Rimqart (anbalcabtagene autoleucel), a CAR-T cell therapy developed by Curocell, has passed its first major review by the Health Insurance Review and Assessment Service (HIRA) for health insurance coverage in South Korea. This milestone allows the treatment for adult lymphoma patients who have failed two or more prior therapies to move toward government-subsidized pricing, significantly reducing the financial burden on patients.
HIRA Approves Reimbursement Eligibility for Rimqart
Curocell announced on October 4, 2024, that Rimqart received recognition for its reimbursement appropriateness during the 9th Drug Evaluation Committee meeting held on October 3. The approval is contingent upon Curocell accepting the evaluation price proposed by the committee. According to the company, this step is a critical part of the process to have the drug listed for health insurance coverage, which the company aims to finalize by the end of the year.
The therapy previously received product approval from the Ministry of Food and Drug Safety (MFDS) in April 2024 and passed the Cancer Disease Review Committee in July. Rimqart is the 42nd domestically developed new drug in South Korea. It is currently designated as a target for the MFDS Global Innovative Products Fast Track (GIFT) and is part of a pilot project that allows for the simultaneous processing of approval, evaluation, and negotiation.
Clinical Efficacy and Safety Data
Data from a Phase 2 clinical trial, published in the peer-reviewed journal Blood, indicates a 75.3% overall response rate in patients. Among these participants, 67.1% achieved complete remission, meaning the cancer disappeared entirely.
The trial also tracked severe side effects common to CAR-T therapies:
- Cytokine Release Syndrome (CRS): Occurred in 8.9% of patients.
- Neurotoxicity: Occurred in 3.8% of patients.
Manufacturing and Hospital Accessibility
Rimqart is produced in facilities meeting domestic Good Manufacturing Practice (GMP) standards. The treatment process involves collecting a patient’s T-cells and sending them to Curocell for modification and manufacturing. Curocell states that because the company handles the manufacturing, medical institutions do not need to build their own cell-processing facilities to administer the treatment.
Company officials expect that insurance coverage will enable regional base hospitals, which currently lack the specialized infrastructure for CAR-T therapies, to provide Rimqart to patients.
Next Steps for Insurance Listing
Following the official notification of the Drug Evaluation Committee’s results, Curocell will review the detailed conditions. The remaining steps to achieve full insurance coverage include:
- Price negotiations with the National Health Insurance Service (NHIS).
- Final decision by the Health Insurance Policy Review Committee.
Kim Gun-su, CEO of Curocell, stated that the HIRA approval recognizes the technical value of Rimqart and that the company will focus on the remaining procedures to ensure the therapy reaches patients with relapsed or refractory hematologic cancers quickly.
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