CSL Behring's long-acting hemophilia B treatment Idelvion (albutrepenonacog alfa) has come to receive reimbursement in Korea.

CSL Behring Korea said Tuesday that Idelviion is now covered by health insurance for treating adult and pediatric patients with hemophilia B, citing a notification by the Ministry of Health and Welfare.

Idelvion won approval for the control of bleeding and routine prophylaxis in adult and pediatric patients with hemophilia B (congenital deficiency of Factor IX) and perioperative management (control and prevention of bleeding during surgical procedures), and gets coverage under the relevant reimbursement standards, the company said.

In March 2020, Idelvion won the nod from the Ministry of Food and Drug Safety for treating hemophilia B in children and adults based on top-line clinical results. It can be administered at intervals of up to 21 days as a preventive therapy, making it the longest dosing interval of any long-acting hemophilia B treatment approved in Korea.

According to the Ministry of Health and Welfare's “Notification on Partial Amendment of Details on the Application Standards and Methods of Insurance Benefits (for Pharmaceuticals),” the single dose is 23 IU/kg (30 IU/kg for children), and for moderate or severe bleeding, up to 39 IU/kg (up to 50 IU/kg for children) is allowed based on the doctor's medical judgment. However, in cases where hospitalization is required but outpatient treatment is provided, an increase in the dose may be authorized with a physician's certificate if it is necessary based on clinical symptoms and test results.

Patients are allowed to receive up to two doses at the first visit every four weeks and one dose at the second visit (two doses for severe patients), and three doses (four doses for severe patients) may be prescribed at one visit every four weeks based on the physician's medical judgment. Critically ill patients are those with a clotting factor activity of less than 1 percent.

Idelvion is a recombinant protein fused to recombinant factor 9 and recombinant albumin (rFIX-FP) that has been shown to maintain high FIX trough levels, which has a terminal half-life of 143 hours at the 21-day dosing regimen (100 IU/kg).

In Idelvion's pivotal clinical CSL654 - 3001 and 3002 patients (factor 9 activity of 2 percent or less), the median trough concentrations of factor 9 as determined by pharmacokinetic data were 22.6 percent for the seven-day regimen (25-50 IU/kg) and 12.4 percent for the 14-day regimen (50-75 IU/kg) in patients 12 years of age and older, and 12.9 percent for the seven-day regimen (25-55 IU/kg) in patients <12 years of age, depending on the dosing interval. The median annualized spontaneous bleeding rate (AsBR) in these patients was 0.00.

In the 3003 extension study, the median trough blood level of the nine coagulation factors in patients 18 years of age and older on the 21-day regimen (100 IU/kg) was 7.7 percent, with an AsBR of 0.00.

"In clinical trials, we have seen factor 9 nadirs of more than 20 percent with seven-day interval prophylaxis in patients over 12 years of age, and repeated PK measurements in many patients have shown consistent results, making it easy to predict treatment effects,” said Professor Choi Eun-jin of the Department of Pediatrics at Daegu Catholic University Medical Center. “In addition, the convenience of a once-every-three-weeks dosing schedule is expected to help patients manage their disease as hemophilia requires lifelong self-injection."

CSL Behring Korea CEO Kim Ki-woon said, "Since 2016, Idelvion has been actively used as a prophylactic treatment for hemophilia B in the United States, Japan, France and other countries, regardless of age. We are pleased to be able to share this news of Idelvion’s insurance coverage with hemophilia specialists and patients in Korea. CSL Behring will continue to strive to develop and supply innovative therapies to help patients achieve freedom from hemophilia."