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.

Results Manufacturer PSPs are the default pathway for people to afford and access high-cost specialty and biologic prescription medicines in Canada. Though they are the only care pathway available, participants experienced support as variably helpful, stressful and superfluous; variable over time and across patients’ experiences; and available at the discretion of the PSP. Across participants, four core themes were identified: (1) patients are required to engage with PSPs in exchange for access; (2) outsourcing supports for access to medicines gives rise to a parallel, private health system, generating additional health system complexity; (3) programs are inherently designed for physicians, thus adoption is prioritised over access; and (4) this results in calculated policy trade-offs and health system and patient risks when depending on manufacturer PSPs for affordable access to medicines.

Conclusions Patients and health systems are precariously dependent on manufacturers to afford and access high-cost, specialty medicines. As a parallel, private care system, there remains little transparency nor patient accountability, with access at the discretion of manufacturers through physician intermediaries. Thus, reliance on pharmaceutical industry resources for affordable access to medicines may incur greater costs for patients and health systems in the longer term. Policymakers need to consider how to design patient-centred, equitable, accountable systems that ensure affordable access to important medicines.