CAR-T Cell Therapies' Pathway: Evolution of Management and of Costing Methodology in the French Cost-Effectiveness Analyses (CEA) Landscape

OBJECTIVES: The number of CAR-T cell therapies accessing the market is witnessing a great increase, inducing a regulatory landscape evolution. Practices adopted to identify and collect relevant cost inputs are evolving accordingly. Objectives of this analysis are to review relevant literature sources, enumerate CAR-T cell therapy steps and gather approaches used to estimate cost inputs of CAR-T cell therapies’ related CEA in the French health-economics landscape.

METHODS: Available French efficiency opinions of CAR-T cell therapies in oncology and recent French publications on CAR-T cell pathway management were reviewed. Costing approaches were identified, compared, and enriched with requests addressed by the French HTA and with recent relevant items identified in the economic official updates.

RESULTS: Seven efficiency opinions, three full papers and two posters were reviewed. CAR-T pathway steps associated to costs included: CAR-T eligibility, leukapheresis, bridging and lymphodepletive chemotherapies’ administration, CAR-T infusion, hospital-stay and post-infusion follow-up, hospital discharge either to patient-hotel or to rehabilitation center, management of adverse events specific to CAR-T (AESC).

Leukapheresis was costed using Disease Related Group (GHM) 28Z16Z. Inpatient and outpatient chemotherapy administration were costed using GHM 28Z07Z and 17M06 respectively. CAR-T infusion was costed using GHM 27Z03 initially then 17M15. A new act FGLF671 specific to CAR-T infusion was introduced in 2022.

Cost of CAR-T storage and of hospitals’ training were considered from collective perspective only. A 15000€ complementary technical fee was introduced in 2021 and updated in 2023. While grade 3-4 adverse events were usually included in CEAs, when available, grade 1-2 AESC and their associated costs were requested to be included.

CONCLUSIONS: This review helped elaborating a costing approach of CAR-T patients’ management in France considering the relevant publications available and reflecting the costs evolution over time. It remains obvious that real-world studies are the most accurate sources to document the costs related to CAR-T patients’ management.