[Edaily Reporter KIM SAE-MI ] Curocell Inc.(372320)’s chimeric antigen receptor T-cell (CAR-T) therapy, “Limcato,” has cleared the first hurdle toward health insurance coverage following a re-review.

Curocell Inc. announced on the 9th that the Health Insurance Review and Assessment Service’s (HIRA) 6th Severe Disease Deliberation Committee—specifically the Cancer Disease Deliberation Subcommittee—held on the 8th had approved the reimbursement criteria for Limcato.

Eligibility for coverage applies to adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed or failed to respond to two or more systemic treatments. These are the indications approved by the Ministry of Food and Drug Safety (MFDS) last April.

Limkato’s approval by the Cancer Disease Review Committee came on its second attempt. Previously, at the 5th Cancer Disease Review Committee meeting held on May 27, Limkato had received a decision stating that “reimbursement criteria had not been established.” At that time, the decision was influenced by the judgment that additional objective scientific evidence was needed, as the clinical trial results had not been published in internationally recognized academic journals. The lack of sufficient publications in international academic journals—rather than the clinical data itself—was cited as the reason for the re-review.

Curocell Inc. subsequently submitted the Phase 2 clinical trial results for Rimkato as supplementary data after they were published in “Blood,” an international journal published by the American Society of Hematology. In that paper, Rimkato recorded an objective response rate of 75.3% and a complete remission rate of 67.1% according to the Independent Review Committee’s evaluation criteria. The incidence rates of Grade 3 or higher cytokine release syndrome and neurotoxicity were 8.9% and 3.8%, respectively.

With this approval by the Cancer Drug Review Committee, Rimcato will now proceed through a series of steps, including deliberation by the Drug Reimbursement Evaluation Committee, price negotiations with the National Health Insurance Service, a resolution by the Health Insurance Policy Deliberation Committee, and a formal announcement by the Ministry of Health and Welfare. The Cancer Drug Review Committee is the stage where reimbursement criteria are established by reviewing the clinical utility of anticancer drugs and the scope of reimbursement eligibility.

Limkato is a product included in the Ministry of Health and Welfare’s “Pilot Project for Concurrent Approval, Evaluation, and Negotiation.” According to the company, this approach—which conducts the approval, reimbursement evaluation, and drug price negotiation processes simultaneously—can significantly shorten the time required for national health insurance listing compared to conventional new drugs. The company expects the final reimbursement notice to be issued and actual prescriptions to begin within the second half of this year.

A Curocell Inc. official stated, “Curocell Inc. will swiftly complete the remaining follow-up procedures, such as the Drug Evaluation Committee review and drug price negotiations, to provide health insurance benefits to patients in the second half of the year and drive full-scale sales growth.”