share_log

Telix Welcomes CMS Decision to Improve Payments for Diagnostic Radiopharmaceuticals

Telix Welcomes CMS Decision to Improve Payments for Diagnostic Radiopharmaceuticals

Telix 歡迎 康哲藥業 決定改善診斷放射性藥物的付款方式
PR Newswire ·  11/04 06:07

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 Pharmaceuticals Limited (ASX: TLX,Telix,該公司) 今天歡迎美國 (U.S.) 醫療保險與醫療補助服務中心 (CMS) 宣佈,將爲醫院門診設置的專業診斷性放射性藥物[1] 就醫費用分開支付,超過過渡性過渡期 ("過渡")。這對患者和醫院來說是一個重要的決定,這一改變將有助於未來所有患者平等獲取先進成像藥劑。

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.

到2025年,醫院門診前瞻性支付系統 (OPPS) 下的分開付款將基於醫院索賠數據推導出的平均單位成本 (MUC),適用於沒有過渡性地位並且每天成本超過630美元的任何專業診斷性放射性藥物。

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.

新規定確保了醫療保險服務患者在過渡性地位到期後可獲得一致的補償。對醫院門診設置的醫生和患者來說,這將使購買決策基於最新的臨床重要診斷工具和效用證據,而不僅僅基於報銷結構。對於Telix等商業放射性藥物創新者,這爲所有客戶群體提供了更大的價格政策確定性和一致性。

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.

新的分開支付規則將在 '過渡' 狀態過期後,即從2025年7月1日開始適用於Illuccix。如果獲得CMS批准和報銷,並且過渡期過後,也將適用於Telix的調查診斷成像試劑系列 - TLX007-CDx,用於前列腺癌的PSMA成像的新產品,TLX250-CDx (Zircaix[2]),用於腎癌成像,以及TLX101-CDx (Pixclara[2]) 用於腦癌 (膠質瘤) 成像 - 。

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一直在爲醫生和患者的利益在前列進行前列前列癌症成像的創新投資。如果TLX007-CDx在美國獲得批准[3],Telix將成爲市場上唯一擁有兩種PSMA-PEt成像劑的公司,使患者覆蓋面更廣,包括目前受到忽視的人群,也更具靈活性,根據患者的臨床資料,適應症和報銷資格,提供最適合的產品。對於目前在醫院門診設置中需要支付部分費用的任何Medicare患者,這可能尤爲有益。

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."

Precision Medicine的首席執行官Kevin Richardson表示:「Telix歡迎CMS解除對診斷放射製劑的支付捆綁,因爲這將爲尋求接觸安全有效的診斷放射製劑的患者和醫生提供確定性。此外,它將促進繼續投資,將新的成像劑推向市場,覆蓋多種疾病狀態,因爲有明確的商業途徑來收回對創新投資和提供高質量服務給患者的重要基礎設施和運營成本。作爲精準醫學和診斷放射製劑領域的領先創新者,我們很高興看到報銷景觀有利於患者的變化。這將確保繼續使用提供有意義信息以推動癌症患者治療決策和結果的先進成像劑。」

About Telix Pharmaceuticals Limited

關於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是一家專注於治療和診斷放射藥物及相關醫療設備的生物製藥公司。Telix總部位於澳大利亞墨爾本,國際業務遍及美國、歐洲(比利時和瑞士)以及日本。Telix正在開發一系列臨床和商業化階段的產品,旨在解決腫瘤學和罕見病領域的重大醫療需求。Telix在澳大利亞證券交易所上市(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)[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的領先成像產品鎵-68(68Ga)gozetotide注射劑(也被稱爲68Ga PSMA-11,以品牌名Illuccix銷售)已獲得美國食品和藥物管理局(FDA)[4],澳大利亞治療物品管理局(TGA)[5]以及加拿大衛生部的批准[6]。其他Telix產品沒有在任何司法管轄區獲得營銷許可。

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.

Telix投資者關係

Telix Investor Relations

Ms. Kyahn Williamson

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Kyahn Williamson女士
Telix Pharmaceuticals有限公司
高級副總裁投資者關係和企業傳訊
郵箱: kyahn.williamson@telixpharma.com

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

此公告已經獲得Telix Pharmaceuticals Limited披露委員會授權,代表董事會發布。

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.

您應該閱讀此公告連同我們在澳大利亞證券交易所(ASX)最近提交的報告中披露的風險因素或在我們的網站上披露的風險因素。

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不打算在包括美國在內的任何管轄區作爲Telix Pharmaceuticals Limited (Telix)證券的認購提供、邀請或推薦。本公告中包含的信息和意見可能隨時改變,無需事先通知。根據法律最大允許範圍,Telix不承擔對本公告中包含的任何信息或意見的更新或修訂的任何義務或承諾,包括任何前瞻性陳述(如下所述),不論是因爲新信息、未來發展、期望或假設的改變還是其他原因。就本公告中包含的信息或表達的意見的準確性或完整性,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.

本公告可能包含涉及預期未來事件、財務表現、計劃、戰略或業務發展的前瞻性聲明。前瞻性聲明通常可通過使用「可能」、「預期」、「打算」、「計劃」、「估計」、「預測」、「相信」、「展望」、「預測」和「指導」等詞語來識別,或者這些詞語的負面形式或其他類似術語或表達。前瞻性聲明涉及已知和未知的風險、不確定性和可能導致我們的實際結果、活動水平、表現或成就與這些前瞻性聲明所表達或暗示的任何未來結果、活動水平、表現或成就存在重大差異的其他因素。前瞻性聲明基於Telix對未來存在並影響Telix的業務和運營的財務、市場、監管和其他風險和考慮的誠信假設,不能保證這些假設之一會被證明是正確的。在Telix業務的背景下,前瞻性聲明可能包括但不限於關於:Telix臨床前研究和臨床試驗以及Telix研發計劃的啓動、時間安排、進展和結果;Telix推動產品候選物進入、招募和成功完成臨床研究,包括跨國臨床試驗的時間或可能性;針對Telix產品候選物的監管申報和批准的時間或可能性、製造活動和產品營銷活動;Telix的銷售、營銷和分銷以及製造能力和策略;Telix的產品候選物的商業化,如果或在獲得批准後;爲其產品和產品候選物以合理成本獲取足夠原材料的能力的估計;Telix的費用、未來收入和資本需求;Telix的財務表現;與Telix的競爭對手和行業相關的發展;以及Telix的產品候選物的定價和報銷,如果獲得批准後。Telix的實際結果、表現或成就可能與這些聲明所表達或暗示的結果有重大不同,這些差異可能是不利的。因此,您不應過分依賴這些前瞻性聲明。

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年Telix製藥有限公司。 Telix製藥、Illuccix、Pixclara2和Zircaix2的名稱和標誌是Telix製藥有限公司及其關聯公司的商標-保留所有權利。

[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] 康哲藥業2024年11月1日新聞稿;康哲藥業2024年11月1日簡報:

[2] 品牌名稱需最終獲得監管機構批准。

[3] TLX007-CDx處方藥物用戶費法案(PDUFA)目標日期爲2025年3月24日。Telix澳交所披露日期爲2024年7月23日。

[4]2021年12月20日Telix ASX披露。

[5] Telix ASX披露 2021年11月2日。

[6] Telix ASX披露 2022年10月14日。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論