Regulatorische Updates

With coverage extending to severe type‑2 diabetes, groups call for a shift from upfront payment to direct co‑payment at pharmacies for CGM and insulin pump devices.

Korea's Health Insurance Review & Assessment Service released a list of 14,013 drugs for price‑ceiling re‑evaluation, excluding 1,576 items, leaving 12,437 for review.

TipsoBoc (ivosidenib) from Korea Serb... has entered health‑insurance price negotiations for IDH1‑mutant locally advanced or metastatic cholangiocarcinoma after passing the benefits evaluation committee in July.

At a forum on sustainable healthcare, Professor Ahn Hee‑kyung highlighted bottlenecks in Korean patients’ access to innovative anticancer drugs and urged a valuation framework that includes clinical and socioeconomic benefits.

Qurocell’s CAR‑T product Rimkato (anvalkaptagen autologous cell) has cleared the Cancer Disease Review Committee and the Drug Reimbursement Evaluation Committee, opening the path to health‑insurance coverage and a potential market launch within the year.

South Korea's Ministry of Health and Welfare unveiled a four‑year, stepwise drug price ceiling re‑evaluation plan that includes extra 20% cuts for non‑compliant drugs and a safeguard against lowering already low prices.

Pineteplaac for Dravet syndrome, Breztri Aerosphere for COPD, Polaiviju for DLBCL and Beova‑jeong for overactive bladder are expected to enter Korea's health‑insurance reimbursement list on Sep 1, pending final approval.

Korean Pharmaceutical Association secured a three‑day temporary reimbursement for di‑octahedral smectite dispensed to patients under 19, easing pharmacy billing concerns after pediatric indication was withdrawn.

The National Anti‑Corruption and Civil Rights Commission says the limitation period for health‑insurance claims should be calculated from the reimbursement decision date, not the original treatment date, and urges HIRA to issue new guidelines.

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

The Korean Pharmaceutical Association warned pharmacists that, following MFDS approval changes, the pediatric use of DiOctahexdylsMechtaite formulations is prohibited and health‑insurance coverage will cease for prescriptions from July 6 2026.

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.