MARLBOROUGH, Mass.–(BUSINESS WIRE)–
GE HealthCare Pharmaco-Economic Study Demonstrates Adding Breast Oncology PET Tracer to Standard Workup of Patients with Metastatic or Recurrent Breast Cancer May Yield Beneficial Clinical and Economic Outcomes, Potentially Saving $142M Over Five Years in the US
In a GE HealthCare sponsored pharmaco-economic study published in peer-reviewed journal PLOS ONE, the incidence, prevalence, diagnostic pathways, and treatments of different patients with metastatic or recurrent breast cancer were analyzed using a combination of widely accepted statistical modelling methods to estimate the clinical and associated economic impact of adding a PET/CT scan with [18F]FES, a breast oncology PET tracer, to the current standard diagnostic process.
Breast cancer is the most diagnosed cancer worldwide, with approximately 2.3 million new cases appearing in 2020 alone.3 Correct identification of the receptor status in breast cancer is crucial to optimize treatment; however, the diagnostic standard of care which involves biopsy/IHC and imaging, can yield inconclusive results. [18F]FES can be a powerful tool, providing high diagnostic accuracy in detection of estrogen receptor (ER)-positive lesions. The study demonstrated that adding a PET/CT scan with [18F]FES to biopsy/IHC may increase the diagnostic accuracy of the ER status in all appropriate patients with metastatic or recurrent breast cancer. The clinical and economic benefits were especially pronounced in those situations where a tumor sample cannot be obtained, or the risk of a biopsy-related complication is high.
Regina Young, Head of Global Market Access in the Pharmaceutical Diagnostics segment of GE HealthCare and lead author of the study said, “We found that if [18F]FES PET/CT was added to the standard diagnostic work up and in line with the Appropriate Use Criteria (AUC) for ER-targeted PET Imaging,4 the increase in diagnostic accuracy could improve the clinical outcomes. Additionally, results suggested a positive correlation between increased diagnostic accuracy, especially when multiple lesions are present,” said Young. “The increase in true ER-positive and ER-negative results may have beneficial clinical and economic outcomes primarily driven by the avoidance of repeated biopsies and futile treatments.”
In 2023, FES PET imaging was added to the National Cancer Care Network (NCCN) Clinical Practice Guidelines in Oncology for ER-positive disease under certain circumstances during the systemic staging workup of patients with metastatic and recurrent breast cancer. This inclusion came after the Society of Nuclear Medicine and Molecular Imaging (SNMMI) published its AUC to guide referring and imaging physicians in appropriate use of ER-targeted PET imaging with 16α-18F-fluoro-17ß Fluoroestradiol. According to SNMMI, the inclusion of FES PET in its AUC is intended to help healthcare practitioners provide patients with the best care in a cost-effective manner. The AUC may also enable more efficient approval of FES use by payers.5
GE HealthCare’s Cerianna is the only FDA-approved FES PET imaging agent. Cerianna is indicated for use with PET imaging for the detection of ER-positive lesions as an adjunct to biopsy in patients with metastatic and recurrent breast cancer. Providing a whole-body view of ER-positive lesions, Cerianna may deliver a comprehensive assessment to assist in making an informed diagnosis and individualized treatment plan for the patient.
GE HealthCare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 119 million procedures per year globally, equivalent to four patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology, and oncology, with an innovative pipeline, all aimed at enabling better-informed diagnosis and monitoring for improved therapy decision-making and clinical outcomes.
About GE HealthCare Technologies Inc.
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.
Follow us on LinkedIn, X (formerly Twitter), Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
INDICATIONS AND USAGE:
CERIANNA is indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.
Limitations of Use:
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).
Important Safety Information
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Risk of Misdiagnosis
Inadequate Tumor Characterization and Other ER-Positive Pathology
False Negative CERIANNA Scan
Radiation Risks
Pregnancy Status
ADVERSE REACTIONS
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
Lactation
Risk Summary
Pediatric Use
Geriatric Use
DRUG INTERACTIONS
Systemic Endocrine Therapies that Bind to ER
To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800 654 0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800 FDA 1088 or www.fda.gov/medwatch
1 Munter-Young R, Fuentes-Alburo A, DiGregorio N, Neeser K, Gultyaev D (2024) Clinical and economic outcomes of adding [18F]FES PET/CT in estrogen receptor status identification in metastatic and recurrent breast cancer in the US. PLoS ONE 19(5): e0302486. https://doi.org/10.1371/journal.pone.0302486 |
2 Munter-Young, Fuentes-Alburo, DiGregorio, Neeser, Gultyaev, 2024, Table 3 |
3 Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209–49. Epub 20210204. pmid:33538338. |
4 Ulaner G, Mankoff D, Clark AS, Fowler AM, Linden HM, Peterson LM, Dehdashti F, Kurland BF, Mortimer J, Mouabbi J, Hyuk Moon D, de Vries EGE (2023) Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-F-Fluoro-17β-Fluoroestradiol. The Journal of Nuclear Medicine 64 (3) 351-354. |
5 Ulaner G, Mankoff D, Clark AS, Fowler AM, Linden HM, Peterson LM, Dehdashti F, Kurland BF, Mortimer J, Mouabbi J, Hyuk Moon D, de Vries EGE (2023) Summary: Appropriate Use Criteria for Estrogen Receptor-Targeted PET Imaging with 16α-F-Fluoro-17β-Fluoroestradiol. The Journal of Nuclear Medicine 64 (3) 351-354. |
Contacts
GE HealthCare Media Contact:
Emmy Elguizaoui
+1 (978) 243-7503
Emmy.Elguizaoui@gehealthcare.com
Distribution Agreement Brings LungVision® AI-Powered Image Guidance to JapanCAMPBELL, Calif.--(BUSINESS WIRE)--#AdvancedBronchoscopy--Body Vision Medical, a leader…
159 of CSNHC’s Skilled Nursing Facilities (SNFs) now have access to a CoreCare’s new AI-powered…
LOS ANGELES--(BUSINESS WIRE)--Cofertility, the human-centered fertility ecosystem offering a scalable approach to egg freezing and…
HUNTSVILLE, AL / ACCESSWIRE / June 4, 2024 / Curiteva, Inc., a privately held manufacturing…
AcuityMD now supports more than 200 MedTech companies, including leaders BD and SI-BONEBOSTON--(BUSINESS WIRE)--AcuityMD today…
Latest update brings maternal health capabilities of The Journey Pregnancy App to Fitbit’s global network…