Yuhan’s Leclaza zooms through the NHI listing process

Cancer Deliberation Committee to review in February, immediately after marketing authorization

Lung Cancer Association urges for coverage, presumably listing and pricing to be processed fast

Yuhan Corporation’s new drug Leclaza could break the record of receiving the National Health Insurance reimbursement the fastest as an anticancer treatment.

 

After the South Korean health authority approved of the drug on Jan.

 

18, the company immediately entered a talk to list the drug.

 

The pharmaceutical industry source reported the Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee is to deliberate Leclaza (lazertinib), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) like Tagrisso (osimertinib), from next month.

 

Yuhan Corporation is rushing through the commercialization process by fully utilizing the conditional approval and the approval-reimbursement linkage system.

 

Leclaza was cleared for marketing in South Korea on Jan.

 

18.

 

If the Cancer Deliberation Committee reviews the drug in the February meeting, the drug would be taking only a month to reach a reimbursement review.

 

Generally, a novel anticancer treatment takes about four to five months to be deliberated by the Cancer Deliberation Committee after applying for the reimbursement.

 

Considering the typical speed of the listing procedure, the 31st Korean-made new drug Leclaza may set the historic record of passing the Drug Reimbursement Evaluation Committee after the Cancer Deliberation Committee, settling a drug pricing and listing itself for the reimbursement.

 

The related academic society also seems to be supporting for the Leclaza coverage.

 

The Korean Association for Lung Cancer submitted a statement to urge for the healthcare benefit on Leclaza.

 

The society claimed, “The National Health Insurance reimbursement should be granted on lazertinib, as it has demonstrated acceptable level of safety and low cardiac toxicity, and also the treatment is highly demanded by the patients to fight against a severe disease.“ Leclaza was approved as a first-in-class second-line treatment in EGFR T790M mutation-positive patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who has been treated with EGFR-TKI previously.

 

The drug approval was cleared based on the Phase II clinical trial (therapeutic exploratory trial) outcomes conducted in South Korea, but with a condition to conduct a post-marketing Phase III trial (therapeutic confirmatory trial).