Zionexa US Corp., a wholly owned subsidiary of Zionexa SAS, specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, announced that Cerianna has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) code A9591 “Fluoroestradiol F 18, diagnostic, 1 millicurie” effective January 2021. Cerianna also currently has Transitional Pass-Through status in the Hospital Outpatient Prospective Payment System (OPPS) setting.
Cerianna (fluoroestradiol F-18) injection is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer (MBC). Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer. The permanent HCPCS code, A9591 “Fluoroestradiol F 18, diagnostic, 1 millicurie” will be effective January 2021.
“Having both a permanent code and Transitional Pass-Through coincide with our initial Cerianna launch January and will help us to provide broad based access to patients with all major insurers,” said Peter Webner, CEO of Zionexa USA. “We expect to launch Cerianna January 2021 in San Francisco, Los Angeles, New York, Philadelphia, Raleigh Durham, and Jacksonville.”
About Metastatic Breast Cancer
Metastatic breast cancer is the most advanced stage of breast cancer. Also called stage IV or advanced breast cancer, MBC means that the cancer has spread beyond the breast to other parts of the body. MBC affects more than 168,000 patients in the United-States.
 Mariotto et al, 2017
CERIANNA is a radioactive diagnostic agent 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
Adverse Reactions – Reported adverse reactions include: injection site pain and dysgeusia.
Radiation Risks – Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure.
Risk of Misdiagnosis – Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.
Contraindications – None.
Use in Specific Populations – Lactation: Interrupt breastfeeding.
Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration
To report SUSPECTED ADVERSE REACTIONS, contact Zionexa US Corp at +1.844.946.6392 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.