Chinese MM drug Xpovio reattempts reimb listing in KOR

Received non-reimbursement at DREC level last November...reapplies for reimb listing

The only available 5th line treatment for multiple myeloma…patients urge for prompt reimbursement listing

A new drug for multiple myeloma that was developed by the Chinese pharmaceutical company Antengene is attempting reimbursement listing again in Korea.

 

The drug’s name is Xpovio Tab 20mg (Selinexor).

 

The drug received a non-reimbursement decision at the Drug Reimbursement Evaluation Committee meeting that was held in November last year.

 

According to industry sources on the 8th, Antengene applied for the reimbursement listing of its Xpovio 20mg Tab.

 

to HIRA.

 

The drug was approved in August 2021 for two indications: ▲ for use in combination with dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors (PI), at least two immunomodulatory medicinal products (IMiD), and an anti-CD38 monoclonal antibody (mAb); and ▲ as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment.

 

The company has since applied and filed for reimbursement coverage, but its first reimbursement attempt was thwarted by a non-reimbursement decision at the DREC level in November last year.

 

Established in 2017, Antengene is an anticancer drug specializing company that has received investment from the global pharmaceutical giant BMS Pharmaceuticals.

 

Its headquarters is based in Shanghai, China.

 

In Korea, the company obtained import authorization for the drug in 2021 and appointed Min-Young Kim, former head of Ipsen Korea, as its General Manager.

 

Antengene successfully applied for Xpovio ‘s reimbursement from Canada in August 2022, raising expectations for its reimbursement listing in Korea.

 

Canada is one of the 8 countries that Korea references for new drug reimbursement.

 

The company's success in obtaining reimbursement in the US after Canada raised expectations that it would be able to set an appropriate drug price in Korea, but it failed to cross HIRA’s threshold.

 

However, multiple myeloma patients are calling for its expedited reimbursement, explaining how Xpovio is the only drug available in the fifth line for their treatment.

 

Therefore, the public’s eyes are on whether the authorities will fulfill the dire wishes of the patients and reimburse the drug this time.

 

Meanwhile, the first new drug made by a Chinese pharmaceutical company to be reimbursed in Korea is Beigene Korea's blood cancer drug ‘Brukinsa’.

 

The drug has been reimbursed for Waldenström macroglobulinemia (WM) since May last year.