Will changes be made to Hemlibra’s reimbursement standards?

Influenced by criticisms from NA and ACRC

In addition to continued requests from hemophilia patients and their caregivers, and a national petition filed to Cheong Wa Dae

As the Anti-Corruption & Civil Rights Commission (ACRC) in addition to the National Assembly raised the need to ease the reimbursement standards for the hemophilia treatment Hemlibra (emicizumab), the growing sense of urgency on the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA)’s behalf to take follow-up actions is expected to increase.

 

The NA and ACRC requested the standards be changed so that pediatric patients under the age of 12 can use the subcutaneous injection Hemlibra immediately without prior use of the intravenous drug treatment ‘immune tolerance induction (ITI) therapies.

 

Sun-Woo Kang of the Democratic Party of Korea had first criticized the inappropriateness of Hemlibra’s reimbursement standards in June, then the ACRC had also made recommendations to the MOHW to change the reimbursement standards.

 

The NA member pointed out that the existing reimbursement standards that acknowledge reimbursement of Hemlibra in pediatric patients aged under 12 only after they fail intravenous injections that accompany great pain should be changed.

 

The ACRC also decided that it was harsh to recognize insurance benefits for Hemlibra only after the pediatric patients that have weak blood vessels undergo ITI therapy that require intravenous injections for 2-3 years.

 

The NA and ACRC’s move was influenced by the appeals made by guardians of pediatric patients with hemophilia that were posted on the National Petition board of Cheong Wa Dae.

 

A total of 4 requests to change the reimbursement standards of Hemlibra had been posted on the national petition board from November 2019 to date.

 

2019 was when JW Pharmaceutical had received marketing authorization for Hemlibra.

 

JW Pharmaceutical received approval for Hemlibra from the Ministry of Food and Drug Safety on January 20th, 2019.

 

In the earlier petitions, the request was focused on approving reimbursement for Hemlibra, but from last year, the content of the petitions changed to request modification or ease of reimbursement standards for patients aged less than 12 years.

 

Recently, the caregivers of patients (parents) had requested MOHW and HIRA to delete the mandatory ITI therapy prerequisite for Hemlibra’s reimbursement in pediatric patients aged 1 to 12 years old.

 

They criticized that the current reimbursement standards violate human rights by forcing pediatric patients to receive intravenous injections even though Hemlibra, a subcutaneous injection option, is available.

 

Upon receiving such criticism, the MOHW and HIRA are making a move to improve the reimbursement standards.

 

HIRA had held an expert advisory meeting on the efficient operation of ITI therapies for hemophilia A, and the MOHW is planning to amend the reimbursement standards for pediatric patients based on HIRA’s discussion results.

 

In particular, the need to improve the standards grew with the NA strongly criticizing Hemlibra’s reimbursement standards as “standards that approve reimbursements based on the pain and suffering of our children.” Also, the fact that other countries do not limit reimbursement of Hemlibra by age raises the validity on the need for the health authorities to improve the benefit standards.

 

The U.K .approves reimbursement of Hemlibra when the patient satisfies any one of the following conditions: those who fail ITI therapy, or cannot control bleeding, or administers the drug as maintenance therapy or bleeding therapy with bypassing agents, or as maintenance therapy to prevent bleeding symptoms during ITI therapy.

 

In response to the continued criticism from the NA, ACRC, and caregivers of pediatric patients, the MOHW and HIRA are expected to present a bill to revise the benefit standards in the near future.

 

On Sun-Woo Kang’s criticism, the Minister of Health and Welfare Kwon Deok-Cheol said that he would “comprehensively review the issue with experts and discuss how to improve the reimbursement standard of Hemlibra in consideration of the characteristics of pediatric patients.”