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, announced that it welcomes the Centers for
Medicare & Medicaid Services’ (CMS’) Proposed Medicare Hospital
Outpatient Prospective Payment System (OPPS) Rule for calendar year
2025 for improved payment for specialized diagnostic
radiopharmaceuticals to support patient access for Medicare
beneficiaries.
Today, CMS shared its proposed refinements to the existing
packaging policy to improve the accuracy of the overall payment
amounts by paying separately for any diagnostic radiopharmaceutical
with a per day cost greater than $630. Under current OPPS rules,
the costs associated with diagnostic radiopharmaceuticals are
packaged into the payment for the nuclear medicine tests. In the
proposed rule, innovative diagnostic radiopharmaceuticals,
including PYLARIFY, would continue to be paid separately by CMS for
traditional Medicare Fee for Service patients in the hospital
outpatient setting following the expiry of traditional pass-through
payment status. Proposed rules are published annually and will have
a 60-day comment period, which will end on September 9, 2024. The
final rule will be issued in early November and take effect January
1, 2025.
"At Lantheus, we advocate for equitable access to advanced
diagnostic radiopharmaceuticals to aid providers in diagnosing and
staging disease, ultimately leading to better patient outcomes,”
said Brian Markison, Chief Executive Officer of Lantheus. “We are
pleased that the proposed rules recognize the value of diagnostic
radiopharmaceuticals, including PYLARIFY, and the need to change
the current payment system. We will work with coalition partners
and advocates to enact separate payment for 2025, while continuing
to implement multi-faceted strategies to maintain patient
access.”
About PYLARIFY® (piflufolastat F
18) InjectionPYLARIFY® (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 350,000 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 MisinterpretationImaging
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 RisksDiagnostic 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 ReactionsThe 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 “would,”
“will,” “continuing” 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 inclusion of separate diagnostic
radiopharmaceutical payment in CMS’s final rule; (ii) the timing of
the implementation and duration of such a separate payment as part
the implementation of a final rule; (iii) the success of our
multi-faceted strategies to maintain patient access; and (vi) 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).
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/s40644-020-02906PYLARIFY® [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
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