Navigating the Future of Cellular Therapies: Molly Schiffer, PharmD, BCOP, Discusses Efficacy, Safety, and Reimbursement Challenges

Pharmacy Times® interviewed Molly Schiffer, PharmD, BCOP, stem cell transplant and cellular therapy clinical pharmacy specialist at Yale New Haven Hospital in Connecticut, on her presentation on the logistical and operational challenges of delivering cellular therapies in the outpatient setting at the 2025 American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR) Tandem Meeting in Honolulu, Hawaii.

A depiction of lymphocytes battling cancer cells in the immune system to prevent metastasis. Image Credit: © Anastasiia - stock.adobe.com

During the interview, Schiffer compared commercially available therapies, such as CAR T-cell products and tumor infiltrating lymphocyte (TIL) therapies, highlighting their efficacy and safety profiles in treating conditions such as B cell lymphomas, acute lymphoblastic leukemia, multiple myeloma, and metastatic melanoma. Schiffer also emphasized the logistical challenges of administering these therapies, such as tumor harvesting for TILs and the need for personalized treatment choices based on the specific therapy and patient condition.

Additionally, Schiffer discusses the financial and reimbursement considerations tied to cellular therapies. She explains how reimbursement varies depending on whether therapies are delivered in inpatient or outpatient settings, with outpatient care typically resulting in lower overall costs.

Schiffer notes the importance of pharmacists understanding insurance coverage and reimbursement nuances, such as the 72-hour rule for CAR T-cell therapy. Looking ahead, Schiffer highlights the growing potential of cellular therapies in non-oncology settings, such as autoimmune diseases and dermatology, and the need for pharmacists to stay informed about these emerging treatments.

Pharmacy Times: What are the key differences between currently available cellular therapies, such as CAR T-cell therapy, and other forms of adoptive cell therapy, in terms of efficacy and safety?

Molly Schiffer, PharmD, BCOP: There are many types of cell therapy products being studied. But to speak specifically today, I just want to focus on the commercially available options.

The first one we'll talk about is CAR T products. CAR T products are genetically engineered T cells that target specific antigens such as CD19 or BCMA. The current FDA approved indications are for B cell lymphomas, acute lymphoblastic leukemia, and then multiple myeloma. There are various products available for each of these indications, and each have varying efficacy and safety outcomes, so those are all things that we need to consider when contributing to how a provider might choose which product is best for their patient.

The other FDA approved—more recently—cell therapy product is our TIL therapies. These are products that are derived from T cells and the tumor itself. So that requires a procedure for tumor harvesting, whereas with our CAR T it's a leukophoresis procedure.

For our TIL therapy, there's only one that's FDA approved. These are mainly being studied in our solid tumor malignancies, and the one that's approved is for metastatic melanoma. There's not much safety or efficacy data to compare it to, since it is the only one that's FDA approved right now, other than looking at what else has been studied and is in the process of being studied for other solid malignancies.

Pharmacy Times: How do you approach navigating the financial and reimbursement complexities of cellular therapies?

Schiffer: You definitely need to have a thorough understanding of the reimbursement based on what the patient's primary payer is. Whether they have public or private insurance, definitely plays into the reimbursement. Post CAR T costs are generally lower in the outpatient infusion setting than they are in the inpatient setting. There are data to show that in that 6 month period, after they get their CAR T, those costs will be 2 to 4 times higher in the inpatient setting. So, it's definitely beneficial for the hospital and then also for the patient to be getting their care in the outpatient setting

The reimbursement also varies based on whether you're giving inpatient or outpatient. In an ideal world, we're trying to keep the patients outpatient as long as possible, so that they hopefully don't have to be admitted and are being managed well in the outpatient setting. But also depending on their insurance, we use the 72 hour rule: If they get admitted within the 72 hour time after their infusion, then, from my understanding, the reimbursement for the CAR T cells itself gets lumped into the inpatient stay. So as long as patients are outpatient for 72 hours after the CAR T infusion, the reimbursement changes. Obviously, it's important to do what's in the best care for the patient. But that's something to keep in mind, just about reimbursement purposes.

The outpatient reimbursement rate, I believe, is the average price for the CAR T plus 6%, so that's just something to consider, compared to when it's being given inpatient. That inpatient reimbursement is more of a diagnosis related group cause.

Pharmacy Times: What emerging trends in cellular therapy should pharmacists be prepared for over the next few years?

Schiffer: There's a lot of different cell therapies being studied. In these upcoming years, there's really going to be a growing patient population with more products that are being studied and more products being approved in the non-oncology setting for things like different autoimmune diseases. I know there's a lot of trials going on with like dermatology indications, rheumatology indications, and then also non-hematology indications. So, all of our CAR T products right now are hematology indications. But like I said, with the TIL therapy, now we have a commercially approved melanoma cell therapy. There are trials looking at patients getting cell therapies for breast cancer and for lung cancer. So, a lot of things to consider as this patient population is growing, and you're going to be seeing cell therapy in many different disease states.