Commentary
Video
Author(s):
Debra Patt, MD, PhD, MBA, and Houston Holmes, MD, explore how the removal of risk evaluation and management strategies (REMS) for chimeric antigen receptor (CAR) T-cell (CAR T) therapies can improve health equity, expand access in community settings, and elevate the pharmacist’s role in care coordination.
In an interview with Pharmacy Times®, Debra Patt, MD, PhD, MBA, executive vice president of Texas Oncology and vice president of the Community Oncology Alliance, and Houston Holmes, MD, a physician at Texas Oncology with specialties in hematologic malignancies, emphasized the pivotal role pharmacists play in managing side effects, educating patients, and coordinating logistics in lieu of the FDA’s decision to eliminate Risk Evaluation and Mitigation Strategies (REMS) requirements for BCMA- and CD19-directed chimeric antigen receptor (CAR) T-cell (CAR T) therapies. The experts also reflected on how eliminating REMS requirements could help dismantle systemic barriers to CAR T access—particularly for rural and underserved populations—though reimbursement and infrastructure gaps remain significant hurdles.
Pharmacy Times: Does Texas Oncology—and other community oncology centers—already have the infrastructure and clinical readiness to safely deliver CAR T therapies without the REMS framework?
Houston Holmes, MD: Yes. We started using CAR T therapies about 10 years ago, even before FDA approval, through clinical trials. Several of our sites have treated patients in these trials and have long-standing experience. The first FDA approval came in 2017, and more have followed. We've continued using these therapies at multiple sites across Texas. As Dr. Patt said, we'd like to provide it more widely—but logistical, policy, and reimbursement challenges make it harder to offer closer-to-home care for many patients. With the REMS program no longer being a hurdle, we hope to overcome more of those obstacles and expand access.
Pharmacy Times: How might this decision affect the role of pharmacists—particularly in community or specialty settings—regarding CAR T coordination and patient counseling?
Debra Patt, MD, PhD, MBA: Great and important question. Our pharmacists are incredibly skilled at providing patient education and supporting patients through complicated therapies. CAR T requires next-level education due to the potential severity and sudden onset of toxicities and because patients need extended support. But our pharmacists are up to the challenge. They already administer complex therapies across Texas. Inventory management is also key. With CAR T, you must be ready to treat side effects. One reason for the REMS program early on was uncertainty about toxicities like cytokine release syndrome—how to recognize and manage them. Now that we understand them better, pharmacists are more equipped to handle the responsibility. We have a great pharmacy team ready to support this.
Holmes: If I can just add to what Dr. Patt said—we really do have an outstanding pharmacy team. They’ve helped administer these therapies in our clinics during clinical trials and are very experienced.
Pharmacy Times: What impact do you anticipate this policy shift will have on access to CAR T for patients in rural or underserved communities?
Holmes: As for the policy shift, I see it as an incremental but helpful step. REMS had strict requirements for patient monitoring, documentation, and training. Now that we better understand how to manage toxicities and reduce treatment risks, it helps to remove those hurdles. Still, other issues remain—financial, regulatory, and logistical. We'd also like to move more patients to outpatient rather than inpatient settings. But this decision helps us move things forward.
Pharmacy Times: Do you think this decision could pave the way for how other advanced therapies, like bispecifics or future cell and gene therapies, are regulated and delivered?
Patt: Absolutely. What we’re seeing is that when a new therapy with unique toxicities is first approved, there’s a need to go slowly and apply heavy oversight. But once there’s strong clinical awareness and management of side effects, some restrictions can be lifted. I expect we’ll see a similar approach with bispecifics and future gene therapies. This is a wise and appropriate cadence as we bring novel therapies to patients.
Pharmacy Times: Is there anything else that you would like to add?
Patt: I’m really excited about the changes in CAR T therapy. We live in an incredible era of cancer care where we can often prevent cancer from taking lives or livelihoods. Progress like this makes these therapies more accessible, and that’s what we want for all patients.
Holmes: I agree. This is an amazing innovation in treating hematologic malignancies. CAR T is curative for some, yet still underutilized. Not every patient who could benefit from CAR T is receiving it—not just in Texas, but across the U.S. So anything we can do to remove barriers and increase access is a step forward.
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