https://orcid.org/0000-0002-4906-6022
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Abstract
Aim
Our study aimed to evaluate the cost-effectiveness of the chimeric antigen receptor (CAR) T-cell therapy, axicabtagene ciloleucel (axi-cel), compared to standard of care (SOC) in Sweden for second-line (2L) treatment of adult transplant-intended diffuse large B-cell lymphoma (DLBCL) patients who relapse within 12 months from completion of, or are refractory to (early r/r), first-line (1L) chemoimmunotherapy.
Methods
Cost-effectiveness was assessed using a three-state partitioned survival model. Mixture cure models were used to extrapolate time-to-event data from the ZUMA-7 trial (NCT03391466) beyond the observational period. Sensitivity and scenario analyses were performed to test the robustness of the base case results, including an analysis that assumed no switching to off-protocol CAR T-cell therapy in subsequent lines in the SOC arm.
Results
The model estimated an incremental cost-effectiveness ratio (ICER) of SEK 534,704 (EUR 50,303) per quality-adjusted life year (QALY) gained over a lifetime horizon of 50 years, with an incremental cost of SEK 812,944 (EUR 76,479) and incremental QALY of 1.52 for axi-cel compared with SOC. The probabilistic sensitivity analysis showed that axi-cel was cost-effective in 73% of the simulations when assuming a willingness-to-pay threshold of SEK 1,000,000 (EUR 94,077) per QALY. The ICER was SEK 694,351 (EUR 65,313) in the scenario analysis where the costs and effects of treatment switching were not included.
Conclusion
2L treatment with axi-cel in transplant-intended DLBCL patients with early r/r after completing 1L chemoimmunotherapy was cost-effective compared to SOC in a Swedish setting. Administering axi-cel in 2L is cost-effective as it enhances the possibility of curing more patients, resulting in not just a survival advantage, but also a reduction in the burden on quality of life and cost of subsequent therapy. This will be advantageous to both patients and society.
Transparency
Declaration of financial/other interests
Axicabtagene ciloleucel is a product of Gilead Sciences (funder). Gilead Sciences provided support in the form of payments to Incentive Denmark. Authors O.E, S.V and V.K are employees at Gilead Sciences and Kite Pharma, a Gilead company. Incentive Denmark was a paid vendor to Gilead Sciences, and authors A.L, E.M and A.D were paid employees of Incentive Denmark.
Author contributions
A.L, E.M and A.D: Methodology, formal analysis, validation, and writing - original draft. O.E: Methodology, validation, writing - review & editing, project administration and funding acquisition. S.V and V.K: Methodology, validation, and writing - review & editing. All authors have approved the final version of the manuscript to be published and agree to be accountable for all aspects of the work.
Acknowledgement
No assistance in the preparation of this article is to be declared.
Data availability statement
Due to ethical, legal and commercial reasons supporting data is not available beyond what is already disclosed in the Supplementary Materials.
Reviewer disclosures
A reviewer on this manuscript has disclosed that they have done consulting for Gilead SRL. The other peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.