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iv Abstract was poor, therefore this should be borne in mind when interpreting the model results. Conclusions: Drug therapy seems to be superior to no drug therapy, no significant differences between the various drugs in terms of efficacy or side effects were found, mainly owing to lack of evidence, and the additional benefits from behavioural therapy (in combination with drug therapy) are uncertain. Given the lack of evidence for any differences in effectiveness between the drugs, the economic model tended to be driven by drug costs, which differed considerably. Future trials examining MPH, DEX and ATX should include the assessment of tolerability and safety as a priority. Longer term follow-up of individuals participating in trials could further inform policy makers and health professionals. Such data could potentially distinguish between these drugs in a clinically useful way. In addition, research examining whether somatic complaints are actually related to drug treatment or to the disorder itself would be informative.
Glossary and list of abbreviations ............. vii Executive summary .................................... xiii 1 Aim of the review ...................................... 1 2 Background ................................................ 3 Description of underlying health problem ....................................................... 3 Current service provision ........................... 4 Description of intervention ........................ 5 3 Methods for reviewing effectiveness and cost-effectiveness ....................................... 7 Search strategy ........................................... 7 Inclusion and exclusion criteria: clinical effectiveness ................................................ 8 Inclusion and exclusion criteria for systematic reviews: clinical effectiveness ................................................ 9 Data extraction strategy: clinical effectiveness ................................................ 10 Quality assessment strategy: clinical effectiveness ................................................ 10 Analysis strategy: clinical effectiveness ...... 10 Cost-effectiveness ....................................... 11 4 Clinical effectiveness .................................. 13 Quantity and quality of research available ...................................................... 13 Assessment of effectiveness ........................ 13 Summary of clinical effectiveness data ...... 75 Summary of adverse events data ............... 76 5 Review of economic evaluations of ADHD drug interventions in children and adolescents ................................................. 79 Aim ............................................................. 79 Literature review ........................................ 79 Review of quality of life and cost-effectiveness literature ........................ 79 Review of the Janssen-Cilag submission .................................................. 86 Review of the Celltech submission ............. 93 Review of the Eli Lilly submission ............. 96 6 Economic model ......................................... 101 Methods ...................................................... 102 Results ........................................................ 109 Discussion ................................................... 122 Contents © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 7 Discussion ................................................... 125 Effectiveness evidence ................................ 125 Adverse events ............................................ 125 Economic evidence ..................................... 126 Limitations of the clinical effectiveness studies and need for further research ........ 127 8 Conclusion .................................................. 129 Research recommendations ....................... 129 Acknowledgements .................................... 131 References .................................................. 133 Appendix 1 Clinical effectiveness research ...................................................... 147 Appendix 2 Economic evaluations and health-related quality of life research ........ 165 Appendix 3 Excluded studies from the updated search (after the first screening) (n = 115) .................................................... 171 Appendix 4 Excluded studies from NICE, CCOHTA and AHRQ reviews (n = 28) ...................................................... 175 Appendix 5 Quality assessment questions used for clinical effectiveness studies (as modified from CRD Report No. 4) ...... 177 Appendix 6 Economic evaluation quality assessment checklist ................................... 179 Appendix 7 Economic evaluation data extraction forms ......................................... 181 Appendix 8 All possible treatment strategies ..................................................... 187 Appendix 9 WinBUGS code ...................... 189 Appendix 10 Health state descriptions used to elicit standard gamble utility estimates from parents of children with ADHD ......................................................... 191 Appendix 11 WinBUGS code for extended MTC model ................................................ 199 v
Page 1 and 2: A systematic review and economic mo
Page 3 and 4: A systematic review and economic mo
Page 5: Objectives: To assess the clinical
Page 9 and 10: Glossary Adverse effect An abnormal
Page 11 and 12: Glossary continued effects. Sometim
Page 13 and 14: Glossary continued point between tw
Page 15 and 16: Background Attention deficit hypera
Page 17 and 18: mean differences with 95% confidenc
Page 19: This review examines the clinical a
Page 22 and 23: 4 Background E. Symptoms should not
Page 24 and 25: 6 Background Concerta XL Concerta X
Page 26 and 27: 8 Methods for reviewing effectivene
Page 28 and 29: 10 Methods for reviewing effectiven
Page 31 and 32: Quantity and quality of research av
Page 33 and 34: TABLE 1 The quality of included stu
Page 35 and 36: TABLE 2 An overview of trials inclu
Page 37 and 38: TABLE 2 An overview of trials inclu
Page 39 and 40: TABLE 3 MPH low dose (≤15 mg/day)
Page 41 and 42: Quality of life Only one of the 12
Page 43 and 44: TABLE 5 MPH medium dose (15-30 mg/d
Page 45 and 46: Hyperactivity All nine studies that
Page 47 and 48: TABLE 6 Results for hyperactivity [
Page 49 and 50: Study Parallel trials Buitelaar 199
Page 51 and 52: TABLE 8 Results for hyperactivity [
Page 53 and 54: Study Parallel trials Gittelman-Kle
Page 55 and 56: TABLE 11 MPH high dose (>30 mg/day)
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TABLE 14 ER-MPH medium dose (20-40
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Study Crossover trials Stein 2003 S
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TABLE 19 Results for hyperactivity
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TABLE 22 MPH low dose (≤ 15 mg/da
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TABLE 24 MPH medium dose (15-30 mg/
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assessed by parents and teachers. I
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Page 71 and 72:
TABLE 30 DEX medium dose (10-20 mg/
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Page 75 and 76:
TABLE 38 DEX medium dose (10-20 mg/
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TABLE 41 DEX-SR plus non-drug inter
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Study Michelson 2001 [0.5] Michelso
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Hyperactivity Five trials (publishe
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TABLE 47 IR-MPH low-dose (≤ 15 mg
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STP. 77,78 Neither examined hyperac
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Adverse events No significant diffe
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did report that there were no signi
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Summary The one study in this categ
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showed persisting significant super
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easily rectified with dosage adjust
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Aim The aim of this chapter is to r
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only level of social disability tha
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did not include a ‘global’ HRQo
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might decrease but costs would be e
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1st line pharmacotherapy Response,
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TABLE 70 Data for weighted average
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The probabilistic results were used
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The review also uncovered a mis-ref
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TABLE 77 Results of sensitivity ana
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TABLE 80 Response a rates (%) estim
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TABLE 82 Drug costs used in the cos
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The review of the economic evidence
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Extrapolation A secondary analysis
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economic model rests on the assumpt
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TABLE 87 Data used in calculating w
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not fully probabilistic. The averag
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Probability cost-effective 1.0 0.9
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TABLE 93 Results of sensitivity ana
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Base case model Responder to MPH Re
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TABLE 96 Results of the sensitivity
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The same method for synthesising th
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TABLE 103 Results of the economic m
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of the 64 identified in the clinica
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126 Discussion impact of active dru
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MPH, DEX and ATX improve hyperactiv
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1. National Institute for Clinical
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tutoring on the behavior and achiev
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91. Stein MA, Blondis TA, Schnitzle
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140. Hill P, Taylor E. An auditable
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189. Francis S, Fine J, Tannock R.
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235. Rhodes SM, Coghill DR, Matthew
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hyperactive boys: comparative and c
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This version of HTA monograph volum
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380 Health Technology Assessment Pr
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382 Health Technology Assessment Pr
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