Assumptions & Limitations

Clinical

• Bridging rates for Product B Indications 1 and 2 as well as Product A Indication 1 are based on clinical trial evidence (Abramson et al 2020, Abramson et al 2023, Otero et al 2023) while Product A Indication 2 is based on real world evidence (Hansen et al 2023). In addition, default bridging rates for Indication 1 transplant eligible and ineligible patients (58%) are based on the average of the TRANSFORM (63%; Abramson et al 2023) and PILOT Trials (52%; Sehgal et al 2022). Bridging rates in the real world may differ.
• The bridging regimens were based on clinical trial evidence for Product B and Product A. The type of bridging therapy may vary in the real-world as well as by indication. The proportion of patients receiving each type of bridging therapy was based on clinical trial evidence (except for Indication 1, where it was assumed that the 3 regimens were uniformly distributed) and was assumed to be the same across lines of therapy for Product B and Product A.
• CRS, NE, severe infection, and prolonged cytopenia AE rates for Product B Indication 1, Indication 2 and Product A Indication 2 are based on real world evidence (Bobillo et al 2024, Crombie et al 2023). AE rates for Product A Indication 1 are based on clinical trial evidence and may differ in the real world. All grade 3+ adverse events are managed in the inpatient setting, while it assumed that 50% of grade 1 and 2 CRS and NE can be managed in the outpatient setting. However, when a Product is administered in the inpatient setting, any outpatient managed AEs that occur within the cell therapy administration episode of care are managed as an inpatient AE event.

Costs

• Cost inputs reflect the true cost to the perspective selected.
• Apheresis, bridging, lymphodepletion and long-term monitoring were all assumed to only occur in the outpatient setting of care.
• Drug administration cost inputs were derived from the 2025 CMS Physician Fee Schedule, which is assumed to represent the Physician Office setting. These costs are converted to a hospital outpatient setting of care using an outpatient to clinic cost ratio. Real world costs may differ. C administration in the inpatient setting was assumed to be based on 1 inpatient cost day using the average cost per day of a patient with either Indication.
• The default assumption for outpatient administration of Product B is based on Tiwana et al. 2024, which was a comparative study that evaluated hospitalizations, and critical care stays for patients with R/R Indication treated with Product therapies. The study reported that 44% of Product B Indication patients received the infusion in the outpatient setting. As there is no real-world data for Product A, the default assumption is 100% inpatient.
• When administered in the inpatient setting, week 1 monitoring costs are based on an assumed 7-day length of stay. When administered in the outpatient setting, week 1 monitoring costs are based on 7 daily visits. It is assumed that from weeks 2-4, monitoring is done in the hospital outpatient for an inpatient administered Product. For week 2-4 of the first month, it is assumed 3 visits per week. After one month, patients are assumed to have 1 outpatient visit every month.
• Inpatient AE management costs were based on the average length of stay for the event, and by applying the cost per non-ICU or ICU day. This cost per day is an average across Indications and the AE management costs are assumed to be common across Product B and Product A.

Reimbursement

• The estimates are relevant for a Medicare Fee-For-Service (FFS), Medicare Advantage (MA), or Commercial patient administered a BMS cell therapy in a Prospective Payment System (PPS) hospital. All default inputs and estimated results for reimbursement and costs are based on publicly available data, published literature, and methods documents from CMS. The estimates are not intended to represent the amounts that any particular hospital for any particular cell therapy patient will receive or incur. The actual amounts are likely to vary considerably across hospitals and patients. The default reimbursement amounts for Medicare FFS, MA, and Commercial payers are based on available literature on payment-to-cost ratios (Lopez et al 2020, MedPAC. March 2024). In the outpatient setting of care, therapies are reimbursed at ASP + 4.3% by Medicare and Commercial payers (Nguyen et al 2020). In 2013, a 2% cut was implemented to Part B drug reimbursement. However, the sequester is taken off the top of the 80% paid by Medicare, resulting in an outpatient reimbursement decline of ASP + 6% to ASP + 4.3%.
• CRS and NE adverse event rates for the selected time horizon are distributed over time to allow for the correct mapping of AE costs to reimbursement method using median time to onset, range of time to onset, and an assumed uniform distribution post median days to onset.
• When an inpatient AE event occurs within 3 calendar days of an outpatient cell therapy administration, it is assumed that the outpatient setting is wholly owned and operated by the inpatient setting and the outpatient Product event will be rolled into an MS-DRG 018 payment (or commercial/Medicare advantage equivalent), per the Medicare 3-Day Payment Window Rule (CMS. Outpatient Services Treated as Inpatient, 2025).