Cellular Therapy: Recommendations for Developing a Cell Therapy Program

Cellular therapy treatment has been around for 50 years, getting its start with hematopoietic stem cell transplant bone marrow transplant (HSCT) as the treatment of blood cancers. In 2017, a new type of treatment called Chimeric Antigen Receptor T-cell (CAR-T) therapy, has been effective for many patients with far advanced relapsed and refractory blood cancers, and may be used increasingly in the future to supplant BMT. CAR-T uses a patient’s reengineered T-cells to seek and destroy cancer cells in the patient’s body. UPHS, like many other established BMT centers, had to prepare by building the infrastructure to onboard these therapies.  Development of a CAR-T therapy infrastructure has created issues that were unique from BMT, including the high dollar cost of the therapy that puts increased risk on centers when delivering this care to patients.

CAR-T therapy has unique operational and economic challenges that can impact a center’s interest to offer these treatments. Those challenges include training, auditing, site of care, infrastructure development, FACT accreditation, unique patient-care concerns, and most importantly, cost and reimbursement of the therapy. Assessing the business plan of a medical center offering CAR-T may require senior leadership approval to start a program.  

For inexperienced centers that want to offer CAR-T, we found the best approach was to have representation from finance, operations, IT (for EMR integration of the therapy), and clinicians in meetings to develop workflows for the entire episode of care. The problem when doing this has been that each department develops their workflow, may or may not incorporate their part into the EMR, which ultimately does not provide the complete operational picture of delivering this care.Our solution, and one we would recommend, is to develop a complete operational process map of episode of care. From identification of patients, to who has what responsibility in the process, purchase order generation and reconciliation, inpatient and outpatient treatment, toxicity management, to what data points should be collected (for reporting purposes) are examples of the level of detail in the process map put that UPHS put together for the purpose of integrating these details throughout the EMR. 

The process map also became a blueprint for how the hospital intended to operationalize CAR-T and served as the template for developing a pro forma that determined year one startup costs.As a result, the hospital was able to determine their year one costs only required hiring a cell therapy coordinator (RN) to start.

"Putting together a good plan can be the difference between success or failure of a cell therapy program. Having all departments collaborate on a comprehensive operational plan will help to determine the best approach for onboarding this type of treatment​"

UPHS developed this method as we worked with a community hospital with no experience with either CAR-T or BMT. The project started in August of 2021 and was completed in May of 2022, 9 months of effort. The net result was that UPHS successfully expanded its cell therapy program to another hospital in its system. Patient number one at the community hospital was infused with CAR-T in the outpatient setting, closer to their home. As a result of this success, the community hospital is now ready to onboard more therapies, has been recognized by the pharmaceutical companies as a possible site to offer cell therapy research, and is in position to also offer other novel therapies such as bispecific antibodies (as they are now familiar with toxicity management). We believe bringing these novel therapies into the community will now provide access to highly effective treatments to many more patients who previously could not or would seek care at the major academic institutions. 

Putting together a good plan can be the difference between success or failure of a cell therapy program. Having all departments collaborate on a comprehensive operational plan will help to determine the best approach for onboarding this type of treatment.