ABSTRACT
Objectives
ORIENT-16, a phase III clinical trial conducted at 62 hospitals in China, reported that add-on sintilimab (Sin) to chemotherapy (Chemo) had favorable efficacy (p < 0.05) for patients with advanced HER2-negative gastric or gastroesophageal junction cancer (GC/GEJC). This study aimed to evaluate the cost-utility of the Sin+Chemo based on results of ORIENT-16 from the perspective of Chinese healthcare payers.
Methods
A three-state partitioned survival model was developed to simulate the 10-year life expectancy and total healthcare costs for patients with advanced HER2-negative GC/GEJC. Primary measure outcomes were: cost, quality-adjusted life-years (QALYs), and incremental cost-utility ratios (ICURs). Sensitivity/scenario analyses were conducted to assess the model robustness.
Results
In all patients, Sin+Chemo vs Chemo increased costs by $6,472, additionally providing 0.61 QALYs, resulting in an ICUR of $10,610/QALY. While, in PD-L1 combined positive score ≥ 5 cohort, the ICUR was $9,738/QALYs. The ICUR was most sensitive to the utility of progression-free survival. The probabilistic sensitivity analysis showed that add-on Sin had a 100% probability of being cost-effective at a willingness-to-pay threshold of $18,625/QALY gained.
Conclusions
Sin+Chemo is a cost-effective first-line treatment option for advanced HER2-negative GC/GEJC in China.
Clinical trial registration
ORIENT-16, www.clinicaltrials.gov, identifier is NCT03745170.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Availability of data and materials
All data generated or analyzed during this study are included in this article and its supplementary materials.
Author contributions
W Li drafted and revised the manuscript. W Li and L Wan contributed to study conception and design and performed analysis and interpretation of included data. Both authors had final approval of the version of the article to be published and agreed to be accountable for all aspects of the work.
Supplemental data
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737167.2024.2341859