Healthcare is undergoing a transformative shift, largely driven by the growing utilization of biologic therapies. While biologics have significantly advanced the treatment of complex and chronic diseases, their high costs have introduced considerable financial strain on both healthcare systems and patients. The creation of biosimilars, agents that are highly similar to their branded reference biologics, have emerged as a promising solution. They offer substantial cost savings and increased patient access without compromising therapeutic efficacy. However, the widespread adoption of biosimilars has been hindered by several challenges, including complex regulatory pathways, evolving reimbursement models, inventory management issues, and payer-imposed restrictions.
Developing and implementing a biosimilar formulary presents unique challenges that Pharmacy and Therapeutics (P&T) Committees have not traditionally encountered. This project was initiated with two primary objectives. The first objective is to establish a systematic process for evaluating both current and future biologic agents in order to develop and maintain a comprehensive formulary for the health system. To achieve this, a structured evaluation framework was created, encompassing key considerations such as drug availability, acquisition cost, site of care, reimbursement pathways, payer policies, and patient access. The data collected through this framework is then analyzed and synthesized into a biologics formulary. Unlike traditional formularies, which often designate a single preferred agent, this biologics formulary ranks the reference product and its biosimilars by site of care, enabling more nuanced and context specific decision making.
The second objective is to implement a standardized workflow that integrates formulary based decision making into clinical practice seamlessly, with no disruption to patient care. To accomplish this, a multidisciplinary team of clinical providers, prior authorization coordinators, and reimbursement specialists collaborates to operationalize the formulary. This integrated approach ensures that the most clinically and economically appropriate agent is selected, balancing the needs of both the health system and the patient.
Looking at biologic invoices for the cancer center with actionable products from September 1, 2025 to March 30, 2026, a total of 963 units were purchased equaling a total of $890,795.56. Reference products accounted for $261,456.22 of the total with only 109 units purchased. Even though the quantity of biosimilars purchased was initially greater than expected, there was a lack of consistency in ordering prior to initiating the formulary, creating missed opportunity for selecting the preferred product with the most reimbursement. Based on the same purchasing data, if all products were switched to the most preferred biologic, it is estimated to have saved a total of $496,625.04. The totals excluded biologics that did not have available biosimilars.
Implementing a biologic formulary has the potential to generate considerable savings and reimbursement. The creation and maintenance of the formulary was without significant challenge. However, the implementation into patient care did have a few setbacks. Most notably there were multiple instances where the most preferred product could not be selected due to insufficient quantities available for purchase, forcing the decision to choose the next best product with reliable stock to not delay patient treatment. There are also instances where patient preference for convenience outweighs the transition to the preferred biosimilar. The majority of implementation of the biosimilar formulary remains at initiation of a new start to therapy, with a few patients transitioning to the preferred biosimilar at the time of insurance authorization renewal. Despite the few setbacks, the initial data are reassuring to confirm the potential of cost savings and maximizing reimbursement to lower financial burden on both the health system and patients.
