Health insurance will cover PSMA PET-CT, an imaging test that precisely checks for metastasis and recurrence of prostate cancer.
According to the industry on the 2nd, PET-CT scans using ProstaSeek, a diagnostic radiopharmaceutical for positron emission tomography (PET) targeting prostate-specific membrane antigen (PSMA), have been covered under the national health insurance reimbursement criteria since the 1st.
This follows the Ministry of Health and Welfare's notice on the 31st of last month setting reimbursement criteria for PET-CT procedures. It comes about 11 months after passing the Health Insurance Review & Assessment Service (HIRA) evaluation in Oct. last year.
Coverage applies to prostate cancer patients at moderate or higher risk of metastasis. It includes cases where metastasis is suspected before surgery or radiation therapy and cases where recurrence is suspected after treatment due to a rise in prostate-specific antigen (PSA) levels.
PSMA PET-CT is used to determine the stage of prostate cancer or to assess recurrence. The National Comprehensive Cancer Network (NCCN) guidelines also recommend using PSMA PET-CT when administering PSMA-targeted therapies such as Novartis' Pluvicto.
ProstaSeek is a diagnostic radiopharmaceutical that targets PSMA, a protein highly expressed in prostate cancer cells. It visualizes areas in the patient's body where PSMA is abundant to determine whether prostate cancer has metastasized or recurred. It was developed by Blue Earth Diagnostics in Italy, and in Korea, DuChemBio(176750) holds exclusive distribution rights and supplies it.
A total of 391 people participated in phase 3 clinical trials. Among early recurrent patients with PSA levels below 0.5 ng/mL, the lesion detection rate using ProstaSeek was 64%. DuChemBio said this is higher than the roughly 20% of conventional MRI or CT. Among patients whose treatment plans were based on previous test results, 89% changed their plans according to the ProstaSeek findings.