Hemlibra is likely to establish criteria for reimbursement

Anti-Corruption and Civil Rights Commission & the HIRA, a positive meeting with patient groups

Attention is focusing on whether or not the medication will resume

Hemlibra's reimbursement standard applied in February this year is ▲for patients who fail ITI, ▲ if there is a doctor's opinion that it meets the requirements for ITI but cannot be implemented, and ▲approved only if antibodies are regenerated after ITI success.

 

These benefits criteria could be cut from the HIRA's screening after prescribing drugs depending on interpretation, resulting in discontinuation of administration for some pediatric patients, and patients' carers have sought solutions from various angles, including filing a national petition to the HIRA.

 

The HIRA and the patient's group, led by the Anti-Correction and Civil Rights Commission, held a recent meeting and exchanged in-depth mutual opinions and positions on the validity of ITI prerequisites.

 

According to the industry, the HIRA subcommittee is expected to proactively consider ITI when treating hemophiliacs under the age of 12, but discuss salary standards on a case-by-case basis based on prescriptions for communications and respect for medical rights.

 

Treatment of Hemlibra subcutaneous injections in pediatric hemophiliacs, which are currently suspended, is likely to resume as early as this month or next month.

 

In particular, the suspension of administration of pediatric antibody patients is expected to have a significant positive impact on the establishment of Hemlibra's standards for non-antibody patients.

 

Analysis of Hemlibra clinical data shows that donor licensing is superior to factor VIII preparation and can help improve the quality of life of patients by improving the convenience of administration with subcutaneous injections.

 

First-in-class Hemlibra, which has gained an advantage in economic evaluation due to its cheaper and easier to administer than conventional treatments, is currently expanding benefits to hemophilia A non-antibodies even among A7 countries.

 

Patients exposed to factor XIII drugs inevitably produce antibodies at a certain rate, and factor XIII alone is likely to fail to control bleeding.

 

Hemlibra is a dual antibody mechanism that replaces factor XIII, which is considered a new alternative to hemophilia treatment as it is free from intravenous pain in both pediatric and adult patients and avoids concerns about antibody production.

 

According to the hemophilia patient group, the full treatment of Hemlibra in pediatric non-antibody patients must be paid by the patient, and the patient group is constantly asking the HIRA to set a benefit standard for this.