A systematic review of the effectiveness of adalimumab

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170 Appendix 8 TABLE 84 Chiou et al., 2004 170 (cont’d) Modelling summary A decision tree was developed in Data 4.0 (TreeAge software) to compare the costs and outcomes of a hypothetical cohort of patients. The time-horizon was 1 year, and effectiveness was measured at 6 and 12 months. The structure of the model is flexible, allowing for data that may be available over a longer follow-up period. If effectiveness data were not available at 12 months, 6- and 12-month effectiveness data were assumed to be equivalent. Within the model 16 health states were used: these were the product of the severity of SAE and the ACR response criteria, e.g. a patient could have no ACR, ACR20, ACR50 or ACR70 and could be experiencing no SAE, mild SAEs, moderate SAEs or severe SAEs Outcome measures used in Effectiveness was measured in QALYs. It was assumed that patients would live with one of economic evaluations the 16 health states at any given time. Preference weights for each health state, used to calculate the QALYs, were measured using a VAS (HAQ) obtained from a survey of 748 patients with RA Direction of result with NE quadrant. Monotherapies: etanercept NE quadrant, US$13,387 per QALY. Adalimumab appropriate quadrant location dominated. Combination therapies: etanercept + MTX NE quadrant, US$7925. Adalimumab + MTX and infliximab + MTX dominated Statistical analysis for Not undertaken patient-level stochastic data Appropriateness of statistical NA analysis Uncertainty around Not undertaken cost-effectiveness expressed Appropriateness of method NA dealing with uncertainty around cost effectiveness Sensitivity analysis Yes: one-way sensitivity analyses were performed on all input variables. Cost variables were varied from 50 to 200% of baseline and probability values increased and decreased by 50% of baseline. Cost of treatment and the probability of achieving ACR response criteria were the main drivers of ICERs. Costs of SAEs, probabilities of developing SAEs, healthcare resource costs and the cost of MTX did not affect the ICERs Modelling inputs and Yes techniques appropriate Authors’ conclusions Anakinra was the least expensive option and etanercept dominated other treatments. Cost of drugs and probability for achieving response were the main drivers of ICERs TABLE 85 Bansback et al., 2005 166 Authors Bansback, Brennan, Ghatnekar Date 2005 Type of economic evaluation Cost–utility analysis Country of origin UK, Sweden Currency used Euros Year to which costs apply 2001 Perspective Healthcare Study population Patients with moderate to severe RA for whom at least two traditional DMARDs had failed (simulation of 10,000 patients) Intervention 1 Adalimumab monotherapy Intervention 2 Adalimumab + MTX (study nos DE009 and DE019) Intervention 3 Adalimumab + MTX (study no. DE009) Intervention 4 Etanercept monotherapy Intervention 5 Etanercept + MTX Intervention 6 Infliximab + MTX continued
TABLE 85 Bansback et al., 2005 166 (cont’d) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Intervention 7 Traditional drug treatment (DMARDs) Source of effectiveness data Treatment response data from a published review and conference abstracts. Two combination RCTs were available for adalimumab. The first, ARMADA, was similar to the etanercept and infliximab trials in design and patient numbers. The second, a larger, more comprehensive study, also included radiographic evaluations. In Sweden, decisions to continue treatment are made using the DAS response criteria. This study presents results for two definitions of classifying successful response: ACR20 and ACR50. Comparison of trials suggests similarities between the results of ACR and DAS responses. This model assumes that ACR20 corresponds to a moderate DAS28 score and ACR50 corresponds to a good DAS score. In addition, HAQ was mapped to a health utility measure (HUI 3). Analysis of patient-level adalimumab data was used to calculate HAQ improvement in ACR20 and ACR50 responders. The model assumed that HAQ worsened after withdrawal from treatment, immediately at the point of withdrawal and equalled the initial HAQ improvement for all treatments Cost data handled Yes appropriately Modelling summary A decision-analytic model building on two previously described models. Patient-based transition state model, simulating a population of 10,000 patients. A cycle length of 6 months was used, within which the risks of withdrawal, adverse events and mortality were determined, based on experiences of an average patient. Patients were simulated for their lifetime. Model parameter values were derived from patient-level data analysis of adalimumab RCTs or published sources Outcome measures used in At each 6-month cycle in the model the patients’ health-related quality of life scores were economic evaluations evaluated by simple linear transformation from the HAQ-DI score. From this a cost–utility analysis was possible Direction of result with NE quadrant appropriate quadrant location For the group ACR50/DAS28 good: €34,167 per QALY (adalimumab + MTX) €34,922 per QALY (adalimumab + MTX) a €35,760 per QALY (etanercept + MTX) €48,333 per QALY (infliximab + MTX) €41,561 per QALY (adalimumab) €36,927 per QALY (etanercept) For the group ACR20/DAS28 moderate: €40,875 per QALY (adalimumab + MTX) €44,018 per QALY (adalimumab + MTX) a €51,976 per QALY (etanercept + MTX) €64,935 per QALY (infliximab + MTX) €65,499 per QALY (adalimumab) €42,480 per QALY (etanercept) Statistical analysis for Patient-level data were used to calculate HAQ improvement in patients who were ACR20 patient-level stochastic data and ACR50 responders Appropriateness of statistical Yes analysis Uncertainty around Yes. Cost-effectiveness acceptability curve and cost-effectiveness plane cost-effectiveness expressed Appropriateness of method Yes. Appropriate methods were used: both central values and probability density functions dealing with uncertainty were used to describe the distribution of uncertainty around cost effectiveness Sensitivity analysis Yes. Univariate sensitivity analysis and multivariate sensitivity analysis were used. Uncertainty in assumptions around model structure was also explored Modelling inputs and Yes techniques appropriate Authors’ conclusions Adalimumab appears to be cost-effective for the treatment of moderate to severe RA. Results suggest that adalimumab is at least as cost-effective as other TNF inhibitors, with the exception of infliximab; the cost results were between €35,000 and €42,000 per QALY, a range normally considered cost-effective in European countries a Including additional information from a larger adalimumab trial in a pooled analysis. 171
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A systematic review of the effectiv
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A systematic review of the effectiv
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Objectives: This report reviews the
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Glossary and list of abbreviations
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viii Glossary and list of abbreviat
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Background Rheumatoid arthritis (RA
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increased risk of serious infection
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Summary RA is a common, chronic, in
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(IL-2) and interleukin-6 (IL-6), pr
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Assessment of response to DMARDs Re
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combination with methotrexate or al
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disease between clinic appointments
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14 Effectiveness in juvenile arthri
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16 Effectiveness adalimumab plus me
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18 Effectiveness Monoclonal Antibod
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20 TABLE 1 Description of included
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22 TABLE 2 Quality of included RCTs
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24 Effectiveness change in modified
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26 Effectiveness TABLE 4 Meta-analy
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28 Effectiveness Review: Adalimumab
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30 Effectiveness Review: Adalimumab
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32 TABLE 6 Effectiveness Descriptio
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34 TABLE 6 Effectiveness Descriptio
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36 TABLE 7 Effectiveness Quality of
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38 Effectiveness etanercept trials.
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40 Effectiveness TABLE 9 Summary of
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42 Effectiveness Review: Etanercept
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54 Effectiveness TABLE 11 Summary o
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56 TABLE 12 Description of included
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58 TABLE 13 Quality of included RCT
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60 Effectiveness per week and escal
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62 Effectiveness significant advant
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64 Effectiveness Review: Infliximab
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66 Effectiveness Review: Infliximab
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68 Effectiveness FIGURE 44 Malignan
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70 TABLE 17 Effectiveness Summary o
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Summary of review of existing econo
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TABLE 20 Summary of published ICERs
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TABLE 21 Published etanercept econo
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TABLE 23 Published economic analyse
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TABLE 25 Treatment sequences: adali
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management of RA, i.e. 1st and 2nd
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To estimate the long-term consequen
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TABLE 32 TNF inhibitors as last act
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TABLE 34 Basic structure of the mod
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een quit on grounds of toxicity, ad
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TABLE 39 Strategy set: adalimumab a
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TABLE 43 Beta distributions for HAQ
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TABLE 44 Early cessation of DMARDs:
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TABLE 46 Unit costs for tests and v
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following properties, according to
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TABLE 52 Base case: TNF inhibitors
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TABLE 54 Base case: TNF inhibitors
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TABLE 59 Third TNF inhibitor follow
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TABLE 65 Sensitivity analyses: TNF
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TABLE 67 Sensitivity analyses: TNF
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The substantial economic impact of
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Summary Effectiveness: principal fi
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Page 139: Adalimumab, etanercept and inflixim
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TABLE 156 Variation 16: TNF inhibit
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A systematic review of the effectiveness of adalimumab

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