Illuccix® Granted Transitional Pass-Through Payment Status

News provided by

May 31, 2022, 07:00 ET

INDIANAPOLIS, May 31, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announced that its prostate cancer imaging agent Illuccix® (kit for preparation of gallium Ga 68 gozetotide injection) has been granted Transitional Pass-Through Payment Status 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. Transitional Pass-Through Payment Status – 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 a 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, Pharmalogic and United Pharmacy Partners, Inc. (UPPI) 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.

According to the American Cancer Society, more than 268,000 men in the U.S. will be diagnosed this year with prostate cancer, and nearly 35,000 will die from their disease. Reliable and flexible diagnostic tools are essential for treatment teams in narrowing the gap between understanding the spread of disease and appropriate individualised treatment by healthcare professionals.^[1]

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 and follow Telix on Twitter (@TelixPharma) and LinkedIn.

About Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Telix's lead product, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection), also known as ⁶⁸Ga PSMA-11 injection, has been approved by the U.S. Food and Drug Administration (FDA),^[2] and by the Australian Therapeutic Goods Administration (TGA).^[3] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^{^[4]} and Canada.^{^[5]}

INDICATIONS AND USAGE

Illuccix®, after radiolabeling with Ga 68, is a radioactive diagnostic agent 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

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis

Image interpretation errors can occur with gallium Ga 68 gozetotide 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 gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing [email protected].

Please see full Prescribing Information

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.

^[1]American Cancer Society – Key Statistics for Prostate Cancer - https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
^[2]ASX disclosure 20 December 2021.
^[3]ASX disclosure 2 November 2021.
^[4] ASX disclosure 10 December 2021.
^[5]ASX disclosure 16 December 2020.

SOURCE Telix Pharmaceuticals Limited