A systematic review of the effectiveness of adalimumab

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166 Appendix 8 TABLE 81 Welsing et al., 2004 165 (cont’d) Cost data handled Yes. Costs were assigned from a 48-week multicentre trial with MTX that included appropriately 411 patients. Medical and non-medical (absence from paid work, travel expenses) costs were collected Modelling summary A Markov model consisting of health states defined by the DAS. A cycle length of 3 months was used. Markov states from remission (DAS 2.4), moderate disease activity (2.4< DAS >3.7) and high disease activity (DAS28>3.7) were used. A time limit of 5 years (20 cycles) was applied. A specific Markov model was used with the same structure and the same costs and utility values of the Markov states for each treatment strategy. The models used specific transition probabilities and costs for the respective drug treatments. Using these models, the expected costs and effects were compared between the different treatment strategies Outcome measures used in QALYs were compared between the different treatment strategies to calculate cost per economic evaluations QALY and ICERs. EQ-5D was used to calculate utilities. Also considered was cost per patient-year in the three DAS28 states Direction of result with NE quadrant, except for a small number of studies in the NW quadrant, relating to appropriate quadrant location comparisons between interventions 4 and 5. Etanercept alone was dominated by leflunomide/etanercept combinations. Versus usual treatment the ICERs were €163,556 per QALY for LEF–Etan and €297,151 per QALY for Etan–LEF. Versus leflunomide the ICERs were €317,627 per QALY for LEF–Etan and €517,061 per QALY for Etan–LEF Statistical analysis for Not undertaken patient-level stochastic data Appropriateness of statistical NA analysis Uncertainty around Yes. Model uncertainty was explored using PSA. Distributions were specified for the cost-effectiveness expressed transition probabilities, the costs and the utility values of the Markov states and for the response of etanercept (EULAR good/moderate) and leflunomide treatment (ACR20) after 3 months. 2.5–97.5 percentiles were reported from PSA for costs and QALYs, but no ICERs were given Appropriateness of method Yes dealing with uncertainty around cost effectiveness Sensitivity analysis Yes. One-way sensitivity analysis was applied to determine the relative importance of different parameters for the primary outcome. Correlations between the parameters and outcomes were calculated. Important model parameter values as defined by the correlation were also varied in a one-way sensitivity analysis Modelling inputs and Yes techniques appropriate Authors’ conclusions Treatment strategies that include TNF inhibitors are probably the most effective for patients in whom two DMARDs have previously failed, of which one is MTX. From these strategies, treatment starting with leflunomide, and in the case of non-response switching to a TNF inhibitor, probably results in the most favourable ratio between the extra costs and effects PSA, probabilistic sensitivity analysis.
TABLE 82 Brennan et al., 2004 160 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Authors Brennan, Bansback, Reynolds, Conway Date 2004 Type of economic evaluation Cost–utility analysis Country of origin UK Currency used Pounds sterling Year to which costs apply 2000 Perspective NHS in the UK Study population Patients with RA who failed to respond previously to at least two DMARDs (MTX as first line and sulfasalazine as second line) Intervention 1 Treatment pathway I: third option: etanercept monotherapy; fourth: intramuscular gold; and fifth: ciclosporin and MTX Intervention 2 Treatment pathway II: third option: intramuscular gold; fourth: ciclosporin and MTX; and fifth: leflunomide Source of effectiveness data DAS28 scores were used. Comparative data on the DAS28 for etanercept was unavailable, therefore data from a Phase III study of etanercept vs placebo were used, alongside published data for other DMARDs. Patient characteristics of published data were compared with those of the Phase III study to identify studies that enrolled similar patients. Where comparable studies were unavailable, ACR20 response was assumed to be 35%, using published meta-analysis of patient with >10 years, disease duration. These sources were used to inform model parameter values relating to initial response to therapy and initial HAQ response Long-term HAQ response was estimated from published sources and data from a long-term, open-label study of etanercept. ERAS was used as a source of data for HAQ improvements during periods of non-response. Long-term withdrawal was estimated using data from a study based on clinical practice in Sweden, showing an annual withdrawal of 8.3% Evidence presented in four separate studies was used as a basis for the relationship between HAQ and utility to inform quality of life data. Variation in the results was small and the median relationship was used in the primary analysis. Trial data were used to inform response rates of treatment and HAQ improvements Cost data handled Yes. Drug and monitoring costs and other direct costs were examined for each treatment. appropriately Drug costs derived from current list prices and monitoring costs were estimated using BSR guidelines. Evidence from studies in the USA and Sweden suggests a strong correlation between HAQ score and direct costs. Costs reported in these studies were used to inform parameter values (converted to 2000 UK currency using the purchaser parity index and inflation). Both gave an almost identical linear relationship of £860 p.a. increase in direct costs. In the model the difference in the two comparators HAQ score trends is converted into a difference in direct healthcare costs, i.e. worse HAQ scores generate higher direct costs, pro rata Sensitivity analyses were used: first, to examine the impact of the additional costs associated with home help, residential and nursing home care and, secondly, to examine the impact of economic productivity to society through maintained employment. Data from a Swedish study were used to inform the latter Modelling summary A decision-analytic model was developed in Excel. Patients following each treatment pathway (etanercept vs DMARD sequence) were simulated. A cycle length of 6 months was used. A patient population of 10,000 was simulated over the lifetime and a Monte Carlo approach taken. Discounting was applied to costs (6% p.a.) and benefits (1.5% p.a.) in line with guidance from NICE Outcome measures used in QALYs through the use of etanercept compared with current UK clinical practice. HAQ and economic evaluations EQ-5D data were used to calculate QALYs through regression Direction of result with NE quadrant. £16,330 per QALY appropriate quadrant location Statistical analysis for Yes: patient-level data were used taken from the model simulation patient-level stochastic data Appropriateness of statistical Yes analysis continued 167
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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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TABLE 150 Variation 15: TNF inhibit
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A systematic review of the effectiveness of adalimumab

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