Lantheus Announces CMS Grants Transitional Pass-Through Payment for PYLARIFY® (piflufolastat F 18) Injection, Effective January 1, 2022

Rhea-AI Summary

Lantheus Holdings, Inc. (NASDAQ: LNTH) announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through Payment Status for PYLARIFY (piflufolastat F 18) effective January 1, 2022. This payment status allows Medicare to provide additional payments for PET-CT scans using PYLARIFY in hospital outpatient settings. PYLARIFY is the first FDA-approved PSMA-targeted PET imaging agent for prostate cancer, enhancing early disease detection. Prostate cancer remains a significant health issue, with nearly 250,000 cases expected in 2021 alone.

Positive

• CMS granted Transitional Pass-Through Payment Status for PYLARIFY, effective January 1, 2022, enhancing patient access.
• PYLARIFY is the first FDA-approved PSMA-targeted PET imaging agent, marking a significant advancement in prostate cancer diagnostics.

Negative

• None.

PYLARIFY is the first and only commercially available, FDA-approved PSMA-targeted PET imaging agent for prostate cancer

NORTH BILLERICA, Mass., Nov. 22, 2021 (GLOBE NEWSWIRE) -- 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® (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

About PYLARIFY^® (piflufolastat F 18) Injection
PYLARIFY^® (piflufolastat F 18) injection (also known as ¹⁸F-DCFPyL or PyL) is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. For men with prostate cancer, PYLARIFY PET combines the accuracy of PET imaging, the precision of PSMA targeting and the clarity of an F 18 radioisotope for superior diagnostic performance. The recommended PYLARIFY dose is 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection.^2-7

PYLARIFY® (piflufolastat F 18) Injection
Indication
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• with suspected metastasis who are candidates for initial definitive therapy.
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Important Safety Information
Contraindications
None.

Warnings and Precautions
Risk of Image Misinterpretation
Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions
The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug interactions
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and 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. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY^® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; PYLARIFY^®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; TechneLite^® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA^® for the treatment of certain rare neuroendocrine tumors; and RELISTOR^® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “anticipate,” “believe,” “confident,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the Company’s ability to successfully launch PYLARIFY as a commercial product, including (A) Lantheus’ ability to obtain FDA approval for additional PET manufacturing facilities (PMFs) that could manufacture PYLARIFY, (B) the ability of those PMFs to supply PYLARIFY to customers, and (C) Lantheus’ ability to sell PYLARIFY to customers; and (ii) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q), including, but not limited to those related to PYLARIFY.

¹American Cancer Society. Facts & Figures 2021. American Cancer Society. Atlanta, GA. 2021.
²Tan N, Oyoyo U, Bavadian N, et al. PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis. Radiology. 2020;296:44-55. doi:10.1148/radiol.2020191689
³Mena et al. 18 F-DCFPyL PET/CT Imaging in Patients with Biochemically Recurrent Prostate Cancer After Primary Local Therapy J Nucl Med 2020 Jun;61(6):881-889. doi: 10.2967/jnumed.119.234799. Epub 2019 Nov 1.
⁴Alipour et al. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019; 11: 1758835919876828.
⁵Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.
⁶Petersen LJ, Zacho HD. PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review. Cancer Imaging. 2020;20(1):1-8. doi:10.1186/s40644-020-0290
⁷PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company

Contacts:
Mark Kinarney
Senior Director, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Director, Corporate Communications
646-975-2533
media@lantheus.com

FAQ

What is PYLARIFY and its significance for prostate cancer?

PYLARIFY (piflufolastat F 18) is the first FDA-approved PSMA-targeted PET imaging agent for prostate cancer, allowing for earlier and more accurate disease detection.

When did CMS grant Transitional Pass-Through Payment Status for PYLARIFY?

CMS granted Transitional Pass-Through Payment Status for PYLARIFY effective January 1, 2022.

How many new prostate cancer cases are estimated for 2021?

In 2021, nearly 250,000 new cases of prostate cancer are expected to be diagnosed in the United States.

What are the potential adverse reactions associated with PYLARIFY?

The most frequently reported adverse reactions for PYLARIFY include headaches, dysgeusia, and fatigue, occurring at rates of ≤2% during clinical studies.

What is the role of PYLARIFY in PET imaging for prostate cancer?

PYLARIFY enables visualization of PSMA positive lesions, aiding in the detection of recurrent and metastatic prostate cancer.