Expanded dosage for patients below 1% factor activity

GC Biopharma, represented by Eun-Chul Huh, has announced an expansion in the health insurance coverage criteria for the A-type hemophilia treatment 'GreenMono,' effective January 1st. This revision increases the maximum dosage for Korean A-type hemophilia patients with less than 1% coagulation factor activity in their blood, allowing up to twice the standard dosage per kilogram of body weight for plasma-derived 8-factor products used as prophylactic therapy within the approved care services range.
Under the updated insurance guidelines, the single dosage of plasma-derived 8-factor products remains at 20-25 IU/kg, with a maximum of 30 IU/kg for moderate to severe bleeding cases. However, the criteria for acknowledging dosage increase have been broadened to facilitate access.
Previously, dosage increases required a physician's statement when outpatient treatment was received despite the necessity for inpatient care or when administration was deemed necessary based on clinical symptoms and test results. However, the revised reimbursement policy now considers approval even if Pharmacokinetics testing results show the lowest coagulation factor activity remains below 1% 48 hours after administration, provided a physician's statement accompanies the request.
Following the expansion of insurance coverage criteria for the recombinant gene therapy 'Greengene f' in August 2023, 'GreenMono'—the plasma-derived therapy—has also been included this month. This inclusion means both A-type hemophilia treatments now meet the expanded insurance coverage criteria.
A spokesperson from GC Biopharma expressed, "The expanded insurance coverage criteria for GreenMono will enable more individuals suffering from severe hemophilia to undergo everyday prophylactic therapy with adequate dosages."
