JW Jungwoo Pharmaceutical's New Hemophilia Drug Opens Insurance Coverage Path for Non-Antibody Patients
HIRA Recognizes the Appropriateness of Coverage for 'Hemlibra'
[Asia Economy Reporter Myunghwan Lee] JW Pharmaceutical announced on the 10th that Hemlibra (generic name Emicizumab) has been recognized for its reimbursement appropriateness as a prophylactic treatment for non-inhibitor severe hemophilia A patients, following the review results of the Drug Benefit Evaluation Committee held by the Health Insurance Review and Assessment Service on the 9th.
Hemlibra is a routine prophylactic treatment for hemophilia A caused by a deficiency of coagulation factor VIII. It is an innovative new drug applying bispecific antibody technology that simultaneously binds to coagulation factors IX and X, mimicking the coagulation mechanism of factor VIII.
Following this review result by the Health Insurance Review and Assessment Service, JW Pharmaceutical and the National Health Insurance Service will proceed with drug price negotiations. After the Ministry of Health and Welfare announces the expanded reimbursement criteria, severe non-inhibitor patients will be able to receive insurance benefits. Reimbursement for inhibitor patients was first listed in May 2020.
According to the 2019 Hemophilia Foundation White Paper, there are a total of 1,746 hemophilia A patients in South Korea. They are divided into 78 inhibitor patients who have developed resistance to existing treatments (factor VIII products) and 1,589 non-inhibitor patients. Severe patients account for 1,259, representing 72.1%.
A JW Pharmaceutical official stated, "Hemlibra is a treatment that can dramatically improve the quality of life for hemophilia patients due to its dosing convenience and excellent efficacy," adding, "We will do our best to ensure that severe non-inhibitor hemophilia A patients can promptly receive medical benefits through expanded health insurance coverage."
Hemlibra is a hemophilia A treatment developed by Chugai Pharmaceutical, a subsidiary of the global pharmaceutical company Roche. JW Pharmaceutical secured the domestic development and distribution rights for Hemlibra in 2017 and received approval from the Ministry of Food and Drug Safety in 2019.
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Hemlibra is the only hemophilia A treatment with an extremely low risk of antibody (inhibitor) formation. It can be used not only by hemophilia patients with inhibitors but also by non-inhibitor patients without antibodies. All previously released treatments required intravenous injections two to three times a week, but Hemlibra maintains prophylactic effects with subcutaneous injections from once a week up to once every four weeks.
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