYs were calculated from EQ-5D-5L and 12-Item Short Form survey (SF-12) results, with primary analysis using the EQ-5D-5L value set for England. Resource use was collected from primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use. Costs were calculated by applying standard UK unit costs to resource use. Adjustments were made for baseline variables.ResultsParticipants randomised to discontinuation had significantly worse utility scores at 3 months (− 0.032; 95% confidence interval [CI] − 0.053 to − 0.011) but no significant difference in QALYs (− 0.011; 95% CI − 0.026 to 0.003) or costs (£3.11; 95% CI − 41.28 to 47.50) at 12 months. The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained.ConclusionsDiscontinuation of antidepressants was unlikely to be cost effective compared with maintenance for currently well patients on long-term antidepressants. However, this analysis provides no information on the wider impact of antidepressants. Our findings provide information on the potential impact of discontinuing long-term maintenance antidepressants and facilitate improving guidance for shared patient–clinician decision making.Trial RegistrationEudraCT number 2015-004210-26; ISRCTN number ISRCTN15969819.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40258-021-00693-x.

Estimated societal costs of stroke in the UK based on a discrete event simulation.

ABSTRACTBackgroundthere are around 100,000 new stroke cases and over a million people living with its consequences annually in the UK. This has large impacts on health and social care, unpaid carers and lost productivity. We aimed to estimate associated costs.Methodswe estimated 2014/2015 annual mean cost per person and aggregate UK cost of stroke for individuals aged ≥40 from a societal perspective. Health and social care costs in the first and subsequent years after stroke were estimated from discrete event simulation modelling, with probability of progression and length of receipt of different health and social care services obtained from routine registry and audit data. Unpaid care hours and lost productivity were obtained from trial data. UK unit costs were applied to estimate mean costs. Epidemiological estimates of stroke incidence and prevalence were then applied to estimate aggregate costs for the UK.Resultsmean cost of new-onset stroke is £45,409 (95% CI 42,054-48,763) in the first year after stroke and £24,778 (20,234–29,322) in subsequent years. Aggregate societal cost of stroke is £26 billion per year, including £8.6 billion for NHS and social care. The largest component of total cost was unpaid care (61%) and, given high survival, £20.6 billion related to ongoing care.Conclusionthe estimated aggregate cost of stroke substantially exceeds previous UK estimates. Since most of the cost is attributed to unpaid care, interventions aimed at rehabilitation and reducing new and recurrent stroke are likely to yield substantial benefits to carers and cost savings to society.

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

BackgroundLimited 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 MethodsThe 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.ResultsCases 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).ConclusionEvidence 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.

Cost-effectiveness of a bacterial-binding dressing to prevent surgical site infection following caesarean section.

A randomised controlled trial (RCT) recruited women undergoing caesarean section (CS) in Poland. The aim of the trial was to assess the efficacy of a dialkylcarbamoyl chloride (DACC)-impregnated surgical dressing (bacterial-binding dressings) compared with standard of care (SoC) in preventing surgical site infection (SSI). The aim of the present analysis was to evaluate the cost-effectiveness of the bacterial-binding dressings in the context of the UK National Health Service (NHS). The clinical trial randomised patients to a bacterial-binding dressing (n=272) or a standard surgical dressing (n=271). The study recorded the presence of SSI and associated resource use up to 14 days postoperatively. To generalise results to the NHS, UK unit costs were applied to resource use recorded in the trial. An alternative approach applied a single UK-specific episode cost per SSI. There were 543 women recruited to the trial. SSI rates were 5/272 (1.8%) and 14/271 (5.2%) for bacterial-binding dressings and SoC, respectively (p=0.04). Patients in the bacterial-binding dressing group had six fewer outpatient visits and 33 fewer hospital bed-days. The mean length of SSI-attributable hospitalisation was 2.36 days. Applying UK unit costs at 2017 prices to resource use recorded in the trial, costs of SSI prophylaxis and treatment were £48.97 and £24.69 per patient in the SoC and bacterial-binding dressing groups respectively, a difference of £24.27 (49.6%) per patient. The alternative costing approach produced a cost saving of £119 (57.6%) per patient with the bacterial-binding dressing. Use of bacterial-binding dressings following CS has the potential to reduce the incidence of SSI and costs to the NHS.

PDB63 - COST-EFFECTIVENESS ANALYSIS OF EMPAGLIFLOZIN TREATMENT IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC HEART FAILURE BASED ON SUBGROUP OF EMPA-REG OUTCOME IN THE UNITED KINGDOM

In type 2 diabetes (T2D) patients with established CV disease, empagliflozin reduced heart failure hospitalizations (HHF) and CV death compared to SoC, regardless of HF at baseline. Given the poor outcomes and economic burden of these comorbidities, we investigated the cost-effectiveness of empagliflozin on top of SoC in T2D patients with HF at baseline over a lifelong time horizon from a UK perspective. Discrete event simulation economic model was developed to project CV events including HHF, CV death, and kidney outcomes for EMPA-REG OUTCOME T2D patients with HF at baseline. Respective risk equations were derived using event-free survival curves with time-dependent covariates. Model validity was assessed by comparing predicted and observed outcomes at three years. UK unit costs of complications and QoL data were obtained from literature. The drug costs were from the British National Formulary and Monthly Index of Medical Specialties. Outcomes included event rates per 100 patient-years (PYs), life years (LYs), costs, and quality-adjusted life years (QALYs). Patients on empagliflozin were projected to experience fewer events of 1st HHF (3.64 vs 4.61 per 100 PY) and recurrent HHF (2.78 vs 4.92 per 100 PY), CV deaths (6.07 vs 7.37 per 100 PY), and non-fatal MI (2.67 vs 3.31 per 100 PY), but higher event rate for non-fatal stroke (2.57 vs 1.54 per 100 PY), compared to SoC. Treatment with empagliflozin projected 1.22 LYs and 0.65 QALYs gained. Incremental Cost-Effectiveness Ratio (ICER) for empagliflozin compared with SoC was £434/QALY. Probabilistic sensitivity analyses suggested that the probability of empagliflozin being cost-effective in patients with T2D and HF at a threshold of £20,000/QALY was 89%. Based on results of EMPA-REG OUTCOME, this cost effectiveness analysis suggests that empagliflozin on top of SoC is a cost-effective treatment option for patients with T2D and chronic HF from the UK NHS perspective.

Economic analysis of oral dexamethasone for symptom relief of sore throat: the UK TOAST study

ObjectivesTo undertake an economic analysis assessing the cost-effectiveness of a single dose of oral dexamethasone compared with placebo for the relief of sore throat.DesignA UK-based, multicentre, two arm, individually randomised,...

One-year costs of bilateral or single internal mammary grafts in the Arterial Revascularisation Trial

ObjectiveCoronary artery bypass grafting (CABG) using bilateral internal mammary arteries (BIMA) may improve survival over CABG using single internal mammary arteries (SIMA), but may be surgically more complex (and therefore...

Prophylactic platelet transfusions in patients with blood malignancies: cost analysis of a randomized trial.

This cost analysis uses data from a randomized trial comparing a no prophylaxis versus prophylactic platelet (PLT) transfusion policy (counts <10 × 10(9) /L) in adult patients with hematologic malignancies. Results are presented for all patients and separately for autologous hematopoietic stem cell transplantation (HSCT) (autoHSCT) and chemotherapy/allogeneic HSCT (chemo/alloHSCT) patients. Data were collected to 30 days on PLT and red blood cell (RBC) transfusions, major bleeds, serious adverse events, critical care, and hematology ward stay. Data were costed using 2011 to 2012 UK unit costs and converted into US$. Sensitivity analyses were performed on uncertain cost variables. Across the whole trial no prophylaxis saved costs compared to prophylaxis: -$1760 per patient (95% confidence interval [CI], -$3250 to -$249; p < 0.05). For autoHSCT patients there was no cost difference between arms: -$110 per patient (95% CI, -$1648 to $1565; p = 0.89). For chemo/alloHSCT patients no prophylaxis cost significantly less than prophylaxis: -$5686 per patient (95% CI, -$8580 to -$2853; p < 0.01). The cost impact of no prophylaxis differed significantly between subgroups. Sensitivity analyses varying daily treatment costs and ward stay for chemo/alloHSCT patients reduced cost differences to -$941 per patient (p = 0.21) across the whole trial and -$2927 per patient (p < 0.05) in chemo/alloHSCT subgroup. It is unclear whether a no-prophylaxis policy saves costs overall. In chemo/alloHSCT patients cost savings are apparent but their magnitude is sensitive to a number of variables and must be considered alongside clinical data showing increased bleeding rates. In autoHSCT patients savings generated through lower PLT use in no-prophylaxis arm were offset by cost increases elsewhere, for example, additional RBC transfusions. Cost-effectiveness analyses of alternative PLT transfusion policies simultaneously considering costs and patient-reported outcomes are warranted.

150 Cost of spasticity associated with multiple sclerosis in the UK

ObjectiveTo assess the cost of spasticity in MS in the UK.Methodswe conducted a questionnaire survey. We defined five levels of spasticity. Level 1 corresponds to 0–2 on a 10 point...

The Cost of Relapse for Patients with a Manic/Mixed Episode of Bipolar Disorder in the EMBLEM Study

Bipolar disorder (BD) is characterized by episodes of mania and depression. The debilitating symptoms during an acute episode require intensive treatment, frequently leading to inpatient psychiatric care, which places significant demands on health and social care systems and incurs substantial costs. However, no study to date has estimated the economic impact of relapse. To estimate the direct costs associated with relapse in the treatment of BD following an acute manic or mixed episode over a 21-month follow-up period in routine clinical practice in Europe, using data from a large, prospective, observational study. EMBLEM was a prospective, observational study on the outcomes of patients with a manic/mixed episode of BD conducted in 14 European countries. Patients eligible for analysis were those enrolled in the 21-month maintenance phase of the study, following the 3-month acute phase. Relapse was defined as achieving any one of the following criteria: (i) at least a one-point increase in Clinical Global Impression - Bipolar Disorder (CGI-BP) overall score from the previous visit, with a final rating of > or =4; (ii) inpatient admission for an acute episode of BD; or (iii) psychiatrists' confirmation of relapse. Data on healthcare resource use were recorded retrospectively for the four respective periods (3-6, 6-12, 12-18 and 18-24 month visits). Multivariate analyses were performed to compare the cost of resource use (inpatient stay, day care, psychiatrist visits and medication) for those who relapsed during the 21-month maintenance phase and those who never relapsed. A sensitivity analysis was also conducted to examine the 6-month costs during relapse. The analyses were adjusted for patient characteristics and took account of non-Normality of the cost data by using a log link function. UK unit costs were applied to resource use. The analysis was repeated after multiple imputation for missing data. All costs were presented as year 2007/08 values. A total of 1379 patients completed all visits during the maintenance phase and were eligible for inclusion in the present analysis. Of these, over half (54.3%) experienced relapse during this period. A total of 792 patients without any missing data were eventually included in the final cost model. Costs incurred by patients who relapsed during the 21-month maintenance phase were approximately double those incurred by patients who never relapsed (pounds sterling 9140 vs pounds sterling 4457; p < 0.05). Of the cost difference, 80.3% was accounted for by inpatient stay. Estimates on the economic impact were higher (pounds sterling 11,781 vs pounds sterling 4789; p < 0.05) in the additional analysis with imputed missing data. The impact of relapse was even greater in the 6-month cost comparison. The average 6-month costs for patients who relapsed were found to be about three times higher than for those who did not relapse (pounds sterling 4083 vs pounds sterling 1298; p < 0.05). Our findings confirm the significant economic impact of relapse in BD patients after an acute manic or mixed episode, even when considering direct costs only. Such costs were dominated by inpatient stay. Nevertheless, the use of UK unit costs requires caution when interpreting this costing in the context of a specific country, as resource use and the associated costs will differ by country.

PTU-078 Cost-effectiveness analysis comparing surgical and endoscopic drainage in patients with obstructive chronic pancreatitis

Introduction Two published randomised controlled trials (RCTs)[1][1] ,[2][2] have reported that surgical drainage of the pancreatic duct was more effective than endoscopic drainage for patients with chronic pancreatitis. The objective of this analysis was to assess the cost-effectiveness of surgical vs endoscopic drainage in obstructive chronic pancreatitis. Methods This analysis was conducted mainly based on one RCT[1][1], from a UK National Health Service perspective, and over a 24-month time horizon for the base-case analysis (median follow-up time in the trial). A lifetime horizon was used in the sensitivity analysis. The health outcome was the Quality-Adjusted Life Year (QALY), which was generated using EQ-5D data collected during the trial. Also collected were details of the use of diagnostic and therapeutic procedures, time in hospital and the treatment of pancreatic exocrine and endocrine insufficiency. This resource use was combined with UK unit costs. Key elements of resource use, such as complication rates and conversion to surgery were varied in sensitivity analyses. The trial reported one death in the endoscopy group (5%), which was not clearly related to the intervention. For the base-case analysis, we assumed no mortality in either group and applied a mortality rate of up to 2% to surgical drainage in the sensitivity analysis. Results The result of the base-case analysis was that surgical drainage of the pancreatic duct dominated endoscopic drainage, being both more effective and less costly. The sensitivity analysis showed that the surgical option remained dominant in a majority of scenarios. When compared with a threshold of £20 000 per QALY gained, all analyses indicated that the probability that surgical drainage is cost-effective compared to endoscopic drainage exceeds 95%. Conclusion In patients with obstructive chronic pancreatitis, surgical drainage is highly cost-effective compared to endoscopic drainage. This economic analysis was developed from a UK perspective, but given the magnitude of the improvement in quality of life, the substantial cost savings and the robustness of the results to sensitivity analyses, it is likely that this conclusion can be generalised to other healthcare systems. [1]: #ref-1 [2]: #ref-2

PW01-181 - Economic consequences of medication nonadherence in the treatment of schizophrenia: 36-month results from the SOHO (schizophrenia outpatient health outcomes) study

ObjectiveTo estimate costs associated with medication non-adherence over a 3-year follow-up period in the treatment of schizophrenia in routine clinical practice in Europe.MethodsSOHO is a 3-year, prospective, observational study of 10972 outpatient participants across 10 European countries. Data were collected at baseline and at 6-month intervals up to 36 months. Medication adherence was assessed at each visit by participating psychiatrists during 4 weeks prior to the visit as: (1) not prescribed medication; (2) always adherent; (3) partially adherent; and (4) never adherent. In this post-hoc analysis, multivariate analyses were performed to compare the costs of resource use (inpatient stay, day care, psychiatrist visits and medication) in patients who were adherent, partially adherent, and non-adherent, using a log-link function. Adherence status was included as a time-varying variable, and other baseline patient characteristics were adjusted for. UK unit costs were applied to resource use.ResultsOut of 5364 patients who were prescribed medication prior to baseline, 5.9% were non-adherent while 77.1% and 17.0% were adherent and partially adherent, respectively, at baseline. The average 6-month cost incurred by non-adherent patients was £2505 while that for adherent and partially adherent patients was £2029 and £2130 respectively. This difference was mainly due to inpatient costs. The inpatient costs incurred by non-adherent patients (£987) were almost double those for adherent patients (£475).ConclusionNon-adherence in schizophrenia was likely to incur more inpatient services, which may indicate poorer clinical prognosis. A study limitation is that adherence was assessed by investigators using a single-item measure.

The cost of relapse in patients with schizophrenia in the European SOHO (Schizophrenia Outpatient Health Outcomes) study

Background Relapse in schizophrenia is one of the greatest burdens of the illness. Aims To estimate the costs associated with relapse in a pan-European naturalistic setting. Method The SOHO study is a 3-year, prospective, observational study of 10,972 outpatients with schizophrenia across 10 European countries. The cost of resource use (inpatient stay, day care, psychiatrist visits and medication) for those who ever relapsed in three years was compared to those who never relapsed. One-year costs for both groups were also compared for a more stringent comparison. The analyses were adjusted for patient characteristics and took account of non-normality of the cost data by using a log-link function. UK unit costs were applied to resource use. The analysis was repeated after multiple imputation for missing data. Results Costs incurred by patients who ever relapsed (£14,055) during three years were almost double to those incurred by patients who never relapsed (£7417). 61% of the cost difference was accounted for by hospital stay. The impact of relapse was even greater in the 1-year cost comparison. Results from the additional analysis with imputed missing data remained largely consistent. Conclusions Our findings confirm the significant economic burden of relapse, and show such costs were mainly due to hospital stay. Nevertheless, the use of UK unit costs requires caution when interpreting this costing in the context of a specific country, as resource use and their associated costs will differ by country.

Cost‐effectiveness of budesonide/formoterol for maintenance and reliever asthma therapy

Budesonide/formoterol (Symbicort) Maintenance and Reliever Therapy (SMART) is an effective asthma-management approach that treats symptoms with rapid increases in budesonide/formoterol. The cost-effectiveness of SMART vs higher fixed-dose budesonide/formoterol or salmeterol/fluticasone is unknown. This 6-month, double-blind study randomized patients with asthma uncontrolled by inhaled corticosteroids alone (n = 3335; age > or =12 years) to budesonide/formoterol 160/4.5 microg b.i.d. plus additional doses as needed (SMART), budesonide/formoterol 320/9 microg b.i.d. plus as-needed terbutaline, or salmeterol/fluticasone 50/250 microg b.i.d. plus as-needed terbutaline. Economic analysis, assuming health care and societal perspectives, applied 2004 UK and Australian unit costs to pooled resource-use data. The effectiveness variable was the rate of severe exacerbations/patient/6 months. Patients treated using the SMART approach experienced fewer severe exacerbations than fixed-dose budesonide/formoterol and salmeterol/fluticasone patients (0.12 vs 0.16 and 0.19 events/patient/6 months, respectively; P < or = 0.0048). Budesonide/formoterol (Symbicort) Maintenance and Reliever Therapy provided similar improvements in other markers of asthma control at a lower overall daily inhaled corticosteroid dose compared with fixed-dose treatment. Study drug costs accounted for a majority of both direct costs (DC; 78-87%) and total costs (TC; 50-63%) for all treatments, and were significantly lower in the SMART group compared with the fixed-dose groups (P < or = 0.0014). Direct and TC per patient/6 months were lower for SMART vs salmeterol/fluticasone (DC:-AUS$154, P < 0.0001; TC:-AUS$163, P = 0.0036;-87 pound sterling, P = 0.0026) and vs budesonide/formoterol using UK costs (DC:-73 pounds sterling, P < 0.0001; TC:- 91 pounds sterling, P = 0.0014). Costs tended to be lower for SMART vs budesonide/formoterol using Australian costs (DC:-AUS$35, P = 0.16; TC:-AUS$70, P = 0.20). Results were stable under sensitivity testing. Indirect resource use and cost were not significantly different between groups. Compared with higher fixed-dose budesonide/formoterol and salmeterol/fluticasone, SMART reduces the incidence of severe exacerbations at a lower or similar overall cost and can be considered a cost-effective treatment regimen.

Improvement in the Process of Induction of Labour Using Isosorbide Mononitrate (IMN) for Cervical Ripening

Cervical ripening has been shown to reduce associated operative morbidity prior to induction of labour. Agents commonly employed for cervical ripening include prostaglandin analogues, although these are associated with several adverse effects such as abdominal pain, gastrointestinal upset and vaginal bleeding. This study examines Isosorbide mononitrate (IMN) as a cervical ripening agent, administered on an outpatient basis, in women prior to induction of labour. There is no evidence of its cost-effectiveness although it is hypothesised that, compared with placebo treatment, the use of IMN will result in a shorter inpatient stay before delivery, hence decreased costs to the health service, as well as greater maternal satisfaction. There is also evidence that IMN may eliminate fetal heart rate abnormalities compared to the placebo. Preliminary findings will be reported on in relation to a prospective economic evaluation conducted alongside a randomised controlled trial estimating the cost-effectiveness of IMN. Three hundred women scheduled for induction of labour at Princess Royal Maternity Hospital, Glasgow, will be recruited to the study. The cost differences between the two groups, the IMN and placebo groups, will be measured, valued and combined with the clinical effectiveness data from the trial. Data will be collected on the health service resources used in the treatment of each woman and infant during the period between randomisation and hospital discharge. Data will be obtained from the trial data collection forms as well as observational research to provide details of the resources and staff inputs required for the induction of labour, as well as staff time, tests, procedures, drugs and equipment entailed by complications. Current UK unit costs will be applied to each resource item to value total resource use in each arm of the trial. The economic evaluation will be conducted from a health service perspective and will take two forms; (i) an overall cost analysis and (ii) an incremental cost-effectiveness analysis, which will be expressed in several forms, for example, incremental cost per operative delivery prevented. In the absence of stochastic data for all variables, a series of multi-way sensitivity analyses will be undertaken to explore the implications of uncertainty on the base-case incremental cost-effectiveness ratios. In addition, cost-effectiveness acceptability curves will be constructed using the net benefits approach. All analyses will be performed with a microcomputer using Statistical Package for the Social Sciences (SPSS) software.

A comparison of the cost-effectiveness of five strategies for the prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal toxicity: a systematic review with economic modelling

OBJECTIVES: To assess the relative effectiveness, patient acceptability, costs and cost-effectiveness of four strategies for the prevention of non-steroidal anti-inflammatory drugs (NSAIDs)-induced gastrointestinal (GI) toxicity: (1) Cox-1 NSAIDs plus histamine-2 receptor antagonist (H2RA), (2) Cox-1 NSAIDs plus proton pump inhibitors (PPIs), (3) Cox-1 NSAIDs plus misoprostol, and (4) Cox-2 NSAIDs (later expanded to 4a Cox-2 coxibNSAIDs and 4b Cox-2 preferential NSAIDs). DATA SOURCES: Electronic databases up to May 2002. REVIEW METHODS: Relevant studies were selected, assessed and analysed. Pooled relative risk ratios (RR) from the systematic review were combined with up-to-date UK resource use and unit costs data in an incremental economic analysis. A probabilistic decision-analytic model was designed and populated with data to carry out incremental economic analysis. Incremental cost-effectiveness ratios (ICERs) were generated for the outcome measure, endoscopic ulcer or serious GI event averted, against total cost, and non-parametric bootstrapping was used to simulate variance of these ICERs. RESULTS: Of 118 selected trials, including 125 relevant comparisons (which included 76,322 participants) only 138 deaths and 248 serious GI events were reported. Seven comparisons were judged to be at low risk of bias. Comparing the gastroprotective strategies against placebo, there was no evidence of effectiveness of H2RAs against any primary outcomes (few events reported), PPIs may reduce the risk of symptomatic ulcers [RR 0.09, 95% confidence interval (CI) 0.02 to 0.47], misoprostol reduces the risk of serious GI complications (RR 0.57, 95% CI 0.36 to 0.91) and symptomatic ulcers (RR 0.36, 95% CI 0.20 to 0.67), Cox-2 'preferentials' reduce the risk of symptomatic ulcers (RR 0.41, 95% CI 0.26 to 0.65) and Cox-2 'coxibs' reduce the risk of symptomatic ulcers (RR 0.49, 95% CI 0.38 to 0.62) and possibly serious GI events (RR 0.55, 95% CI 0.38 to 0.80). All strategies except Cox-2 'preferentials' reduce the risk of endoscopic ulcers. There were only 12 direct comparisons between gastroprotective strategies. All they suggest is that Cox-2 preferentials are better than misoprostol for preventing GI complications. Indirect comparisons suggested that PPIs may prevent symptomatic ulcers better than Cox-2 coxibs, but this is very weak evidence. For prevention of endoscopic ulcers PPIs and misoprostol appear more successful than H2RAs and misoprostol is better than Cox-2 preferentials. There were no UK head-to-head published economic analyses with regard to the main gastroprotective strategies. There were generally insufficient data with regards to cardiac or renal outcomes, serious GI outcomes or life-years gained to populate the mode. Mean (2.5th and 97.5th percentile) costs per endoscopic ulcer averted compared with Cox-1 NSAIDs alone were as follows: Cox-1 plus H2RAs, -186 pounds (-555 to 804); Cox-1 plus PPIs, 454 pounds (251 to 877); Cox-1 plus misoprostol, 54 pounds (-112 to 238); Cox-2 selective NSAIDs, 263 pounds (-570 to 1280), or Cox-2 specific NSAIDs, 301 pounds (189 to 418). With regard to the prevention of endoscopic ulcers, Cox-1 NSAID plus H2RA is a dominant option. Cost-effectiveness acceptability analysis showed a 95% probability that this combination was less costly and more effective. Cost-effectiveness acceptability frontiers showed that if the decision-maker is willing to pay up to 750 pounds to avoid an endoscopic ulcer, then Cox-1 plus H2RA is the optimal strategy. If the decision-maker is willing to pay over 750 pounds, the optimal strategy is NSAID plus misoprostol. Between 1900 pounds and 3750 pounds, Cox-2 selective inhibitors are optimal, and over 3750 pounds, Cox-2 specific inhibitors become optimal. NSAID plus PPI is never the optimal strategy. Sensitivity and subgroup analyses suggest that Cox-1 NSAID plus H2RA and Cox-1 NSAID plus misoprostol become more cost-effective in the older age group. Some conclusions we

PMH35 THE COST OF RELAPSE IN PATIENTS WITH SCHIZOPHRENIA IN THE PAN-EUROPEAN SOHO (SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES) STUDY

Background Relapse in schizophrenia is one of the greatest burdens of the illness. Aims To estimate the costs associated with relapse in a pan-European naturalistic setting. Method The SOHO study is a 3-year, prospective, observational study of 10,972 outpatients with schizophrenia across 10 European countries. The cost of resource use (inpatient stay, day care, psychiatrist visits and medication) for those who ever relapsed in three years was compared to those who never relapsed. One-year costs for both groups were also compared for a more stringent comparison. The analyses were adjusted for patient characteristics and took account of non-normality of the cost data by using a log-link function. UK unit costs were applied to resource use. The analysis was repeated after multiple imputation for missing data. Results Costs incurred by patients who ever relapsed (£14,055) during three years were almost double to those incurred by patients who never relapsed (£7417). 61% of the cost difference was accounted for by hospital stay. The impact of relapse was even greater in the 1-year cost comparison. Results from the additional analysis with imputed missing data remained largely consistent. Conclusions Our findings confirm the significant economic burden of relapse, and show such costs were mainly due to hospital stay. Nevertheless, the use of UK unit costs requires caution when interpreting this costing in the context of a specific country, as resource use and their associated costs will differ by country.