Lantheus Applauds CMS’ CY25 Rule to Enhance Payment for Specialized Diagnostic Radiopharmaceuticals, Advancing Patient Access and Care
Lantheus Holdings (NASDAQ: LNTH) welcomes the Centers for Medicare & Medicaid Services' (CMS) final rule for calendar year 2025 Medicare Hospital Outpatient Prospective Payment System. The new rule, effective January 1, 2025, will 'unbundle' diagnostic radiopharmaceuticals and provide separate payments for products with daily costs exceeding $630. This change ensures continued separate payment for innovative products like PYLARIFY® after pass-through payment status expires, improving access for traditional Medicare Fee for Service patients in hospital outpatient settings.
Lantheus Holdings (NASDAQ: LNTH) accoglie con favore la regola finale dei Centers for Medicare & Medicaid Services (CMS) per il sistema di pagamento prospettico per gli ospedali Medicare per l'anno solare 2025. La nuova regola, che entrerà in vigore il 1° gennaio 2025, 'separerà' i radiofarmaci diagnostici e fornirà pagamenti separati per i prodotti con costi giornalieri superiori a 630 $. Questa modifica garantisce un pagamento separato continuo per prodotti innovativi come PYLARIFY® dopo la scadenza dello status di pagamento pass-through, migliorando l'accesso per i pazienti del tradizionale Medicare Fee for Service negli ospedali ambulatoriali.
Lantheus Holdings (NASDAQ: LNTH) da la bienvenida a la regla final de los Centros de Servicios de Medicare y Medicaid (CMS) para el Sistema de Pago Prospectivo de Pacientes Ambulatorios de Medicare para el año calendario 2025. La nueva regla, que entrará en vigor el 1 de enero de 2025, 'desagregará' los radiofármacos diagnósticos y proporcionará pagos separados para productos con costos diarios que superen los 630 $. Este cambio asegura el pago separado continuo para productos innovadores como PYLARIFY® después de que expire el estado de pago por traspaso, mejorando el acceso para los pacientes del Medicare Fee for Service tradicional en entornos ambulatorios hospitalarios.
Lantheus Holdings (NASDAQ: LNTH)는 Medicare 및 Medicaid 서비스 센터(CMS)의 2025 회계연도 병원 외래 진료 지급 시스템 최종 규정을 환영합니다. 2025년 1월 1일부터 시행되는 이 새로운 규칙은 진단 방사성 의약품을 '분리'하여 일일 비용이 630달러를 초과하는 제품에 대해 별도의 지급을 제공합니다. 이 변화는 PYLARIFY®와 같은 혁신적인 제품의 지급이 통과 지급 상태 종료 이후에도 계속 이루어지도록 보장하며, 병원 외래 환경에서 전통적인 Medicare 서비스 요금제 환자들의 접근성을 개선합니다.
Lantheus Holdings (NASDAQ: LNTH) se félicite de la règle finale des Centers for Medicare & Medicaid Services (CMS) concernant le système de paiement prospectif pour les hôpitaux Medicare pour l'année 2025. La nouvelle règle, qui entrera en vigueur le 1er janvier 2025, 'dégroupement' les radio-pharmaceutiques diagnostiques et fournira des paiements séparés pour les produits dont les coûts journaliers dépassent 630 $. Ce changement garantit un paiement séparé continu pour des produits innovants comme PYLARIFY® après l'expiration du statut de paiement par passage, améliorant l'accès pour les patients traditionnels de Medicare Fee for Service dans les établissements hospitaliers ambulatoires.
Lantheus Holdings (NASDAQ: LNTH) begrüßt die endgültige Regelung der Centers for Medicare & Medicaid Services (CMS) für das Medicare Krankenhaus-Ambulanz-Zahlungssystem für das Kalenderjahr 2025. Die neue Regel, die am 1. Januar 2025 in Kraft tritt, wird diagnostische Radiopharmazeutika 'entkoppeln' und separate Zahlungen für Produkte mit täglichen Kosten über 630 $ bereitstellen. Diese Änderung gewährleistet eine fortgesetzte separate Zahlung für innovative Produkte wie PYLARIFY®, nachdem der Status der Durchlaufzahlung abgelaufen ist, und verbessert den Zugang für traditionelle Medicare Fee for Service-Patienten in Krankenhaus-Ambulanz-Einrichtungen.
- New CMS payment rule ensures separate reimbursement for PYLARIFY® and other qualifying radiopharmaceuticals
- Improved payment structure potentially increases product accessibility and market reach
- Enhanced reimbursement model supports long-term business sustainability
- Only products with daily costs exceeding $630 qualify for separate payments
Insights
This CMS payment reform represents a significant shift in Medicare reimbursement policy that will have substantial financial implications for Lantheus. The unbundling of diagnostic radiopharmaceuticals with per day costs exceeding
The policy change strengthens Lantheus' market position by ensuring predictable reimbursement flows and reducing barriers to hospital adoption. This particularly benefits PYLARIFY, their flagship PSMA-PET imaging agent for prostate cancer, by maintaining favorable economics for healthcare providers. The timing of implementation in January 2025 allows for smooth transition planning and should support continued market penetration of their diagnostic portfolio.
BEDFORD, Mass., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, applauds the Centers for Medicare & Medicaid Services’ (CMS) final rule for the calendar year 2025 Medicare Hospital Outpatient Prospective Payment System (OPPS). The rule, announced and detailed on the CMS website late Friday, recognizes the value of and ensures broad patient access to specialized diagnostic radiopharmaceuticals by improving the accuracy of payment amounts for these products.
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
“Today’s landmark decision by CMS is a win for broader and more equitable patient access and supports long term innovation in the field of diagnostic radiopharmaceuticals,” said Brian Markison, Chief Executive Officer of Lantheus. “At Lantheus, we applaud all those involved in spearheading reform of the payment structure for these potentially life-altering diagnostic tools for underserved populations with high unmet needs. We remain focused on supporting physicians and hospitals with our diagnostic radiopharmaceuticals to help achieve better patient outcomes for traditional Medicare FFS beneficiaries.”
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 ≤
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” 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 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
When will the new CMS payment rule for Lantheus (LNTH) radiopharmaceuticals take effect?
What is the cost threshold for separate payments under the new CMS rule for Lantheus (LNTH) products?
How does the new CMS rule affect Lantheus's (LNTH) PYLARIFY® reimbursement?
