Yuhan Corporation's Lung Cancer Drug 'Reclaza' to Receive Insurance Coverage for First-Line Treatment Starting Next Year

Yuhan Corporation's non-small cell lung cancer treatment 'Reclaza' (active ingredient: Lazertinib) will be available to patients as the first-line treatment for the relevant mutation through health insurance coverage starting next year.

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

Yuhan Corporation announced on the 27th that Reclaza, an epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer treatment, will be covered by health insurance for first-line treatment starting from the 1st of next month.

With this expansion of Reclaza's coverage, in addition to treating T790M mutation-positive locally advanced or metastatic patients who showed disease progression after receiving EGFR-tyrosine kinase inhibitor (TKI) as a second-line treatment, health insurance coverage will be extended to first-line treatment for patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.

During the coverage expansion process, the drug price was slightly reduced. The price per daily dose (80 mg, 3 tablets) decreased by 8.1%, from 206,892 KRW to 190,110 KRW. The actual cost borne by patients is approximately 3.47 million KRW, applying a 5% co-payment rate for cancer patient support.

This coverage application was based on the clinical efficacy of first-line treatment for EGFR mutation non-small cell lung cancer confirmed through the 'LASER301' Phase 3 clinical trial announced in December last year. The randomized, double-blind, multinational Phase 3 clinical trial evaluated the efficacy and safety of Reclaza compared to Iressa (Gefitinib) in 393 patients with previously untreated active EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (258 Asians and 135 non-Asians).

As a result, the Reclaza treatment group achieved a median progression-free survival (PFS) of 20.6 months, the primary endpoint based on investigator assessment, showing a statistically significant improvement compared to the 9.7 months in the Gefitinib treatment group. PFS is the period during which a patient survives without cancer progression and is a key indicator of anticancer drug efficacy.

Jo Wook-je, CEO of Yuhan Corporation, stated, “I am very pleased that Reclaza, a new treatment option for EGFR mutation non-small cell lung cancer, which is common among Koreans and ranks first in cancer mortality, will improve treatment accessibility for patients through the expansion of first-line treatment coverage. I would like to express my deep gratitude to all those involved who helped deliver this hopeful news of Reclaza's coverage expansion to patients, caregivers, and the public from the new year of Gapjin. I also extend my respect to the medical staff who worked hard to operate the Reclaza Early Access Program (EAP) until the coverage expansion.” He added, “Yuhan Corporation will continue to strive for innovative drug development and improved treatment accessibility for the healthy lives of patients and the public.”