Illuccix® Reimbursement Milestone and Launch Updates: Pass-Through Status Granted in the U.S.

MELBOURNE, Australia and INDIANAPOLIS, May 30, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today provides an update on the U.S. and Australian launch and reimbursement status for its prostate cancer imaging agent, Illuccix^® (kit for preparation of gallium (⁶⁸Ga) gozetotide).

U.S. Launch Update: Full reimbursement in the U.S. to be effective from July 1

Telix's prostate cancer imaging agent Illuccix® has been granted Transitional Pass-Through Payment Status ("Pass-Through") by the U.S. Centers for Medicare and Medicaid Services (CMS).

From 1 July 2022, CMS and commercial health insurers will recognise the Healthcare Common Procedure Coding System (HCPCS) Level II code, A9596 assigned to Illuccix for reimbursement. Pass-Through, also effective from 1 July 2022, will enable CMS to provide separate payments for the radiopharmaceutical and the PET-CT scan, when performed with Illuccix in the hospital outpatient setting.

Illuccix is a kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:

• suspected metastasis who are candidates for initial definitive therapy;
• suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Dr. Christian Behrenbruch, Group CEO of Telix Pharmaceuticals said, "Illuccix is fulfilling an unmet need for convenient and flexible access to PSMA-PET imaging for patients across the country. This diagnostic agent is being rapidly adopted by physicians, who recognise its value in determining the extent of disease and to guide treatment decisions. With prostate cancer the most common cancer in American men – after skin cancer – this reimbursement milestone is a win for patients and will facilitate even greater access to this tool which is quickly being considered as a potential standard of care."

Illuccix can be ordered by health care professionals from 128 pharmacies across the Cardinal Health and Pharmalogic and United Pharmacy Partners, Inc. (UPPI^[1]) pharmacy networks, and is accessible to approximately 85 percent of PET imaging sites across the U.S. More sites will be added in the coming months.

Illuccix is also now available for purchase to all Veterans Affairs entities that are entitled to Federal Supply Service (FSS) pricing.

Illuccix U.S. sales revenues will be reported in the Company's Appendix 4C and Activities Report for the June 2022 quarter.

Australian launch update

Illuccix is available to order for nationwide delivery to all PET imaging sites in Australia, for patient scheduling from 1 July 2022. The Australian launch of Telix's lead imaging product coincides with the listing of prostate-specific membrane antigen (PSMA) positron emission tomography (PET) (PSMA-PET) imaging for patients with prostate cancer on the Medicare Benefits Schedule (MBS).

From 1 July 2022, MBS funding will cover the initial staging of intermediate to high-risk patients with prostate cancer and the re-staging of patients with recurrent prostate cancer, commensurate with the broad clinical indications granted in Australia for Illuccix.

Dr. David N. Cade, CEO Telix Asia Pacific said, "This marks an important milestone for Australian men and for Telix as physicians in our home market can now order doses and schedule patients for Illuccix scans. With the Australian launch of Illuccix timed to coincide with the commencement of Medicare funding, Telix and our distribution partner Global Medical Solutions Australia, are pleased to enable broad equity of access to PSMA-PET imaging for men with prostate cancer."

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, Switzerland, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com^[2] and follow Telix on Twitter^[3] (@TelixPharma) and LinkedIn^[4].

About Illuccix®

Telix's lead product, Illuccix (kit for preparation of gallium Ga 68 gozetotide (also known as ⁶⁸Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA),^[1] and by the Australian Therapeutic Goods Administration (TGA).^[2] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^[3] and Canada.^[4]

Important Safety Information: https://www.illuccixhcp.com/important-safety-information^[5]

Please see full U.S. Prescribing Information at: https://illuccixhcp.com/wp-content/uploads/illuccixprescribing-information.pdf^[6]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[7]

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

Legal Notices

This announcement may include 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", "outlook", "forecast" and "guidance", or other similar words. 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 the Company's good-faith assumptions as to the financial, market, regulatory and other considerations that exist and affect the Company'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 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.

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.  

The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).  

[1] ASX disclosure 20 December 2021.[2] ASX disclosure 2 November 2021.[3] ASX disclosure 10 December 2021.[4] ASX disclosure 16 December 2020.

References

1. ^{^} UPPI (www.uppi.org)
2. ^{^} www.telixpharma.com (www.telixpharma.com)
3. ^{^} Twitter (twitter.com)
4. ^{^} LinkedIn (www.linkedin.com)
5. ^{^} https://www.illuccixhcp.com/important-safety-information (www.illuccixhcp.com)
6. ^{^} https://illuccixhcp.com/wp-content/uploads/illuccixprescribing-information.pdf (illuccixhcp.com)
7. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)