1. Pharmacological treatment

1.1. Review question: What is the most clinically and cost-effective pharmacological treatment for people with ADHD?

1.1.1. PICO table

For full details see the review protocol in appendix A.

Table 1

PICO characteristics of review question.

1.1.2. Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual.⁴⁷⁴ Methods specific to this review question are described in the review protocol in appendix A.

Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy.

This review sought to evaluate the clinical and cost effectiveness of pharmacological interventions to treat ADHD. The population of this review was stratified by age (children aged under 5 years, children and young people (5–18 years), and adults (over 18) as the guideline committee believed that the effectiveness of pharmacological treatment would vary between these populations and some outcomes were relevant for only one of the age strata.

Studies were excluded if they selected for a population exclusively on the basis of response to the drug under investigation, for example if the inclusion criteria were ‘previously used and responded to methylphenidate’ and the study compared methylphenidate with placebo.

A number of Cochrane reviews were identified which evaluated the effectiveness of pharmacological treatments for people with ADHD^{144, 512, 513, 520, 627, 628}. As all of the reviews included some studies that did not match the review protocol (for example, treatments not on the protocol, studies that included only known responders), no review was fully included. Rather, the references of each review were checked, and the data from relevant studies were independently extracted and assessed for quality.

A network meta-analysis was considered for this question but deemed inappropriate due to concerns over differences in trial populations, exact trial interventions and insufficient data available for the relevant outcomes (see the methodology chapter for further details).

1.1.3. Clinical evidence

1.1.3.1. Included studies (children under the age of 5)

Four RCTs were included in the review^{41, 275, 291, 540} that evaluated the effectiveness of pharmacological treatments in pre-school age children (under 5 years of age); these are summarised in Table 2 below.

Two studies compared the effectiveness of methylphenidate versus placebo^{275, 291}, one study compared risperidone versus placebo⁴¹, while the other compared risperidone versus standard treatment ⁵⁴⁰. One of these studies⁴¹ did not state whether any children included in the sample had previously received medication. The other studies included both stimulant naïve children and children that had previously received psychotropic medication^{146, 275, 291}. The last study compared risperidone to standard treatment had both groups receiving methylphenidate ⁵⁴⁰. Evidence from these studies is summarised in the clinical evidence summary tables below (Table 5, Table 6 and Table 7)

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

1.1.3.2. Excluded studies

See the excluded studies list in appendix I.

1.1.3.3. Summary of clinical studies included in the evidence review (children under the age of 5)

Table 2

Summary of studies included in the evidence review for pre-school children.

See appendix D for full evidence tables.

1.1.3.4. Included studies (children and young people aged 5 to 18)

Seventy RCTs were included in the review^{3, 25, 35, 45, 62, 67, 87, 89, 95, 100, 118, 129, 142, 167, 172, 177, 178, 181, 198, 200, 202, 208, 235, 260, 267, 272, 293, 309, 316, 341, 346, 347, 351, 362, 367, 379, 390, 391, 430, 450, 452, 456, 457, 460, 469, 471, 476, 479, 491, 503, 539, 546, 553, 554, 576, 577, 590, 592, 598, 615, 631, 633, 639, 647, 657, 658, 672, 695, 702, 712} that evaluated the effectiveness of pharmacological treatments in children and young people (5–18 years of age); these are summarised in Table 3 below. The following comparisons were included in the review:

• eight RCTs compared immediate release methylphenidate versus placebo^{172, 178, 293, 491, 503, 576, 633, 702},
• four RCTs compared osmotic-release oral system methylphenidate versus placebo^{3, 167, 235, 476}
• one RCT compared immediate release methylphenidate versus extended release methylphenidate ⁷⁰²
• one RCT compared lisdexamfetamine versus placebo ¹⁶⁷
• one RCT compared methylphenidate versus lisdexamfetamine ¹⁶⁷
• 26 RCTs compared atomoxetine with placebo^{25, 45, 62, 100, 118, 200, 202, 208, 267, 272, 309, 316, 341, 367, 391, 430, 450, 452, 460, 476, 592, 598, 615, 657, 658, 672}
• two RCTs compared atomoxetine versus methylphenidate ^{476, 647}
• one compared atomoxetine versus guanfacine extended release ³⁴¹
• one RCT compared guanfacine versus placebo ⁵⁵³
• eight RCTs compared guanfacine extended release versus placebo ^{89, 181, 341, 379, 479, 546, 554, 695}.
• four RCTs compared clonidine versus placebo^{351, 491, 577, 633}
• one RCT compared clonidine versus methylphenidate ⁴⁹¹
• one RCT compared clonidine versus desipramine ⁵⁷⁷
• one RCT compared clonidine versus carbamazepine ⁴⁷¹
• two RCTs compared desipramine versus placebo ^{577, 590}
• one RCT compared venlafaxine versus methylphenidate ⁷¹²
• three RCTs compared risperidone versus placebo ^{129, 347, 469}
• one RCT compared aripiprazole versus placebo ⁶³¹
• one RCT compared buspirone versus placebo ¹⁹⁸
• two RCTs compared buspirone versus methylphenidate ^{198, 459}
• two RCTs compared bupropion with placebo ^{142, 177}
• two RCTs compared buproprion versus methylphenidate ^{67, 346}
• three RCTs compared modafinil versus placebo ^{95, 362, 539}
• one RCT compared modafinil versus methylphenidate ³⁵
• one RCT compared melatonin versus placebo ⁶³⁹
• one RCT compared amantadine versus methylphenidate ⁴⁵⁷
• two RCTs compared clonidine and methylphenidate combined versus methylphenidate monotherapy, clonidine monotherapy and placebo monotherapy^{491, 633}
• one RCT compared atomoxetine versus fluoxetine versus atomoxetine.³⁹⁰

Evidence from these studies is summarised in the clinical evidence summary tables below.

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

Table 3

Summary of studies included in the review for children and young people.

See appendix D for full evidence tables.

1.1.3.5. Included studies (adults)

Thirty nine RCTs were included in the review^{8, 11, 12, 16, 21, 34, 50, 84, 90, 91, 110, 117, 140, 162, 216, 282, 287, 288, 306, 386, 393, 401, 446, 449, 494, 522, 524, 527, 533, 591, 593, 608, 620, 621, 625, 666, 667, 689, 711} that evaluated the effectiveness of pharmacological treatments in adults these are summarised in Table 4 below. The following comparisons were included in this review:

• eight RCTs compared immediate release methylphenidate versus placebo^{21, 110, 386, 393, 591, 593, 625, 666}
• twelve RCTs compared controlled release methylphenidate versus placebo^{21, 90, 91, 117, 140, 162, 282, 287, 446, 524, 533, 593}
• three RCTs compared dexamfetamine versus placebo ^{494, 620, 621}
• three RCTs compared lisdexamfetamine versus placebo^{8, 11, 84}
• ten RCTs compared atomoxetine versus placebo^{12, 16, 216, 288, 401, 449, 608, 667, 689, 711}
• one RCT compared guanfacine versus placebo ⁶²¹
• one RCT compared guanfacine versus dexamfetamine ⁶²¹
• one RCT compared reboxetine versus placebo ⁵²⁷
• one RCT compared venlafaxine versus placebo ³⁴
• two RCTs compared bupropion versus placebo ^{306, 393}
• one RCT compared bupropion versus methylphenidate ³⁹³
• two RCTs compared modafinil versus placebo ^{50, 620}
• one RCT compared modafinil versus dexamfetamine ⁶²⁰
• one RCT compared atomoxetine and buspirone versus placebo ⁶⁰⁸

Evidence from these studies is summarised in the clinical evidence summary below.

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

Table 4

Summary of studies included in the review for adults.

See appendix D for full evidence tables.

1.1.3.6. Quality assessment of clinical studies included in the evidence review (children under the age of 5)

Table 5

Clinical evidence summary: Methylphenidate versus placebo.

Table 6

Clinical evidence summary: Risperidone versus methylphenidate.

Table 7

Clinical evidence summary: Risperidone and methylphenidate versus methylphenidate.

1.1.3.7. Quality assessment of clinical studies included in the evidence review (children aged 5 to 18 years)

Table 8

Clinical evidence summary: Immediate release methylphenidate versus placebo.

Table 9

Clinical evidence summary: OROS Methylphenidate versus placebo.

Table 10

Clinical evidence summary: IR methylphenidate versus OROS methylphenidate.

Table 11

Clinical evidence summary: Lisdexamfetamine versus placebo.

Table 12

Clinical evidence summary: Methylphenidate versus lisdexamfetamine.

Table 13

Clinical evidence summary: Atomoxetine versus placebo.

Table 14

Clinical evidence summary: Atomoxetine versus methylphenidate.

Table 15

Clinical evidence: Atomoxetine versus guanfacine extended release.

Table 16

Clinical evidence summary: Guanfacine versus placebo.

Table 17

Clinical evidence summary: Extended release guanfacine versus placebo.

Table 18

Clinical evidence summary: Clonidine versus placebo.

Table 19

Clinical evidence summary: Clonidine versus methylphenidate.

Table 20

Clinical evidence summary: Clonidine versus desipramine.

Table 21

Clinical evidence summary: Clonidine versus carbamazepine.

Table 22

Clinical evidence summary: Desipramine versus placebo.

Table 23

Clinical evidence summary: Venlafaxine versus methylphenidate.

Table 24

Clinical evidence summary: Risperidone versus placebo.

Table 25

Clinical evidence summary: Aripiprazole versus placebo.

Table 26

Clinical evidence summary: Buspirone versus methylphenidate.

Table 27

Clinical evidence summary: Bupropion versus placebo.

Table 28

Clinical evidence summary: Bupropion versus methylphenidate.

Table 29

Clinical evidence summary: Modafinil versus placebo.

Table 30

Clinical evidence summary: Modafinil versus methylphenidate.

Table 31

Clinical evidence summary: Melatonin versus placebo.

Table 32

Clinical evidence summary: Amantadine versus methylphenidate.

Table 33

Clinical evidence summary: Methylphenidate and clonidine versus methylphenidate.

Table 34

Clinical evidence summary: Methylphenidate and clonidine versus clonidine.

Table 35

Clinical evidence summary: Methylphenidate and clonidine versus placebo.

Table 36

Clinical evidence summary: Atomoxetine and fluoxetine versus atomoxetine and placebo.

1.1.3.8. Quality assessment of clinical studies included in the evidence review (adults)

Table 37

Clinical evidence summary: Immediate release Methylphenidate versus placebo.

Table 38

Clinical evidence summary: OROS methylphenidate versus placebo.

Table 39

Clinical evidence summary: Dexamfetamine versus placebo.

Table 40

Clinical evidence summary: Lisdexamfetamine dimesylate versus placebo.

Table 41

Clinical evidence summary: Atomoxetine versus placebo.

Table 42

Clinical evidence summary: Guanfacine versus placebo.

Table 43

Clinical evidence summary: Guanfacine versus dexamfetamine.

Table 44

Clinical evidence summary: Reboxetine versus placebo.

Table 45

Clinical evidence summary: Venlafaxine versus placebo.

Table 46

Clinical evidence summary: Bupropion versus placebo.

Table 47

Clinical evidence summary: Bupropion versus methylphenidate.

Table 48

Clinical evidence summary: Modafinil versus placebo.

Table 49

Clinical evidence summary: Modafinil versus dexamfetamine.

Table 50

Clinical evidence summary: Atomoxetine and buspirone versus placebo.

See appendix F for full GRADE tables.

1.1.4. Economic evidence

1.1.4.1. Included studies

1.1.4.1.1. 2008 guideline literature

One study from CG72 was included in this review³⁷²

The included study can be found in Table 51.

1.1.4.1.2. Published literature

Two health economic studies were identified in children with the relevant comparison and have been included in this review.^188,332 One economic evaluation was also identified in adults.⁷¹⁷

One study on children was from the UK and used a decision model to compare an algorithm with atomoxetine as first line treatment versus an algorithm of standard treatment (without atomoxetine) in different subgroup populations (only the medication naïve group have been included in this review question).

The second study on children adapted the model from the UK study to a Spanish context, however it compared a sequence of atomoxetine as first line versus atomoxetine as second line (and did not include dexamfetamine in the sequence). Therefore the interventions were different, and it only looked at some of the subgroups that the UK paper looked at (again only some of which are included in this review), therefore the models were thought to be sufficiently different to be included as separate studies.

Note that although these studies compare sequences in different ways, they are both essentially asking which drug you should start with.

The adult study was from the UK and used a decision model to compare lisdexamfetamine with atomoxetine or extended release methylphenidate.

These are summarised in the health economic evidence profiles below (Table 52, Table 53) and the health economic evidence tables in Appendix H.

See also the health economic study selection flow chart in Appendix G.

1.1.4.2. Excluded studies

Five studies ^{211, 250, 278, 357, 473, 718} from CG72, all in children, have been selectively excluded due to limited applicability and/or methodological limitations.

These are listed in Appendix I, with reasons for exclusion given.

See also the health economic study selection flow chart in appendix G.

1.1.4.3. Summary of studies included in the economic evidence review

Table 51

Health economic evidence profile: [2008 guideline included economic evaluations].

Table 52

Health economic evidence profile: [Children; first line Atomoxetine algorithm versus standard treatment algorithm or second line atomoxetine algorithm].

Table 53

Health economic evidence profile: [Adults; Lisdexamfetamine versus Atomoxetine or extended release Methylphenidate].

Since the previous guideline, the price of dexamfetamine has substantially increased. This is likely to affect the conclusions of all included economic studies with dexamfetamine, as they are out of date with the costs.

King et al 2006³⁷² was replicated using the information in the study, to see what impact updating the cost of the interventions would have. The original base case result of King 2006 showed that the most cost effective strategy was;

Dexamfetamine – Methylphenidate IR – Atomoxetine – No treatment.

This was also the case when the model was replicated without changing the drug costs. This added reassurance that the replication was similar to the original model (although some assumptions had to be made based on the information provided in the paper in order to replicate the model).

After updating the model to include up to date drug prices, the most cost effective option was;

Methylphenidate IR – Atomoxetine – Dexamfetamine – No treatment.

This shows that keeping all other parts of the model the same except for updating the drug prices is having an impact of the results enough to change the conclusions. The increased price of dexamfetamine means that it is no longer cost effective first or second line even though it has a higher response rate and fewer withdrawals than the other drugs. The increased cost is outweighing the additional benefit.

Note that the same limitations of the model remain as the purpose of this exercise was only to see the impact of the price changes and structural and data aspects of the model cannot be altered as it is not an original guideline model. Notable limitations include that the treatments in the sequence are independent of each other which is unlikely to reflect reality, and also the limited number of sources informing the clinical effect.

Cottrell 2008 also included dexamfetamine in the sequences evaluated. This study had 5 subgroups, which had different sequences for the intervention and comparator of each subgroup depending on previous history with stimulants. As the purpose of this study is to estimate the costs and benefits of atomoxetine versus other treatments, then the intervention arm for each subgroup always had atomoxetine first followed by other treatments, and the comparator sequence was the same sequence but without atomoxetine.

For example for a stimulant naïve population the treatments being evaluated are a sequence of; ATX - IR MPH - IR DEX - no treatment, versus; IR MPH - IR DEX - no treatment.

Because of this, dexamfetamine will always be closer to the front of the sequence in the comparator arm. Meaning that in the comparator arm, more people will be on dexamfetamine because you only go on to the next treatment if you fail the previous one. Therefore a dexamfetamine price increase will increase the total cost of the comparator arm more than the total cost of the intervention arm, therefore making the incremental cost smaller and the intervention arm more cost effective. It may even make the intervention cost saving. These are assumptions about what the impact will be, but it has been shown from the update of the King model that sequences with dexamfetamine lower down the treatment line are likely to be more cost effective than sequences with dexamfetamine nearer the front of the sequence, because of the higher price of dexamfetamine.

1.1.4.4. Unit costs

Relevant unit costs are provided below to aid consideration of cost-effectiveness. The drugs listed below are based on those identified from the clinical review as well as those commonly used even if the review did not find evidence on them, and therefore do not include the entire list of interventions from the protocol.

The costs below are illustrative. For the commonly used ADHD drugs; a low and high dose has been demonstrated and taken from the BNF. Some doses were not taken from the BNF and the reason for this is highlighted. Advice has also been taken from the BNF about whether a single dose per day or the doses can be divided, where available. For drugs that are not used for ADHD then the clinical review was used for dosing information.

Note that there can be various branded generic versions of a drug, but drugs of the same class with the same dose have the same cost in the drug tariff regardless of who manufactures it.

Table 54

UK costs of ADHD drugs for children.

Table 55

UK costs of ADHD drugs for adults.

The pricing structure of the different drugs can also impact the overall cost, as if you are taking a higher dose you could do this once a day, then a higher dose tablet tends to be cheaper than taking two tablets of half the dose. So with most drugs then are economies of scale of the higher formulations. This isn’t always the case though. With some drugs it is possible to take only one tablet a day such as the modified release versions but with others you would need to take tablets at multiple points in the day which means more pills per day of lower formulations.

Costs of other healthcare resource such as hospital appointments that may differ by intervention is illustrated below.

Table 56

Staff costs associated with selecting and monitoring medication treatment.

For example, people on stimulants may see healthcare professionals more frequently in the beginning in order to make sure the dose is appropriate and then may see healthcare professionals less frequently.

1.1.5. Resource impact

We do not expect recommendations resulting from this review area to have a significant impact on resources.

1.1.6. Evidence statements

1.1.6.1. Clinical evidence statements

1.1.6.1.1. Children under 5

Methylphenidate versus placebo

• No evidence was identified for quality of life, CGI-I, serious adverse events or discontinuation due to adverse events. No evidence was identified for any of the important outcomes except behavioural outcomes measured by the children’s global assessment scale.
• There was a clinically important benefit of methylphenidate for ADHD symptoms total (parent-teacher composite; 1 study very low quality) (parent rated; 1 study low quality) and behavioural symptoms (1 study low quality)

Risperidone versus methylphenidate

• No evidence was identified for quality of life, CGI-I or serious adverse events. No evidence was identified for any of the important outcomes.
• There was no clinical difference between risperidone and methylphenidate on total, inattentive and hyperactivity ADHD symptoms (parent rated; 1 study very low quality).
• The number of children discontinuing their medication due to adverse events was lower for risperidone compared to methylphenidate, and this was clinically important (1 study very low quality).

Risperidone and methylphenidate versus methylphenidate

• No evidence was identified for quality of life. No evidence was identified for any of the important outcomes except behavioural outcomes measured by the CPRS oppositional subscale.
• There was no clinical difference on total, inattention and hyperactivity ADHD symptoms and behaviour outcomes as reported by parents (1 study very low quality).
• There was a clinically important benefit of methylphenidate and risperidone combined on CGI-I (1 study very low quality).
• There was clinically important harm of risperidone and methylphenidate combined on discontinuation due to adverse events (1 study low quality).

1.1.6.1.2. Children and young people aged 5 to 18

Immediate release (IR) methylphenidate versus placebo

• No evidence was identified for quality of life, or serious adverse events. No evidence for any of the important outcomes except behavioural outcomes measured by children’s Global assessment scale.
• There was a clinically important benefit of methylphenidate for ADHD total symptoms (parent rated; 2 studies low quality) (teacher rated; 2 studies low quality) (teacher rated; 1 study moderate quality), ADHD inattention symptoms (parent rated; 1 study moderate quality) (teacher rated; 1 study moderate quality), ADHD hyperactivity symptoms (teacher rated, 3 studies low to moderate quality), CGI-I (3 studies moderate quality), behavioural outcomes (2 studies low quality).
• There was no clinical difference for ADHD symptoms total (parent rated; 3 studies moderate quality), ADHD hyperactivity symptoms (parent rated; 1 study low quality) (teacher rated; 1 study low quality), discontinuation due to adverse events (4 studies low quality) and serious adverse events (1 study moderate quality).

OROS Methylphenidate versus placebo

• No evidence was identified for serious adverse events. No evidence was identified for any of the important outcomes except for behavioural outcomes and academic achievement.
• There was a clinically important benefit of methylphenidate for quality of life (1 study low quality), total ADHD symptoms (parent rated; 2 studies moderate quality) (teacher rated; 1 study moderate quality) (investigator rated 1 study moderate quality), ADHD inattention symptoms (parent rated; 2 studies moderate quality) (teacher rated; 2 studies low quality) (investigator rated; 1 study very low quality), ADHD hyperactivity symptoms (parent rated; 2 studies moderate quality) (teacher rated; 2 studies moderate quality) (investigator rated; 1 study very low quality), CGI-I (2 studies moderate quality), behavioural outcomes (1 study low quality) and academic achievement (1 study low quality).
• There was no clinical difference in the number of children discontinuing their medication due to adverse events (3 studies low quality).

IR methylphenidate versus OROS methylphenidate

• No evidence was identified for quality of life, serious adverse events or any of the important outcomes.
• There was no clinically important difference for ADHD inattention symptoms (teacher rated; 1 study moderate quality) (parent rated; 1 study moderate quality), ADHD hyperactivity symptoms (teacher rated; 1 study moderate quality) (parent rated; 1 study moderate quality), CGI-I (1 study low quality) and discontinuation due to adverse events (1 study low quality).

Lisdexamfetamine versus placebo

• No evidence was identified for quality of life, inattentive or hyperactivity ADHD symptoms or serious adverse events. No evidence for any of the important outcomes except behaviour outcomes as measured by the WFIRS-P scale and academic achievement as measured by the CHIP-CE academic achievement subscale.
• There was a clinically important benefit of lisdexamfetamine for ADHD total symptoms (investigator rated; 1 study moderate quality), CGI-I, academic achievement and behaviour outcomes (1 study moderate quality).
• There was no clinical difference for discontinuation due to adverse events (2 studies very low quality).

Methylphenidate versus lisdexamfetamine

• No evidence was identified for quality of life, inattentive or hyperactivity ADHD symptoms and serious adverse events. No evidence for any of the important outcomes except behaviour outcomes as measured by the WFIRS-P scale and academic achievement as measured by the CHIP-CE academic achievement subscale.
• There was a clinically important benefit of lisdexamfetamine for ADHD total symptoms (investigator rated; 1 study moderate quality) and CGI-I (1 study, low quality).
• There was no clinical difference for discontinuation due to adverse events, academic achievement and behaviour outcomes (1 study low quality).

Atomoxetine versus placebo

• No evidence for any of the important outcomes except behavioural outcomes measured by various scales and academic achievement measured by the CHIP-PRF achievement subscale.
• There was a clinically important benefit of atomoxetine for quality of life (2 studies moderate quality) (1 study low quality), treatment response (2 studies low quality), ADHD total symptoms (investigator rated; 3 studies low quality) (investigator rated; 6 studies moderate quality) (teacher rated; 5 studies moderate quality) (teacher rated; 1 study low quality) (parent rated; 9 studies high quality) (parent rated; 2 studies low quality) (parent rated; 3 studies moderate quality), ADHD inattention symptoms (investigator rated; 5 studies low quality) (teacher rated; 5 studies low quality) (parent rated; 9 studies low quality) (parent rated; 2 studies low quality) (parent rated; 3 studies moderate quality), ADHD hyperactivity symptoms (investigator rated; 5 studies moderate quality) (teacher rated; 4 studies moderate quality) (teacher rated; 1 study low quality) (parent rated; 12 studies moderate quality) (parent rated; 2 studies very low quality), CGI-I (5 studies moderate quality) and behavioural outcomes (2 studies low quality).
• There was no clinical difference for behavioural outcomes (3 studies moderate quality), academic achievement (1 study low quality), discontinuation due to adverse events (16 studies moderate quality) (2 studies low quality) and serious adverse events (3 studies low quality).

Atomoxetine versus methylphenidate

• No evidence was identified for CGI-I or serious adverse events. No evidence for any of the important outcomes except behavioural outcomes measured on the CPRS oppositional subscale.
• There was no clinical differences for quality of life (1 study moderate quality), total, inattentive and hyperactivity ADHD symptoms (parent rated; 2 studies moderate quality) or behavioural outcomes (1 study moderate quality). More children discontinued atomoxetine due to adverse events compared to methylphenidate (1 study moderate quality).

Atomoxetine versus guanfacine extended release

• No evidence was identified for quality of life, serious adverse events or any important outcomes.
• There was a clinically important benefit of guanfacine for ADHD total symptoms (investigator rated; 1 study low quality), CGI-I (1 study low quality)
• There was no clinically important difference in the number of children discontinuing due to adverse events (1 study low quality).

Guanfacine versus placebo

• No evidence was identified for quality of life, discontinuation due to adverse events or serious adverse events. No evidence for any of the important outcomes.
• There was a clinically important benefit of guanfacine for total and hyperactivity ADHD symptoms (investigator rated; 1 study moderate quality) and CGI-I scores (1 study high quality).
• There was no clinically important difference for ADHD inattention symptoms (investigator rated; 1 study moderate quality).

Extended release Guanfacine versus placebo

• No evidence was identified for quality of life. No evidence for any of the important outcomes except for academic achievement as measured by the WFIRS academic performance subscale.
• There was a clinically important benefit of extended release guanfacine for total ADHD symptoms (investigator rated; 6 studies low quality), ADHD inattention symptoms (investigator rated; 4 studies low quality), ADHD hyperactivity symptoms (investigator rated; 5 studies high to moderate quality) and CGI-I scores (5 studies moderate quality).
• There was clinically important harm of extended release guanfacine for serious adverse events (1 study very low quality); 1 participant in the guanfacine arm had a serious adverse event, compared to zero in the placebo arm.
• There was no clinically important difference for academic outcomes (1 study high quality) and discontinuation due to adverse events (8 studies high quality).

Clonidine versus placebo

• No evidence was identified for quality of life or CGI-I. No evidence for any of the important outcomes except for behavioural outcomes, as measured by CGAS.
• There was a clinically important benefit of clonidine for ADHD total symptoms (parent rated; 2 studies low quality) (teacher rated; 2 studies low quality) (investigator rated; 1 study low quality), ADHD inattention symptoms (investigator rated; 1 study low quality) and hyperactivity symptoms (investigator rated, 1 study low quality) (parent/teacher rated; 1 study high quality) and behaviour outcomes (2 studies very low quality).
• There was no clinical difference for discontinuation due to adverse events (2 studies moderate quality) or serious adverse events (1 study high quality).

Clonidine versus methylphenidate

• The only evidence identified was on ADHD total symptoms, discontinuation due to adverse events and behavioural outcomes, as measured by CGAS.
• There was a clinically important benefit of methylphenidate for ADHD total symptoms (teacher rated; 1 study very low quality) (parent rated; 1 study very low quality).
• There was no clinical difference for behavioural outcomes (1 study low quality) or in discontinuation rates due to adverse events (1 study very low quality).

Clonidine versus desipramine

• The only evidence identified was on ADHD hyperactivity symptoms.
• There was a clinically important benefit of desipramine for ADHD hyperactivity symptoms (parent/teacher rated; 1 study high quality).

Clonidine versus carbamazepine

• The only evidence identified was on ADHD symptoms.
• There was a clinically important benefit of clonidine for ADHD inattention symptoms (investigator rated; 1 study very low quality), ADHD hyperactivity symptoms (investigator rated; 1 study low quality) and ADHD impulsivity symptoms (investigator rated; 1 study low quality).

Desipramine versus placebo

• The only evidence identified was on total ADHD symptoms.
• There was a clinically important benefit of desipramine for ADHD total symptoms (investigator rated; 1 study high quality) and ADHD hyperactivity symptoms (parent/teacher rated; 1 study high quality).

Venlafaxine versus methylphenidate

• The only evidence identified was for total ADHD symptoms.
• There was no clinical difference in ADHD total symptoms (parent and teacher rated; 1 study moderate quality).

Risperidone versus placebo

• No evidence was identified for quality of life, CGI-I, ADHD total symptoms and discontinuation due to adverse events. No evidence for any of the important outcomes except for behavioural outcomes as measured by multiple scales including CGAS.
• There was a clinically important benefit of risperidone for behaviour outcomes (1 study moderate quality) and serious adverse events (1 study low quality).
• There was no clinical difference for ADHD inattention and hyperactivity symptoms (parent rated; 1 study moderate quality) or behavioural outcomes measured by the ABC and CPRS oppositional subscale (2 studies moderate quality).

Ariprazole versus placebo

• The only evidence identified was for ADHD total symptoms.
• There was clinically important harm of ariprazole for ADHD total symptoms (parent rated; 1 study low quality).

Buspirone versus methylphenidate

• The only evidence identified was for ADHD total symptoms, discontinuation due to adverse events and serious adverse events.
• There was a clinically important benefit of methylphenidate for ADHD total symptoms (parent rated; 2 studies low to very low quality) (teacher rated; 1 study moderate quality).
• There was clinically important harm of buspirone for discontinuation due to adverse events (1 study very low quality).
• There was no clinical difference for serious adverse events (1 study low quality).

Buproprion versus placebo

• The only evidence identified was for ADHD total symptoms and discontinuation due to adverse events.
• There was a clinically important benefit of buproprion for ADHD total symptoms (parent and teacher rated, 2 studies moderate quality).
• There was clinically important harm of buproprion for discontinuation due to adverse events (2 studies low quality).

Buproprion versus methylphenidate

• The only evidence identified was for ADHD symptoms, serious adverse events and discontinuation due to adverse events.
• There was a clinically important benefit of methylphenidate for ADHD total symptoms (parent rated; 2 studies low quality) (teacher rated; 1 study low quality), ADHD inattention symptoms (parent rated; 1 study low quality).
• There was no clinical difference for ADHD total symptoms (teacher rated; 1 study low quality), ADHD inattention symptoms (parent rated; 1 study low quality) (teacher rated, 1 study low quality), ADHD hyperactivity symptoms (parent rated; 1 study very low quality) (teacher rated; 1 study low quality), discontinuation due to adverse events (1 study low quality) and serious adverse events (1 study low quality).

Modafinil versus placebo

• No evidence was identified for quality of life or ADHD hyperactivity or inattention symptoms. No evidence for any important outcomes.
• There was a clinically important benefit of modafinil for ADHD total symptoms (parent rated; 1 study low quality) (teacher rated; 2 studies very low quality) and CGI-I (1 study low quality).
• There was no clinical difference for serious adverse events (1 study low quality).
• There was clinically important harm of modafinil for discontinuation due to adverse events (1 study very low quality).

Modafinil versus methylphenidate

• The only evidence identified was for ADHD total symptoms.
• There was no clinical difference for total symptoms (parent and teacher rated; 1 study low quality).

Melatonin versus placebo

• The only evidence identified was for quality of life, discontinuation due to adverse events and behavioural outcomes as measured by the Teachers Report Form.
• There was no clinical difference for quality of life, behavioural outcomes or discontinuation due to adverse events (1 study moderate to high quality).

Amantadine versus methylphenidate

• The only evidence identified was for ADHD inattention and hyperactivity symptoms.
• There was no clinical difference for ADHD inattention or hyperactivity symptoms (parent and teacher rated; 1 study low quality).

Methylphenidate and clonidine versus methylphenidate

• The only evidence identified was for ADHD total symptoms, behaviour outcomes (measured by CGAS) and discontinuation due to adverse events.
• There was a clinically important benefit of ADHD total symptoms (parent and teacher rated; 1 study low to very low quality), and behaviour outcomes (1 study very low quality).
• There was clinically important harm of methylphenidate and clonidine combined for discontinuation due to adverse events (1 study low quality).

Methylphenidate and clonidine versus clonidine

• The only evidence identified was for ADHD total symptoms, behaviour outcomes (measured by CGAS) and discontinuation due to adverse events.
• There was a clinically important benefit of methylphenidate and clonidine combined for ADHD total symptoms (parent and teacher rated; very low quality), and behaviour outcomes (1 study very low quality).
• There was no clinical difference for discontinuation due to adverse events (1 study very low quality).

Methylphenidate and clonidine versus placebo

• The only evidence identified was for ADHD total symptoms, behaviour outcomes (measured by CGAS) and discontinuation due to adverse events.
• There was a clinically important benefit of methylphenidate and clonidine for ADHD total symptoms (parent and teacher rated; 2 studies very low quality), and behaviour outcomes (2 studies very low quality).
• There was clinically important harm of methylphenidate and clonidine combined for discontinuation due to adverse events (1 study very low quality).

Atomoxetine and fluoxetine versus atomoxetine

• The only evidence identified was for ADHD symptoms and discontinuation due to adverse events.
• There was a clinically important benefit of atomoxetine and fluoxetine combined for ADHD inattention symptoms (investigator rated; 1 study very low quality).
• There was no clinical difference for ADHD total and hyperactivity symptoms (investigator rated; 1 study very low quality) or discontinuation due to adverse events (1 study very low quality).

1.1.6.1.3. Adults

Immediate release methylphenidate versus placebo

• There was no evidence identified for quality of life or serious adverse events. No evidence for important outcomes except for behaviour outcomes, as measured by the global assessment of functioning and problem behaviour scale.
• There was a clinically important benefit of methylphenidate for ADHD total symptoms (investigator rated; 3 studies very low to moderate quality), treatment response (2 studies low quality) and CGI-I (2 studies moderate quality).
• There was clinically important harm of methylphenidate for discontinuation due to adverse events (2 studies high quality).
• There was no clinical difference for behaviour outcomes (2 studies moderate quality).

OROS methylphenidate versus placebo

• There was no evidence for serious adverse events.
• There was a clinically important benefit of methylphenidate for treatment response (3 studies moderate quality), ADHD total symptoms (investigator rated; 4 studies low quality) (investigator rated; 2 studies moderate quality) (self-rated, 2 studies moderate quality) (self-rated; 2 studies low quality) (self-rated; 1 study low quality), ADHD inattention symptoms (investigator rated; 1 study low quality) (investigator rated; 1 study low quality) (self rated; 1 study moderate quality), ADHD hyperactivity symptoms (investigator rated; 2 studies low quality), CGI-I (3 studies moderate quality) and behaviour outcomes (1 study high quality), emotional dysregulation (1 study moderate quality).
• There was no clinical difference for ADHD inattention symptoms (investigator rated; 2 studies moderate quality), ADHD hyperactivity symptoms (investigator rated; 2 studies low quality)(self-rated; 1 study moderate quality) and emotional dysregulation (1 study very low quality).
• There was clinically important harm of methylphenidate for discontinuation due to adverse events (9 studies high quality) or quality of life (1 study high quality)

Dexamfetamine versus placebo

• The only evidence identified was for ADHD symptoms and CGI-I.
• There was a clinically important benefit of dexamfetamine for ADHD total, inattention and hyperactivity symptoms (investigator rated; 2 studies moderate quality) and CGI-I (1 study moderate quality).

Lisdexamfetamine versus placebo

• No evidence was identified for serious adverse events. No evidence for important outcomes except for behaviour outcomes, as measured by the GAF scale,
• There was a clinically important benefit of lisdexamfetamine for ADHD total symptoms (investigator rated; 3 studies moderate quality), ADHD inattention symptoms (investigator rated; 1 study low quality), ADHD hyperactivity symptoms (investigator rated; 1 study low quality), CGI-I (1 study moderate quality) and behaviour outcomes (1 study low quality).
• There was no clinical difference for quality of life (1 study very low quality) or discontinuation due to adverse events (3 studies very low quality).

Atomoxetine versus placebo

• There was no evidence for CGI-I or serious adverse events.
• There was a clinically important benefit of atomoxetine for quality of life (5 studies low to moderate quality), ADHD total symptoms (investigator rated, 10 studies low to very low quality) (self-rated; 2 studies low quality), ADHD inattention symptoms (self-rated; 2 studies low quality) (investigator rated; 9 studies low to very low quality) and ADHD hyperactivity symptoms (investigator rated; 9 studies very low quality) (self-rated, 2 studies moderate quality).
• There was clinically important harm of atomoxetine for discontinuation due to adverse events at 24 weeks (1 study moderate quality).
• There was no clinical difference for behaviour outcomes (2 studies low quality) or discontinuation due to adverse events up to 14 weeks (7 studies moderate quality).

Guanfacine versus placebo

• The only evidence identified was for ADHD symptoms.
• There was a clinically important benefit of guanfacine for ADHD total, inattention and hyperactivity symptoms (investigator rated; 1 study moderate quality).

Guanfacine versus dexamfetamine

• The only evidence identified was for ADHD symptoms.
• There was no clinical difference of ADHD total, inattention or hyperactivity symptoms (investigator rated; 1 study low to moderate quality)

Reboxetine versus placebo

• The only evidence identified was for ADHD symptoms, discontinuation due to adverse events and behaviour outcomes as measured by the GAF scale.
• There was a clinically important benefit of reboxetine for ADHD total symptoms (investigator rated; 1 study low quality), ADHD inattention symptoms (investigator rated; 1 study very low quality) and behaviour outcomes (1 study low quality).
• There was no clinical difference for ADHD hyperactivity symptoms (1 study very low quality) or discontinuation due to adverse events (1 study low quality).

Venlafaxine versus placebo

• The only evidence identified was for ADHD symptoms, discontinuation due to adverse events and serious adverse events.
• There was a clinically important benefit of venlafaxine for ADHD total, inattention and hyperactivity symptoms (self-rated; 1 study low to moderate quality).
• There was no clinical difference for discontinuation due to adverse events (1 study very low quality) or serious adverse events (1 study low quality).

Bupropion versus placebo

• The only evidence identified was for ADHD total symptoms, CGI-I and discontinuation due to adverse events.
• There was a clinically important benefit of buproprion for ADHD total symptoms (investigator rated, 1 study moderate quality), CGI-I (1 study low quality) and discontinuation due to adverse events (1 study very low quality)
• There was no clinical difference for ADHD total symptoms (investigator rated, 1 study very low quality)

Bupropion versus methylphenidate

• The only evidence identified was for ADHD total symptoms, CGI-I and discontinuation due to adverse events.
• There was a clinically important benefit of buproprion for ADHD total symptoms (investigator rated, 1 study low quality), CGI-I (1 study very low quality) and discontinuation due to adverse events (1 study low quality).

Modafinil versus placebo

• There was no evidence identified for CGI-I, serious adverse events or emotional dysregulation.
• There was a clinically important benefit of modafinil for ADHD total symptoms (self-rated; 1 study low quality) (investigator rated; 1 study moderate quality), ADHD inattention symptoms (investigator rated; 1 study high quality) and ADHD hyperactivity symptoms (investigator rated; 1 study moderate quality).
• There was clinically important harm of modafinil for discontinuation due to adverse events (1 study low quality).
• There was no clinical difference for quality of life (1 study low quality) or behaviour outcomes (1 study low quality).

Modafinil versus dexamfetamine

• The only evidence identified was for ADHD symptoms.
• There was no clinical difference for ADHD total, inattention and hyperactivity symptoms (investigator rated; 1 study moderate to low quality).

Atomoxetine and buspirone versus placebo

• The only evidence identified was for ADHD symptoms and discontinuation due to adverse events.
• There was a clinically important benefit of atomoxetine and buspirone for ADHD total symptoms (investigator rated; 1 study low quality).
• There was no clinical difference for ADHD inattention or hyperactivity symptoms (investigator rated; 1 study low quality) or discontinuation due to adverse events (1 study low quality).

1.1.6.2. Health economic evidence statements

• One cost-utility analysis found that a sequence of; Dexamfetamine – [methylphenidate-IR] – atomoxetine – no treatment, was dominant compared to other sequences of drugs for treating ADHD in children. This analysis was assessed as partially applicable with potentially serious limitations.
  This analysis was adapted with up to date intervention costs and found that a sequence of; [methylphenidate-IR] – Atomoxetine – Dexamfetamine – no treatment, was cost effective compared to other sequences of drugs for treating ADHD in children (ICER: £485 compared to no treatment). This analysis was assessed as partially applicable with potentially serious limitations.
• One cost-utility analysis found that for treating ADHD in children:

  • In stimulant naive patients, a sequence of atomoxetine – IR-MPH (or XR-MPH) – IR-DEX – no treatment was cost effective compared to the same sequence without atomoxetine (ICER: £15,244 if IR-MPH and £13,241 with XR-MPH)
  • In stimulant contraindicated (naive) patients, a sequence of atomoxetine – no treatment was cost effective compared to no treatment alone (ICER: £11,523)

This analysis was assessed as partially applicable with potentially serious limitations.

• One cost-utility analysis found that for treating ADHD in children:

  • In stimulant naïve patients, a sequence of atomoxetine – IR-MPH – no treatment was not cost effective compared to a sequence of IR-MPH – atomoxetine – no treatment (ICER: £31,007)
  • In stimulant naïve patients, a sequence of atomoxetine – XR-MPH – no treatment was cost effective compared to a sequence of IR-MPH – atomoxetine – no treatment at a threshold of £30,000 per QALY gained, but was not cost effective at a threshold of £20,000 per QALY gained (ICER: £21,971)
  • In stimulant naïve patients with contraindications, atomoxetine was cost effective compared to no treatment at a threshold of £30,000 per QALY gained, but was not cost effective at a threshold of £20,000 per QALY gained (ICER: £21,079)

This analysis was assessed as partially applicable with potentially serious limitations.

• One cost-utility analysis found that Lisdexamfetamine was dominant compared to atomoxetine and ER-MPH for treating ADHD in adults. This analysis was assessed as directly applicable with veryserious limitations.

1.2. Review question: What is the most clinically and cost-effective sequence of pharmacological treatment for children and young people and adults with ADHD?

1.2.1. PICO table

For full details see the review protocol in appendix A.

Table 57

PICO characteristics of review question.

1.2.2. Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual.⁴⁷⁴ Methods specific to this review question are described in the review protocol in appendix A.

This review sought to evaluate the clinical and cost effectiveness of the sequence of pharmacological interventions to treat ADHD in people who have previously been either intolerant or non-responsive to pharmacological treatment. Studies were only included if the population had been selected based on previous failed attempt to use any one specific drug (for example all were intolerant to atomoxetine), an exception was made if the population had all failed a previous attempt of the stimulant class. It was noted in each outcome whether the previous treatment was stopped or continued throughout the trial. Previous treatment continued was termed augmentation and previous treatment that was stopped was called substitution.

Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy.

1.2.3. Clinical evidence

1.2.3.1. Included studies (pre-school children: under 5 years of age)

No relevant clinical studies were identified.

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

1.2.3.2. Included studies (children and young people aged 5 to 18)

Six randomised trials across 9 papers were included in the review; ^{139, 197, 206, 207, 257, 349, 378, 470, 691} these are summarised in Table 60 below. Evidence from these studies is summarised in the clinical evidence summary tables below

Table 58

Lisdexamfetamine dimesylate versus placebo for ADHD in Children and Young People (substitute for methylphenidate).

Table 59

Lisdexamfetamine dimesylate versus atomoxetine for ADHD in Children and Young People (substitution for methylphenidate).

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

The study results were not meta-analysed as the sequence of treatments in each study was different.

1.2.3.3. Excluded studies

See the excluded studies list in appendix I.

1.2.3.4. Summary of clinical studies included in the evidence review

Table 60

Summary of studies included in the evidence review.

See appendix D for full evidence tables.

1.2.3.5. Included studies (adults)

One study was included in the review; ¹³⁴ this is are summarised in Table 61 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 69).

See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.

The study compared guanfacine to placebo in people who had a sub-optimal response to CNS stimulants including lisdexamfetamine, amphetamine/dextroamphetamine or methylphenidate.

Table 61

Summary of studies included in the review.

1.2.3.6. Quality assessment of clinical studies included in the evidence review

1.2.3.6.1. Clinical evidence (children under 5)

No evidence was found.

1.2.3.6.2. Clinical evidence (children and young people aged 5 to 18)

Table 62

Clinical evidence summary: Methylphenidate versus placebo for ADHD in children and young people (augmentation of atomoxetine).

Table 63

Lisdexamfetamine dimesylate versus placebo for ADHD in Children and Young People (substitution for methylphenidate).

Table 64

Lisdexamfetamine dimesylate versus atomoxetine for ADHD in Children and Young People (substitution for methylphenidate).

Table 65

Guanfacine AM versus placebo for ADHD in children and young people (augmentation of CNS stimulants).

Table 66

Guanfacine PM versus placebo for ADHD in children and young people (augmentation of CNS stimulants).

Table 67

Clonidine versus placebo for ADHD in Children and Young People (augmentation of CNS stimulants).

Table 68

Risperidone and parent training versus placebo and parent training for ADHD in children and young people (augmentation of methylphenidate).

See appendix F for full GRADE tables.

1.2.3.6.3. Clinical evidence (adults)

Table 69

Clinical evidence summary: guanfacine versus placebo in adults with a sub-optimal response to CNS stimulants (augmentation of CNS stimulants).

1.2.4. Economic evidence

1.2.4.1. Included studies

1.2.4.1.1. 2008 guideline literature

No studies were identified with the relevant comparison for this review.

1.2.4.1.2. Published literature

Seven health economic studies were identified with the relevant comparison and have been included in this review. ^{188,332,221,644,557,395,716} These are summarised in the health economic evidence profiles below (Table 70, Table 71, Table 72, Table 73) and the health economic evidence tables in appendix H.

Two of these studies compare an atomoxetine treatment algorithm with standard care or no treatment in subgroups of children with ADHD who have either failed stimulants, or are averse or contraindicated to them, in keeping with the populations of this sequencing review. Hong 2009³³² is a different version of Cottrell 2008¹⁸⁸ model but is thought to be sufficiently different and is presented as a separate study. Subgroups from these studies that were stimulant naïve are reported in the pharmacological effectiveness review.

Three studies compare types of extended release methylphenidate with immediate release methylphenidate in children who are responding sub-optimally to immediate release methylphenidate because of inadequate medication intake. Van der Schans 2015⁶⁴⁴ and Schawo 2015⁵⁵⁷ are different versions of the Faber 2008²²¹ model but are thought to be sufficiently different and are presented as separate studies.

Lachaine 2016³⁹⁵ compares guanfacine extended release added as an adjunct to long-acting stimulants with long-acting stimulants alone in children who are only partially responding to the stimulants.

Finally Zimovetz 2016⁷¹⁶ compares Lisdexamfetamine with Atomoxetine in children who had an inadequate response to Methylphenidate.

See also the health economic study selection flow chart in appendix G.

1.2.4.2. Excluded studies

No health economic studies that were relevant to this question were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in appendix G.

1.2.5. Summary of studies included in the economic evidence review

Table 70

Health economic evidence profile: [Atomoxetine algorithm versus standard treatment algorithm, or no treatment].

Table 71

Health economic evidence profile: [Extended release methylphenidate versus Immediate release methylphenidate].

Table 72

Health economic evidence profile: [Guanfacine extended release (GXR) + long-acting stimulant versus long-acting stimulant monotherapy].

Table 73

Health economic evidence profile: [Lisdexamfetamine versus Atomoxetine].

Subgroup 3 of the Cottrell¹⁸⁸ study, and the subgroup presented from the Hong³³² study, have similar interventions (atomoxetine followed by no treatment compared to no treatment, and atomoxetine compared to no treatment, respectively), yet they have quite different ICERS. One reason for this is that the cost of atomoxetine in the Hong study, which is European, is around twice the cost atomoxetine in the Cottrell study, which might explain why the incremental cost in Hong is about twice that of Cottrell. One concern the committee had abaout the Cottrell and Hong studies was that the studies assumed atomoxetine did not have an insomnia side effect, which the commitee believed was an underestimate. Had this been included in the Cottrell study, it may have had some effect on the result, but it is uncertain if it would have such a large effect as to increase the ICER above the NICE threshold.

The studies comparing extended release methylphenidate to immediate release methylphenidate all have results showing extended release methylphenidate is cost effective, but they can vary from showing the intervention is dominant to having an ICER of around £10,000. This could be explained by the fact that the Van der Schans and Schawo studies are updating the Faber model and therefore there are some differences between all three studies. Faber for example has different health states for the intervention and comparator arm, whereas Van Der Schans and Schawo do not. In the Faber paper there was no suboptimal state in the comparator arm, instead there was a non-compliance state which had the same costs attached as the optimal state, meaning that there might have been lower costs in the comparator arm in that study leading to a larger incremental cost for consultations and other intervention costs, than in van der Schans. However the incremental medication costs are larger in the Faber model, as MPH OROS is around 5 times more expensive than MPH IR. It is less than 4 times more expensive in the Van der Schans study. Therefore there are many trade-offs taking place affecting the total incremental costs of the studies.

The utilities are from different sources in all the papers, and are much closer together in the Faber study, helping to explain why the incremental QALY is smaller in that study.

The medication costs are lower for the medikinet/Equasym arm compared to MPH OROS and this alongside the savings from the resource use (because more people are ‘optimal’ compared to IR MPH) is why there is a cost saving of £449 in the Van Der Schans study.

In the Schawo paper, the transition probabilities are very different to Faber and Van Der Schans. Transitions that were not in Faber like restarting treatment after it is stopped are included and this is more so in the OROS arm, so there are higher costs of the other interventions aside from medication in the IR MPH arm which are expensive, and could explain the very large cost saving compared to the other studies. There is not a breakdown of total costs in the Schawo paper which might have provided more detail.

1.2.5.1. Unit costs

Please see section 1.1.4.4 for an illustration of the costs of the different medications.

Note that some of the clinical data identified for this question involves adding adjuncts to existing medication rather than changing medication, which would incur higher drug costs.

1.2.6. Resource impact

We do not expect recommendations resulting from this review area to have a significant impact on resources.

1.2.7. Evidence statements

1.2.7.1. Clinical evidence statements

• No quality of life data was found for any age group in this evidence report.
• No clinical evidence was found in the pre-school children age group for any interventions

Methylphenidate versus placebo (augmentation of atomoxetine)

• No clinical difference for discontinuation due to adverse events and serious adverse events (1 study very low quality, children and young people).

Lisdexamfetamine versus placebo (augmentation of CNS stimulants)

• Clinical benefit of lisdexamfetamine dimesylate for a combined ADHD total, inattention and hyperactivity symptoms and CGI-I outcome (1 study very low quality)
• No clinical difference was found for adverse events leading to hospitalisation/death/disability (1 study very low quality, children and young people)

Lisdexamfetamine versus atomoxetine (substitution for methylphenidate)

• Clinical benefit of lisdexamfetamine compared to atomoxetine for investigator rated ADHD total, hyperactivity and inattention symptoms (1 study low quality)
• No clinical difference for discontinuation of treatment due to adverse events or adverse events leading to hospitalisation/death/disability (1 study low quality, children and young people), or behavioural outcomes (1 study moderate quality), and CGI-S (1 study moderate quality, children and young people).

Guanfacine versus placebo

• Clinical benefit of guanfacine for CGI-I (1 study low quality, children and young people)
• Clinical harm of methylphenidate in adverse events leading to hospitalisation/death/disability (1 study very low quality, children and young people)
• No cilinical difference for ADHD total, inattention and hyperactivity symptoms (1 study very low quality, adults), CGI-S (1 study very low quality, adults), discontinuation due to adverse events (1 study very low quality, children and young people) and CGI-S and adverse events leading to hospitalisation/death/disabilities (1 study very low to low quality, adults)

Clonidine versus placebo (augmentation of CNS stimulants)

• No clinicall difference in investigator rated ADHD total, inattention and hyperactivity symptoms and no clinical difference in discontinuing treatment due to adverse events (1 study very low quality, children and young people)

Risperidone and parent training versus placebo (augmentation of methylphenidate)

• In children and young people there was a clinical benefit of risperidone for parent rated and teacher rated ADHD total symptoms (1 study moderate to low quality), parent and teacher rated ADHD inattention symptoms (1 study moderate quality), ODD DSM-IV (parent rated, 1 study low quality)
• In children and young people there was clinical harm of risperidone for teacher and parent rated ADHD hyperactivity symptoms (1 study low to moderate quality)
• No clinical difference for ADHD inattention symptoms (1 study low quality, children and young people) and teacher rated and parent rated behavioural outcomes (2 studies, moderate to very low quality)

1.2.7.2. Health economic evidence statements

• One cost-utility analysis found that for treating ADHD in children:

  –

  In stimulant failed patients, a sequence of Atomoxetine followed by IR-DEX followed by no treatment was cost effective compared to the same sequence without atomoxetine (ICER: £14,945)

  –

  In stimulant averse (exposed) patients, a sequence of atomoxetine followed by IR-MPH (or XR-MPH) followed by IR-DEX followed by no treatment was cost effective compared to the same sequence without atomoxetine (ICER: £15,878 if IR-MPH and £14,169 if XR-MPH)

  –

  In stimulant contraindicated (exposed) patients, a sequence of Atomoxetine followed by no treatment was cost effective compared to no treatment alone (ICER: £12,370)

  This analysis was assessed as partially applicable with potentially serious limitations.
• One cost-utility analysis found that Atomoxetine was cost effective compared to no treatment at a threshold of £30,000 per QALY gained for treating ADHD in children who have failed stimulants, but was not cost effective at a threshold of £20,000 per QALY gained (ICER: £21,528). This analysis was assessed as partially applicable with potentially serious limitations.
• One cost-utility analysis found that OROS MPH was cost effective compared to IR-MPH for treating ADHD in children with sub optimal symptom control from IR-MPH because of incorrect medication intake (ICER: £10,161). This analysis was assessed as partially applicable with potentially serious limitations.
• One cost-utility analysis found that for treating ADHD in children;

  –

  OROS MPH was cost effective compared to IR-MPH in children with sub optimal symptom control from IR-MPH because of poor compliance (ICER: £1,879).

  –

  Medikinet CR/Equasym XL was dominant (less costly and more effective) compared to IR-MPH in children with sub optimal symptom control from IR-MPH because of poor compliance

  This analysis was assessed as partially applicable with potentially serious limitations.
• One cost-utility analysis found that OROS MPH was dominant compared to IR-MPH for treating ADHD in children with sub optimal symptom control from IR-MPH because of incorrect medication intake. This analysis was assessed as partially applicable with very serious limitations.
• One cost-utility analysis found that Guanfacine extended release (GXR) + long-acting stimulant was cost effective compared with long-acting stimulant monotherapy for treating ADHD in children who are partial responders to long acting stimulants (ICER: £13,321). This analysis was assessed as partially applicable with potentially serious limitations.
• One-cost-utility analysis found that Lisdexamfetamine was cost effective compared to Atomoxetine for treating ADHD in children who had an inadequate response to methylphenidate (ICER: £1,586). This analysis was assessed as directly applicable with potentially serious limitations.

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Appendices

Final

Intervention evidence review

These evidence reviews were developed by the National Guideline Centre

Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.

NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.