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BRIEF RESEARCH REPORT

J. Pharm. Pharm. Sci.

Volume 28 - 2025 | doi: 10.3389/jpps.2025.14587

This article is part of the Special IssueVolume 2: Real World Evidence (RWE): Paths to Enhancing Patient Access to New MedicationsView all 4 articles

A Review to Determine Regulatorily and Reimbursement Successes of Studies

  • Consultant, Toronto, Canada

The final, formatted version of the article will be published soon.

Introduction: Patient Support Programs (PSPs) are g r o w i n g g l o b a l l y t o s u p p o r t e a r l y r e i m b u r s e m e n t , d i s e a e a s e a n d d o s i n g m a n a g e m e n t proliferating in managing complex diseases and 65 challenging dosing administrations globally. In Canada, the lack of public health support has 76 promoted the rapid rise of company-supported disease-specific or drug-product-specific PSPs. 87 Data collected from tThese programs g e n e r a t e u n i q u e C a n a d i a n d a t a could servinge as a source of real-world data (RWD), widely adopted in Europe and the US for evidence generation. This review 98 evaluates the suitability for regulatory or reimbursement submissions of PSP data, based on recently published Real World Evidence guidelines by the Canadian Drug Agency (CDA-AMC).Methods: Peer-reviewed publications evaluating patients with chronic diseases enrolled in a PSP from January 1, 2020, to March 31, 2025, were selected for review. The checklist in the CDA-AMC RWE Guideline was used to measure the quality and suitability of the PSP data for regulatory or reimbursement submissions.Results: Nine studies were reviewed against the checklist.

Keywords: Regulatory, Patient-support-program(PSP), Canada's-Drug Agency CDA-AMC, RWE-checklist, Health Canada

Received: 05 Mar 2025; Accepted: 23 Jul 2025.

Copyright: © 2025 Lau. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Catherine Y Lau, Consultant, Toronto, Canada

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.