HIRA Reimbursement Review & NHIS Price Negotiation – South Korea
Reimbursement listing application (HIRA Drug Reimbursement Evaluation Committee)National Health Insurance Act; positive list system
Description & Eligibility
Approval alone does not make a drug affordable. Korea runs a positive list system: the Health Insurance Review and Assessment Service assesses clinical utility and cost-effectiveness, then the National Health Insurance Service negotiates price. Orphan and anticancer drugs may use risk-sharing agreements, and drugs for severe conditions with no alternative may be waived from submitting a pharmacoeconomic dossier.
Eligibility Criteria
Drug already holding MFDS marketing authorisation; pharmacoeconomic waiver available where no alternative exists, the condition is severe or life-threatening, and the patient population is small
Legal Reference / Source
Health Insurance Review & Assessment Service (HIRA)
www.hira.or.kr/eng/main.doCountries Using This Pathway (1)
HIRA Reimbursement Review & NHIS Price Negotiation – South Korea
| Approval Form | Reimbursement listing application (HIRA Drug Reimbursement Evaluation Committee) |
| Legal Status | National Health Insurance Act; positive list system |
| Source Ref. | Health Insurance Review & Assessment Service (HIRA) |
| Countries | 1 countries |
Compliance Check
Legal Review9/1/2026
Global ValidityVerified