Takeda Pharmaceutical Korea said Tuesday that the health insurance coverage criteria for its hemophilia A treatments, Advate and Adynovate injections, has been expanded from Aug. 1.  

The expanded reimbursement allows Korean patients with hemophilia A with less than 1 percent coagulation factor activity in their blood to receive up to twice the approved dose for prophylaxis with a factor VIII formulation.

Accordingly, the single dose of factor VIII standard half-life formulation and extended half-life formulation remains the same as 20~25 IU/kg. Still, the criteria for recognizing dose increase has been expanded. 

Previously, a dose increase had to be authorized with a physician's certificate. Under the changed criteria, additional doses will be authorized within the scope of the license even if the clotting factor activity is less than 1 percent at 48 hours for Advate and 72 hours for Adynovate based on the results of pharmacokinetics (PK) tests. 

Additionally, Takeda plans to support personalized treatment for prophylaxis by offering myPKFiT to patients with hemophilia A receiving Advate or Adynovate. It is a medical device based on population PK to obtain an estimate of an individual patient's PK information from just two blood draws or predict an individual patient's factor VIII activity over time in response to a dose of factor VIII. 

Consequently, if a PK test with myPKFiT is performed after the standard single-dose dose of 20-25 IU/kg and the factor VIII activity falls below 1 percent at 48 hours after Advate or 72 hours after Adynovate, the dose can be increased to a maximum of 40 IU/kg for adult patients on Advate and 50 IU/kg for adult patients on Adynovate.

Moreover, the myPKFiT patient app allows patients to view real-time factor VIII activity and predict factor VIII activity at specific time points after dosing, allowing them to dose their formulation according to their physical activity plan. 

"We are grateful to the academic community and the government for their efforts to create an enabling environment for the dosing of factor VIII at the level recommended by the World Hemophilia Federation (WHF) in Korea," said Kim Na-kyung, Head of the Hemophilia Division at Takeda Pharmaceutical Korea. "We will continue to ensure that more patients with rare blood diseases receive appropriate treatment."