Ethics approval and consent to participate
This study was performed in accordance with legal and regulatory requirement, and followed research practices for retrospective observational studies, consistent with the Declaration of Helsinki, International Confederation on Harmonization Good Clinical Practice Guidelines, and Good Publication Practice recommendations, and applicable legislation on Non-Interventional Studies and/or Observational Studies. Based on US federal regulations (45 CRF 46.104 – Exempt Research), this study was exempt from Institutional Review Board approval and patient informed consent because it was retrospective, non-interventional, and used de-identified, fully Health Insurance Portability and Accountability Act compliant data from The Optum Market Clarity Dataset.
Consent for publication
Not applicable
Availability of data and materials
The data that support the findings of this study are available from Optum, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of Optum.
Competing interests
MEB is an employee of Benofit Consulting PTY LTD, Brisbane, Australia and has received consulting fees from Travere Therapeutics, Inc. and Amgen, Inc. KMT has a consulting contract with Travere Therapeutics, Inc. and does not have any equity interest in Travere Therapeutics, Inc. EVL received consulting fees from Travere Therapeutics, Inc. and has received payments as a speaker/advisory board member for Akebia/Otsuka, Astra Zeneca, Bayer, Glaxo Smith Kline, Otsuka, Travere Therapeutics, Inc., and Vifor, as a steering committee member for Bayer, and has received royalties from Elsevier, McGraw-Hill, Springer, and Wolters Kluwer. RL received consulting fees from Travere Therapeutics, Inc. CMB was an employee of Travere Therapeutics, Inc. for 3 years and is now a consultant for Travere Therapeutics, Inc and has stock shares. KW was an employee and stockholder of Travere Therapeutics, Inc. at the time that the study was being conducted. WG is a stockholder and an employee of Travere Therapeutics, Inc. ARR, MVM, DO, and DTA are employees of Genesis Research (Hoboken, NJ, USA) which received compensation from Travere Therapeutics, Inc. for design and conduct of this study. DMWC was an employee of Genesis Research at the time the study was conducted. JCQV received consultation fees from Travere Therapeutics, Inc., Calliditas, Mallinckrodt Pharmaceuticals and Bayer Pharmaceuticals.
Funding
Travere Therapeutics, Inc. funded this study and approved submission of this report for publication. EVL received consulting fees from Travere Therapeutics, Inc. MEB is the Managing Director of BenofitConsulting which received consulting fees from Travere Therapeutics, Inc; KMT has a consulting contract with Travere Therapeutics, Inc. and does not have any equity interest in Travere Therapeutics, Inc.; RL received consulting fees from Travere Therapeutics, Inc.; CMB is a consultant for Travere Therapeutics, Inc.; KW is a stockholder and former employee of Travere Therapeutics, Inc.; WG is a stockholder and an employee of Travere Therapeutics, Inc.; DO, ARR, DTA, and MVM are employees of Genesis Research which received compensation from Travere Therapeutics, Inc.; DMWC was an employee of Genesis Research (Newcastle upon Tyne, UK) at the time the study was conducted; JCQV received consulting fees from Travere Therapeutics, Inc.
Authors' contributions
Research idea and study design: MEB, KMT, MB, KW, WG, DTA, DO, ARR, DC; data acquisition: MEB; data analysis/interpretation: MEB, KMT, EVL, JCQV, RL, MB, KW, WG, MVM, DO, ARR; statistical analysis: KW, WG, DO, MVM; supervision or mentorship: EL, JCQV, DTA, DC. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved.
Acknowledgements
A subset of these findings was presented as a poster at the ISPOR US Conference in 2022.