The CAR-T (chimeric antigen receptor T-cell) cell therapy 'Yescarta Injection' and the oral anticancer drug 'Lipofaxel Solution' passed the Cancer Disease Review Committee, the first hurdle for National Health Insurance coverage.
According to the Health Insurance Review & Assessment Service on Thursday, Yescarta and Lipofaxel Solution were granted coverage criteria at the 9th Cancer Disease Review Committee of 2026 held the previous day.
Gilead Sciences Korea's 'Yescarta Injection' (axicabtagene ciloleucel) was also granted coverage criteria for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) who relapse or are refractory within 12 months after first-line chemoimmunotherapy.
Yescarta is a CAR-T cell therapy that collects a patient's T cells, genetically modifies them to recognize CD19 on the surface of cancer cells, and then re-administers them.
Daewoong Pharmaceutical's oral paclitaxel formulation 'Lipofaxel Solution' was granted coverage criteria for the treatment of advanced, metastatic, or locally recurrent gastric cancer, and as first-line treatment for recurrent or metastatic HER2-negative breast cancer.
Biogen Medicine Korea's 'Tevimbra Injection' (tisotumab vedotin) had different review results depending on the indication. The regimen combining gemcitabine and cisplatin for first-line treatment of patients with metastatic or recurrent nasopharyngeal carcinoma that is not amenable to radical surgery was granted coverage criteria.
On the other hand, the regimen combining etoposide and platinum-based chemotherapy for first-line treatment of patients with extensive-stage small cell lung cancer was not granted coverage criteria.
The proposal to combine platinum-based chemotherapy as neoadjuvant therapy before surgery for patients with resectable non-small cell lung cancer and use it as a single agent as adjuvant therapy after surgery received a decision requiring supplementary materials.
The Cancer Disease Review Committee is the stage that reviews the clinical necessity of anticancer drugs, the scope of patients requiring coverage application, administration conditions, etc.
Subsequently, the Drug Coverage Evaluation Committee of the Health Insurance Review & Assessment Service comprehensively evaluates clinical utility, cost-effectiveness, and impact on the National Health Insurance fund. The final coverage status and scope of application may vary depending on subsequent procedures and negotiation results.
Meanwhile, patient groups expressed welcome regarding the establishment of Yescarta's coverage criteria. The Korea Leukemia and Lymphoma Patient Association said, "We welcome the establishment of coverage criteria for Yescarta Injection as second-line treatment for diffuse large B-cell lymphoma (DLBCL)."
It further urged, "The government and pharmaceutical companies must each fulfill their responsibilities to ensure rapid National Health Insurance listing so that patients do not miss precious opportunities while waiting for treatment."
in THEBIO
