Telix Welcomes CMS Decision to Improve Payments for Diagnostic Radiopharmaceuticals
Telix Welcomes CMS Decision to Improve Payments for Diagnostic Radiopharmaceuticals
MELBOURNE, Australia, Nov. 4, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today welcomes the announcement by the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) that it will pay separately for specialised diagnostic radiopharmaceuticals[1] for Medicare Fee for Service patients in the hospital outpatient setting, beyond the transitional pass-through payment period ("pass-through"). This is a significant decision for patients and hospitals, with the change facilitating equitable access to advanced imaging agents for all patients into the future.
澳大利亞墨爾本,2024年11月4日 /PRNewswire/ — Telix Pharmicals Limited(澳大利亞證券交易所股票代碼:TLX、Telix、該公司)今天對美國(美國)的宣佈表示歡迎醫療保險和醫療補助服務中心(CMS)表示,在過渡性直通支付期(「直通」)之後,它將單獨爲醫院門診服務患者的醫療保險費用支付專業診斷放射藥物 [1]。對於患者和醫院來說,這是一個重大決定,這一變化促進了未來所有患者公平獲得先進成像藥劑的機會。
In 2025, the separate payments under the Hospital Outpatient Prospective Payment System (OPPS) will be based on Mean Unit Cost (MUC), derived from hospital claims data and apply to any specialised diagnostic radiopharmaceutical without pass-through status and with a threshold per day cost greater than US$630.
2025年,醫院門診預期支付系統(OPPS)下的單獨付款將基於平均單位成本(MUC),該費用來自醫院索賠數據,適用於任何沒有直通身份且每日費用門檻超過630美元的專業診斷放射性藥物。
The new rule ensures consistent reimbursement for Medicare Fee for Service patients, following expiry of pass-through status. For physicians and patients in the hospital outpatient setting this will enable purchasing decisions to be made based on the latest clinically significant diagnostic tools and evidence of utility, and not purely on reimbursement structure. For commercial radiopharmaceutical innovators such as Telix, this provides greater certainty and consistency in pricing policy across all customer segments.
新規定確保在直通身份到期後,向服務患者持續報銷醫療保險費用。對於住院門診的醫生和患者來說,這將使購買決策能夠根據最新的臨床重要診斷工具和效用證據來做出,而不僅僅是基於報銷結構。對於像Telix這樣的商業放射性藥物創新者來說,這爲所有客戶群的定價政策提供了更大的確定性和一致性。
The new separate payment rule will apply to Illuccix after its pass-through status expires, from July 1, 2025. It will also apply to Telix's pipeline of investigational diagnostic imaging agents – TLX007-CDx, a new product for PSMA imaging of prostate cancer, TLX250-CDx (Zircaix[2]) for kidney cancer imaging, and TLX101-CDx (Pixclara[2]) for brain cancer (glioma) imaging – if approved and reimbursed under CMS, and after pass-through expires.
從2025年7月1日起,在Illuccix的直通身份到期後,新的單獨付款規則將適用於Illuccix。它還將適用於Telix的研究性診斷成像藥物產品線——TLx007-CDX,一種用於前列腺癌PSMA成像的新產品,用於腎癌成像的TLx250-CDX(Zircaix [2]),以及用於腦癌(神經膠質瘤)成像的TLx101-CDX(Pixclara [2]),如果獲得CMS的批准和報銷,並且在直通到期之後。
Telix has continued to invest in innovation in prostate cancer imaging for the benefit of physicians and patients. Should TLX007-CDx be approved in the U.S.[3], Telix will be the only company with two PSMA-PET imaging agents on the market, enabling broader patient reach, including into currently underserved populations, and with greater flexibility to offer the product most suitable for a patient based on their clinical profile, indication and eligibility for reimbursement. This may be particularly beneficial for any Medicare patients currently subject to a copayment in hospital outpatient settings.
Telix繼續投資於前列腺癌成像創新,以造福醫生和患者。如果TLX007-CDx在美國獲得批准 [3],Telix將成爲唯一一家在市場上擁有兩種PSMA-PET成像藥物的公司,這將擴大患者的覆蓋範圍,包括覆蓋目前服務不足的人群,並且可以根據患者的臨床狀況、適應症和報銷資格更靈活地提供最適合患者的產品。這對於目前在醫院門診環境中需要自付的任何醫療保險患者可能特別有益。
Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, "Telix welcomes the decision by CMS to unbundle payments for diagnostic radiopharmaceuticals, as it will provide certainty for patients and physicians seeking access to safe and effective diagnostic radiopharmaceuticals. Moreover, it will promote continued investment in bringing new imaging agents to market across a range of disease states, as there is a clear commercial pathway to recouping the investment in innovation and the significant infrastructure and operational costs of delivering high quality service to patients. As a leading innovator in precision medicine and diagnostic radiopharmaceuticals, we are pleased to see the reimbursement landscape change in favour of patients. This will ensure continued access to advanced imaging agents that provide meaningful information to drive treatment decisions and outcomes for cancer patients."
Telix精準醫療首席執行官凱文·理查森表示:「Telix歡迎CMS決定取消診斷放射性藥物的支付,因爲這將爲尋求獲得安全有效的診斷放射性藥物的患者和醫生提供確定性。此外,它將促進持續投資,將新的成像藥物推向各個疾病州的市場,因爲有一條明確的商業途徑可以收回創新投資以及爲患者提供高質量服務的巨額基礎設施和運營成本。作爲精準醫療和診斷放射藥物領域的領先創新者,我們很高興看到報銷格局向患者傾斜。這將確保持續獲得先進的成像藥物,這些藥物提供有意義的信息,以推動癌症患者的治療決策和結果。」
About Telix Pharmaceuticals Limited
關於泰利克斯製藥有限公司
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是一家生物製藥公司,專注於治療和診斷放射性藥物及相關醫療設備的開發和商業化。Telix總部位於澳大利亞墨爾本,在美國、歐洲(比利時和瑞士)和日本開展國際業務。Telix正在開發臨床和商業階段產品組合,旨在解決腫瘤學和罕見疾病中未滿足的重大醫療需求。Telix在澳大利亞證券交易所 (ASX: TLX) 上市。
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)[4], by the Australian Therapeutic Goods Administration (TGA) [5], and by Health Canada[6]. No other Telix product has received a marketing authorisation in any jurisdiction.
Telix的主要成像產品鎵-68(68Ga)戈澤託肽注射液(也稱爲68Ga PSMA-11,以Illuccix品牌銷售)已獲得美國食品藥品監督管理局(FDA)[4]、澳大利亞治療用品管理局(TGA)[5] 和加拿大衛生部 [6] 的批准。沒有其他Telix產品在任何司法管轄區獲得上市許可。
Visit 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.
訪問了解有關Telix的更多信息,包括最新股價的詳細信息,向澳大利亞證券交易所發佈的公告,投資者和分析師的演講,新聞稿,活動詳情以及其他可能感興趣的出版物。你也可以在 X 和 LinkedIn 上關注 Telix。
Telix Investor Relations
Telix 投資者關係
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
凱恩·威廉姆森女士
泰利克斯製藥有限公司
投資者關係和企業傳播高級副總裁
電子郵件:kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
本公告已獲Telix Pharmicals Limited披露委員會代表董事會授權發佈。
Legal Notices
法律聲明
You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website.
您應閱讀本公告以及我們的風險因素,正如我們在最近向澳大利亞證券交易所(ASX)或我們的網站上提交的報告中所披露的那樣。
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. 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.
本公告中包含的信息無意成爲包括美國在內的任何司法管轄區的Telix Pharmicals Limited(Telix)證券的認購、邀請或推薦要約。本公告中包含的信息和觀點如有更改,恕不另行通知。在法律允許的最大範圍內,Telix不承擔任何義務或承諾更新或修改本公告中包含的任何信息或觀點,包括任何前瞻性陳述(如下所述),無論這些信息或觀點是由於新信息、未來發展、預期或假設的變化還是其他原因造成的。對於本公告中包含的信息或表達的觀點的準確性或完整性,不作任何明示或暗示的陳述或保證。
This announcement may contain forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance 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 trials, 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 for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; 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.
本公告可能包含與預期的未來事件、財務業績、計劃、戰略或業務發展相關的前瞻性陳述。前瞻性陳述通常可以通過使用 「可能」、「期望」、「打算」、「計劃」、「估計」、「預測」、「相信」、「展望」、「展望」、「預測」 和 「指導」 等詞語來識別,或者這些詞語的否定詞或其他類似術語或表達。前瞻性陳述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致我們的實際業績、活動水平、業績或成就與這些前瞻性陳述所表達或暗示的任何未來業績、活動水平、業績或成就存在重大差異。前瞻性陳述基於Telix對存在並影響Telix未來業務和運營的財務、市場、監管和其他風險和考慮因素的真誠假設,無法保證任何假設都會被證明是正確的。在Telix的業務背景下,前瞻性陳述可能包括但不限於以下方面的陳述:Telix臨床前和臨床試驗的啓動、時間、進展和結果,以及Telix的研發計劃;Telix推進候選產品進入、註冊和成功完成臨床研究(包括多國臨床試驗)的能力;監管機構申報和批准Telix的時間或可能性候選產品、製造活動和產品營銷活動;Telix的銷售,營銷、分銷和製造能力和戰略;Telix候選產品的商業化(如果或當它們獲得批准);Telix以合理的成本爲其產品和候選產品獲得充足的原材料供應的能力;對Telix支出、未來收入和資本需求的估計;Telix的財務業績;與Telix競爭對手和行業相關的發展;以及Telix候選產品的定價和報銷,前提是它們已獲得批准。Telix的實際業績、業績或成就可能與此類陳述所表達或暗示的業績、業績或成就存在重大差異,而且差異可能是負面的。因此,您不應過分依賴這些前瞻性陳述。
2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals, Illuccix, Pixclara2 and Zircaix2 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
2024 泰利克斯製藥有限公司。Telix Pharmicals、Illuccix、Pixclara2和Zircaix2的名稱和徽標是Telix Pharmicals Limited及其附屬公司的商標——版權所有。
[1] CMS press release 1 November 2024: ; CMS fact sheet 1 November 2024: |
[2] Brand name subject to final regulatory approval. |
[3] TLX007-CDx Prescription Drug User Fee Act (PDUFA) goal date March 24, 2025. Telix ASX disclosure 23 July 2024. |
[4] Telix ASX disclosure 20 December 2021. |
[5] Telix ASX disclosure 2 November 2021. |
[6] Telix ASX disclosure 14 October 2022. |
[1] 2024 年 11 月 1 日 CMS 新聞稿:;2024 年 11 月 1 日的 CMS 情況說明書: |
[2] 品牌名稱尚待監管部門的最終批准。 |
[3] TLx007-CDX《處方藥使用者費用法》(PDUFA)的目標日期爲2025年3月24日。Telix ASX 2024 年 7 月 23 日披露。 |
[4] Telix ASX 2021 年 12 月 20 日披露。 |
[5] Telix ASX 2021 年 11 月 2 日披露。 |
[6] Telix ASX 2022年10月14日披露。 |
譯文內容由第三人軟體翻譯。