CAR T Therapy Advances, but Access Still Lags Behind

Chimeric antigen receptor (CAR) T-cell therapy demonstrates significant, clinically meaningful outcomes for patients with hematologic malignancies, such as B-cell lymphomas or multiple myeloma (MM). These novel therapies are at the helm of innovation and the evolution of cellular immunotherapies. At the 2026 Community Oncology Alliance meeting, experts discussed the current landscape for CAR T-cell treatment and how clinics, cancer centers, and other points of care can expand access to these efficacious therapies to patients who need them.

What is CAR T-Cell Therapy?

CAR T-cell therapy is an innovative approach to utilizing a patient’s own immune system to attack cancer cells. The process involves harvesting the immune cells and manufacturing them to target specific antigens or biomarkers on the surface of malignant cells. Emerging data from research and clinical trials show improved response rates and, notably, minimal residual disease (MRD) negativity. Over the past few years, and per the updated International Myeloma Working Group, MRD plays a central role in assessing treatment response.^1,2

There are multiple CAR T-cell products in various stages of approval and development that are available. Ciltacabtagene autoleucel (cilta-cel; Carvykti, Janssen Biotech, Inc/Legend Biotech) is particularly notable for its efficacy, as demonstrated in the CARTITUDE-1 trial (NCT03548207). Patients with MM received a single infusion of cilta-cel and achieved remission without the need for maintenance therapy. These outcomes imply the curative potential of CAR T-cell therapy, further establishing its critical role in the treatment landscape for MM and other hematologic malignancies.³

As of April 2026, there are 7 FDA approved CAR T-cell therapies and multiple other investigational products (Table). However, despite their significant efficacy, challenges for implementation and operationalizing these therapies remains a persistent challenge across clinical settings.³

What Challenges Prevent Operationalizing CAR T-Cell?

Operationalizing novel therapies in cancer care is one of the most significant hurdles for successful implementation of specific treatments in clinics. In the case of CAR T-cell therapy, a plethora of challenges present themselves.³

“Where do you begin? I think putting up a CAR T program is no small project,” explained Ralph V Boccia, MD, FACP, medical director for the Center for Cancer and Blood Disorders in Bethesda, Maryland, and clinical associate professor of Medicine at Georgetown University in Washington, DC. “It requires so much in the way of engaging all the different stakeholders first in the practice to see how to put the program together in a safe and effective way.”³

As implied by Boccia, scaling a CAR T program presents significant challenges due to the involvement of various stakeholders, not limited to practice leadership, clinicians, pharmacy, quality, finance, contracts, payers, hospital partners, and more. With so many parties involved, it can take over a year of planning, developing workflows, and determining process design before launch. These yield significant financial burdens with startup costs hitting an average 7 figures and ongoing cost related to physicians on call, coordination, quality, nursing, hospital coordination, and so on.³

Another financial challenge concerns Medicare reimbursement—which is lower than for academic 340B centers, making community programs financially fragile. Community programs usually infuse outpatient but still need hospital backup for toxicity. Many hospitals are reluctant to be formally involved due to reimbursement. Clinicians may be supportive, but hospital administrations can block or stall true partnership. For example, some systems do not allow inpatient CAR T infusions, forcing purely outpatient models and making complex patients (ie, central nervous system involvement, on dialysis) hard to manage locally.³

Operational and staffing challenges present their own obstacles when implementing a CAR T-cell therapy program, which require a cell therapy–savvy team or intensive education to that standard. Workflows must be well-defined to effective patient selection and referral, authorization and billing, product logistics and freezing, and toxicity monitoring and escalation.³

In community oncology, productivity is tied to seeing patients—not meetings. Yet, CAR T requires many internal coordination meetings that aren’t rewarded by traditional productivity metrics.³

“You've got to think differently about your pricing and delivery CAR T-cell therapy in the community setting,” said Gary Simmons, MD, MSHA, from the Virginia Oncology Associates in Virginia. “You're going to have to develop different models if you want to see these numbers expand.”³

What Factors Bar Patients from Care?

Payer policies remain one of the most persistent barriers for patients when trying to access CAR T-cell therapy, particularly as they struggle to keep pace with how and where care is actually delivered. Many insurers still rely on outdated Centers of Excellence models that were developed when CAR T was almost exclusively administered at large academic institutions. As a result, these policies often exclude qualified community-based programs that now have significant experience and infrastructure.³

Coverage limitations also extend to how CAR T is delivered. Some payers continue to deny recognition of outpatient CAR T programs, even when those programs have demonstrated strong safety records. In some situations, patients are forced into complex and unrealistic insurance workarounds just to access treatment. Financial barriers also play a substantial role. For patients covered under Medicare or Medicare Advantage, CAR T is typically billed as a drug, which can result in significant out-of-pocket costs.³

Geographic barriers further compound the issue. In some regions, patients may live more than 100 miles from the nearest academic center, making travel a significant obstacle. Community oncology networks often serve large, dispersed populations, including rural areas where access to specialized care is already limited.³

Time to treatment is another critical factor. A significant proportion of eligible patients never ultimately receive CAR T therapy, in part due to delays in the authorization and referral process. Transitioning a patient from the decision to treat through payer approval, evaluation at a treatment center, and ultimately apheresis can take weeks—time that many patients simply do not have.³

How Can Clinics Implement CAR T-Cell Programs?

Designing a CAR T-cell therapy program requires early, deliberate decisions about the care model, particularly around structure and setting. Practices must determine whether they will adopt a hub-and-spoke approach—centralizing expertise while extending access through affiliated sites—or instead build programs directly in locations where patient volume and access needs are greatest. Another key decision is whether to operate as a purely outpatient program or use a mixed inpatient-outpatient model. Some community oncology groups have successfully implemented predominantly outpatient programs, relying on hospital admission only when patients develop significant toxicities.³

Staffing and expertise are foundational to program success. A dedicated cell therapy team is essential, ideally composed of individuals with prior experience in transplant or cellular therapy—or at minimum, a willingness to be trained to that level of competency.³

Even in outpatient-focused models, strong hospital partnerships are indispensable. Patients receiving CAR T therapy can develop acute, potentially severe toxicities that require inpatient management, making it critical to have an engaged and responsive hospital partner; however, these relationships can be challenging to establish and maintain. Practices must proactively establish clear escalation pathways, including defined protocols for emergency department evaluation and inpatient admission, as well as real-time communication channels between outpatient and hospital teams.³

Payer policies are highly variable, with differing definitions of quality, documentation requirements, and restrictions on where CAR T can be administered. These inconsistencies can create significant friction in care delivery. At the same time, the financial burden on patients can be substantial, as CAR T is often billed as a drug with associated cost-sharing. Comprehensive financial counseling and support services are therefore essential parts of the care model, helping patients navigate costs and access available assistance programs.³

Finally, CAR T programs require substantial physical and technical infrastructure. This includes specialized equipment such as cell therapy freezers, liquid nitrogen storage systems, and secure processes for handling and tracking cellular products. Programs must also ensure 24/7 clinical coverage, with clear protocols for after-hours patient management and rapid response to emerging symptoms.³

“Know how deep the water is before you jump in,” said Simmons. “Not every program and community oncology practice should be doing this or needs to do this.”³

What Is Next for CAR T-Cell Therapy Programs?

Taken together, the discussion underscores a central tension in the evolution of CAR T-cell therapy: the therapies themselves are advancing rapidly, with the potential to transform—and even cure—disease, while the systems required to deliver them are still catching up. Expanding access will depend not only on clinical expertise, but also on alignment across payers, providers, and health systems to modernize policies, invest in infrastructure, and support community-based care models. As more programs mature and real-world data continue to validate safety and outcomes in diverse settings, the opportunity to bring CAR T closer to patients becomes increasingly achievable—provided stakeholders are willing to adapt alongside the science.

“But without a doubt, these therapies are curative,” said Ameet Patel, MD, MMHC, a bone marrow transplant and cell therapy specialist at Florida Cancer Specialists & Research Institute in Florida. “I think with ongoing education over time with payers, you'll realize that the cost of care can be better for patients in the long run. So, facilitating those conversations with payers are important. These the success of CAR T-cell therapy programs at the end of the day are built on relationships and a group of great people having a vision of improve access and quality of care.”³

REFERENCES

1. Landgren O, Kazandjian D. MRD and Plasma Cell Dynamics after CAR T-cell Therapy in Myeloma. Blood Cancer Discov. 2023;4(5):346-348. doi:10.1158/2643-3230.BCD-23-0134

2. Kumar S, Paiva B, Anderson KC, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016;17(8):e328-e346. doi:10.1016/S1470-2045(16)30206-6

3. Boccia R, Byrne M, Patel A, et al. CAR T Comes to Main Street: Expanding Access, Empowering Care. Presented at: 2026 COA Annual Meeting. April 28-29, 2026. Orlando, FL.