Presentation (CTI)

Problem Statement: F18 fluoroestradiol (Cerianna) is an FDA-approved imaging agent that detects whole-body estrogen receptor-positive (ER+) lesions, guiding therapy decisions and reducing treatment futility. The increasing evidence from numerous studies supported an update to the NCCN® guidelines to include Cerianna PET/CT. Its benefits were also captured in the SNMMI guidelines through appropriate use criteria (AUC). However, one of the major National Radiology Benefit Managers (RBMs) still lacked coverage, based on limited evidence that overlooked Cerianna’s clinical and economic benefits in informing treatment decisions for metastatic (mBC) and recurrent breast cancer (rBC) patients.
Description: Only a limited number of economic analyses have been conducted for Cerianna PET/CT in mBC and rBC patients. To evaluate the clinical and economic impact of incorporating Cerianna PET/CT into standard diagnostic pathways, we conducted a budget impact and cost-effectiveness analysis comparing its use alongside biopsy/IHC for determining ER+ status in patients with mBC and rBC in the United States _[1]. The analysis demonstrated improvements in diagnostic accuracy, reductions in misclassification rates, and enhanced alignment of treatment selection according to ER status. The model projected cumulative healthcare savings of up to $142 million over five years and gains in quality-adjusted life years (QALYs), indicating both clinical and economic value.
Lessons Learned: While evidence continues to emerge demonstrating Cerianna’s positive impact on patient outcomes and economic value, a scientifically rigorous study was needed to analyze the clinical and economic benefits of adding Cerianna PET/CT to biopsy for ER status determination. Despite the inclusion in most US payer medical policies, some RBMs still cite insufficient evidence or low added value, highlighting the need for continued real-world evidence generation and stakeholder engagement.The study’s publication, along with NCCN guideline inclusion, contributed to broader acceptance.
Stakeholder Perspective: EviCore, a national RBM, revised its coverage policy to include Cerianna as a covered medical benefit. As the largest RBM in the United States, EviCore provides benefits management services to numerous national and regional health plans, collectively covering over 100 million lives. Prior to this update, Cerianna had been designated as experimental and investigational in EviCore’s guidelines since its initial market launch. The policy revision reflects a shift in EviCore’s imaging guidelines, recognizing Cerianna as medically necessary. This change underscores the value of sustained evidence generation efforts in informing payer decision-making.