Blue Earth Diagnostics, a Bracco Company, Lauds CMS Proposal to Support Patient Access Through Improved Payment for Specialized Diagnostic Radiopharmaceuticals
15 Julio 2024 - 7:30AM
Business Wire
Bracco and Blue Earth Diagnostics Ltd, a Bracco company and
recognized leader in the development and commercialization of
innovative PET radiopharmaceuticals, welcomes proposed changes
announced on July 10, 2024, by the Centers for Medicare &
Medicaid Services (CMS) for the Hospital Outpatient Prospective
Payment System (OPPS) Rule. The rule is designed to improve
payments for diagnostic radiopharmaceuticals for U.S. Medicare
patients, and has the potential to increase access to innovative
radiopharmaceuticals that have lost, or will lose, their
Transitional Pass-Through payment status. Blue Earth Diagnostics
has been a pioneer in championing the discussions with CMS to
secure this rule change.
“We are excited about this proposed CMS rule, which will
increase patient access to advanced diagnostic imaging products to
inform patient management, and, at the same time, enhance industry
innovation and sustainability,” said Marco Campione, Chief
Executive Officer of Blue Earth Diagnostics.
“Adoption of innovative radiopharmaceutical products, and
importantly, patient access to these products, has been hampered
for years by limitations of the CMS payment methodology,” added
Terri Wilson, President, Blue Earth Diagnostics, Inc. “In the case
of Blue Earth Diagnostics, this new proposed rule will support our
entire portfolio of diagnostic imaging agents. POSLUMA®
(flotufolastat F 18) will maintain its Pass-Through payment status
for diagnostic imaging radiopharmaceutical reimbursement until
September 30, 2026. Upon passage of the proposed rule, Axumin®
(fluciclovine F 18), which previously lost Pass-Through status in
January 2020, will gain separate payment.”
The proposed OPPS rule requires further refinement over a 60-day
comment period. Blue Earth Diagnostics is looking forward to
continued cooperation with CMS to determine necessary details to
identify the new separate payment rates (which are proposed to
differ from those under Transitional Pass-Through), build a model
for future adjustments and ensure successful implementation of the
rule. The final rule will be issued in early November 2024 and take
effect January 1, 2025.
Indication and Important Safety
Information About Axumin
INDICATION
Axumin® (fluciclovine F 18) injection is indicated for positron
emission tomography (PET) imaging in men with suspected prostate
cancer recurrence based on elevated blood prostate specific antigen
(PSA) levels following prior treatment.
IMPORTANT SAFETY INFORMATION
- Image interpretation errors can occur with Axumin PET imaging.
A negative image does not rule out recurrent prostate cancer and a
positive image does not confirm its presence. The performance of
Axumin seems to be affected by PSA levels. Axumin uptake may occur
with other cancers and benign prostatic hypertrophy in primary
prostate cancer. Clinical correlation, which may include
histopathological evaluation, is recommended.
- Hypersensitivity reactions, including anaphylaxis, may occur in
patients who receive Axumin. Emergency resuscitation equipment and
personnel should be immediately available.
- Axumin use contributes to a patient’s overall long-term
cumulative radiation exposure, which is associated with an
increased risk of cancer. Safe handling practices should be used to
minimize radiation exposure to the patient and health care
providers.
- Adverse reactions were reported in ≤ 1% of subjects during
clinical studies with Axumin. The most common adverse reactions
were injection site pain, injection site erythema and
dysgeusia.
To report suspected adverse reactions to Axumin, call
1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Full Axumin prescribing information is available at
https://www.axumin.com/prescribing-information.pdf.
Indication and Important Safety
Information About POSLUMA
INDICATION
POSLUMA® (flotufolastat F 18) injection is 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
- Image interpretation errors can occur with POSLUMA PET. 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 POSLUMA for imaging metastatic pelvic
lymph nodes in patients prior to initial definitive therapy seems
to be affected by serum PSA levels and risk grouping. The
performance of POSLUMA for imaging patients with biochemical
evidence of recurrence of prostate cancer seems to be affected by
serum PSA levels. Flotufolastat F 18 uptake is not specific for
prostate cancer and may occur in other types of cancer, in
non-malignant processes, and in normal tissues. Clinical
correlation, which may include histopathological evaluation, is
recommended.
- Risk of Image Misinterpretation in Patients with Suspected
Prostate Cancer Recurrence: The interpretation of POSLUMA PET may
differ depending on imaging readers, particularly in the
prostate/prostate bed region. Because of the associated risk of
false positive interpretation, consider multidisciplinary
consultation and histopathological confirmation when clinical
decision-making hinges on flotufolastat F 18 uptake only in the
prostate/prostate bed region or only on uptake interpreted as
borderline.
- POSLUMA use contributes to a patient’s overall long-term
cumulative radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk for cancer. Advise
patients to hydrate before and after administration and to void
frequently after administration. Ensure safe handling to minimize
radiation exposure to the patient and health care providers.
- The adverse reactions reported in ≥0.4% of patients in clinical
studies were diarrhea, blood pressure increase and injection site
pain.
- 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 flotufolastat F 18
in prostate cancer. The effect of these therapies on performance of
POSLUMA PET has not been established.
To report suspected adverse reactions to POSLUMA, call
1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Full POSLUMA prescribing information is available at
www.posluma.com/prescribing-information.pdf.
About Blue Earth Diagnostics
Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging
S.p.A., is a growing international molecular imaging company
focused on delivering innovative, well-differentiated diagnostic
solutions that inform patient care. Formed in 2014, the Company’s
success is driven by its management expertise and supported by a
demonstrated track record of rapid development and
commercialization of positron emission tomography (PET)
radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology
portfolio encompasses a variety of disease states, including
prostate cancer and neuro-oncology. Blue Earth Diagnostics is
committed to the timely development and commercialization of
precision radiopharmaceuticals for potential use in imaging and
therapy. For more information, please visit:
www.blueearthdiagnostics.com.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is a
world-leading diagnostic imaging provider. Headquartered in Milan,
Italy, Bracco Imaging develops, manufactures and markets diagnostic
imaging agents and solutions. It offers a product and solution
portfolio for all key diagnostic imaging modalities: X-ray imaging
(including Computed Tomography-CT, Interventional Radiology, and
Cardiac Catheterization), Magnetic Resonance Imaging (MRI),
Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through
radioactive tracers and novel PET imaging agents to inform clinical
management and guide care for cancer patients in areas of unmet
medical need. Our continually evolving portfolio is completed by a
range of medical devices, advanced administration systems and
dose-management software. In 2019 Bracco Imaging enriched its
product portfolio by expanding the range of oncology nuclear
imaging solutions in the urology segment and other specialties with
the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging
established Blue Earth Therapeutics as a separate, cutting-edge
biotechnology vehicle to develop radiopharmaceutical therapies.
Visit: www.braccoimaging.com.
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For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice
President, Corporate Communications (M) (781) 799-7917
priscilla.harlan@blueearthdx.com
For Blue Earth Diagnostics (UK) Clare Gidley Associate
Director Marketing and Communications Tel: +44 (0)1865 784186
clare.gidley@blueearthdx.com
Media Sam Brown Inc. Mike Beyer (M) (312) 961-2502
mikebeyer@sambrown.com