TOWARDS OPTIMIZED CAR-T CELL THERAPY MANAGEMENT: CURRENT OPERATIONAL AND REGULATORY CHALLENGES FROM A PROCESS PERSPECTIVE
Author(s)
Anika Teichert, MSc1, Marija Radic, PhD1, Julia Busch-Casler, PhD1, Catrina Pietralla, MSc2, Jens O. Brunner, PhD2.
1Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany, 2Technical University of Denmark, Copenhagen, Denmark.
1Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany, 2Technical University of Denmark, Copenhagen, Denmark.
OBJECTIVES: Cell and gene therapies are among the most expensive therapies within the healthcare sector. Systematic reviews of economic evaluations of CAR-T therapies for cancer treatment show that they tend to be more costly, but also more effective than comparable treatments. As their use increases, optimizing the CAR-T therapy management process is necessary to reduce the diagnosis to treatment time (turnaround process). This reduces therapy manufacturing time and associated costs, thereby facilitating better access for patients.
METHODS: We conducted 17 semi-structured interviews between July 2025 and February 2026 with clinicians, pharmacists, laboratory staff, and CAR-T coordinators from Germany, Ireland, and Spain. Based on the findings, we map the CAR-T cell therapy process using Business Process Model and Notation to identify process-related challenges and critical interfaces.
RESULTS: We derive ten challenges with potential for optimization along the CAR-T therapy process: 1. Limited patient access to CAR-T therapies driven by policy constraints and high one-time treatment costs, 2. Lack of digitization combined with high process complexity, 3. Complex, multifactorial decision-making regarding treatment, coupled with uncertainty about treatment funding, 4. Apheresis and reinfusion steps as bottlenecks due to limited bed and staffing capacity and manufacturer-specific requirements, 5. Long manufacturing cycles due to complex quality controls and error-prone logistics processes, 6. Patients' health conditions deteriorate due to long manufacturing cycles, 7. Lack of standardization across products and manufacturers, 8. High patient burden throughout entire process due to mostly inpatient set-up and stringent regulations during monitoring, 9. Adverse events lead to “revolving door effect” between outpatient care and inpatient stays at the CAR-T center, 10. Stringent regulation leads to delays in treatment and constrained access.
CONCLUSIONS: This study identifies critical challenges in the CAR-T cell therapy process. Our findings structure the complexity of the treatment pathway emphasizing the need for targeted optimization to enhance efficiency, accessibility and reduce costs.
METHODS: We conducted 17 semi-structured interviews between July 2025 and February 2026 with clinicians, pharmacists, laboratory staff, and CAR-T coordinators from Germany, Ireland, and Spain. Based on the findings, we map the CAR-T cell therapy process using Business Process Model and Notation to identify process-related challenges and critical interfaces.
RESULTS: We derive ten challenges with potential for optimization along the CAR-T therapy process: 1. Limited patient access to CAR-T therapies driven by policy constraints and high one-time treatment costs, 2. Lack of digitization combined with high process complexity, 3. Complex, multifactorial decision-making regarding treatment, coupled with uncertainty about treatment funding, 4. Apheresis and reinfusion steps as bottlenecks due to limited bed and staffing capacity and manufacturer-specific requirements, 5. Long manufacturing cycles due to complex quality controls and error-prone logistics processes, 6. Patients' health conditions deteriorate due to long manufacturing cycles, 7. Lack of standardization across products and manufacturers, 8. High patient burden throughout entire process due to mostly inpatient set-up and stringent regulations during monitoring, 9. Adverse events lead to “revolving door effect” between outpatient care and inpatient stays at the CAR-T center, 10. Stringent regulation leads to delays in treatment and constrained access.
CONCLUSIONS: This study identifies critical challenges in the CAR-T cell therapy process. Our findings structure the complexity of the treatment pathway emphasizing the need for targeted optimization to enhance efficiency, accessibility and reduce costs.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HSD62
Topic
Health Service Delivery & Process of Care
Disease
Oncology