Greenmono, Green Cross's Hemophilia Treatment, Expands Insurance Coverage Criteria

Hemophilia A with Factor VIII Deficiency
Maintaining Activity Below 1% with Dose Escalation
Expanded Insurance Coverage Approval

GC Green Cross announced on the 2nd that from the 1st, the health insurance coverage criteria for its hemophilia A treatment ‘Greenmono’ have been expanded.

GC Green Cross's Hemophilia A treatment 'GreenMono' [Photo by GC Green Cross]

Hemophilia, classified into types A, B, and C, is a congenital disorder caused by a deficiency of blood coagulation factors. Type A involves factor VIII deficiency, type B involves factor IX deficiency, and type C involves factor XI deficiency. Among these, patients with severe hemophilia A, whose factor VIII levels are below 1%, have been recommended to maintain coagulation factor levels through regular administration of coagulation factor concentrates as maintenance therapy, even in the absence of bleeding.

However, the previously allowed single dose of factor VIII concentrate under health insurance coverage was limited to 20?25 IU/kg (up to 30 IU/kg in cases of moderate or severe bleeding), making it difficult to expect adequate hemostatic effects when bleeding occurs, and raising concerns about limitations in maintenance therapy as well.

In response, in August, the Ministry of Health and Welfare added criteria allowing up to double the dosage compared to the insurance coverage standard for recombinant factor VIII treatments such as GC Green Cross’s ‘Greengene F’ and SK Chemicals’ ‘Aptila’, upon submission of a physician’s statement. Previously, this was only possible in cases of ▲hospitalization required but outpatient treatment received ▲administration needed based on clinical symptoms and test results, but the coverage criteria were expanded to include ▲cases where pharmacokinetic (PK) test results show a trough coagulation factor activity below 1% at 48 hours post-administration.

However, although international guidelines recommend plasma-derived products like Greenmono at the same level as recombinant products, plasma-derived products were excluded from the previous criteria expansion, sparking controversy. With this recent revision of the insurance coverage notice, Greenmono has now been included in the same expanded coverage criteria.

A GC Green Cross representative stated, “With the expansion of insurance coverage criteria for Greenmono, more patients with severe hemophilia can now perform routine prophylaxis with sufficient dosages,” adding, “We are grateful to the academic community and government for their efforts in creating an environment for patient-tailored treatment.”

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