Chimeric antigen receptor T-cell therapy real-world assessment of total cost of care and clinical events for the treatment of relapsed or refractory lymphoma.

Abstract

e19500 Background: Axicabtagene ciloleucel and tisagenlecleucel are FDA approved to treat relapsed or refractory B-cell lymphoma. CAR-T therapy involves a complex process of extraction, transfection, administration and management of adverse reactions such as cytokine release syndrome. Little has been established using real world evidence identifying CAR-T episode total cost of care (TCC) and post administration clinical events (CE) among the commercially insured population. Methods: Integrated pharmacy and medical claims were queried among a population of 15 million commercially insured members from Jan 2018 to June 2020 to identify members 18 years and older with a CAR-T drug claim cost of > $250,000, lymphoma dx, no leukemia dx, and continuously enrolled through a CAR-T episode of 30 days prior to and 56 days post the CAR-T administration date. The TCC and CAR-T specific costs were calculated for the episode. Inpatient (IP) days pursuant to CAR-T administration were calculated using admission and discharge dates. Post CAR-T administration date CEs defined as subsequent chemotherapy, bone marrow transplant (BMT), and death or hospice, as well as time to event (TTE) were identified. Subsequent chemotherapy post CAR-T administration was identified. Results: 74 members, 59% male and mean age 55 years (min 18, max 76), met inclusion criteria. Mean CAR-T episode TCC was $711,884 (median $610,999) with mean CAR-T drug cost $527,547 (median $411,278). Mean IP days per episode were 17.3 (standard deviation [SD]) 9.6). 29 members (39%) experienced any CE with a mean 228 (SD 217) TTE. No CE identified among 21 (28%) members who disenrolled or ceased claim activity after a mean 253 days (SD 167). 24 (32%) remained enrolled with no CEs with a mean follow-up of a 390 days (SD 264), as of Oct 2020. Non-mutually exclusive CEs include: 22 (30%) members received subsequent chemotherapy, mean TTE 263 days (SD 238); 4 (7%) had a BMT, mean TTE 245 days (SD 108); and 13 (18%) had an identified death or hospice, mean TTE 297 days (SD 143). The most common non-mutually exclusive subsequent chemotherapy observed in 22 members were: rituximab (9 members), bendamustine (8), lenalidomide (8), obinutuzumab (5), pembrolizumab (4), polatuzumab vedotin (4), cyclophosphamide (3), ibrutinib (2), and venetoclax (2). 14 additional subsequent therapies with 1 unique utilizer were also observed. Conclusions: These 74 members show substantial variation in CAR-T episode TCC and clinical experience. 29 (39%) members did not have a durable response to CAR-T with providers initiating subsequent chemotherapy in 22 of 29 cases in the absence of clear guidelines. These data inform managed care activities such as performance metrics, case rates, and value based arrangements. Additionally, these data are important in actuarial forecasting for given the potential future volume of treated patients and spend.