Benzinga | Nov 22, 2021 08:35AM EST

Lantheus Announces Centers For Medicare & Medicaid Services Grants Transitional Pass-Through Payment For PYLARIFY Injection, Effective January 1, 2022

Lantheus Holdings, Inc. (the "Company") (NASDAQ:LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that the Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through Payment Status for PYLARIFY(r) (piflufolastat F 18) injection effective January 1, 2022. Transitional Pass-Through Payment Status enables Medicare to provide an incremental payment for PET-CT scans done with PYLARIFY in the hospital outpatient setting.

"We have been thrilled with the response to PYLARIFY in the prostate cancer community," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "PYLARIFY is a transformative diagnostic tool that identifies disease earlier and more accurately than conventional imaging, providing more information to guide treatment decisions. The granting of Transitional Pass-Through Payment Status for PYLARIFY further facilitates patient access to our game-changing PSMA-targeted imaging agent for prostate cancer."

PYLARIFY is a radioactive diagnostic agent indicated for PET imaging of PSMA positive lesions in men with prostate cancer: with suspected metastasis who are candidates for initial definitive therapy and/or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. PYLARIFY was approved by the U.S. Food and Drug Administration (FDA) in May 2021 after being granted Priority Review Status and remains the first and only commercially available PSMA-targeted PET imaging agent for prostate cancer.

Prostate cancer is the second most common form of cancer affecting men in the United States. An estimated one in eight men will be diagnosed with prostate cancer in their lifetime and the American Cancer Society estimates that in 2021, almost 250,000 new cases of prostate cancer will be diagnosed, and more than 30,000 men will die of the disease. Approximately 3.1 million men in the United States live with this disease.1