Keytruda is approved for early-stage perioperative treatment in South Korea for non-small cell lung cancer, triple-negative breast cancer, and head and neck squamous cell carcinoma. The Ministry of Food and Drug Safety grants these approvals, though national insurance coverage often lags behind regulatory status for early-stage use.
- Approved indications: Validated for resectable non-small cell lung cancer and high-risk early-stage triple-negative breast cancer.
- Latest expansion: Head and neck squamous cell carcinoma received perioperative approval in October 2025.
- Regulatory authority: The Ministry of Food and Drug Safety (MFDS) oversees all immunotherapy drug approvals.
- Insurance gap: National Health Insurance coverage for many perioperative uses is expected by 2026.
Bookimed Expert Insight: While South Korean clinics like Severance Hospital hold Joint Commission International accreditation, a significant gap exists between drug approval and insurance reimbursement. International patients often access these early-stage treatments as non-reimbursed services, which costs $5,200 to $8,500 per cycle. This is still approximately 68% lower than the $21,500 average cost in the United States.
Patient Consensus: Patients report that while regulatory approval exists, accessing Keytruda for early-stage cancer requires navigating complex hospital-specific committees. Many recommend preparing international clinical trial data to support out-of-pocket treatment requests at major Seoul centers.