381 [18F]FDG-PET/CT: cost-utility analysis alongside an RCT 6 Discussion The EfFECTS trial compared an [18F]FDG-PET/CT-driven diagnostic workup to diagnostic surgery in Bethesda III and IV thyroid nodules and previously demonstrated that [18F]FDG-PET/CT ensured an oncologically safe 40% reduction in diagnostic surgery for benign nodules, accurately ruling out malignancy with a sensitivity of 94.1% [501]. The current cost-utility study demonstrated that an [18F]FDG-PET/CT-driven workup reduced the 1-year thyroid nodule-related and societal costs. The clear 1-year cost differences persisted over the lifelong period, albeit with a larger 95% CI due to additional modelling uncertainties. Sustained HRQoL was observed over the first year as well as the lifelong period. Consequently, an [18F]FDG-PET/CT-driven is very likely cost-effective as compared to diagnostic surgery for Bethesda III/IV nodules. The current study is in line with the results of the previous cost-effectiveness study from our group, which reported modelled cost-effectiveness of [18F]FDG-PET/CT-driven management in a Dutch setting over a five year horizon and provided the rationale for the EfFECTS trial [29]. According to that study, [18F]FDG-PET/CT was dominant over three reported alternative strategies, reducing costs while preserving HRQoL with an incremental net benefit of €3,700, €1,000, and €3,900 as compared to diagnostic surgery or management driven by one of two commercial molecular marker panels, respectively. These two specific molecular marker panels have greatly evolved over recent years and improved their diagnostic accuracy. It is likely that the cost-utility balance has changed in their favour. However, at $3,600 per test (i.e., €3,109; €1=$1.13 on 10-01-2022, Medicare reimbursement rate [496]), nearing the costs of a hemithyroidectomy procedure, cost-effectiveness of these molecular marker panels likely remains challenging in a European setting. Approximately a dozen cost-effectiveness studies are currently available on the use of commercially available molecular marker panels in indeterminate thyroid nodules. These mostly American studies generally focussed on the direct medical costs for thyroid-nodule related care only, including the costs and utilities for molecular testing, surgery, potential surgical complications, and (postoperative) observation. From different types of cost-effectiveness models, mixed conclusions regarding cost-effectiveness were reached [495, 496, 558, 579]. Nicholson et al. reported that both the Afirma® GSC and ThyroSeq® v3 were superior to diagnostic surgery [496]. In contrast, Balentine et al. demonstrated that diagnostic surgery was less costly and more effective than Afirma® GEC testing and ultrasound surveillance over a 5-year period. Similar to the results of the current study, their results proved sensitive to the estimated postoperative utilities and those of surveillance after a negative test [495]. Hu et al. recently demonstrated that selective molecular testing (i.e., molecular testing following a repeat Bethesda III or single Bethesda IV result) admittedly prevented 9.5% fewer diagnostic surgeries for benign nodules than reflexive molecular testing (i.e., molecular testing
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