Will Koselugo’s reimb listing pick up speed in Korea?

AZ submits 3rd supplementary material and RSA proposal to health authorities

Continues efforts for listing after receiving the only non-reimbursement decision during DREC review

AstraZeneca is bracing up its battle to receive reimbursement approval for its Koselugo (selumetinib, AZ) within the year.

 

The company’s new neurofibromatosis drug was unable to pass review by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee last year.

 

AstraZeneca submitted its 3rd supplementary material and RSA proposal recently.

 

Whether the agenda will be reviewed at HIRA’s DREC meeting and determined adequate for reimbursement is receiving attention.

 

According to industry sources on the 16th, AZ withdrew its previous drug listing and reimbursement price application for Koselugo in January and submitted a new application in February.

 

Koselugo received a non-reimbursement decision from DREC last March.

 

It was the only drug that received a non-reimbursement decision among all drugs that were reviewed by DREC last year.

 

Unwaivered, the company continued its attempt to pass HIRA’s gates.

 

Due to a lack of treatment options for neurofibromatosis, the demand for treatment in the area from the HCPs and patients has been high.

 

Neurofibromatosis is a rare disease that presents abnormalities of the skin, nervous system, bones, and soft tissues.

 

Around 4,900 patients are known to be ailing from the disease in Korea.

 

The only available treatment option for neurofibromatosis until now had been surgical removal.

 

However, as complete excision of these tumors is difficult, the possibility of relapse always remains even after surgery.

 

The Phase II SPRINT study that became the basis for Koselugo’s approval showed that Koselugo reduced tumor size by over 20% in 68% of the patients that received the drug, and achieved its primary endpoint of ORR.

 

Also, 82% of the patients that showed a partial response had sustained responses lasting at least 12 months.

 

The issue is Koselugo’s price.

 

It is an expensive drug that costs 200 million won a year.

 

Therefore, industry prospects were that its reimbursement listing would only be possible if the company submits a solid RSA plan in addition to its proof of effect.

 

Determined to receive reimbursement, the company had continuously submitted supplementary data even after the non-reimbursement decision last year and is continuing on its attempt this year by submitting a new reimbursement application.

 

In April, the company changed its application drug price and applied for expedited listing.

 

Since then, the company has submitted supplementary data three times and has persistently knocked on the DREC’s door.

 

More recently, the company had also prepared a risk-sharing agreement plan as a reimbursement failsafe for the government.

 

Starting this year, the insurance authorities have been applying the expedited listing process to treatments for diseases that threaten the quality of life of children.

 

In this aspect, there is a higher chance that Koselugo will get listed faster if the pharmaceutical company submits a solid plan on how it would share the burden of high prices.

 

Therefore, attention is focusing on whether Koselugo can overcome last year’s non-reimbursement decision and expedite its listing this year.