Shire Korea said Wednesday that the Ministry of Food and Drug Safety has approved the change in reimbursement in the number of doses and frequency for three of its hemophilia treatments – Advate, Adynovate and Rixubis.
Advate and Adynovate are factor VIII gene recombinant hemophilia A treatments and Rixubis is a factor XI Hemophilia B treatment.
The change in insurance coverage will take effect from this year.
The main content of the change in insurance coverage for the drug relates to the relaxation of the limit in the number of doses administered according to the number of visits.
Until now, to receive the maximum dosage every month, patients had to visit the hospital twice a month. Under the revised plan, the doctor can decide to administer the maximum amount of doses once every four weeks if the patient's condition is stable.
Therefore, the new plan can reduce the visits a patient has to make down to 11 times when receiving the maximum dosage, improving convenience for the patient.
Notably, the new arrangement includes the Adynovate, an extended half-life factor VIII gene recombinant hemophilia A treatment, launched here in September.
Adynovate is an injectable therapy that has the same ingredient as Shire’s Advate, the most commonly used hemophilia A treatment in Korea. The medication touts improvements over Advate in the form of an extended half-life and fewer injections that require patients to take the drug only twice a week. Standard injectable treatments for hemophilia A require three to four intravenous shots a week.
Patients who use the treatment can receive reimbursement up to seven times (eight for severe patients) by going to the hospital once every four weeks.
Regarding Advate, patients can receive reimbursement of up to 10 times, 12 for severe patients, for the same period.
Rixubis received the same injection amount as Adynovate. The drug also received approval to increase dosage to severe patients from the ministry. Previously, patients with severe bleeding received a maximum dose of 44 IU/kg (56 IU/kg for children). Under the new plan, however, severe patients can receive up to 55 IU/kg (70 IU/kg for children).
“The company is very pleased with the expansion of reimbursement for Advate, Adynovate and Rixubis,” Shire Korea CEO Moon Hee-seok said. “Shire Korea will continue to strive to provide patients with more stable hemophilia care and will continue to do research and support to improve the hemophilia treatment environment.”