JW Pharmaceutical announced on the 15th that the colorimetric assay (CSA test) for assessing the severity of hemophilia in patients treated with the hemophilia A treatment 'Hemlibra' has been commercialized in South Korea. The Ministry of Health and Welfare recently established the CSA test as a non-reimbursable health insurance item, which has been in effect since the 1st.
Hemophilia is a bleeding disorder caused by a deficiency of coagulation factors (substances that clot the blood) in the blood. The CSA test measures the activity of coagulation factors in hemophilia patients to diagnose the severity of the disease and observe the effectiveness of treatment. In particular, it can precisely measure the activity of factor VIII, which is deficient in patients with hemophilia A and is also suitable for patients using non-coagulation factor preparations like Hemlibra.
However, the primary test used in South Korea until now has been the one-stage coagulation assay (OSA test). This test has limitations in accurately diagnosing mild patients and confirming the severity of hemophilia in patients treated with Hemlibra. For this reason, the World Federation of Hemophilia (WFH) recommends conducting both the OSA and CSA tests, and specifically recommends the CSA test for assessing the severity of hemophilia in patients receiving Hemlibra and for evaluating hemostatic capacity after co-administration of factor VIII.
Hemlibra is an innovative drug that mimics the missing blood coagulation factor VIII in patients with hemophilia A. It is the only therapeutic agent among hemophilia A treatments that can be used by patients who have developed antibodies against existing therapies (factor VIII preparations) as well as those who do not have antibodies. Another feature is that it provides a continuous preventive effect with subcutaneous injections once every four weeks.
Professor Park Young-sil of the Department of Pediatrics and Adolescent Medicine at Kangdong Kyunghee University Hospital noted, "The commercialization of the CSA test now allows for the assessment of hemophilia severity in patients treated with Hemlibra," and added, "The diagnostic environment for mild patients who could not be accurately diagnosed with the existing OSA test, as well as female hemophilia patients (carriers), will also improve."
A representative from JW Pharmaceutical stated, "The commercialization of the CSA test will significantly contribute to the advancement of hemophilia diagnosis and treatment," adding, "We will do our best to increase treatment accessibility for hemophilia A patients and improve their quality of life."