[Edaily Reporter NA EUN-KYUNG ] Duchem Bio ( DuChemBio Co.,LTD.(176750)) announced on the 2nd that health insurance coverage standards for PET-CT scans using “Prostasic,” a radiopharmaceutical for prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) diagnostics, took effect on the 1st.

This coverage is in accordance with the Ministry of Health and Welfare’s notice on insurance coverage for PET-CT procedures, coming approximately 11 months after the product passed an evaluation by the Health Insurance Review and Assessment Service last October.

Eligibility for coverage applies to prostate cancer patients with a moderate or higher risk of metastasis who are suspected of having metastases prior to their first surgery or radiation therapy, as well as those suspected of recurrence due to elevated prostate-specific antigen (PSA) levels following treatment. With the establishment of these coverage criteria, eligible patients can now undergo the examination by paying only their share of the cost under the National Health Insurance program.

Prostasic is a diagnostic radiopharmaceutical that tracks lesions by targeting PSMA, which is highly expressed in prostate cancer cells. It is the exclusively licensed product in Korea for “Posluma,” which has been approved by the U.S. Food and Drug Administration (FDA); Korea is the second country to approve it, following the United States.

Prostasic’s diagnostic performance was evaluated in a Phase 3 clinical trial involving a total of 391 participants. According to the company, the lesion detection rate for Prostasic was 64% in patients with early-stage recurrence and PSA levels below 0.5 ng/mL. The company explains that this is a high rate compared to the approximately 20% detection rate of conventional MRI or CT scans. Treatment plans were modified based on Prostasic test results for 89% of patients diagnosed using conventional tests.

According to National Cancer Registry statistics, the number of new prostate cancer patients in South Korea reached 22,640 in 2023, an increase of approximately 9% from the previous year’s figure of 20,606. PSMA-targeted PET is used to determine the stage of prostate cancer and to confirm recurrence after treatment.

Integration with PSMA-targeted therapies is also anticipated. The National Comprehensive Cancer Network (NCCN) guidelines in the U.S. recommend PSMA PET diagnosis when administering PSMA-targeted therapies, such as Novartis’ prostate cancer treatment “Flubicto.” This approach verifies whether a patient expresses the target of the therapy through PSMA-targeted diagnosis.

DuChemBio Co, LTD has also expanded its supply chain to meet the increased demand resulting from the inclusion of the test in the national health insurance coverage. In addition to its existing Good Manufacturing Practice (GMP) facilities in the Seoul metropolitan area and Busan, the company established a supply chain last August to serve tertiary general hospitals in the Yeongnam and Jeolla regions. Because radiopharmaceuticals have a short half-life for their radioactive isotopes, it is crucial to deliver them quickly to medical institutions after production.

Kim Sang-woo, CEO of DuChemBio Co, LTD, said, “We expect that diagnostic access will improve for patients who had been postponing testing due to cost,” adding, “Since both the diagnostic agent and the therapeutic agent target the same PSMA, it can also be used to identify patients eligible for treatment.”