A systematic review of the effectiveness of adalimumab

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76 Health economics TABLE 20 Summary of published ICERs for TNF inhibitor a (cont’d) Drug Comparator Study Date Time-horizon ICER Baseline level Kobelt163 2004 NA After 3 months of treatment €43,500 per QALY (failed at least two DMARDs, including MTX) After 6 weeks of treatment: €36,900 per QALY DMARD sequence Bansback 166 2005 Lifetime ACR50/DAS28 good: €48,333 per QALY (+ MTX) ACR20/DAS28 moderate: €64,935 per QALY (+ MTX) DMARD sequence Jobanputra 1 2002 Lifetime £115,937 per QALY Anakinra Chiou164 2004 1 year Infliximab + MTX dominated a Industry-sponsored studies are highlighted in shaded cells. b Cost-effectiveness analysis; all other studies are cost–utility analyses. Etan, etanercept; LEF, leflunomide; QALY, quality-adjusted life-year. is no response; leflunomide followed by etanercept if there is no response to leflunomide (LEF–Etan); and finally, etanercept switching to leflunomide with non-response (Etan–LEF)]. Kobelt and colleagues 167 considered etanercept alone and etanercept combined with methotrexate. Two studies found high ICERs. Choi and colleagues 159 suggested that recommendations regarding use depended on whether an ICER over $40,000 per ACR20 or ACR70WR was considered acceptable. Welsing and colleagues 165 recommended use of etanercept following leflunomide after two other DMARDs (where the first is methotrexate) had failed. In contrast, Brennan and colleagues 160,168 reported a much lower ICER and suggested “etanercept was costeffective when compared with non-biologic agents”. Kobelt and colleagues 167 reported the ICER for etanercept in combination with methotrexate to be within the “acceptable range”. Each study used a different modelling approach. Choi and colleagues 159 used a simple decision-tree structure and modelled costs and outcomes over 6 months. Welsing and colleagues 165 and Kobelt and colleagues 167 used a Markov model structure with a 5-year time-horizon and a 5- and 10-year timehorizon, respectively. Brennan and colleagues 160 developed an individual patient-level simulation model to calculate lifetime costs and outcomes. RCT data were used to model outcomes; it has been suggested that observational data are a more realistic representation of outcomes in practice and therefore more suitable for cost-effectiveness analyses. 169 Each study took different approaches; for example, the evaluation undertaken (cost- effectiveness or cost–utility analysis), the treatment comparators and the time-horizon chosen (each used a different time-horizon, varying from 6 months to lifetime). Kobelt 167 used a cycle length of 1 year, which is not clinically relevant. A cycle length of around 4 months is more clinically relevant as decisions about the efficacy of DMARDs are generally made over this time. Three analyses were from a societal perspective, an approach that leads to a more favourable ICER. If a treatment is more effective, then patients are more able to work, thus leading to lower indirect costs. The Choi study 159 did not calculate cost per QALYs, therefore comparison with other results is not possible. Two of the ten identified published studies report an economic analysis of infliximab in combination with methotrexate (Table 22), and were sponsored by the manufacturer Schering-Plough. Both studies were cost–utility analyses using a societal perspective and the comparator explored was methotrexate alone. The quality of life data used by Wong and colleagues 161 was based on selfreported global health using a visual analogue scale (VAS) from ATTRACT and the Arthritis, Rheumatism and Aging Medical Information System (ARAMIS) database. However, there are problems with VAS such as context bias and endpoint aversion, and the method is not truly preference based. Other methods are more appropriate, for example using a utility measure such as EuroQol 5 Dimensions (EQ-5D). Therefore, results should be treated with some caution. Costs were obtained from the ARAMIS database, based on a North American population, and are not directly transferable to a UK
TABLE 21 Published etanercept economic analyses perspective, and the analysis was carried out from a societal perspective. The study authors concluded that infliximab with methotrexate was cost-effective, especially when including indirect costs of loss of productivity. However, costeffectiveness is dependent on the ICER threshold of the decision-maker. The effectiveness data used by the Kobelt study 162 is from observational data only, and uses a societal perspective, therefore giving a more favourable ICER. This perspective also leads to a large difference in ICERs between the UK and Sweden as this difference was driven by indirect costs. Differences arose owing to higher average salary and more generous long-term illness benefits in Sweden, plus a lower proportion of UK patients in advanced HAQ states had taken early retirement compared with Sweden. A Markov model was used in both studies, with Wong 161 projecting 54-week results of an RCT to a lifetime horizon and Kobelt 162 producing results for a 10-year time-horizon. The latter uses a 1-year cycle length, which is not clinically appropriate as © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Study Sponsor Patient Comparator(s) Base-case ICER group Choi et al., Not stated RA Four monotherapy Etanercept vs SSZ 2002 159 comparators: leflunomide, $41,900 per ACR20 MTX, SSZ, no second line agent Etanercept vs MTX $40,800 per ACR70WR Welsing et al., Not stated (but used RA Two comparators: Etanercept alone was dominated by 2004 165 data from Wyeth) usual treatment, LEF leflunomide/etanercept combinations Versus usual treatment €163,556 per QALY for LEF–Etan €297,151 per QALY for Etan–LEF Versus leflunomide: €317,627 per QALY for LEF–Etan €517,061 per QALY for Etan–LEF Brennan et al., Not stated (but two RA DMARD sequence £16,330 per QALY 2004 160,168 authors from Wyeth) Kobelt et al., Wyeth Research RA MTX Etanercept alone dominated. 2005167 Treatment for 2 years, extrapolation to 10 years: Etan–MTX €37,331 per QALY Treatment for 2 years, extrapolation to 5 years: Etan–MTX €54,548 per QALY Treatment for 10 years: Etan–MTX €46,494 per QALY Treatment for 5 years, extrapolation to 10 years. Etan–MTX €47,316 per QALY a patient may change DMARDs over a much shorter period. The remaining four cost-effectiveness analyses considered more than one TNF inhibitor therapy (Table 23). Kobelt and colleagues 163 reported a cost–utility analysis using patient-level direct costs and effectiveness using data from a cohort of 160 patients. Patients received etanercept (n = 113) or infliximab (n = 47), but drug allocation was not randomised. Data were shown for use of a TNF inhibitor compared with resource use and quality of life for the year before treatment (baseline). Jobanputra and colleagues 1 considered etanercept and infliximab in comparison with a DMARD sequence. This work formed the economic evaluation of the previous NICE appraisal for TNF inhibitor drugs undertaken by the current authors and will therefore not be described further. Bansback and colleagues, 166 funded by Abbott Laboratories, used a patient-level simulation model to conduct cost–utility analyses 77
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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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Page 44 and 45: 28 Effectiveness Review: Adalimumab
Page 46 and 47: 30 Effectiveness Review: Adalimumab
Page 48 and 49: 32 TABLE 6 Effectiveness Descriptio
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Page 52 and 53: 36 TABLE 7 Effectiveness Quality of
Page 54 and 55: 38 Effectiveness etanercept trials.
Page 56 and 57: 40 Effectiveness TABLE 9 Summary of
Page 58 and 59: 42 Effectiveness Review: Etanercept
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Page 84 and 85: 68 Effectiveness FIGURE 44 Malignan
Page 86 and 87: 70 TABLE 17 Effectiveness Summary o
Page 89 and 90: Summary of review of existing econo
Page 91: TABLE 20 Summary of published ICERs
Page 95 and 96: TABLE 23 Published economic analyse
Page 97 and 98: TABLE 25 Treatment sequences: adali
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Page 103 and 104: TABLE 32 TNF inhibitors as last act
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Page 109 and 110: TABLE 39 Strategy set: adalimumab a
Page 111 and 112: TABLE 43 Beta distributions for HAQ
Page 113 and 114: TABLE 44 Early cessation of DMARDs:
Page 115 and 116: TABLE 46 Unit costs for tests and v
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Page 119 and 120: TABLE 52 Base case: TNF inhibitors
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Page 123 and 124: TABLE 59 Third TNF inhibitor follow
Page 125 and 126: TABLE 65 Sensitivity analyses: TNF
Page 127 and 128: TABLE 67 Sensitivity analyses: TNF
Page 129: The substantial economic impact of
Page 133 and 134: Summary Effectiveness: principal fi
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Page 139: Adalimumab, etanercept and inflixim
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1. Jobanputra P, Barton P, Bryan S,
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46. Young A, Dixey J, Cox N, Davies
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tumor necrosis factor therapy in th
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arthritis: a 12-week, double-blind,
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171. Geborek P, Crnkic M, Petersson
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216. Schotte H, Willeke P, Mickholz
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The Health Assessment Questionnaire
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Cochrane Library (CENTRAL) 2005 Iss
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Appendix 3 © Queen’s Printer and
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TABLE 69 Studies excluded from clin
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148 Appendix 4 TABLE 71 Meta-analys
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150 Appendix 4 TABLE 73 Meta-analys
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152 Appendix 4 Infliximab versus pl
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154 Appendix 4 Infliximab plus MTX
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Ovid MEDLINE(R) 1966 to February we
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Appendix 8 © Queen’s Printer and
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TABLE 79 Wong et al., 2002 161 © Q
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TABLE 80 Kobelt et al., 2003 162 (c
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TABLE 82 Brennan et al., 2004 160
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TABLE 85 Bansback et al., 2005 166
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176 Appendix 9 TABLE 89 Strategy se
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Extensive sensitivity analysis was
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TABLE 96 Variation 1: TNF inhibitor
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TABLE 99 Variation 2: TNF inhibitor
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TABLE 102 Variation 3: TNF inhibito
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TABLE 132 Variation 10: TNF inhibit
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No. 25 A rapid and systematic revie
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A systematic review of the effectiveness of adalimumab

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