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Pain Points In Bispecific Operationalization

Opinion
Video

An expert panel unpacks challenges in implementing bispecific therapies for operational excellence.

The following is a video synopsis/summary of a Peer Exchange involving Ryan Haumschild, PharmD, MS, MBA, CPEL; Kirollos Hanna, PharmD, BCPS, BCOP, FACCC; Sarah Rockwell, PharmD, BCOP; Melody Chang, RPh, MBA, BCOP; and Ryan Cain, PA-C.


Experts discuss the challenges and pain points associated with operationalizing bispecific antibodies within a healthcare organization. Ryan Cain, PA-C, emphasizes the importance of addressing the transitions of care, particularly in the relationship between the organization and local hospitals. The strain between inpatient and outpatient care poses difficulties that need careful management.

One significant challenge highlighted is the unpredictability of toxicities associated with bispecifics. While predictions can be made, the variability over time may lead to patients requiring hospitalization at any moment. This unpredictability necessitates substantial efforts in managing these patients, making it a significant operational hurdle.

Another notable obstacle is the fear factor among clinics unfamiliar with the therapy, typically initiated in academic centers. As the therapy transitions to community settings, there is a considerable unknown for providers who have not directly dealt with the associated toxicities. Overcoming this fear becomes a crucial pain point in advancing the implementation of bispecific antibodies.

Guidelines and requirements also add complexity, with uncertainty regarding the necessity of hospitalization based on the REMS program. Some centers, with varying experiences, may not require extended hospitalizations, leading to site-specific challenges. Developing protocols suitable for specific settings requires collaboration and agreement among decision-makers, presenting another operational challenge.

Study design, particularly the disparity between studies conducted in academic centers and real-world community settings, is identified as a pain point. The pharmaceutical company's setup may not seamlessly translate into practical applications, burdening community and rural settings with additional requirements.

Financial considerations, including billing and coding complexities, the presence of a J code for reimbursement, and the overall cost of the drug, add to the challenges. Smaller community centers face a financial burden, requiring seamless integration for long-term viability.

In conclusion, Mr. Cain summarizes the massive undertaking of introducing a new therapy with unique toxicities to an entire healthcare system. The need for multidisciplinary care and an operational champion to navigate these challenges is emphasized, recognizing the essential role in ensuring successful implementation. The comprehensive discussion extends beyond academic settings, acknowledging the involvement of the community in therapies for various medical conditions.

Video synopsis is AI-generated and reviewed by AJMC editorial staff.

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