Real-World Data: FACT vs Non-FACT CAR T Outcomes Compared

In "Real-World Data: FACT vs Non-FACT CAR T Outcomes Compared," the panel reviews the study Dr. Patt calls the highlight of this year's ASCO meeting.

Dr. Graff walks through a retrospective study presented at ASCO 2026, led by a researcher at the University of Tennessee using the Komodo Health Claims Database. The study included roughly 6,700 patients treated at FACT-accredited sites and 109 at non-FACT sites, a gap she attributes to how recently non-FACT treatment began. Patients at FACT sites traveled more than 50 miles on average, compared to roughly 17 miles for patients at non-FACT sites, meaning non-FACT patients received care closer to home even when admitted. More importantly, she says, rates of CRS, ICANS, and infections were statistically the same across both site types, as were response rates and time to next therapy.

She calls the findings encouraging for patients and hopes similar studies, including ongoing CIBMTR research, will help persuade payers that safety concerns should not automatically favor FACT-accredited sites, especially now that the REMS program has been discontinued. She acknowledges the study will draw criticism over its small non-FACT sample size, a limitation of only having eight years of non-FACT sites to study, and says larger studies, including work being submitted for the upcoming ASH meeting, are already underway.

Dr. Patt agrees that clinical characteristics, safety, time to next treatment, and healthcare resource utilization were comparable between the two groups. She argues clinicians, health systems, and payers should use this data to expand access, noting that outpatient treatment costs less than inpatient care, though current payer incentives still penalize hospital admissions. She concludes that FACT status should not be the deciding factor in coverage, even as reasonable quality standards remain appropriate to expect.

The next episode in this series, "The Path Forward for Community CAR T-Cell Therapy Access," closes with Dr. Porter's outlook on where access must go from here.