Insurance delays play significant role in ongoing ‘battle’ to receive CAR T-cell therapy
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Key takeaways:
- Patients whose insurance required a single-case agreement experienced significant delays in brain-to-vein time.
- Delays related to agreements did not have a significant impact on survival outcomes.
SAN DIEGO — Individuals with private insurance that requires a signed agreement before receiving chimeric antigen receptor T cells had significant delays in treatment, study results presented at ASH Annual Meeting and Exposition showed.
Although patients with diffuse large B-cell lymphoma who experienced insurance-related delays had lower complete response rates and shorter survival outcomes, the study findings revealed these differences did not reach statistical significance compared with patients whose insurance does require a single-case agreement (SCA) before receiving CAR-T, the researchers noted.
“Before I walk in the door, I find myself asking our CAR T-cell manager what type of insurance the patient has,” Matthew A. Lunning, DO, FACP, associate professor at University of Nebraska Medical Center and medical director for cellular therapy at the Fred & Pamela Buffett Cancer Center, told Healio.
“What insurance they have may influence what treatment I recommend to even get the patient to CAR T cells,” he added. “Right now, half the battle is just getting the patient to the point where they can receive CAR T cells and the other half occurs after they are infused. We must recognize the battle that exists before infusion of CAR T cells.”
Background
After approval of the first CAR T-cell therapy for DLBCL, clinicians who administer the therapy noticed additional delays in the process that did not occur during the clinical trial phase, according to Lunning.
“We noticed a stark difference when we went from clinical trial workflows to commercial workflows,” he said. “This period of additional time emerged from when we actually decided on CAR T cells, to when the patient was apheresed in the commercial environment.”
Additional experience with commercial CAR-T in the real-world setting revealed emerging patterns in treatment delays depending on the type of insurance, Lunning said. The biggest choke point became the need for an SCA between the insurer and the center providing CAR-T, he added.
“Our hypothesis was that people who required single case agreements took longer to get apheresis,” Lunning said. “What we didn’t know was the impact this would have on getting patients, not only to a best response of complete remission, but how this delay would impact progression-free survival and overall survival.”
Methodology
Lunning and colleagues conducted a single-center retrospective study to determine whether insurance-related delays impacted the time from when treatment with CAR-T is decided upon until the patient is infused with the final manufactured product and whether delays influenced treatment outcomes.
The analysis included consecutive patients with relapsed or refractory DLBCL evaluated for CAR T-cell therapy at University of Nebraska Medical Center between 2018 and 2022.
The final study cohort included 65 patients who received at least two previous lines of therapy and intended to receive CAR-T.
The investigators evaluated delays using the cellular therapy intent quotient (CTIQ), which is calculated by dividing the number of patients infused with CAR-T by the number of those who intended to receive CAR T-cell therapy. The latter number includes those who intended to go on and receive CAR-T but did not undergo apheresis or infusion of the final manufactured product.
Intent to undergo CAR-T served as the starting point in the period researchers called brain-to-vein, which ended once the patient underwent apheresis. The investigators defined vein-to-vein time as the period between apheresis and infusion of the final manufactured product.
Key findings
Of the 65 patients included in the study, 43 (66%) required an SCA between the insurer and treatment center to have benefits cover CAR-T.
All patients whose insurer required an SCA had private insurance or Medicare with a managed plan. The remaining 22 patients who did not need an SCA had Medicare with a supplement plan.
Researchers observed the SCA group to be significantly older and more likely to have treatment-refractory disease.
Analysis of brain-to-vein time showed a CTIQ of 92.3% for the entire study population, 90.7% for the SCA group and 95.5% for the non-SCA group.
Investigators reported a significant delay in median brain-to-vein time for patients whose insurers required and SCA (37 vs. 17 days; P = .0005).
At a median follow-up of 29.5 months, they also noted numerically longer median PFS (14.9 vs. 8 months) and median OS (44.6 vs. 18.8 months) for the non-SCA group, but this did not reach statistical significance. Likewise, the non-SCA group had an insignificantly higher complete response rate (57% vs. 46%) compared with the SCA group.
The study’s results are limited by its small sample size and single-center design, Lunning said. Another limitation included evaluation of only one CAR-T construct during the study.
Clinical implications
Lunning hopes the results of a study like this will help spark a conversation about how requirements related to insurance coverage of high-cost treatments can delay care or even prevent patients who need it from receiving timely treatment.
“When people die during the brain-to-vein period during clinical trials, they are not accounted for. And in the real-world experience, this patient population is not accounted for,” he told Healio. “The intent-to-treat clock should start not when the patient is apheresed, but when the CAR-T is recommended by a clinician for a patient.”
Although not statically significant in this limited single-center study, the trend for OS appears much more favorable for those who did not experience delays due to insurance agreements, Lunning added.
“Further investigation assessing brain-to-vein time, CTIQ and outcomes with commercial CAR-T products is warranted to ensure patients receive equitable access regardless of the source of their health care benefits,” he said.
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Gromowsky M, et al. Abstract 258. Presented at: ASH Annual Meeting and Exhibition; Dec. 9-12, 2023; San Diego.
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