New drug Leclaza, only drug price negotiations remain

Expected to be quickly registered by applying the'permission-insurance drug price evaluation linkage system'

The NHIS applies a notice when it passes the deliberation committee after the 60-day drug price negotiation

'Leclaza (Lazertinib)', a non-small cell lung cancer treatment by Yuhan Corporation, the 31st new drug developed in Korea, has passed the first step of reimbursement.

 

After receiving approval from the Ministry of Food and Drug Safety on January 18, the HIRA's Pharmaceutical Benefits Advisory Committee recognized the appropriateness of reimbursement within 81 days.

 

When the HIRA notifies the Minister of Health and Welfare of the results of the review, Leclaza will proceed with drug price negotiations for about 60 days with the NHIS at the order of the Minister of Health and Welfare.

 

When the drug price negotiations with the NHIS are over, the final notification is made through the resolution of the Health Insurance Policy Committee of the Ministry of Welfare.

 

According to the data released by the HIRA in 2017, it takes about 1,030 days for anticancer drugs, 475 days for rare disease drugs, and 550 days for general drugs from approval to notification from the MFDS.

 

In comparison, the anticancer drug Leclaza is expected to shorten the salary registration period by about 30 months.

 

'Leclaza's high-speed registration process was accomplished because it utilized the permission-insurance drug price evaluation linkage system.

 

The linkage of permit-reimbursement evaluation has been implemented by the MOHW since September 2014, and it is a system that allows new drugs that have been reviewed for safety and efficacy to request permission from the MFDS and at the same time request an evaluation of benefits from the HIRA.

 

From 2016, it is possible to link approval-benefit evaluation to orphan drugs as well as new drugs, so that the pharmaceutical company can apply for drug price evaluation before formal approval if desired.

 

On the other hand, Leclaza is a drug used for the treatment of patients with EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer who have previously been treated with EGFR-TKI.

 

Based on the results of a phase 2 clinical trial (therapeutic exploration clinical trial) conducted in Korea last January, Yuhan applied for permission to the MFDS under the condition of conducting a phase 3 clinical trial (therapeutic confirmation clinical trial) after marketing.

 

.The MFDS also determined that Leclaza is a target anticancer drug that inhibits the proliferation and growth of lung cancer cells by interfering with the signal transmission involved in lung cancer cell growth, and has the advantage of being less toxic to normal cells

 

.The HIRA initiated a reimbursement review following the approval of the safety and effectiveness of the MFDS

 

.On February 24, the agenda was presented and passed by the Cancer Drugs Benefit Appraisal Committee and the Pharmaceutical Benefits Advisory Committee on April 8

 

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