https://orcid.org/0000-0001-5058-7645
![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
Aims
The objective of this study is to estimate the cost-effectiveness of KTE-X19 versus standard of care (SoC) in the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) post-Bruton tyrosine kinase inhibitor (BTKi) treatment from a UK healthcare perspective.
Materials and Methods
A three-state partitioned survival model (pre-progression, post-progression and death) with a cycle length of one month was used to extrapolate progression-free and overall survival over a lifetime horizon. Population inputs along with KTE-X19 (brexucabtagene autoleucel) efficacy and safety data were derived from the single-arm trial ZUMA-2 (NCT02601313). The composition of SoC was informed by a literature-based meta-analysis, SoC efficacy data were obtained from the SCHOLAR-2 real-world study. Survival was modelled using standard parametric curves for SoC and a mixture-cure methodology for KTE-X19. It was assumed that patients whose disease had not progressed after five years experienced long-term remission. Costs, resource use and utility, and adverse event disutility inputs were obtained from published literature and publicly available data sources. An annual discount rate of 3.5% was applied to costs and health outcomes. Modelled outcomes for KTE-X19 and SoC included expected life years (LY), quality-adjusted life years (QALY) and total costs. Deterministic and probabilistic sensitivity analyses and scenario analyses were performed.
Results
Estimated median survival was 5.96 years for KTE-X19 and 1.38 for SoC. Discounted LYs, QALYs and lifetime costs were 8.27, 5.99 and £385,765 for KTE-X19 versus 1.98, 1.48 and £79,742 for SoC, respectively. The KTE-X19 versus SoC cost per QALY was £67,713 and the cost per LY was £48,645. Influential scenario analyses use alternative KTE-X19 survival curves and discount rates, and shorter time horizons.
Conclusion
Considering the survival and quality of life benefits compared to SoC, KTE-X19 for R/R MCL appears as a cost-effective treatment in the real-world UK setting.
Transparency
Declaration of funding
This study was funded by Kite, a Gilead Company.
Declaration of financial/other interests
SP is employed by OPEN Health Company and is a consultant for or has consulted for Kite, a Gilead Company, Galderma, PTC therapeutics, Bristol Myers Squibb, Celgene Ltd, a Bristol Myers Squibb Company, GlaxoSmithKline, Otsuka, Merck & Co, and AbbVie in the past two years.
CLS is employed by OPEN Health Company and is a consultant for or has consulted for Kite, a Gilead Company, Galderma, PTC therapeutics, Takeda, Bristol Myers Squibb, EMD Serono, Grifols and AbbVie in the past two years.
CB is employed by OPEN Health Company and is a consultant for or has consulted for Kite, a Gilead Company, AbbVie, Amgen, TEVA, Takeda, PTC therapeutics, Galderma, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Tesaro, Gilead and Otsuka in the past two years.
GC is an employee of Kite, a Gilead Company, was employed previously by Amgen, Mundipharma and Janssen Cilag.
JW is an employee of Kite, a Gilead Company, was employed previously by Amgen, Abbott, Genentech and Elan, and is a stakeholder of Gilead, Amgen, Abbott, AbbVie, Avid Bioservices, Curis, Moderna and Viracta Therapeutics.
SW is employed by Wade Outcomes Research and Consulting and is a consultant for or has consulted for Kite, a Gilead Company, AbbVie/Allergan, Johnson & Johnson, and Amgen in the past 2 years.
RS is an employee of Kite, a Gilead Company and is a stakeholder of Gilead and Amgen.
IK is an employee of Kite, a Gilead Company and is a stakeholder of Gilead.
WP is an employee of Kite, a Gilead Company.
GS has been advising Abbvie, Beigene, BMS/Celgene, Debiopharm, Epizyme, Genentech/Roche, Genmab, Incyte, Ipsen, Janssen, Kite/Gilead, Loxo, Milteniy, Morphosys, Novartis, Rapt, Regeneron, Takeda and Velosbio in the past two years.
MW has been advising Pharmacyclics, Celgene, Janssen, AstraZeneca, MoreHealth, Pulse Biosciences, Nobel Insights, Guidpoint Global, InnoCare and BioInvent over the past two years.
GH has been advising Janssen, Genmab, Gilead/Kite, AstraZeneca, Lilly, Roche, Abbvie and Morphosys/Incyte over the past two years.
Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.
Author contributions
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript.
Acknowledgements
The authors would like to thank Nour Chami, (employee of OPEN Health) for the collection of costing inputs used in this study. The authors would also like to thank Greg Maglinte for his contributions during the conception and design of this work.