Yuhan Yanghang's Lung Cancer Drug 'Reclaza' Passes Drug Evaluation Committee... Expansion of Coverage Imminent

Yuhan Corporation's lung cancer drug 'Leclaza' (generic name: Lazertinib) has cleared the hurdle for expanded insurance coverage.

Yuhan Corporation's non-small cell lung cancer treatment 'Leclaza (active ingredient: Lazertinib)'
[Photo by Yuhan Corporation]

According to industry sources on the 12th, the Health Insurance Review and Assessment Service (HIRA) held a Drug Benefit Evaluation Committee meeting that morning and reviewed Leclaza as appropriate for insurance coverage as a first-line treatment. Accordingly, Leclaza is expected to receive health insurance coverage as a first-line treatment for non-small cell lung cancer as early as this year, following drug price negotiations and review by the Health Insurance Policy Deliberation Committee.

Leclaza, developed by Yuhan Corporation and Oscotec, was approved in January 2021 as a second-line treatment for locally advanced or metastatic non-small cell lung cancer with an epidermal growth factor receptor (EGFR) T790M mutation. Second-line treatments can only be used after other drugs have failed or were ineffective for the patient.

In June, the indication was successfully expanded to include first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Subsequently, in August, Leclaza passed the 6th Cancer Disease Deliberation Committee meeting, setting the reimbursement criteria for expanding first-line treatment coverage. This means it passed the cancer committee just two months after the first-line indication expansion approval.

Leclaza is a third-generation EGFR inhibitor. Currently, Yuhan Corporation is implementing an Early Access Program (EAP) to provide Leclaza free of charge to domestic patients until approval as a first-line treatment for non-small cell lung cancer is obtained. Patients eligible for the EAP currently receive Leclaza, which costs 75.5 million KRW annually under the second-line treatment insurance price, free of charge. Approximately 200 patients are reported to be registered under the EAP.