Hemophilia drug Hemlibra coverage expansion

From this month, Hemlibra insurance benefits are expanded to non-antibody patients

60% of domestic hemophilia A patients covered

Hemlibra

JW Pharmaceutical has laid the foundation for developing Hemlibra, a treatment for hemophilia, into a large-scale product.

 

With the expansion of benefits, treatment benefits are provided to more patients, and expectations for sales growth are rising due to increased prescriptions.

 

According to the Ministry of Health and Welfare on the 16th, Hemlibra will be covered for hemophilia A patients over the age of 1 who do not possess factor VIII antibodies from this month.

 

Hemlibra is a routine prophylaxis for hemophilia A, which is caused by a deficiency of coagulation factor VIII.

 

It is a product that applies bispecific antibody technology that simultaneously binds to blood coagulation factor 9 and factor 10.

 

Unlike existing coagulation factor 8 preparations, it is the first non-coagulation factor preparation and can be administered subcutaneously once every 4 weeks at most.

 

Hemlibra was developed by Chugai Pharmaceutical, a subsidiary of the global pharmaceutical company Roche.

 

JW Pharmaceutical secured domestic development and sales rights for Hemlibra in 2017 and received permission from the Ministry of Food and Drug Safety in 2019.

 

Chugai Pharmaceutical applied health insurance benefits to severe hemophilia A antibody patients in May 2020, and from this month, benefits were extended to non-antibody patients.

 

According to JW Pharmaceutical, there are 1,746 patients with hemophilia A in Korea.

 

Among them, severe hemophilia A patients were 1259, or 72%.

 

Among patients with severe hemophilia A, 27 patients had antibodies and 1171 patients had non-antibodies.

 

JW Pharmaceutical explained, “More than 60% of hemophilia A patients in Korea are covered by Chugai Pharmaceutical’s benefits.” JW Pharmaceutical expects that Hemlibra will provide great treatment benefits to patients based on the efficacy and safety proven by large-scale clinical trials.

 

In the HAVEN1 clinical trial for antibody patients, it was confirmed that Hemlibra prophylaxis compared to the existing bypass therapy prophylaxis therapy reduced the annual bleeding rate (ABR) by 3.3 times by about 79%.

 

In the HAVEN3 clinical trial for non-antibody patients, it proved an effect of reducing approximately 68% of the ABR (Annual Bleeding Rate) 1.5 times compared to prophylactic factor 8 therapy.

 

The company explains that Hemlibra has also proven safety through clinical results.

 

HAVEN 1~4 Clinical Results Among patients who received Hemlibra, most side effects were mild injection site manifestations.

 

Quarterly Hemlibra sales (unit: million won, source: IQVIA)

The company said, "Hemlibra has a long half-life of 28 days, so it increases patient convenience by reducing the number of administrations once every 4 weeks, compared to 2-3 times a week for conventional prophylaxis." In contrast to having to do intravenous injection, subcutaneous injection is possible, so it can help patients who have difficulty in intravenous injection or pediatric patients.” According to IQVIA, a pharmaceutical research institute, Hemlibra recorded sales of 7.6 billion won last year.

 

In the first year of application in 2020, it raised 2.1 billion won, followed by 7.2 billion won in 2021, and showed an upward trend last year.

 

Looking at quarterly sales, it recorded 2.2 billion won in the fourth quarter of last year, surpassing 2 billion won in sales for the first time.

 

The cumulative sales of Hemlibra over the past three years were 17 billion won.

 

The company expects that the amount of use will increase sharply as the target of benefit coverage expands significantly in the future.

 

Last year, Hemlibra's global sales increased by 27% to CHF 3.823 billion.

 

Currently, more than 20,000 patients in 144 countries around the world are using Hemlibra.

 

“Hemlibra is an innovative new drug that can dramatically improve the quality of life of hemophilia patients with ease of administration and excellent efficacy,” said an official from JW Pharmaceutical.

 

He said, "We expect that this new standard will expand the treatment accessibility of patients suffering from hemophilia and the choice of medicines for medical staff."