Keytruda Expands Reimbursement for 11 Cancer Indications

Korea MSD’s Keytruda (pembrolizumab) has made significant strides in expanding its reimbursement coverage, securing approval for 11 indications, including gastric and esophageal cancers. The announcement follows the results of the first 2025 Severe (Cancer) Disease Review Committee, disclosed by the Health Insurance Review & Assessment Service (HIRA) on February 12.

The approved indications include HER2-positive and HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, esophageal cancer, endometrial cancer, colorectal cancer, recurrent head and neck squamous cell carcinoma, cervical cancer, triple-negative breast cancer, small intestine cancer, and biliary tract cancer. For HER2-negative cases, a requirement of a CPS score of 10 or higher was applied.

Previously, MSD had submitted additional financial burden-sharing data after the final committee meeting last year deferred Keytruda’s reimbursement. In response, the company provided supplementary clinical data and revised financial proposals. Patient advocacy groups also urged approval, highlighting that delays restricted patients’ access to critical treatment. With the latest decision, MSD is expected to accelerate efforts to further expand Keytruda’s reimbursement in gastric cancer.

The committee’s review yielded mixed results for other therapies. Pfizer Korea’s Methotrexate secured reimbursement for intraocular lymphoma, while Elrexfio, a multiple myeloma treatment, failed its initial review and must reapply. Novartis’ Scemblix was approved for adult patients with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (CML) who have been treated with at least two prior tyrosine kinase inhibitors (TKIs). However, Padcev for urothelial carcinoma and Zolbetuximab for gastric adenocarcinoma were denied reimbursement.