Limkato, the first chimeric antigen receptor T-cell (CAR-T) therapy developed in Korea by Curocell (372320.KQ), has passed the first gateway toward national health insurance coverage. Curocell is now expected to accelerate the commercialization of Limkato in the second half of the year, following remaining steps including the Drug Reimbursement Evaluation Committee review and drug price negotiations.
Curocell said on the 9th that the sixth Cancer Disease Deliberation Committee, under the Health Insurance Review and Assessment Service (HIRA), ruled on the 8th that setting reimbursement criteria for Limkato is appropriate. With reimbursement criteria established at the committee following the drug's marketing approval in April, Limkato is expected to begin full-scale market entry in the second half of the year.
The Cancer Disease Deliberation Committee is the first review body that determines whether specialty drugs, such as anticancer treatments and therapies for rare diseases, qualify for national health insurance coverage. With this approval, Limkato has cleared the first hurdle on its clinical utility and reimbursement appropriateness.
Final reimbursement listing and actual prescriptions for Limkato are expected as early as the second half of this year. The drug was selected for the Ministry of Health and Welfare's pilot program that runs approval, evaluation, and negotiation in parallel, which has significantly shortened its reimbursement listing timeline compared with ordinary drugs.
"Following marketing approval, the process toward commercializing the new drug is proceeding smoothly with the establishment of reimbursement criteria," Curocell CEO Kim Gun-soo said. "We will swiftly complete the remaining procedures, including the Drug Reimbursement Evaluation Committee review and drug price negotiations."
Limkato is a next-generation CAR-T therapy for patients with diffuse large B-cell lymphoma (DLBCL) that has relapsed or proven refractory after two or more systemic treatments. In a large-scale Phase 2 clinical trial, the drug demonstrated a complete response (CR) rate of 67.1% and an objective response rate (ORR) of 75.3%.
