A systematic review of the effectiveness of adalimumab

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98 Health economics TABLE 45 Times to quitting DMARD DMARD a b (years) Mean (years) Source Adal 0.73 5.96 7.26 Assumed same as infliximab AZA 0.39 4.35 15.53 GPRD database 188 CyA 0.5 4.35 8.70 GPRD database 188 Etan 0.73 12.34 15.03 Geborek 171 GST 0.48 1.81 3.91 GPRD database 188 HCQ 0.49 3.52 7.31 GPRD database 188 Infl 0.73 5.96 7.26 Geborek 171 LEF 1 5.98 5.98 GPRD database 188 MTX 0.51 15.73 30.35 GPRD database 188 DPen 0.57 2.60 4.20 GPRD database 188 SSZ 0.46 4.66 11.01 GPRD database 188 Combination CyA+MTX 1 1.74 1.74 Tugwell, 189 Gerards 190 MTX+SSZ 0.46 4.66 11.01 As for SSZ alone MTX+SSX+HCQ 0.49 3.52 7.31 As for HCQ alone GPRD, General Practice Research Database. In implementation, the values of u1 and u2 are compared with critical values calculated so that zones A, B and C in Figure 49 have the appropriate areas to represent the probabilities given in Table 44. This method means that early withdrawal for inefficacy coincides with the minimum HAQ improvement. For patients who remain on treatment after 24 weeks, the time on treatment is assumed to be independent of HAQ improvement. The value of u2 is converted to a value from a Weibull distribution, represented in the curved part of Figure 48. A random variable X has a Weibull distribution with shape parameter a and scale parameter b if X a ( ––) has an exponential distribution with unit b mean. The Weibull distribution is more general than the constant-risk exponential distribution in that it reduces to the exponential distribution when a = 1. If a < 1, then the risk decreases over time, while if a > 1, the risk increases over time. Parameters a and b are shown in Table 45. For convenience, the mean of the distribution is also shown. HAQ changes on treatment The model assumes a constant risk of increase in HAQ score while in treatment and that an individual’s HAQ score increases gradually and in steps of 0.125, apart from the effects of starting and ending treatment. While HAQ can change at any stage of disease, and is known to be more labile in early disease, the assumption of a gradual increase in HAQ is reasonable for the parts of the model where comparisons are being made, as the model applies to the later stages of the disease. The rate of increase in HAQ was chosen to reflect the empirically observed increase reported by Scott and Strand. 191 Toxicity Toxicity of treatments beyond 24 weeks was only an issue if it potentially affected later choices of treatment, as shown in Table 44. Thus, it was only an issue for methotrexate, ciclosporin and the combination methotrexate plus sulfasalazine. For other treatments, cessation because of toxicity or inefficacy has the same consequence in the model; that is, use of the treatment next in sequence. For ciclosporin it was assumed that drug cessation was due to toxicity with a probability of 0.8 regardless of time spent on drug. 192 For methotrexate, the probability p was set to depend on the time t years on the drug, by the formula p = 0.362 + 0.115e –0.457t , which was derived from a comparison between the survival curves given in Maetzel. 193 For methotrexate plus sulfasalazine, it was assumed that the probability for methotrexate alone applies. Costs Costs are made up of drug costs plus monitoring costs. For all treatments, there are higher costs on starting than there are for continued use. The total cost for time on any treatment is modelled as a one-off starting cost followed by a steady annual usage cost. For completeness, all costs are shown. The price year is 2004 in each case. The unit costs of the various inputs are shown in Tables 46 and 47. The monitoring assumptions are listed in Table 48.
TABLE 46 Unit costs for tests and visits Test Cost (£) a Source FBC 3.98 Newchurch 194 ESR 3.07 Newchurch 194 BCP 3.84 Newchurch 194 CXR 15.59 Newchurch 195 Urinalysis 0.08 Newchurch 194 © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 42 Visit GP 24.00 Curtis and Netten 196 Hospital outpatient 91.00 Curtis and Netten 196 Hospital inpatient (per day) 202.00 Curtis and Netten 196 Specialist nurse visit 45.50 Assumed half of outpatient visit a Inflated to 2004 prices using Hospital and Community Health Services (HCHS) inflation index. 196 BCP, biochemical profile; CXR, chest X-ray; FBC, full blood count. TABLE 47 Unit costs for drugs Treatment Cost Assumptions Adal £357.50 per dose 26 doses per year AZA 53.4p per day 150 mg per day CyA £3.73 per day 225 mg per day Etan £178.75 per dose 52 doses of 50 mg per year GST £8.89 per dose 50-mg ampoule, administered at GP visit HCQ 11.4p per day 300 mg per day Infl £419.62 per vial 70-kg patient, drug wastage if full vials not used, cost per administration £124 LEF £1.70 per day 20 mg per day MTX 11.7p per 2.5-mg tablet 15 mg per week DPen 49.2p per day 500 mg per day SSZ 32.9p per day 2.5 g per day Source: BNF 50 (September 2005), accessed online at www.bnf.org 197 TABLE 48 Monitoring assumptions Treatment Pretreatment On treatment Palliation Outpatient visit every 3 months Adal FBC, ESR, BCP, CXR FBC, ESR, BCP at weeks 2, 4, 8, 12, then every 3 months AZA FBC, ESR, BCP FBC and BCP weekly for 6 weeks, then every 2 weeks for 3 visits, then monthly CyA FBC, 2 × BCP, ESR, urinalysis FBC, BCP every 2 weeks for 4 months, then BCP monthly Etan FBC, ESR, BCP, CXR FBC, ESR, BCP at weeks 2, 4, 8, 12, then every 3 months GST FBC, ESR, BCP, urinalysis FBC, BCP, urinalysis every week for up to 21 injections, then every 2 weeks for 3 months, then every 3 weeks for 3 months, then monthly. Treatment given by i.m. injections HCQ FBC, ESR, BCP FBC, ESR, BCP every 3 months Infl FBC, ESR, BCP, CXR FBC, ESR, BCP at weeks 2, 6 and every 8 weeks (at time of infusions) LEF FBC, ESR, BCP, urinalysis FBC every 2 weeks for 6 months, every 8 weeks thereafter. BCP monthly for 6 months, every 8 weeks thereafter MTX FBC, ESR, BCP, CXR FBC, BCP every 2 weeks for 4 months then monthly SSZ FBC, ESR, BCP FBC every 2 weeks and BCP every 4 weeks for 12 weeks, then FBC and BCP every 3 months 99
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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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Page 64 and 65: 48 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 and 104: TABLE 32 TNF inhibitors as last act
Page 105 and 106: TABLE 34 Basic structure of the mod
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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: TABLE 44 Early cessation of DMARDs:
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
Page 155 and 156: The Health Assessment Questionnaire
Page 157 and 158: Cochrane Library (CENTRAL) 2005 Iss
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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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Volume 1, 1997 No. 1 Home parentera
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No. 3 Screening for sickle cell dis
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No. 25 A rapid and systematic revie
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No. 28 Outcomes of electrically sti
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246 Health Technology Assessment Pr
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A systematic review of the effectiveness of adalimumab

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