A systematic review of the effectiveness of adalimumab

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172 Appendix 8 TABLE 86 Kobelt et al., 2005 167 Authors Kobelt, Lindgren, Singh, Klareskog Date 2005 Type of economic evaluation Cost–utility analysis Country of origin Sweden, France, USA Currency used Euros Year to which costs apply 2004 Perspective Societal Study population Patients with active RA who failed to respond to at least two DMARDs, other than MTX. Patients who had been previously exposed to MTX were included provided they were deemed to be appropriate candidates for MTX treatment at the time of enrolment to the study Intervention 1 Etanercept Intervention 2 MTX Intervention 3 Etanercept and MTX Source of effectiveness data A double-blind randomised clinical trial of 682 patients (TEMPO). Disease progression is based on observed transitions in the clinical trial for patients with an HAQ measurement used at both the start and the end of each year for the first 2 years. Transition probabilities for the model beyond the trial data are based on the average reported annual progression of HAQ (0.03). Disease activity and severity was measured in TEMPO by correlating the patient global VAS with the DAS28. As a result, it was found that a DAS28 of 3.2 corresponds to a score of 41 on the global VAS Cost data handled Yes: direct resource use included all healthcare and community services, as well as appropriately investments, devices, transportation and informal help. Indirect costs included early retirement due to RA, long- and short-term sick leave, and loss of leisure time. Costs and benefits were discounted at 3%. Cost data came from a survey of 616 Swedish patients, related to function and disease activity, plus 1810 patients’ early retirement data Modelling summary A Markov model was developed, with five main functional states and cut-off points at HAQ 0.6, 1.1, 1.6 and 2.1. Each state is further separated into two substrates representing high and low disease activity. All resulting ten states are further subdivided according to those receiving study treatments or not. Changes in disease status are modelled as transitions between the states at intervals of 1 year (cycles). Costs and utility are assigned to each of the 20 states, and the model estimates expected costs and QALYs for defined cohorts of patients over given periods. A Monte Carlo simulation was run and bootstrapping was used to estimate uncertainty around input values. The model was run for 10 years of treatment, or for treatment in trial only for 2 years and extrapolation to 10 years Outcome measures used in Data related to function and disease activity (EQ-5D) obtained from a survey of 1016 economic evaluations patients with confirmed RA, carried out in 1997, and a more recent follow-up survey, conducted in 2002, of 616 patients. EQ-5D was related to HAQ scores and disease activity using multiple regression Direction of result with NE quadrant. Treatment for 2 years, extrapolation to 10 years: etanercept alone dominated. appropriate quadrant location Etanercept/MTX vs MTX €37,331 per QALY Treatment for 2 years, extrapolation to 5 years: etanercept alone dominated. Etanercept/MTX vs MTX €54,548 per QALY Treatment for 10 years: etanercept/MTX vs MTX €46,494 per QALY Treatment for 5 years, extrapolation to 10 years: etanercept/MTX vs MTX €47,316 per QALY Statistical analysis for Not undertaken patient-level stochastic data Appropriateness of statistical NA analysis Uncertainty around Yes cost-effectiveness expressed Appropriateness of method Yes: the methods used were appropriate. A Monte Carlo simulation was run and dealing with uncertainty bootstrapping was used to estimate the uncertainty around the model parameter values. around cost effectiveness Cost effectiveness acceptability curves were also used continued
TABLE 86 Kobelt et al., 2005 167 (cont’d) © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Sensitivity analysis Yes: sensitivity analysis was conducted and the results were found to be most sensitive to assumptions about the costs of treatment and the difference in utility between the treatment groups Modelling inputs and Yes techniques appropriate Authors’ conclusions Incorporating the influence of disease activity allows better assessment of the effects of anti- TNF treatment on patients’ general well-being. The cost per QALY gained with combination treatment with etanercept with MTX compared with MTX alone falls within the acceptable range and the probability that the cost-effectiveness ratio is below a threshold of €50,000 is 88% 173
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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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inhibitors, although the incrementa
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Page 139: Adalimumab, etanercept and inflixim
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TABLE 159 Variation 17: TNF inhibit
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A systematic review of the effectiveness of adalimumab

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