Costs associated with adverse events during treatment episodes for adult attention-deficit/hyperactivity disorder

Abstract

Objective

Attention-deficit/hyperactivity disorder (ADHD) medication is frequently associated with adverse events (AEs), but limited real-world data exist regarding their costs from a payer’s perspective. Therefore, this study evaluated the healthcare costs associated with common AEs among adult patients treated for ADHD in the US.

Methods

Eligible adults treated for ADHD were identified from a large US claims database (1 October 2015–30 September 2021). A retrospective cohort study design was used to assess excess healthcare costs and costs directly related to AE-specific claims per-patient-per-month (PPPM) associated with 10 selected AEs during ADHD treatment. To account for all costs associated with the AE, treatment episodes with a given AE were compared to similar treatment episodes without this AE. Entropy balancing was used to create cohorts with similar characteristics. Studied AEs were selected based on their prevalence in clinical trials for common ADHD medications and were identified from ICD-10-CM diagnosis codes recorded in claims.

Results

Among the 461,464 patients included (mean age: 34.2 years; 45.5% males), 49.4% had ≥1 AE during their treatment episode. Treatment episodes with AEs were associated with statistically significant AE-specific medical costs (erectile dysfunction: $57; fatigue: $82; dry mouth: $90; diarrhea: $162; insomnia: $147; anxiety: $281; nausea: $299; constipation: $356; urinary hesitation: $491; feeling jittery: $723) and excess healthcare costs PPPM (erectile dysfunction: $120, fatigue: $248, insomnia: $265, anxiety: $380, diarrhea: $441, dry mouth: $485, nausea: $709, constipation: $802, urinary hesitation: $1,105, feeling jittery: $1,160; p < .05).

Limitations

AEs were identified based on recorded diagnosis on medical claims and likely represent more severe AEs. Therefore, costs may not be representative of milder AEs.

Conclusions

This study found that AEs occurring during ADHD treatment episodes are associated with significant healthcare costs. This highlights the potential of treatments with favorable safety profiles to alleviate the burden experienced by patients and the healthcare system.

Keywords:

• Attention-deficit/hyperactivity disorder
• ADHD
• economic burden
• adverse events
• treatment episode
• ADHD treatment

JEL CLASSIFICATION CODES:

• I11
• I1
• I
• I19

Transparency

Declaration of funding

This study was funded by Otsuka Pharmaceutical Development & Commercialization, Inc. The study sponsor was involved in several aspects of the research, including the study design, interpretation of data, writing of the manuscript, and decision to submit the manuscript for publication.

Declaration of financial/other relationships

JS is an employee of Otsuka Pharmaceutical Development & Commercialization, Inc. MC, RB, and MGL are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Otsuka Pharmaceutical Development & Commercialization, Inc. AC received research support from Allergan, Emalex, Akili, Cingulate, Corium, Lumos, Neurocentria, Otsuka, Purdue, Adlon, Sunovion, Tris, KemPharm, and Supernus; was on the advisory board of Corium, Otsuka, Tris, and Supernus; received consulting fees from Aytu, Cingulate, Corium, Lumos, Neurocentria, Noven, Otsuka, Tris, KemPharm, Supernus, and Tulex; received speaker fees from Takeda, Corium, Ironshore, Tris, and Supernus; and received writing support from Otsuka, Takeda, Corium, Ironshore, Purdue, and Tris. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors have made substantial contributions to the conception or design of the study, or the acquisition, analysis, or interpretation of data, drafting the manuscript and revising it critically for important intellectual content, and have provided final approval of this version to be published and agree to be accountable for all aspects of the work.

Acknowledgements

Medical writing assistance was provided by professional medical writer, Roxanne Wosu, MASc, an employee of Analysis Group, Inc., and was funded by Otsuka Pharmaceutical Development & Commercialization, Inc.

Data availability statement

The data that support the findings of this study are available from PharMetrics Plus, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available.

Ethics statement

Data were de-identified and comply with the patient requirements of the Health Insurance Portability and Accountability Act (HIPAA) of 1996; therefore, no review by an institutional review board was required per Title 45 of CFR, Part 46.101(b)(4) (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.101).

Previous presentations

Part of the material in this manuscript was presented at the American Professional Society of ADHD and Related Disorders (APSARD) 2024 conference held 18–21 January 2024, in Orlando, FL as a poster presentation.