Korea's first domestically made CAR-T Therapy, "RIMQARTO (ingredient name anbalcaptagene autoleucel)," has cleared the first hurdle for health insurance reimbursement.
However, the decision came with the condition that Curocell must accept the proposed assessment price. If the company accepts, the process will move to price negotiations with the National Health Insurance Service and a resolution by the Health Insurance Policy Deliberation Committee (HIPDC).
On Apr. 4, according to the Health Insurance Review & Assessment Service, Curocell was recognized the previous day for the appropriateness of coverage.
The Drug Reimbursement Evaluation Committee concluded that there is appropriateness for coverage "if the assessment price or lower is accepted." This means RIMQARTO can be listed for reimbursement on the condition that its price is set at or below the assessment price proposed by HIRA.
RIMQARTO is indicated for adult patients with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have relapsed after two or more lines of systemic therapy or are refractory to treatment.
The developer, Curocell(372320), plans to proceed with follow-up procedures after officially receiving the detailed deliberation results and reviewing the conditions. The company is targeting listing for reimbursement within the year.
Meanwhile, at the same meeting, the committee also recognized the appropriateness for coverage of treatments for myasthenia gravis and multiple myeloma.
Handok's "VYVGART (ingredient name efgartigimod alfa)" and Korea UCB's "ZILBRYSQ (ingredient name zilucoplan sodium)" were recognized as appropriate for coverage as add-on therapies to standard treatment for adult myasthenia gravis patients who are positive for anti-acetylcholine receptor (AChR) antibodies.
Korea Janssen's multiple myeloma treatment "TEC-VAYLI (ingredient name teclistamab)" was recognized as appropriate for coverage as a monotherapy for patients who have failed at least third-line treatment. Leo Pharma's "ENZUPCO (ingredient name delgocitinib)" and Korea Takeda's "FRUZAQLA (ingredient name fruquintinib)" were also recognized as appropriate for coverage for the treatment of chronic hand eczema and metastatic colorectal cancer, respectively.
In the review to expand coverage scopes for risk-sharing agreement (RSA) drugs, Korea Ono Pharmaceutical's "Opdivo (ingredient name nivolumab)" was recognized as appropriate for expanded coverage in first-line treatment of advanced or metastatic esophageal squamous cell carcinoma and in first-line treatment of hepatocellular carcinoma with the combination therapy of Opdivo and Yervoy (ingredient name ipilimumab). In contrast, the combination therapy for first-line treatment of malignant pleural mesothelioma was not recognized.