Lantheus Continues to Commend CMS’ CY25 Rule to Enhance Payment for Specialized Diagnostic Radiopharmaceuticals and Reaffirms Outlook for PYLARIFY’s Blockbuster Status for 2025

Rhea-AI Summary

Lantheus Holdings (NASDAQ: LNTH) responds to CMS' updated payment rates for Calendar Year 2025 Medicare Hospital Outpatient Prospective Payment System. The new rules will 'unbundle' diagnostic radiopharmaceuticals, enabling separate payments for those costing over $630 per day. This change affects approximately 20% of traditional Medicare Fee for Service patients in hospital outpatient settings. PYLARIFY®, the company's PSMA PET imaging agent, is expected to exceed $1 billion in sales in 2024 and maintain its position as the #1 ordered PSMA PET imaging agent in the U.S. The new payment system will be effective January 1, 2025.

Positive

• PYLARIFY expected to exceed $1 billion in sales in 2024
• Maintains position as #1 ordered PSMA PET imaging agent in U.S.
• New CMS payment system ensures continued separate reimbursement for PYLARIFY

Negative

• None.

Insights

Healthcare Policy Analyst

The CMS policy change for 2025 represents a significant positive development for Lantheus and the radiopharmaceutical industry. The "unbundling" of diagnostic radiopharmaceuticals with costs exceeding $630 per day ensures continued separate reimbursement for PYLARIFY after its pass-through status expires. This preserves favorable economics and market access in the hospital outpatient setting for 20% of traditional Medicare patients.

PYLARIFY's projected $1 billion in 2024 sales and anticipated blockbuster status in 2025 are well-supported by this reimbursement framework. The policy change removes a key market risk and provides stability for continued growth. The separate payment model based on mean unit cost maintains appropriate valuation for innovative diagnostics, supporting both provider adoption and patient access.

BEDFORD, Mass., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, notes that the Centers for Medicare & Medicaid Services (CMS) recently posted updated payment rates in Addendum B related to the final rule for the calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS). The Company continues to commend CMS for recognizing the value of and ensuring broad patient access to specialized diagnostic radiopharmaceuticals. With PYLARIFY^® (piflufolastat F 18) on track to exceed $1 billion in sales in 2024, Lantheus reaffirms its 2025 outlook for PYLARIFY as a blockbuster brand that will continue to be the clear standard and #1 ordered PSMA PET imaging agent in the U.S.

Under the new OPPS rules, previously packaged diagnostic radiopharmaceuticals will now be “unbundled” with payments being made separately for any diagnostic radiopharmaceutical with a per day cost greater than $630. These changes enable innovative diagnostic radiopharmaceuticals, including PYLARIFY, to continue to be paid separately by CMS for the approximately twenty percent of traditional Medicare Fee for Service (FFS) patients in the hospital outpatient setting following the expiry of pass-through payment status at a rate that reflects mean unit cost. The final rule will go into effect January 1, 2025.

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.^1-6

PYLARIFY has made a profound impact on the lives of patients battling prostate cancer. It is the number one ordered PSMA PET imaging agent in the U.S., and is a proven diagnostic backed by real-world experience, including in over 400,000 scans across 48 states.

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.

Please read the accompanying full Prescribing Information also available at PYLARIFY.com.

About Lantheus

Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. 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 “will,” “continue,” “outlook” and other similar terms. Such forward-looking statements, include statements regarding expected PYLARIFY blockbuster status and ranking in the market, and 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. These uncertainties include our ability to continue market expansion and penetration for PYLARIFY in a competitive environment in which other imaging agents have been approved and are being commercialized. 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 are 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).

¹Tan 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.
²Mena 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.
³Alipour 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.
⁴Werner 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.
⁵Petersen 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
⁶PYLARIFY^® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.

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

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

FAQ

What is the expected sales forecast for Lantheus' PYLARIFY (LNTH) in 2024?

PYLARIFY is expected to exceed $1 billion in sales in 2024, maintaining its blockbuster status.

When will the new CMS payment rules affecting Lantheus (LNTH) take effect?

The new CMS payment rules for diagnostic radiopharmaceuticals will take effect on January 1, 2025.

What is the minimum cost threshold for separate CMS payments for diagnostic radiopharmaceuticals under the new 2025 rules?

Under the new rules, diagnostic radiopharmaceuticals with a per day cost greater than $630 will receive separate payments.