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Safety and Cost-Effectiveness of CAR-T Therapy in the Outpatient vs Inpatient Setting
Outpatient chimeric antigen receptor T-cell (CAR-T) therapy is feasible and cost-effective for patients with hematologic malignancies, according to study findings presented at the 2021 ASH Annual Meeting.
“Since the commercial approval of… [CAR-T] therapies, administration and toxicity monitoring have largely been in an inpatient setting due to the risk of significant toxicities such as cytokine release syndrome (CRS) and neurotoxicity in the first 30 days. Administration in the outpatient setting can be safe and cost-effective,” explained Moazzam Shahzad, MD, Internal Medicine, St. Mary’s Medical Center, Huntington, WV, and colleagues.
This study reported cost savings and adverse events of CAR-T therapy in an outpatient setting vs the inpatient setting.
The Vizient Database® was used to investigate cost differences of axicabtagene ciloleucel and tisangenlecleucel between the inpatient and outpatient settings in 2020. Cost analysis was conducted for both settings for the initial 30 days after CAR-T infusion.
Since no billing codes for CRS or neurotoxicity existed until 2021, researchers used clinical fever, hypotension, hypoxia, and sepsis as clinical surrogates for CRS and febrile convulsion not otherwise specified (NOS), febrile seizure NOS, altered mental status, somnolence, stupor, and coma for neurotoxicity.
Dr Shahzad and colleagues noted there were 81 organizations in the database that performed CAR-T procedures in 2017-2020. In 2020, there were 1369 inpatient and 71 outpatient encounters, which were analyzed for cost and adverse events.
The incidence of CRS was 43.2% (n = 592) the inpatient group and 40.8% (n = 29) in the outpatient group. The incidence of neurotoxicity was 37.3% (n = 511) and 29.6% (n = 21) in each group, respectively.
There were 16 (22%) centers that offered both inpatient and outpatient administration in 2020 and were included in the cost analysis. Median inpatient cost was $397,610 ($346,550-$650,749) and median outpatient group cost was $243,050 ($204,344-$408,467). Dr Shahzad and colleagues conducted an analysis of variance (ANOVA) between inpatient and outpatient cases, which was found to be significant (P <.0001).
“As the field of CAR-T therapy continues to grow, outpatient programs are likely to increase. Incidence of adverse effects was lower in the outpatient group, likely patient selection effect. This data suggests that outpatient CAR-T therapy is feasible cost-effective and has the potential to grow and improve value,” concluded Dr Shahzad and colleagues.
“While it appears to be an attractive option, there is a need for more studies on patient selection and creating a robust outpatient infrastructure is needed,” they added.
Shahzad M, Faisal MS, Shippey E, et al. Safety and Cost Effectiveness of Chimeric Antigen Receptor T Cell Therapy in the Outpatient Setting. Presented at the: 2021 Ash Annual Meeting; December 11-14, 2021; Atlanta, GA and virtual. Abstract 2823.