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Article History

Received: 1 July 2024

Accepted: 14 May 2025

First Online: 29 May 2025

Declarations

:

: The study has been conducted in accordance with International Society for Pharmacoepidemiology guidelines for Good Pharmacoepidemiology Practices and applicable regulatory requirements, including the French Data Protection Agency (Commission Nationale de l’Informatique et des Libertés– CNIL) opinion n°2018 − 257 of June 7, 2018 on regulatory requirements and governance for processing PMSI data under expedited regulatory process (MR-006– see https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000037187571). This study was carried out in compliance with the principles set in the Helsinki Declaration. As per MR-006 process, this study only uses secondary data from claims database, qualifying as research not involving human subjects and thus no informed consent or review by an ethics committee is required. Studies carried out using PMSI data must be audited to ensure their compliance with authorized purposes. Also, a collective information note has been added to both stève consultants and BMS websites for this purpose. This information specifies that data subjects have rights of access, rectification and opposition on their data, which may be exercised by contacting the director of the organization managing the compulsory health insurance scheme to which they belong.

: Not applicable– as per MR-006 process.

: SR reports receiving fees from Medtronic, Intuitive Surgical, Astra-Zeneca, BMS and BD/BARD for consulting activities. CC reports receiving honoraria from AstraZeneca, Boehringer Ingelheim, Clovis, GlaxoSmithKline, Hoffman-La Roche, Lilly, Pfizer, BMS, MSD, Novartis, Accord Healthcare, Sandoz, Janssen, Takeda, Sanofi, Pierre Fabre and Amgen for congress participation, communications, training and research work. PDI, FB and SB are employees of stève consultants– a Cytel company– that has been contracted to conduct this study. PC, MC, AFG and FEC are employees of Bristol Myers Squibb.