Long-term effect of patient decision aids on use of joint replacement and health care costs.

OBJECTIVE: Shared decision-making supported by patient decisions aids may improve care and reduce healthcare costs for persons considering total joint replacement. Observational studies and randomized controlled trials (RCTs) have evaluated the short-term impact of decision aids on uptake of surgery and costs, however the long-term effects are unclear. This analysis aimed to evaluate the effect of patient decision aids on 1) use of joint replacement up to 7-years of follow-up, and 2) osteoarthritis-related health system costs. METHODS: 324 participants in a Canadian RCT with 2-years follow-up who were randomized to either a decision aid (n = 161) or usual care (n = 163) had their trial and health administrative data linked. The proportion undergoing surgery up to 7-years were compared using cumulative incidence plots and competing risk regression. Mean per-patient costs were compared using two sample t-tests. RESULTS: At 2-years, 119 of 161 (73.9%) patients in the decision aid arm and 129 of 163 (79.1%) patients in the usual care arm had surgery. Between two and 7-years, 17 additional patients in both the decision aid (of 42, 40.4%) and usual care (of 34, 50.0%) arms underwent surgery. At 7-years, patients exposed to decision aids had a similar likelihood of undergoing surgery (HR = 0.92, 95% CI:0.73 to 1.17, p = 0.49) and mean per-patient costs ($21,965 vs $23,681, incremental cost: -$1,717, 95% CI:-$5,631 to $2,198) compared to those in usual care. CONCLUSIONS: This is the first study to assess the long-term impact of decision aids on use of joint replacement and healthcare costs. These results are not conclusive but can inform future trial design. CLINICAL TRIAL REGISTRATION: The full trial protocol is available at ClinicalTrials.Gov (NCT00911638).

Decision aids for patients considering total joint replacement: a cost-effectiveness analysis alongside a randomised controlled trial.

BACKGROUND: Shared decision-making (SDM) is a key priority to improve patient-centred care, and can play an important role in helping patients decide whether to undergo total joint arthroplasty (TJA). Patient decision aids can support SDM; however, they may incur an upfront cost. We aimed to estimate the health and economic effects of patient decision aids for TJA. METHODS: A cost-effectiveness analysis of a randomised controlled trial (RCT) with 2-year follow-up. 343 patients were recruited from two orthopedic screening clinics in Ottawa, Canada. Patients were randomized to either a patient decision aid plus surgeon preference report (decision aid) or usual care. Primary outcomes were costs (in 2014 CAD$), quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER). Costs were calculated by multiplying self-reported resource use by unit costs. QALYs were calculated by mapping the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to EuroQol 5-Dimension (EQ-5D) health utilities. Costs and QALYs were discounted at 5%. Multiple imputation was used to handle missing data, and bootstrapping was used to estimate uncertainty. RESULTS: The sample comprised 167 intervention and 167 control group patients. The decision aid arm had fewer surgeries over the 2-year period thereby incurring a negative incremental cost of -$560 (95% CI: -$1358 to $426) per patient while providing 0.05 (95% CI: -0.04 to 0.13) additional QALYs per patient. Consequently, the decision aid arm was dominant. CONCLUSION: The use of a patient decision aid was associated with fewer health care costs, while producing similar health outcomes. CLINICAL TRIAL REGISTRATION NUMBER: CT00911638 (clinicaltrials.gov).

The burden of nonadherence among adults with asthma: a role for shared decision-making.

A shared approach to decision-making framework has been suggested for chronic disease management especially where multiple treatment options exist. Shared decision-making (SDM) requires that both physician and patients are actively engaged in the decision-making process, including information exchange; expressing treatment preferences; as well as agreement over the final treatment decision. Although SDM appears well supported by patients, practitioners and policymakers alike, the current challenge is to determine how best to make SDM a reality in everyday clinical practice. Within the context of asthma, adherence rates are poor and are linked to outcomes such as reduced asthma control, increased symptoms, healthcare expenditures, and lower patient quality of life. It has been suggested that SDM can improve treatment adherence and that ignoring patients' personal goals and preferences may result in reduced rates of adherence. Furthermore, understanding predictors of poor treatment adherence is a necessary step toward developing effective strategies to improve the patient-reported and clinically important outcomes. Here, we describe why a shared approach to treatment decision-making for asthma has the potential to be an effective tool for improving adherence, with associated clinical and patient-related outcomes. In addition, we explore insights into the reasons why SDM has not been implemented into routine clinical practice.

DECIDE: a Decision Support Tool to Facilitate Parents' Choices Regarding Genome-Wide Sequencing.

We describe the rationale, development, and usability testing for an integrated e-learning tool and decision aid for parents facing decisions about genome-wide sequencing (GWS) for their children with a suspected genetic condition. The online tool, DECIDE, is designed to provide decision-support and to promote high quality decisions about undergoing GWS with or without return of optional incidental finding results. DECIDE works by integrating educational material with decision aids. Users may tailor their learning by controlling both the amount of information and its format - text and diagrams and/or short videos. The decision aid guides users to weigh the importance of various relevant factors in their own lives and circumstances. After considering the pros and cons of GWS and return of incidental findings, DECIDE summarizes the user's responses and apparent preferred choices. In a usability study of 16 parents who had already chosen GWS after conventional genetic counselling, all participants found DECIDE to be helpful. Many would have been satisfied to use it alone to guide their GWS decisions, but most would prefer to have the option of consulting a health care professional as well to aid their decision. Further testing is necessary to establish the effectiveness of using DECIDE as an adjunct to or instead of conventional pre-test genetic counselling for clinical genome-wide sequencing.

Potential cost-effectiveness for using patient decision aids to guide osteoporosis treatment.

UNLABELLED: We use a model to predict whether using a patient decision aid in patients considering bisphosphonate therapy would be a good use of health resources. We found that if the decision aid improved adherence, and only marginally increased time physicians needed with their patients, then the decision-aid would be cost-effective. INTRODUCTION: Oral bisphosphonates have been shown to reduce the risk of osteoporotic fracture. Adherence is crucial but suboptimal. A recent study suggests that a patient decision aid, which facilitates shared decision-making, could be effective in increasing adherence to bisphosphonates. But decision aids come at a cost in terms of additional time spent with physicians. This study considers the emerging evidence on the role of patient decision aids in improving adherence to bisphosphonates and their potential costs to inform future decision-making and research priorities. METHODS: We estimate the hypothetical cost-effectiveness of a patient decision aid detailing the benefits and risks of bisphosphonates for osteoporotic patients, from a Canadian healthcare perspective. A previously developed and validated Markov microsimulation model was adapted to include use of a patient decision aid to support the decision of whether to initiate bisphosphonate therapy, and subsequent influence on adherence and future fractures. We considered 2014 costs and benefits in terms of quality-adjusted life-years (QALYs). RESULTS: A patient decision aid that could improve treatment initiation rates or persistence (adherence) by 20 %, or a linear combination of the two, in osteoporotic women aged 70+ over a 3-year treatment period was found to have an incremental cost-effectiveness ratio below $50,000/QALY. CONCLUSIONS: Patient decision aids have the potential to be cost-effective in osteoporosis so long as they increase adherence under certain conditions. Funding further research on the long-term effectiveness and costs of a patient decision aid which outlines all treatment options for osteoporosis patients is justified.

Projecting the direct cost burden of osteoarthritis in Canada using a microsimulation model.

OBJECTIVES: To estimate the future direct cost of OA in Canada using a population-based health microsimulation model of osteoarthritis (POHEM-OA). METHODS: We used administrative health data from the province of British Columbia (BC), Canada, a survey of a random sample of BC residents diagnosed with OA (Ministry of Health of BC data), Canadian Institute of Health Information (CIHI) cost data and literature estimates to populate a microsimulation model. Cost components associated with pharmacological and non-pharmacological treatments, total joint replacement (TJR) surgery, as well as use of hospital resources and management of complications arising from the treatment of osteoarthritis (OA) were included. Future costs were then simulated using the POHEM-OA model to construct profiles for each adult Canadian. RESULTS: From 2010 to 2031, as the prevalence of OA is projected to increase from 13.8% to 18.6%, the total direct cost of OA is projected to increase from $2.9 billion to $7.6 billion, an almost 2.6-fold increase (in 2010 $CAD). From the highest to the lowest, the cost components that will constitute the total direct cost of OA in 2031 are hospitalization cost ($2.9 billion), outpatient services ($1.2 billion), alternative care and out-of-pocket cost categories ($1.2 billion), drugs ($1 billion), rehabilitation ($0.7 billion) and side-effect of drugs ($0.6 billion). CONCLUSIONS: Projecting the future trends in the cost of OA enables policy makers to anticipate the significant shifts in its distribution of burden in the future.

Development of a population-based microsimulation model of osteoarthritis in Canada.

OBJECTIVES: The purpose of the study was to develop a population-based simulation model of osteoarthritis (OA) in Canada that can be used to quantify the future health and economic burden of OA under a range of scenarios for changes in the OA risk factors and treatments. In this article we describe the overall structure of the model, sources of data, derivation of key input parameters for the epidemiological component of the model, and preliminary validation studies. DESIGN: We used the Population Health Model (POHEM) platform to develop a stochastic continuous-time microsimulation model of physician-diagnosed OA. Incidence rates were calibrated to agree with administrative data for the province of British Columbia, Canada. The effect of obesity on OA incidence and the impact of OA on health-related quality of life (HRQL) were modeled using Canadian national surveys. RESULTS: Incidence rates of OA in the model increase approximately linearly with age in both sexes between the ages of 50 and 80 and plateau in the very old. In those aged 50+, the rates are substantially higher in women. At baseline, the prevalence of OA is 11.5%, 13.6% in women and 9.3% in men. The OA hazard ratios for obesity are 2.0 in women and 1.7 in men. The effect of OA diagnosis on HRQL, as measured by the Health Utilities Index Mark 3 (HUI3), is to reduce it by 0.10 in women and 0.14 in men. CONCLUSIONS: We describe the development of the first population-based microsimulation model of OA. Strengths of this model include the use of large population databases to derive the key parameters and the application of modern microsimulation technology. Limitations of the model reflect the limitations of administrative and survey data and gaps in the epidemiological and HRQL literature.

Obesity and overweight in Canada: an updated cost-of-illness study.

This study is to update the estimates of the economic burden of illness because of overweight and obesity in Canada by incorporating the increase in prevalence of overweight and obesity, findings of new related comorbidities and rise in the national healthcare expenditure. The burden was estimated from a societal perspective using the prevalence-based cost-of-illness methodology. Results from a literature review of the risks of 18 related comorbidities were combined with prevalence of overweight and obesity in Canada to estimate the extent to which each comorbidity is attributable to overweight and obesity. The direct costs were extracted from the National Health Expenditure Database and allocated to each comorbidity using weights principally from the Economic Burden of Illness in Canada. The study showed that the total direct costs attributable to overweight and obesity in Canada were $6.0 billion in 2006, with 66% attributable to obesity. This corresponds to 4.1% of the total health expenditures in Canada in 2006. The inclusion of newly identified comorbidities increased the direct cost estimates of obesity by 25%, while the rise in national healthcare expenditure accounted for a 19% increase. Policies to reduce being overweight and obese could potentially save the Canadian healthcare system millions of dollars.

The comparative responsiveness of the EQ-5D and SF-6D to change in patients with inflammatory arthritis.

PURPOSE: Comparative evidence regarding the responsiveness of the EQ-5D and SF-6D in arthritis patients is conflicting and insufficient across the range of disease severity. We examined the comparative responsiveness of the EQ-5D and SF-6D in cohorts of patients with early inflammatory disease through to severe rheumatoid arthritis (RA). METHODS: Responsiveness was tested using the effect size (ES) and standardised response mean (SRM). Correlation of change in EQ-5D and SF-6D with disease specific measures was tested using Pearson correlations and the Steiger's Z test. Treatment response and self-reported change were used as anchors of important change. RESULTS: The EQ-5D was more responsive to deterioration (ES ratio (EQ-5D/SF-6D): 1.6-3.0) and the SF-6D more responsive to improvement (ES ratio (SF-6D/EQ-5D): 1.1-1.8) in health. The SF-6D did not respond well to deterioration in patients with established severe RA (ES and SRM 0.08). The EQ-5D provided larger absolute mean change estimates but with greater variance compared to the SF-6D. CONCLUSIONS: The comparative responsiveness of the EQ-5D and SF-6D differs according to the direction of change. The level of mean change of the EQ-5D relative to the SF-6D has implications for cost-effectiveness analysis. Use of the SF-6D in patients with severe progressive disease may be inappropriate.

Economic evaluation of systemic therapies for moderate to severe psoriasis.

BACKGROUND: New biologics have dramatically changed therapeutic options for psoriasis, albeit at additional cost. OBJECTIVES: To determine the cost-effectiveness and optimal treatment sequence for moderate to severe psoriasis. METHODS: Psoriasis Area and Severity Index (PASI) response rates from 22 randomized controlled trials evaluating biologic (adalimumab, efalizumab, etanercept, infliximab) and nonbiologic systemic (methotrexate, ciclosporin) agents were considered. Short-term efficacy was based on relative probabilities of achieving PASI response (50/75/90) in a meta-analysis of trials. Published evidence and assumptions were used to predict long-term efficacy. Treatment benefits were determined by the relationship between PASI response and the EuroQOL 5D health utility measure. Costs included therapy, administration, monitoring and hospitalization. Incremental cost-effectiveness ratios (ICERs) were calculated and treatments ranked relative to supportive care. RESULTS: Infliximab provided the most incremental quality-adjusted life-years (QALYs) vs. supportive care (0.18 QALYs; 95% confidence interval, CI 0.13-0.24), followed by adalimumab (0.16 QALYs; 95% CI 0.11-0.22). Methotrexate and ciclosporin were less beneficial (0.13 and 0.08 QALYs, respectively) but were cost saving and considered the first two treatments in the optimal sequence. Comparing biologics, adalimumab was most cost effective (ICER pound30 000 per QALY), followed by etanercept ( pound37 000 per QALY), efalizumab ( pound40 000 per QALY) and infliximab ( pound42 000 per QALY). CONCLUSIONS: Methotrexate and ciclosporin are cost effective but require monitoring for toxicities. Of the biologics, adalimumab was most cost effective following conventional systemic treatment failure or inadequate response. Payers and policymakers will have to decide how to utilize their budgets effectively for treating patients with moderate to severe psoriasis.

A preliminary model-based assessment of the cost-utility of a screening programme for early age-related macular degeneration.

OBJECTIVES: To estimate the cost-effectiveness of screening for age-related macular degeneration (AMD) by developing a decision analytic model that incorporated and assessed all of the National Screening Committee criteria. A further objective was to identify the major areas of uncertainty in the model, and so inform future research priorities in this disease area. DATA SOURCES: Major databases were searched in March 2004 and updated in January 2005. REVIEW METHODS: Systematic literature reviews covered the epidemiology and natural history of AMD, the screening and treatment effectiveness and health-related quality of life relating to AMD. A hybrid cohort-individual sampling model was implemented to describe the range of pathways between the incidence of age-related maculopathy (ARM) and death via clinical presentation and treatment at different stages of the disease. As significant shortfalls in the data available from the literature were apparent, so a range of primary data sources were also used to populate the model. To obtain estimates for the value of parameters deemed to be within an expert's remit, data describing some parameters were elicited from relevant experts. The data identified informed probability distributions describing the uncertainty around the model parameters. To incorporate joint parameter uncertainty (i.e. correlations between parameters), the AMD natural history model was calibrated probabilistically. Randomly sampled sets of input parameters were assigned weights representing the accuracy of their predictions of a set of observed model outputs. The analysis of the AMD screening model estimated the costs, numbers of quality-adjusted life-years (QALYs) and cases of blindness in a general population sample of 50-year-olds over the remainder of their lifetime, for 16 alternative screening options (including no screening). The reference case analysis incorporated current treatment options of laser photocoagulation and photodynamic therapy. Sensitivity analyses describing six alternative sets of intervention strategies, based on horizon scanning of potential future treatments for AMD, were also undertaken. RESULTS: There remains significant uncertainty about whether any form of screening for AMD is cost-effective. However, annual screening from age 60 years seems to provide the highest mean net benefits, but this is based on a cost-effectiveness estimate that has very poor precision (high levels of uncertainty). The probabilistic sensitivity analysis shows that the 95% credible interval for annual screening from age 60 years ranges from this option dominating the previous option to an incremental cost per QALY of over 0.5 million pounds sterling. Plotting a cost-effectiveness acceptability frontier shows that although annual screening from age 60 years has the highest net benefits at a value of QALY of 30,000 pounds sterling, the associated probability of this option being the most cost-effective option is only around 20%. The sensitivity analyses around potential future treatment options indicate that screening may become more cost-effective with the new treatments. CONCLUSIONS: The conclusions focus on the interpretation of the results from the perspective of defining the major areas of uncertainty, which were defined as disease progression, rates of clinical presentation, screening test and optician effectiveness, treatment effectiveness, and costs of blindness. Future research may be best targeted at assessing how routine data may be used to describe clinical presentation rates of ARM. Other potential studies include a pilot study of the effectiveness of screening and opticians' referral patterns for AMD and a costing study of blindness as a continuum of association with deterioration in vision.

Modelling the cost effectiveness of TNF-alpha antagonists in the management of rheumatoid arthritis: results from the British Society for Rheumatology Biologics Registry.

OBJECTIVE: To evaluate the cost effectiveness of TNF-alpha antagonist therapies for rheumatoid arthritis (RA) in the United Kingdom using data from the British Society for Rheumatology Biologics Registry (BSRBR). METHODS: A simulation model is constructed to quantify the cost effectiveness of the TNF-alpha antagonist therapies (infliximab, etanercept and adalimumab) as a group versus traditional disease-modifying anti-rheumatic drugs, with a time horizon over the full patient lifetime. Participants are UK NHS patients in the BSRBR with RA who have failed at least two traditional disease-modifying anti-rheumatic drugs. The BSRBR aims to recruit all RA patients starting on a TNF-alpha antagonist agent and follows them 6 monthly via consultant and patient administered questionnaires. Data collected include disease activity scores (DAS28), the Health Assessment Questionnaire and the SF-36. Costs include drug, monitoring and hospitalisations. Benefits are measured in disability and quality of life improvements. The main outcome measure is the incremental cost per quality adjusted life-year gained (discounted). RESULTS: The basecase cost per quality adjusted life-year gained by using TNF-alpha antagonist therapies is estimated at pound23 882, with probabilistic uncertainty analysis suggesting that the probability that treatments are below 30,000 pounds per QALY is around 84%. The results are most sensitive to assumptions concerning long-term disability progression, discount rates and the validity or otherwise of SF6D derived utility measures. Subgroup analysis, monotherapy versus combination with methotrexate, and a limited analysis of sequential therapy with two TNF-alpha antagonist agents, suggest cost-effectiveness ratios around 20,000 pounds to 30,000 pounds. CONCLUSIONS: The BSRBR data provide valuable evidence for estimating cost-effectiveness. The analysis concludes that current policies and practice for the use of TNF-alpha antagonist therapies, after RA patients have failed at least two traditional disease-modifying anti-rheumatic drugs, appear cost-effective in the context of the NICE re-appraisal of 2006 for England and Wales, thus supporting their decision to continue their reimbursement. Decision-makers worldwide might adapt this analysis because differential costs, discount rates and other factors could affect results. There remains uncertainty, particularly on long-term disease progression. Further data collection using the BSRBR is recommended, together with a revision to this analysis when data become available.

The efficacy of inhibiting tumour necrosis factor alpha and interleukin 1 in patients with rheumatoid arthritis: a meta-analysis and adjusted indirect comparisons.

OBJECTIVE: New treatments that inhibit the cytokines tumour necrosis factor alpha (TNFalpha) and interleukin 1 (IL-1) in the treatment of rheumatoid arthritis have proven clinical effect against placebo and methotrexate (MTX) in several clinical trials in early and late-stage disease and different severity groups. Since there are no head-to-head randomized controlled trials directly comparing the currently available treatments, etanercept, adalimumab, infliximab or anakinra, we perform a meta-analysis that adjusts for differences between study characteristics, and allows indirect comparisons between treatments. METHODS: Thirteen trials of cytokine antagonists were included from a systematic review of the literature. They reported the primary outcome of American College of Rheumatology (ACR) response criteria at 6 months or beyond. Meta-analytical methods are used to quantify relative treatment effects, using the log odds ratio of an ACR20 or ACR50 response at 6 months, whilst adjusting for study-level variables. RESULTS: In each of the trials, cytokine treatment was efficacious in comparison with placebo or MTX. For each treatment, the inclusion of MTX in combination improved the response. After adjustment for study-level variables, we found TNFalpha antagonists to be more efficacious compared with anakinra (P < 0.05). Indirect comparisons between the three TNFalpha antagonists indicated no difference in efficacy. Sensitivity analysis using a different statistical model structure confirmed these results. CONCLUSION: When the outcome of interest is the probability of an ACR20 or ACR50 response at 6 months we found: (i) treatment with the IL-1 antagonist anakinra is better than placebo; (ii) for each treatment, the use of combination MTX improves the probability of response; (iii) treatment with any of the TNFalpha antagonists is better than with the IL-1 antagonist anakinra; and (iv) all drugs in the TNFalpha antagonist class are no different from each other.

Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis.

Mixed treatment comparison (MTC) is a generalization of meta-analysis. Instead of the same treatment for a disease being tested in a number of studies, a number of different interventions are considered. Meta-regression is also a generalization of meta-analysis where an attempt is made to explain the heterogeneity between the treatment effects in the studies by regressing on study-level covariables. Our focus is where there are several different treatments considered in a number of randomized controlled trials in a specific disease, the same treatment can be applied in several arms within a study, and where differences in efficacy can be explained by differences in the study settings. We develop methods for simultaneously comparing several treatments and adjusting for study-level covariables by combining ideas from MTC and meta-regression. We use a case study from rheumatoid arthritis. We identified relevant trials of biologic verses standard therapy or placebo and extracted the doses, comparators and patient baseline characteristics. Efficacy is measured using the log odds ratio of achieving six-month ACR50 responder status. A random-effects meta-regression model is fitted which adjusts the log odds ratio for study-level prognostic factors. A different random-effect distribution on the log odds ratios is allowed for each different treatment. The odds ratio is found as a function of the prognostic factors for each treatment. The apparent differences in the randomized trials between tumour necrosis factor alpha (TNF- alpha) antagonists are explained by differences in prognostic factors and the analysis suggests that these drugs as a class are not different from each other.

Using contrast sensitivity to estimate the cost-effectiveness of verteporfin in patients with predominantly classic age-related macular degeneration.

AIMS: To re-evaluate the cost-effectiveness of photodynamic therapy with verteporfin (Visudyne, Novartis AG, Switzerland) in patients with predominantly classic and classic choroidal neovascularization (CNV) owing to age-related macular degeneration (AMD), using new evidence on the impact of contrast sensitivity on health status. METHOD: A health economic model is used to synthesise the evidence on contrast sensitivity and treatment rates from the TAP Investigation with health state utilities and costs. Impairment of visual function is estimated using a Markov model to predict transitions between states of contrast sensitivity. Each state is associated with costs and a health state utility. Total expected costs and benefits for a cohort of patients over a defined number of cycles are calculated. The expected health state utility for each disease state was estimated using results from a study of 209 patients with AMD in Sheffield. The model includes the costs associated with treatment and monitoring in the verteporfin treatment arm and costs offset by delaying the deterioration of visual function. RESULTS: Beyond 3 years, the annual costs of the verteporfin arm are estimated to be less than the annual costs of the control arm, owing to the cost associated with higher blindness prevalence in the control arm. Over time, the results show that both the incremental utility and cost decreases. By 10 years, the estimated incremental cost-effectiveness is approximately pound20 996 per Quality-Adjusted Life Years. CONCLUSION: The results of this study suggest that the verteporfin therapy in the treatment for patients with predominantly classic and classic CNV owing to AMD is encouraging.

Determinants of health related quality of life and health state utility in patients with age related macular degeneration: the association of contrast sensitivity and visual acuity.

BACKGROUND: There has been increasing interest in the use of measures of health related quality of life (HRQoL) and health state utility values in Age Related Macular Degeneration (ARMD). Visual acuity has been found to be an important determinant of such measures in previous studies. More recently, another measure of visual impairment, contrast sensitivity has received considerable attention. We designed a study to examine whether the contribution of contrast sensitivity in explaining HRQoL and health utilities over and above that of visual acuity. METHODS: 209 patients with unilateral or bilateral ARMD were recruited into a cross-sectional study of patients from a large teaching hospital. Patients underwent visual tests (near and distant visual acuity, contrast sensitivity) and completed a vision function questionnaire, the VF-14, HUI3, and time trade-off. RESULTS: Using multivariate regression analysis, the study revealed that contrast sensitivity remained a statistically significant predictor of all outcome measures even when visual acuity was included. This result was supported by the correlation coefficients between measures. CONCLUSIONS: The measurement of contrast sensitivity appears to be better related to a person's HRQoL and health utility. Future studies should consider incorporating contrast sensitivity in addition to visual acuity. Studies, in particular economic evaluations, may underestimate the effect of treatment unless contrast sensitivity is considered.

Estimating the cost and health status consequences of treatment with TNF antagonists in patients with psoriatic arthritis.

OBJECTIVES: Tumour necrosis factor (TNF) has been shown to improve the outcomes in patients with psoriatic arthritis (PsA). We estimate the long-term impact on health status of prescribing the TNF antagonist etanercept, and evaluate the cost-effectiveness in a health economic model. METHODS: The relationship between disability (Health Assessment Questionnaire) and health state utility was explored to estimate the quality-adjusted life years (QALYs) gained from the TNF antagonist etanercept. A model was then used to compare sequences of treatments for PsA after failure of two conventional disease modifying anti-rheumatic drugs (DMARDs). One arm commences on etanercept therapy and this is compared with a strategy commencing with combination therapy of methotrexate and ciclosporin and another commencing with leflunomide. Individual patient data from Phase III etanercept trials is used to populate the model supported by published evidence from extensive literature searches. By incorporating a life table specific for a PsA population, and using a number of evidence- and expert opinion-based assumptions for disease progression, the model was extended beyond the trial duration to a 10-yr time horizon. Cost offsets were produced by avoiding surgery through delayed progression; drug and monitoring costs were also modelled. RESULTS: Over the 10 yrs, modelled etanercept treatment gave 0.82 more QALYs when compared with combination therapy with methotrexate and ciclosporin, and 0.65 more QALYs in comparison with leflunomide. This equates to a central estimate for the cost per QALY of pound28 189 and pound28 189 for ciclosporin and leflunomide, respectively. Sensitivity analyses demonstrated this could vary by as much as +/-28%. CONCLUSIONS: With limited data currently available, the potential cost-effectiveness of etanercept in DMARD failures for adults with PsA appears encouraging. The result for other TNF antagonists will depend on how their relative efficacy and drug price compares with etanercept. A number of limitations are described and priorities for further research suggested.

Cost effectiveness of adalimumab in the treatment of patients with moderate to severe rheumatoid arthritis in Sweden.

BACKGROUND: Societal decision makers increasingly emphasise their need for evidence based economic analyses to make reimbursement decisions. OBJECTIVE: To analyse the cost utility of adalimumab, on both incremental cost and incremental quality adjusted life years (QALYs), versus traditional disease modifying antirheumatic drugs and the other tumour necrosis factor (TNF) antagonists suitable for submission to the Swedish LFN (Pharmaceutical Benefit Board). METHODS: Swedish unit costs and treatment guidelines from a lifetime perspective were implemented. A mathematical model, incorporating data from seven trials, simulated the experiences of 10 000 hypothetical patients with moderate to severe rheumatoid arthritis (RA). The primary outcome measure-QALYs-was derived from utility values calculated from a relationship between the Health Assessment Questionnaire (HAQ) Disability Index (DI) and Health Utility Index-III (HUI-3) from adalimumab trial results. The model followed the progression of HAQ-DI through a number of treatments in a sequence accounting for mortality, drug and monitoring costs, and other direct costs. RESULTS: When using ACR50 as a response threshold for determining successful treatment, adalimumab plus methotrexate showed the greatest number of QALYs gained (2.3 from one study and 2.1 from the pooled results of two trials). The etanercept plus methotrexate strategy yielded QALY gains similar to the pooled adalimumab results. Except for the infliximab strategy, the costs results were between 35 000 and 42 000, a range normally considered cost effective in other European countries. CONCLUSION: Adalimumab appears to be cost effective for the treatment of moderate to severe RA. The results suggest that adalimumab is at least as cost effective as other TNF antagonists.