Regulatorische Updates

Rimkato (Anvalcapatgen Autologous Cell), Korea's first CAR‑T drug, cleared the health‑insurance reimbursement hurdle, signaling a shift toward domestic cell‑gene therapies.

A policy forum discussed expanding CGM insurance coverage to insulin‑treated type 2 diabetes patients and shifting reimbursement to a direct benefit system.

Korea’s first CAR‑T drug Limkato has cleared its initial health‑insurance coverage review, paving the way for prescriptions and sales from the second half of 2024.

Qurocell announced its CAR‑T drug Rimcato has passed the HIRA Severe Disease Review Committee, clearing the first hurdle for national health‑insurance reimbursement.

The government reiterated that the 1 trillion won additional funding for health‑insurance fee‑structure reform will not draw on savings from generic drug price cuts, but from reserves, premiums and treasury support.

Rimkatoju, Korea’s first home‑grown CAR‑T drug, passed the first review for national health‑insurance reimbursement, while HER2‑positive breast cancer drug Purgeta’s expansion was postponed.

Patient groups push for rapid reimbursement approval of Rimkatoju, a Korean CAR‑T treatment for relapsed/refractory large B‑cell lymphoma, as HIRA’s cancer committee revisits the issue.

Supporters of Korea's health‑insurance co‑payment cap grew by an average 6.5% per year, reaching 2.135 million in 2025 with expenditures of 2.792 trillion KRW.

32 drugs were newly listed or had expanded coverage, benefiting about 76,600 patients and costing roughly 741 billion KRW annually.

The Ministry of Health and Welfare aims to cut the health‑insurance listing period for rare‑disease therapies from up to 240 days to within 100 days, initially covering about five drugs.

Amid medical sector backlash, the Ministry of Health and Welfare reiterates its plan to implement separate payments for specimen testing and pursue spending efficiency measures.