Role of Publicly-Funded Molecular Testing in Surgical Management of Thyroid Nodules within Canadian Medicare: Clinical Assessment of ThyroSeqv3 Molecular Test Pilot Project at McGill University.

Abstract

ImportanceRecently, the Québec public health care system established a pilot project to cover costs of molecular testing for select patients with cytologically-indeterminate thyroid nodules.ObjectiveThis study aimed to evaluate the clinical utility of the ThyroSeqv3 molecular test pilot project at McGill University in surgical management of thyroid nodules within Canada's single-payer health care system.DesignMulticenter cohort study, in liaison with the Québec Health Ministry.SettingJewish General Hospital and Royal Victoria Hospital in Montreal, Canada.ParticipantsPatients with a Bethesda III or IV and TIRADS 3 or 4 thyroid nodule measuring between 1 and 4 cm in size on ultrasound were analyzed across pre- and post-pilot project phases.InterventionThe pre-pilot project surgical control group included patients who underwent surgical intervention, excluding those who opted for out-of-pocket molecular testing. The post-pilot project surgical exposure group encompassed participants in the pilot project, undergoing publicly-funded ThyroSeqv3 molecular testing and subsequent surgical intervention.Main Outcome MeasuresSurgical malignancy/noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) rate.ResultsA total of 314 patients qualified for the pilot project, with 207 (65.9%) having Bethesda III nodules and 107 (34.1%) having Bethesda IV nodules. Molecular testing yielded a result of negative in 238 (75.8%) cases and positive in 76 (24.2%) cases. Histopathology reports of positive patients who opted for surgery revealed a surgical malignancy/NIFTP rate of 73.1%. The surgical malignancy/NIFTP rate at our institution prior to the implementation of the pilot project for patients adhering to the inclusion criteria was statistically significantly lower at 47.9% (P = .0025).ConclusionsThe ThyroSeqv3 molecular test pilot project has improved upon physicians' traditional clinical practice by enabling a wider patient population to access this otherwise costly technology. It not only curtailed futile diagnostic hemithyroidectomies but also led to a more discerning allocation of surgeries, as corroborated by an increased surgical malignancy/NIFTP rate post-implementation.RelevanceThe results of our study suggest that publicly-funded molecular testing could contribute positively to the Canadian single-payer health care system by optimizing patient outcomes as well as fiscal policy.