Understanding treatment patterns and patient-reported outcomes associated with the use of authorized generics and corresponding independent generics across multiple therapeutic areas

Abstract

Objectives

To assess patient characteristics, treatment patterns, and patient-reported outcomes (PROs) associated with authorized generics (AGs) and independent generics (IGs) use.

Methods

Prescription claims and National Health and Wellness Survey (NHWS) data were linked. Adults with billable national drug code (AG or IG), NHWS completion from June 2015 to July 2019, AG or IG on-hand at NHWS completion, and continuous insurance eligibility in 12 months pre- and post-NHWS completion were included. To be included, all unique medication formulations had to have at least one AG and one IG observation. PRO index date was NHWS completion; claims index date was defined as the first prescription claim identified during the 180-day period prior to NHWS completion for the same active ingredient and formulation type that was on-hand at NHWS completion.

Results

Patients (N = 20,229; 17.2% AG users) in six therapeutic areas (attention deficit-hyperactivity disorder [ADHD], antidepressants, beta blockers [BBs], calcium channel blockers [CCBs], statins, and thyroid) were included. Generally, AG (vs. IG) users were younger and differed in regional access and insurance type (all, p < .05). In multivariable analysis, significant differences were observed for presenteeism and overall work impairment (BBs), healthcare provider visits (BBs), and indirect costs (thyroid) (all, p < .05). AG and IG users differed in persistence (ADHD and statins; both, p < .05) and switch (BBs and CCBs; both, p < .01) rates.

Conclusions

PRO differences were often small in magnitude and varied by therapeutic area. The impact of switching should consider observed PRO differences, patient preferences, and market availability of AG and IG alternatives.

Keywords:

• Authorized generics
• costs
• generic medications
• healthcare resource utilization
• patient-reported outcomes
• treatment patterns

Transparency

Declaration of funding

This study was sponsored by Upjohn, formerly a division of Pfizer, and now part of Viatris. The sponsor’s role in study design, collection, analysis, and interpretation of data, writing of the manuscript, and the decision to submit the manuscript for publication was limited to the involvement of manuscript authors who are employees of the sponsor.

Declaration of financial/other relationships

Dr. Alderfer is an employee and stockholder of Pfizer and was an employee of Viatris, formerly Upjohn, a division of Pfizer, at the time the study was conducted; Dr. Alderfer also declares stock ownership for Viatris, formerly Upjohn, a division of Pfizer. Dr. Alvir is an employee and stockholder of Pfizer and also declares stock ownership for Viatris. Dr. Cook is an employee and stockholder of Viatris, formerly Upjohn, a division of Pfizer, and also declares stock ownership for Pfizer. Dr. Gilchrist is an employee and stockholder of Viatris, formerly Upjohn, a division of Pfizer, and also declares stock ownership for Pfizer, Bristol Myers Squibb, AstraZeneca, GlaxoSmithKline, and Gilead. Dr. Maculaitis is an employee of Cerner Enviza, formerly Kantar Health, which received funding from Upjohn, formerly a division of Pfizer, and now part of Viatris, for conducting and reporting on the study. Dr. Thompson is an employee of Cerner Enviza, formerly Kantar Health, which received funding from Upjohn, formerly a division of Pfizer, and now part of Viatris, for conducting and reporting on the study.

A portion of the results reported on in this manuscript was presented at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting, which was held virtually on April 12–16, 2021.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

JA: Conceptualization, Methodology, Writing—Review and Editing, Supervision, Project Administration, Funding Acquisition; JMJA: Conceptualization, Methodology, Writing—Review and Editing; JPC: Conceptualization, Methodology, Writing—Review and Editing; Kim Gilchrist: Conceptualization, Methodology, Writing—Review and Editing; MCM: Conceptualization, Methodology, Writing—Original Draft, Supervision, Project Administration; JT: Conceptualization, Methodology, Formal Analysis, Writing—Review and Editing. All authors have read and approved this manuscript.

Acknowledgements

Support with statistical analysis was provided by Austin Yue, MS, and Vicky Li, MPH, of Kantar Health, New York, NY, which was funded by funded by Upjohn, formerly a division of Pfizer, and now part of Viatris. Medical writing support was provided by Ashwini Atre, PhD, of Indegene Pvt. Ltd, Bangalore, India, which was funded by funded by Upjohn, formerly a division of Pfizer, and now part of Viatris.