A systematic review and economic model of the effectiveness and ...

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xvi Executive summary systematic review highlighted the need for further research into somatic complaints, which may be associated with the disorder itself rather than methylphenidate treatment. Similarly, high doses of DEX appear to be associated with decreased appetite and increased sleeping problems. ATX of any dose may impair appetite. Cost-effectiveness The review highlighted a number of potential limitations in the existing literature. In particular, the review highlighted limitations in estimating treatment effectiveness and associated utility values. These limitations may stem from a lack of available data. A new economic model was developed for this report. Pooling was limited in the clinical effectiveness review, owing to heterogeneity between trials. However, some degree of pooling is necessary to proceed with an economic model. The issue of heterogeneity was overcome by basing the base case on trials that are more similar in terms of how they measure the outcome of interest. In a series of sensitivity analyses more trials were included by relaxing the criterion of similarity in outcome measurement. Data on resource use associated with ADHD in the UK were lacking, and so the model relies on estimates from experts. Given the lack of available evidence for statistically significant differences in efficacy between the alternative drugs, the results of the economic model were largely driven by drug cost, in which there are marked differences. The economic evaluation clearly suggests an optimal treatment strategy, that is, DEX first-line, followed by IR-MPH for treatment failures, followed by ATX for repeat treatment failures. If DEX is considered not suitable as a first-line therapy, the optimal strategy is IR-MPH first-line, followed by DEX as second-line and ATX again as third-line. For patients contraindicated to stimulants, ATX is preferred to no treatment. For patients in whom a midday dose of medication is unworkable, ER-MPH is preferred to ATX, and ER-MPH12 appears more cost-effective than ER- MPH8. The model is not without limitations. As identified in the clinical effectiveness review, the reporting of studies was poor, there are few data to discriminate between the drugs in efficacy or adverse events and there are few data on longterm efficacy and adverse events associated with medical management of ADHD. The data do not allow discrimination between patients with ADHD in terms of ADHD subtype, age, gender or previous treatment. These caveats must be borne in mind when interpreting the model results. Conclusions The main conclusions from this report are as follows: 1. Drug therapy seems to be superior to no drug therapy. 2. No significant differences between the various drugs in terms of efficacy or side effects were found – mainly owing to lack of evidence. 3. The additional benefits from behavioural therapy (in combination with drug therapy) are uncertain. The main additional feature of the economic model is the consideration of costs. Given the lack of evidence for any differences in effectiveness between the drugs, the model tends to be driven by drug costs, which differ considerably. Research recommendations Future trials examining MPH, DEX and ATX should include the assessment of tolerability and safety as a priority. Reporting should be standardised and transparent. Researchers should refer to the CONSORT approach to study design. 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.
This review examines the clinical and costeffectiveness of oral methylphenidate hydrochloride (MPH) (Ritalin ® , Equasym ® , Equasym XL ® , Concerta ® XL), dexamfetamine sulphate (DEX) (Dexedrine ® ) and atomoxetine hydrochloride (ATx) (Strattera ® ) in children and Chapter 1 Aim of the review © Queen’s Printer and Controller of HMSO 2006. All rights reserved. Health Technology Assessment 2006; Vol. 10: No. 23 adolescents (under 18 years of age) diagnosed with attention deficit hyperactivity disorder (ADHD) [including hyperkinetic disorder (HKD)]. It includes an update of the existing National Institute for Health and Clinical Excellence (NICE) Report No. 13. 1 1
Page 1 and 2: A systematic review and economic mo
Page 3 and 4: A systematic review and economic mo
Page 5 and 6: Objectives: To assess the clinical
Page 7 and 8: Glossary and list of abbreviations
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: mean differences with 95% confidenc
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)
Page 57 and 58: TABLE 14 ER-MPH medium dose (20-40
Page 59 and 60: Study Crossover trials Stein 2003 S
Page 61 and 62: TABLE 19 Results for hyperactivity
Page 63 and 64: TABLE 22 MPH low dose (≤ 15 mg/da
Page 65 and 66: TABLE 24 MPH medium dose (15-30 mg/
Page 67 and 68: assessed by parents and teachers. I
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TABLE 27 Results for hyperactivity
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TABLE 30 DEX medium dose (10-20 mg/
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TABLE 33 Results for hyperactivity
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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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