Operationalizing Access for Chimeric Antigen Receptor T cell Therapies: A Cross-functional Perspective.

Chimeric antigen receptor T cell (CAR T) treatment efficacy has been shown to be greater in those who receive timely infusions, while mortality rates increase with each month's delay in treatment. Yet health care infrastructure constraints, an intricate treatment process, and reimbursement complexities present challenges that affect timely patient access to CAR T therapy. Best practices for decreasing time to treatment are not well established. Autolus Inc convened an expert panel of 3 advisors from established hematopoietic stem-cell transplant centers and 3 advisors with extensive national or regional payer experience to identify operational barriers that contribute to treatment delays as well as potential means for addressing them. Opportunities exist to expand treatment capacity by reducing redundant prerequisites for treatment center certification and through collaboration between established centers and newer centers that need critical expertise to gain accreditation. Aligning clinical criteria are important for improving clinician understanding of the treatment process, facilitating timely referral to treatment centers, and streamlining payer authorization processes. Negotiating financial arrangements is the most time-consuming step of the process before CAR T manufacturing can begin; contracts between treatment centers and payers can help to facilitate timely care, but single-case agreements are necessary for treatment centers and payers without extensive CAR T experience. Single-case agreements should consider each side's experience and financial exposure. In identifying obstacles to timely care and working through potential solutions, participants developed a genuine appreciation for the interdependence among stakeholders. Recognition of mutual interest is a starting point for cross-functional cooperation.