A Prospective Economic Analysis of Early Outcome Data From the Alliance A041202/ CCTG CLC.2 Randomized Phase III Trial Of Bendamustine-Rituximab Compared With Ibrutinib-Based Regimens in Untreated Older Patients With Chronic Lymphocytic Leukemia.
Adenine
/ analogs & derivatives
Aged
Antineoplastic Combined Chemotherapy Protocols
/ economics
Bendamustine Hydrochloride
/ economics
Female
Humans
Leukemia, Lymphocytic, Chronic, B-Cell
/ drug therapy
Male
Piperidines
/ economics
Prospective Studies
Rituximab
/ economics
Survival Analysis
Treatment Outcome
Chronic lymphocytic leukemia, Ibrutinib, Bendamustine-rituximab, Phase III trial
Economic analysis
Journal
Clinical lymphoma, myeloma & leukemia
ISSN: 2152-2669
Titre abrégé: Clin Lymphoma Myeloma Leuk
Pays: United States
ID NLM: 101525386
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
24
05
2021
revised:
11
06
2021
accepted:
14
06
2021
pubmed:
3
8
2021
medline:
17
2
2022
entrez:
2
8
2021
Statut:
ppublish
Résumé
The Alliance A041202/CCTG CLC.2 trial demonstrated superior progression-free survival with ibrutinib-based therapy compared to chemoimmunotherapy with bendamustine-rituximab (BR) in previously untreated older patients with chronic lymphocytic leukemia. We completed a prospective trial-based economic analysis of Canadian patients to study the direct medical costs and quality-adjusted benefit associated with these therapies. Mean survival was calculated using the restricted mean survival method from randomization to the study time-horizon of 24 months. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tariffs applied to calculate quality-adjusted life years (QALYs). Costs were applied to resource utilization data (expressed in 2019 US dollars). We examined costs and QALYs associated ibrutinib, ibrutinib with rituximab (IR), and BR therapy. A total of 55 patients were enrolled; two patients were excluded from the analysis. On-protocol costs (associated with protocol-specified resource use) were higher for patients receiving ibrutinib (mean $189,335; P < 0.0001) and IR (mean $219,908; P < 0.0001) compared to BR (mean $51,345), driven by higher acquisition costs for ibrutinib. Total mean costs (over 2-years) were $192,615 with ibrutinib, $223,761 with IR, and $55,413 with BR (P < 0.0001 for ibrutinib vs. BR and P < 0.0001 for IR vs. BR). QALYs were similar between the three treatment arms: 1.66 (0.16) for ibrutinib alone, 1.65 (0.24) for IR, and 1.66 (0.17) for BR; therefore, a formal cost-utility analysis was not conducted. Direct medical costs are higher for patients receiving ibrutinib-based therapies compared to chemoimmunotherapy in frontline chronic lymphocytic leukemia, with the cost of ibrutinib representing a key driver.
Identifiants
pubmed: 34334330
pii: S2152-2650(21)00240-8
doi: 10.1016/j.clml.2021.06.011
pmc: PMC8568662
mid: NIHMS1743967
pii:
doi:
Substances chimiques
Piperidines
0
ibrutinib
1X70OSD4VX
Rituximab
4F4X42SYQ6
Bendamustine Hydrochloride
981Y8SX18M
Adenine
JAC85A2161
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
766-774Subventions
Organisme : NCI NIH HHS
ID : U10 CA180821
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180863
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180882
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233331
Pays : United States
Informations de copyright
Copyright © 2021 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest Dr. Woyach has received honoraria and/or research funding from Pharmacyclics, Abbvie, and Janssen. Dr. Lam has received honoraria from Abbvie and Janssen. Dr. Owen has received honoraria from Janssen.
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