OBJECTIVES: To review the evolution of Patient Support Programs (PSPs) - with immuno-oncology as a case study - and assess the extent to which competition has expanded patient access.

METHODS: This study reviewed the PSPs administered by the 6 approved immuno-oncology agent manufacturers. The following PSP offerings were evaluated: Coverage and Reimbursement Support, IV Oncology Support Program Enrollment Process, IV Oncology Patient Copay Support Programs, IV Oncology PSP Benchmarking, IV Replacement Programs. Analysis focused on the change in Keytruda and Opdivo’s PSP eligibility requirements and access barriers between 2015 and 2019. This was then compared to the PSP offered by Libtayo, the most recently approved immunotherapy.

RESULTS: While analyzing immuno-oncology PSPs, trends emerged indicating changes over time as well as across PSPs. Findings demonstrated that over the years, PSPs have been remodeled to increase access through efforts such as reducing stringent eligibility requirements. For example, Keytruda extended the submission deadline for Explanation Of Benefits (EOB) documents provided by insurance companies from 90 days to 180 days between 2015 and 2019. Additionally, analysis showed a decrease in patient co-payment of $50 to $25 from 2015 to 2019. This trend to reduce access barriers remains consistent across new and existing competitor PSP offerings.

CONCLUSIONS: Given the expanding market of immuno-oncology agents, it is critical for pharmaceutical manufacturers to explore ways in which to differentiate themselves. PSPs serve as a concreate example of how the competitive pharmaceutical landscape may be improving access for patients.