Hemlibra, emerged as an issue of the National Audit Office

Kang Sung-woo, a member of the Welfare Committee, is likely to ask questions at the HIRA parliamentary audit on the 13th and urge the committee to submit it

At the time of approval, all are recognized as preventive therapy

As the administration of non-antibody patients has been delayed for more than three years since Hemlibra, an innovative new drug for hemophilia A, is expected to emerge as a topic of the parliamentary audit.

 

Representative Kang Sun-woo (Democratic Party of Korea), a member of the Health and Welfare Committee, will question the issue of the benefit of hemophilia new drug Hemlibra at a parliamentary audit of HIRA held on the 13th of this month.

 

Kim Kyung-Hwa, a mother of a hemophilia patient with type A as a representative of the Korean Hemophilia Association, will attend as a reference.

 

She is expected to urge health authorities to apply for Hemlibra's delayed health insurance benefits, explaining the problems of existing treatments that should be used to prevent bleeding and why subcutaneous injections are needed at the National Audit Office.

 

Hemlibra is used as a new innovative treatment for many hemophiliac patients, achieving the No.

 

1 global market share, but the application of benefits is being delayed in Korea.

 

Hemlibra, a type A hemophilia treatment imported by JW Pharm in charge of domestic permission and sales, was first approved for sale as a treatment for antibody patients in January 2019 and was first listed in May 2020, and limited standards have been resolved several times since then.

 

In September last year, the Anti-Corruption and Civil Rights Commission recommended a review of the standards, allowing young children to be prescribed Hemlibra without undergoing two to three years of intravenous treatment.

 

The problem is that 90% of about 1,800 hemophilia A patients are non-antibody patients.

 

Hemlibra added an indication for non-antibody patients in March 2020 and applied for benefits in July of that year, but health insurance benefits have not been used even after two years.

 

According to the academic society and replotting organizations, the expansion of Hemlibra's standards was confirmed at the third subcommittee held at the Review Board in July.

 

Looking at the clinical usefulness, Hemlibra judged that it was also worth paying for non-antibody patients.

 

However, the future is a problem.

 

Even if it has passed the subcommittee, it must go through the HIRA Drug Benefit Evaluation Committee and negotiate drug prices and usage with NHIS.

 

Currently, the Drug Benefit Evaluation Committee does not know when it will be held.

 

Hemlibra is the only existing hemophilia A treatment that has been approved for use as a preventive therapy for both antibody and non-antibody patients.

 

It imitates the mechanism of action of the coagulation factor VIII with the first-in-class applied with the technique of simultaneously binding to the coagulation factors VIIII and X, Unlike conventional treatments that supplement the 8th coagulation factor with such a mechanism, antibody production is not risky.

 

The patient's pain was dramatically improved when taking existing drugs with subcutaneous injections up to once every four weeks.

 

In the case of conventional hemophilia treatments, intravenous injections should be performed at least twice a week.

 

In August, the results of phase 3 clinical trials were published in Blood advises that hemophilia A patients with hemophilia administered with Hemlibra had fewer side effects of bleeding during surgery.

 

The result is that the risk of bleeding during surgery is low in a situation where efficacy and safety have been proven as a law.