Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today
welcomes proposed changes announced by the Centers for Medicare
& Medicaid Services (CMS) for the Hospital Outpatient
Prospective Payment System (OPPS) rule to improve payments for
diagnostic radiopharmaceuticals1 for Medicare patients in the
United States (U.S.), facilitating continued patient access after
transitional pass-through payment status expires.
Under the proposed changes, diagnostic
radiopharmaceuticals including Illuccix® will continue to be paid
separately by CMS for traditional Medicare Fee for Service patients
in the hospital outpatient setting following the expiry of
transitional pass-through payment status. This would also apply to
new diagnostic products being developed by Telix, if approved.
Currently in the U.S., the costs associated with
diagnostic radiopharmaceuticals are packaged together into the
payment for the nuclear medicine tests (scans). The CMS is
proposing refinements to this policy to improve the accuracy of
overall payment amounts by paying separately for any diagnostic
radiopharmaceutical with a per day cost greater than US$630.
Kevin Richardson, CEO of Telix Americas
commented: “Telix welcomes the proposed rule, which will facilitate
more equitable and reliable access to advanced imaging for all
patients and support physicians to prescribe the most clinically
appropriate solution. We commend the vision of CMS and the
coalition, along with patient groups, for raising awareness about
the necessity to reform the payment system to enhance patient
outcomes and access. Telix is committed to continued innovation in
the field of radiopharmaceutical diagnostics to provide new
solutions to further patient access, especially for underserved
patient populations and in areas of high unmet clinical need.”
Proposed OPPS rules are published annually and have a 60-day
comment period, which will end on 9 September 2024. The final
rule will be issued in early November 2024 and take effect 1
January 2025.
About Telix
Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on
the development and commercialisation of therapeutic and diagnostic
radiopharmaceuticals and associated medical devices. Telix is
headquartered in Melbourne, Australia, with international
operations in the United States, Europe (Belgium and Switzerland),
and Japan. Telix is developing a portfolio of clinical and
commercial stage products that aims to address significant unmet
medical needs in oncology and rare diseases. Telix is listed on the
Australian Securities Exchange (ASX: TLX).
Telix’s lead imaging product, gallium-68 (68Ga)
gozetotide injection (also known as 68Ga PSMA-11 and marketed under
the brand name Illuccix®), has been approved by the U.S. Food and
Drug Administration (FDA)2, by the Australian Therapeutic Goods
Administration (TGA) 3, and by Health Canada4. No other Telix
product has received a marketing authorisation in any
jurisdiction.
Visit www.telixpharma.com for further
information about Telix, including details of the latest share
price, announcements made to the ASX, investor and analyst
presentations, news releases, event details and other publications
that may be of interest. You can also follow Telix on X and
LinkedIn.
Telix Investor Relations
Ms. Kyahn WilliamsonTelix Pharmaceuticals
LimitedSVP Investor Relations and Corporate CommunicationsEmail:
kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix
Pharmaceuticals Limited Disclosure Committee on behalf of the
Board.
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The information contained in this announcement
is not intended to be an offer for subscription, invitation or
recommendation with respect to shares of Telix Pharmaceuticals
Limited (Telix) in any jurisdiction, including the United States.
No representation or warranty, express or implied, is made in
relation to the accuracy or completeness of the information
contained or opinions expressed in the course of this announcement.
The information contained in this announcement is subject to change
without notification.
This announcement may contain forward-looking
statements that relate to anticipated future events, financial
performance, plans, strategies or business developments.
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materially from any future results, levels of activity, performance
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good-faith assumptions as to the financial, market, regulatory and
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that any of the assumptions will prove to be correct. In the
context of Telix’s business, forward-looking statements may
include, but are not limited to, statements about: the initiation,
timing, progress and results of Telix’s preclinical and clinical
studies, and Telix’s research and development programs; Telix’s
ability to advance product candidates into, enrol and successfully
complete, clinical studies, including multi-national clinical
trials; the timing or likelihood of regulatory filings and
approvals, manufacturing activities and product marketing
activities; the commercialisation of Telix’s product candidates, if
or when they have been approved; estimates of Telix’s expenses,
future revenues and capital requirements; Telix’s financial
performance; developments relating to Telix’s competitors and
industry; and the pricing and reimbursement of Telix’s product
candidates, if and after they have been approved. Telix’s actual
results, performance or achievements may be materially different
from those which may be expressed or implied by such statements,
and the differences may be adverse. Accordingly, you should not
place undue reliance on these forward-looking statements. You
should read this announcement together with our risk factors, as
disclosed in our most recently filed reports with the ASX or on our
website.
To the maximum extent permitted by law, Telix
disclaims any obligation or undertaking to publicly update or
revise any forward-looking statements contained in this
announcement, whether as a result of new information, future
developments or a change in expectations or assumptions.
©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®
and Illuccix® names and logos are trademarks of Telix
Pharmaceuticals Limited and its affiliates – all rights
reserved.
1 CMS Press Release 10 July 2024:
https://www.cms.gov/newsroom/fact-sheets/cy-2025-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center
2 Telix ASX disclosure 20 December 2021.3 Telix ASX disclosure 2
November 2021.4 Telix ASX disclosure 14 October 2022.