Hemlibra Coverage Extended to Hemophilia A Patients Without Antibodies

JW Jungwoo Pharmaceutical "Revision of Health Insurance Coverage for Non-Antibody Hemophilia Patients"

Non-inhibitor hemophilia A patients are now eligible for health insurance coverage for the subcutaneous hemophilia treatment 'Hemlibra'.

JW Pharmaceutical announced on the 2nd that the health insurance coverage for 'Hemlibra Subcutaneous Injection' (active ingredient emicizumab) has been revised to include non-inhibitor severe hemophilia A patients.

Hemlibra.
[Image provided by JW Choongwae Pharmaceutical]

On the 21st of last month, the Ministry of Health and Welfare posted an administrative notice for the partial revision of the 'Detailed Standards and Methods for Application of Medical Care Benefits (Drugs)' regarding Hemlibra. According to the revision, the health insurance coverage for Hemlibra, which was previously applicable only to severe hemophilia A patients with inhibitors resistant to existing treatments (factor VIII concentrates), will be expanded from this month to include non-inhibitor severe hemophilia A patients aged 1 year and older.

As of 2019, there are 1,749 hemophilia A patients in South Korea, including 78 inhibitor patients and 1,589 non-inhibitor patients. Severe cases account for 1,259 patients, representing 72.1% of the total.

JW Pharmaceutical explained that this expansion of Hemlibra coverage is expected to significantly improve the quality of life for severe hemophilia A patients. In particular, Hemlibra, as a subcutaneous injection with improved convenience compared to existing intravenous injections, will be useful for patients requiring continuous prophylactic treatment.

Hemlibra is a routine prophylactic agent for hemophilia A caused by a deficiency of coagulation factor VIII. It is an innovative drug applying bispecific antibody technology that simultaneously binds to coagulation factors IX and X, mimicking the coagulation mechanism of factor VIII. Due to this mechanism, Hemlibra is the only hemophilia A treatment with an extremely low risk of antibody (inhibitor) formation. Therefore, it can be used not only by hemophilia patients with inhibitors but also by non-inhibitor patients without antibodies.

Furthermore, all previously released treatments required intravenous injections 2 to 3 times per week, but Hemlibra maintains prophylactic effects with subcutaneous injections administered once weekly up to once every 4 weeks.

A JW Pharmaceutical official stated, "Hemlibra is an innovative drug that can dramatically improve the quality of life for hemophilia patients due to its dosing convenience and excellent efficacy," adding, "With the establishment of this new coverage standard, we expect improved treatment accessibility for patients suffering from hemophilia and expanded drug selection options for healthcare providers."

Hemlibra is a hemophilia A treatment developed by Chugai Pharmaceutical, a subsidiary of the global pharmaceutical company Roche. JW Pharmaceutical secured domestic development and distribution rights for Hemlibra in 2017 and received approval from the Ministry of Food and Drug Safety in 2019.

This content was produced with the assistance of AI translation services.