Keytruda, a global blockbuster immunotherapy, recorded sales of 11 trillion won in the second quarter alone this year (Captured from MSD website)
The health insurance coverage for the blockbuster immunotherapy drug Keytruda has expanded to a total of 13 cancer types, adding 9 cancers including gastric cancer and breast cancer to the existing 4 cancers such as non-small cell lung cancer. This development is considered significant as it extends insurance benefits beyond simply increasing coverage targets to cancer types that previously had low treatment accessibility.
The Ministry of Health and Welfare held a Health Insurance Policy Review Committee meeting on Dec. 23 and approved the agenda for expanding Keytruda’s reimbursement indications. Accordingly, starting January next year, Keytruda’s coverage will be expanded to include gastric cancer, esophageal cancer, endometrial cancer, colorectal cancer, cervical cancer, breast cancer, small bowel cancer, and biliary tract cancer. While coverage was previously concentrated on certain cancer types such as non-small cell lung cancer, melanoma, Hodgkin lymphoma, and urothelial cancer, this decision is expected to significantly improve treatment accessibility for patients with women’s cancers and rare or neglected cancer types. The annual medication cost per patient will decrease from approximately 73.02 million won to around 3.65 million won. This represents the cost burden when applying a 5% co-payment rate for Keytruda monotherapy.
This coverage expansion is also noteworthy as it serves as an institutional testing ground for reimbursement entry pathways for anticancer drugs with multi-indication approvals. Keytruda has faced difficulties in coverage expansion as it has been intertwined with discussions on introducing an indication-based pricing system (IBP). The analysis suggests that this could serve as a precedent for future multi-indication anticancer drug reimbursement strategies, as the Health Insurance Review and Assessment Service, National Health Insurance Service, and pharmaceutical companies found a broad coverage expansion solution within the current risk-sharing agreement (RSA) framework while concrete IBP plans have not yet been established.
Meanwhile, the Health Insurance Policy Review Committee also confirmed the Community Primary Care Innovation Pilot Program aimed at reorganizing the healthcare delivery system. The government envisions transforming regional primary care into a family physician-based management system that institutionally compensates for patient registration, continuous management, and referral functions, departing from the existing fee-for-service system centered on the number of treatments. The pilot program will be implemented for three years from 2026 to 2028, starting with individuals aged 50 and above who have high demand for integrated management in the first year, with plans to gradually expand the target population.
The core of this pilot program is the transformation of the compensation system. To compensate for the management and coordination functions performed by primary care institutions, a function-enhanced integrated fee will be introduced, designed as a structure that provides advance monthly payments based on monthly flat management fees per patient. Patients will select and register with a family physician, and medical institutions will classify patients into four stages—preventive, general, intensive, and specialized management—applying different management intensities. The government aims to alleviate the concentration of patients at tertiary hospitals and establish a healthcare system that extends from prevention to chronic disease management within local communities.
