Care Pathway and Associated Costs of Patients Treated With CAR T-cells Based on SNDS Data

This retrospective cohort study, based on the French medico-administrative database (SNDS), evaluated the care pathway, the effectiveness of management and the costs associated with patients treated with chimeric antigen receptor (CAR) T cells (CART-cells) (KYMRIAH or YESCARTA): paediatric and young adult patients (up to and including 25 years of age) with acute lymphoblastic leukaemia (ALL); and adult patients (18 years of age or older) with DLBCL.

Study Overview

• Status: Completed
• Conditions: Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia (ALL)

• Study Type: Observational
• Enrollment (Actual): 602

Contacts and Locations

Study Locations

• France
  • Rueil-Malmaison, France, 92563
    • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion criteria:

DLBCL population:

• Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
• Diagnosed with DLBCL (International Classification of Diseases [ICD-10 C833]) when receiving CAR-T AND
• Being 18 years of age or older.

ALL population:

• Patients with hospitalisation for CAR T-cell administration from 2017 to 2020 AND
• Diagnosed with ALL (ICD-10 C910) when receiving CAR-T AND
• Being 25 years of age or younger.

Exclusion criteria:

DLBCL population:

• Patients hospitalised with a diagnosis other than DLBCL during the historical period or during the index stay.

ALL population:

• Patients hospitalised with a diagnosis other than ALL during the historical period or during the index stay.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
KYMRIAH DLBCL
YESCARTA DLBCL
CAR-T DLBCL
KYMRIAH ALL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of medicine, surgery, obstetrics and odontology (MCO) stays per patient	Up to 36 months
Number of outpatient visit (ACE) stays per patient	Up to 36 months
Number of emergency room visits not followed by hospitalisation per patient	Up to 36 months
Number of aftercare and rehabilitation (SSR) stays per patient	Up to 36 months
Number of homecare (HAD) stays per patient	Up to 36 months
Number of consultations per type of healthcare professional	Up to 36 months
Number of consultations per patient (all consultations combined)	Up to 36 months
Number of patients who died	Up to 36 months
Cost of MCO hospitalisation	Up to 36 months
Cost of CAR-T on the supplementary list	Up to 36 months
Cost of medicines on the supplementary list (excluding CAR-T)	Up to 36 months
Hospitalisation cost	Up to 36 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2021
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Hematologic Diseases; Leukemia, Lymphoid; Leukemia; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: CCTL019A0FR03