Evaluating unmet needs in large-volume subcutaneous drug delivery: U.S. payer perspectives on a novel, large-volume on-body delivery system.

Existing healthcare systems face finite resource allocation and budgetary constraints, resulting in a substantial need for innovative solutions to enhance service delivery at reduced costs. A novel, user-friendly on-body delivery system (OBDS) was developed which enables administration of large-volume subcutaneous (SC) drugs in both clinical and home-based settings (at-home HCP administration or at-home self-administration). This research sought to evaluate the potential economic impact of at-home self- or HCP- administration with the OBDS through a comprehensive review of published literature and semi-structured interviews with 17 US payers representing approximately 227 million covered lives. Published literature on OBDS remains limited, but available research highlights the cost-savings of SC administration due to reduced healthcare resource utilization, particularly with home-based care) and improved patient compliance. In interviews, payers identified several attributes that would help address unmet clinical and economic needs. Clinically, the hidden needle and ease-of-use compared to SC syringe pumps was deemed valuable to improve patient compliance and, as OBDS required minimal training, reduce the risk of administration errors. The flexibility to administer drugs at home (self-administration or HCP-administration) or in-clinic was identified as the most impactful attribute on coverage decision making as it has the greatest potential to reduce costs associated with healthcare practitioner administration for several therapeutic areas. Given the ability to help address critical unmet needs for the patient and healthcare system, a large proportion of the payers stated that the novel OBDS would warrant a price premium versus the cost of the standalone SC vial and certainly over the IV counterpart. Future research to quantify the value that OBDS efficiencies could bring to healthcare delivery are warranted.