A systematic review of the effectiveness of adalimumab

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164 Appendix 8 TABLE 80 Kobelt et al., 2003 162 Authors Kobelt, Jonsson, Young, Eberhardt Date 2003 Type of economic evaluation Cost–utility analysis Country of origin France, Sweden, UK Currency used Euros, Swedish Kronor, pounds sterling Year to which costs apply Not stated Perspective Societal Study population Patients with RA not responding to at least two DMARDs (including MTX) Intervention 1 Infliximab + MTX Intervention 2 MTX alone Source of effectiveness data Clinical data from two RA cohorts, followed for up to 15 years, in Sweden and the UK (ERAS), in which average HAQ scores were calculated and used to inform the effectiveness data and the transition probabilities within the model Cost data handled Direct costs included hospitalisation, surgical interventions, ambulatory and community care appropriately and RA medication. Non-medical direct costs and informal care costs were excluded. The cost of hospitalisation was based on the number of inpatient days in different wards and ward-specific costs; the cost of surgical interventions was based on the type of intervention and its duration multiplied by the cost per minute of operating theatre use. Outpatient costs were based on the number of visits to different healthcare professionals. The cost of RA drugs was calculated from the number of months of use and the cost associated with standard drug monitoring protocols in place in the rheumatology departments of participating study centres. Unit cost data were taken from hospital accounting data and official price lists. Indirect costs were calculated as the loss of work capacity of patients in the more advanced disease states. For patients in disease state 1 (i.e. HAQ < 0.6) only shortterm sick leave was considered. The human capital approach was used, in which an individual’s productivity is valued at market price. The total number of productive years lost at each stage (of the model) was compared with the number in state 1, and the difference multiplied by the average gross annual income. The cost of infliximab was calculated using the official list price and the doses prescribed in clinical practice (in Sweden and in the UK, respectively) Modelling summary Markov model with a cycle length of 1 year (in line with the annual follow-up of epidemiological studies). A time-horizon of 10 years was used Outcome measures used in Incremental QALYs (based on EQ-5D) and ICERs economic evaluations Direction of result with NE quadrant. For 1 year of treatment, €3440 per QALY in Sweden and €34,800 per QALY appropriate quadrant location in the UK. The only exception is with the ‘alternative model’ comparing total costs at 1 year (unadjusted) and total costs at 1 year (adjusted for the effect loss at discontinuation) for Sweden. The direction of results in these two cases is the SE quadrant (cost saving) 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 A sensitivity analysis was undertaken by way of an ‘alternative model’, in which a loss of treatment effect was assumed in the year after discontinuation, expressed as a faster disease progression than that reported in the cohorts. Differences in HAQ scores between infliximab and MTX groups in the clinical trials were applied to the cohorts for the treatment arm for the first year. Thus, treatment was compared directly with that of the cohorts. A sensitivity analysis was also undertaken on the price of infliximab continued
TABLE 80 Kobelt et al., 2003 162 (cont’d) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Modelling inputs and Yes techniques appropriate Authors’ conclusions 1 or 2 years of treatment with infliximab reduced direct and indirect resource consumption in Sweden and the UK, thereby partly offsetting the treatment costs. In the base-case analysis, including direct and indirect costs, the cost per QALY gained was SEK32,000 in Sweden (€3440) and £21,600 in the UK (€34,800) for 1 year of treatment. The respective QALY gains were 0.248 and 0.298. With 2 years of treatment, the cost per QALY gained was SEK150,000 in Sweden (€16,100) and £29,900 in the UK (€48,200). The results suggest that 1–2 years of treatment with infliximab and MTX, compared with MTX alone, will lead to savings in both direct and indirect costs. Savings in direct costs are €1500–2000 in Sweden and up to 800 in the UK. These savings will not offset the cost of infliximab. The majority of savings will come from maintaining the patients’ ability to work. However, when only direct costs are included, the cost-effectiveness ratios remain within the usual range for treatments to be recommended for use TABLE 81 Welsing et al., 2004 165 Authors Welsing, Severens, Hartman, van Riel, Laan Date 2004 Type of economic evaluation Cost–utility analysis Country of origin Netherlands Currency used Euros Year to which costs apply Not stated Perspective Societal Study population Patients with RA who satisfy the indication for TNF inhibitors in the Netherlands Intervention 1 Usual treatment Intervention 2 Treatment with leflunomide, in the case of non-response after 3 months switch to usual treatment Intervention 3 Treatment with etanercept, in the case of non-response after 3 months switch to usual treatment Intervention 4 Treatment with leflunomide, in the case of non-response after 3 months switch to etanercept, in the case of non-response switch to TNF-blocking agent, switch to usual treatment Intervention 5 Treatment with etanercept, in the case of non-response after 3 months switch to leflunomide, in the case of non-response switch to leflunomide switch to usual treatment Source of effectiveness data The following sources of effectiveness data were used: 1. QoL data from a 48-week multicentre trial involving 411 patients were assigned to the health states within the Markov model 2. Follow-up data of patients from an open longitudinal study of early RA (disease duration
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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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Page 139: Adalimumab, etanercept and inflixim
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