Implications of relying on manufacturer patient support programs for access to high-cost specialty and biologic medicines: a critical qualitative study

Objectives Pharmaceutical manufacturers routinely launch high-cost, specialty medicines, including biologics and biosimilars, with an accompanying patient support program (PSP). PSPs offer patients financial support, case management and clinical services to facilitate access to the promoted medicine.

Because these programs are proprietary, there is little publicly available information, thus, this study aimed to generate in-depth understandings of the patient, health system and policy-level implications of relying on manufacturer PSPs for affordable access to high-cost medicines. Design Qualitative, critical ethnographic study conducted from November 2023 to April 2025.

We conducted an interpretive, thematic analysis, triangulating fieldnotes (40 hours observations at public events), semistructured in-depth interview transcripts (n=48 interviews with 52 participants) and documents (ie, policies, media, reports). Setting This study examined direct experiences with manufacturer PSPs across Canada.

PSPs have proliferated in Canada as the universal public health insurance scheme does not cover outpatient prescription drugs or infusion services. Participants A purposive sample of 52 participants with direct experience of pharmaceutical industry PSPs, including patients prescribed specialty medicines, clinicians, pharmaceutical industry and PSP provider employees, payers and policymakers.