A systematic review of the effectiveness of adalimumab

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88 Health economics entry Start new treatment On treatment Quit treatment Select next treatment FIGURE 46 Basic structure of the model Strategies compared using the BRAM Baseline for comparison Before considering how TNF inhibitors could be included in treatment strategies, it is convenient to describe the baseline strategy without TNF inhibitors. The baseline strategy, based on a survey of rheumatology consultants in the UK, 25 starts with methotrexate as single therapy. If methotrexate is stopped on grounds of toxicity, it is followed by sulfasalazine as single therapy, otherwise by the combination of methotrexate plus sulfasalazine. Similarly, if this combination is quit on grounds of toxicity, it is followed by leflunomide. But, if the methotrexate–sulfasalazine combination lacks efficacy, hydroxychloroquine is added to the combination. These rules are shown in Table 34 under the heading ‘Moves dependent on toxicity’. For most other treatments, the choice of treatment next in sequence, and the move to the next agent, simply depend on drug cessation, for whatever reason. For example, sulfasalazine as single therapy, in Table 34, is always followed by leflunomide, as shown under the heading ‘Always move to’. In the case of ciclosporin, the preferred next treatment is the combination of ciclosporin plus methotrexate. However, this combination cannot be offered if ciclosporin has just been quit on grounds of toxicity, nor can it be offered if methotrexate was earlier quit for toxicity. This is shown under HAQ increase Death Event taking no time Activity taking a variable amount of time ‘Relevant toxicity’. Palliation is the treatment of last resort and therefore cannot be quit. The structure as shown in Table 34 is more general than the structure used in previous versions of the BRAM: all the previous strategies in the model can be described by tables of this form. Comparisons For clarity, the word ‘comparison’ is reserved for an analysis comparing two options. The term ‘strategy set’ is used for a collection of strategies (treatment sequences) with a common initial sequence and divergence point. Single TNF inhibitors (versus no TNF inhibitor) In these strategy sets only one TNF inhibitor is used. There are six options in each case: adalimumab alone; etanercept alone; each of the three TNF inhibitors combined with methotrexate; and the comparator option without TNF inhibitors. These produce a total of 15 possible comparisons: five (‘major comparisons’) relate to including each TNF inhibitor singly within a sequence without TNF inhibitors and ten (‘minor comparisons’) relate to comparisons between different TNF inhibitors. Single TNF inhibitor at the start In this strategy set, the divergence point is at the start of the sequence, that is, patients are treated with a TNF inhibitor before any other DMARD (see Table 35,
TABLE 34 Basic structure of the model options at the divergence point are shaded). Option 1 starts with adalimumab followed by methotrexate. Option 2 starts with etanercept followed by methotrexate. Option 3 starts with adalimumab in combination with methotrexate followed by sulfasalazine (it would be clinically inappropriate to use methotrexate as single therapy after failing this combination). Similarly, © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Moves dependent on toxicity Treatment Always move to Relevant toxicity If toxic, move to Otherwise, move to MTX MTX SSZ MTX+SSZ SSZ LEF MTX+SSZ MTX+SSZ LEF MTX+SSZ+HCQ MTX+SSZ+HCQ LEF LEF GST GST AZA AZA CyA CyA CyA or MTX a DPen CyA+MTX CyA+MTX DPen DPen Pall a It was assumed that toxicity of MTX+SSZ (± HCQ) would not preclude the use of the combination CyA+MTX. AZA, azathioprine; DPen; penicillamine; GST, injectable gold; HCQ, hydroxychloroquine; Pall, palliation. TABLE 35 Strategy set with TNF inhibitors at the start Moves dependent on toxicity Treatment Always move to Relevant toxicity If toxic, move to Otherwise, move to Option 1 Adal Adal MTX Option 2 Etan Etan MTX Option 3 Adal+MTX Adal+MTX SSZ Option 4 Etan+MTX Etan+MTX SSZ Option 5 Infl+MTX Infl+MTX SSZ Option 6 MTX MTX MTX SSZ MTX+SSZ SSZ LEF MTX+SSZ MTX+SSZ LEF MTX+SSZ+HCQ MTX+SSZ+HCQ LEF LEF GST GST AZA AZA CyA CyA CyA or MTX DPen CyA+MTX CyA+MTX DPen DPen Pall options 4 and 5 start with etanercept and infliximab, respectively, in combination with methotrexate. Option 6, the comparator, starts with methotrexate. Each of options 1, 2 and 6 continues with the complete baseline strategy, while options 3, 4 and 5 join this strategy from sulfasalazine, thus avoiding the early combinations with methotrexate. It is assumed that the 89
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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
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
Page 70 and 71: 54 Effectiveness TABLE 11 Summary o
Page 72 and 73: 56 TABLE 12 Description of included
Page 74 and 75: 58 TABLE 13 Quality of included RCT
Page 76 and 77: 60 Effectiveness per week and escal
Page 78 and 79: 62 Effectiveness significant advant
Page 80 and 81: 64 Effectiveness Review: Infliximab
Page 82 and 83: 66 Effectiveness Review: Infliximab
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 and 92: TABLE 20 Summary of published ICERs
Page 93 and 94: TABLE 21 Published etanercept econo
Page 95 and 96: TABLE 23 Published economic analyse
Page 97 and 98: TABLE 25 Treatment sequences: adali
Page 99 and 100: management of RA, i.e. 1st and 2nd
Page 101 and 102: To estimate the long-term consequen
Page 103: 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
Page 117 and 118: following properties, according to
Page 119 and 120: TABLE 52 Base case: TNF inhibitors
Page 121 and 122: TABLE 54 Base case: TNF inhibitors
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
Page 135 and 136: inhibitors, although the incrementa
Page 137 and 138: introduce bias which generally exag
Page 139: Adalimumab, etanercept and inflixim
Page 143 and 144: 1. Jobanputra P, Barton P, Bryan S,
Page 145 and 146: 46. Young A, Dixey J, Cox N, Davies
Page 147 and 148: tumor necrosis factor therapy in th
Page 149 and 150: arthritis: a 12-week, double-blind,
Page 151 and 152: 171. Geborek P, Crnkic M, Petersson
Page 153 and 154: 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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