Abstract
Background: Attempts to estimate the cost effectiveness of attention-deficit hyperactivity disorder (ADHD) treatments in the past have relied on classifying ADHD patients as responders or non-responders to treatment. Responder status has been associated with a small gain in health-related quality of life (HR-QOL) [or utility, as measured using the generic QOL measure EQ-5D] of 0.06 (on a scale from 0 being dead to 1.0 being full health).
Objectives: The goal of the present study was to develop and validate several ADHD-related health states, and to estimate utility values measured amongst the general public for those states and to re-estimate utility values associated with responder status.
Methods: Detailed qualitative interview data were collected from 20 young ADHD patients to characterize their HR-QOL. In addition, item-by-item clinical and HR-QOL data from a clinical trial were used to define and describe four health states (normal; borderline to mildly ill; moderately to markedly ill; and severely ill). ADHD experts assessed the content validity of the descriptions. The states were rated by 100 members of the UK general public using the time trade-off (TTO) interview and visual analog scale. Statistical mapping was also undertaken to estimate Clinical Global Impression-Improvement (CGI-I) utilities (i.e. response status) from Clinical Global Impression-Severity (CGI-S) defined states. The mapping work estimated changes in utilities from study baseline to last visit for patients with a CGI-I score of ≤2 or ≤3.
Results: The validity of the four health states developed in this study was supported by in-depth interviews with ADHD experts and patients, and clinical trial data. TTO-derived utilities for the four health states ranged from 0.839 (CGI-S state ‘normal’) to 0.444 (CGI-S state ‘severely ill’). From the mapping work, the change in utility for treatment responders was 0.19 for patients with a CGI-I score of ≤2 and 0.15 for patients with a CGI-I score of ≤3.
Conclusions: The present study provides utilities for different severity levels of ADHD estimated in a TTO study. This approach provides a more granular assessment of the impact of ADHD on HR-QOL than binary approaches employed in previous economic analyses. Change in utility for responders and non-responders at different levels of CGI-I was estimated, and thus these utilities may be used to compare health gains of different ADHD interventions.
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The study was funded by Shire Pharmaceuticals, which develops and markets treatment for ADHD. PH and HE are employees and stockholders of Shire Pharmaceuticals. RS was an employee of Shire Pharmaceuticals when the research was undertaken. All three contributed to the conduct of the study, including interpretation of the data, and preparation, review, and approval of the manuscript. AL and AN are employees of Oxford Outcomes, and this company was paid a fixed fee to undertake the study. PF, JB, and RA are all employees of the University of Sheffield who were also paid a fixed fee for their contribution to the study. ESB has received consultancy payments and honoraria from Shire Pharmaceuticals.
AL directed the study, developed the methodology, and took the lead in writing the manuscript. PH conceived the need for the study, contributed to the study throughout, and co-wrote the manuscript. RS contributed to the study methodology throughout and contributed to the manuscript. RA provided a considerable degree of conceptual input at the start of the study and helped to interpret the study findings. ESB provided expert insight into how HR-QOL is affected in ADHD. He also co-wrote large parts of the paper. AN was instrumental in the development of the qualitative study design and planning for analysis. She also co-wrote parts of the manuscript. PF undertook the statistical mapping work. JB contributed to the conception of the study, helped develop the health states, supported the mapping work, and helped co-write parts of the paper.
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Key points for decision makers
• Previous assessments of the cost effectiveness of treatments for ADHD have often relied upon a binary classification of patients as responders or non-responders
• The current work was designed to provide utility estimates reflecting different levels of severity of the patient’s symptoms
• The estimated utility values may offer improved sensitivity and specificity for economic evaluations
• Utilities for responder and non-responder health states were also estimated to provide compatibility with previous economic evaluations
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Lloyd, A., Hodgkins, P., Sasane, R. et al. Estimation of Utilities in Attention-Deficit Hyperactivity Disorder for Economic Evaluations. Patient-Patient-Centered-Outcome-Res 4, 247–257 (2011). https://doi.org/10.2165/11592150-000000000-00000
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DOI: https://doi.org/10.2165/11592150-000000000-00000