SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
8.5 Regulation of Prescriptions and Dispensing by Pharmacies
ance coverage, the criteria for such eligibility, and the maximum reimbursement amount. Finally, the MOHW includes the product on the reimbursement list. How- ever, in the case of medical services, the MOHW stip- ulates medical services not covered by health insur-
After the separation of prescribing and dispensing in 2000, only physicians can prescribe drugs in hos- pitals, and only pharmacists can dispense drugs in pharmacies (this applies to the case of outpatient only, and dispensing drugs in pharmacies within the hos- pital is possible for inpatients). In order to prevent the over-prescription of narcotic or psychotropic drugs such as propofol, monitoring of prescription details is performed through HIRA’s big data management system.
ance (negative-listing system). 8.4 Cost-Benefit Analyses
Where drugs are concerned, it is the principle of the positive listing system to determine the eligibility for reimbursement and reimbursement amount on the basis of the HTA (health technology assessment – ie, cost-utility analysis). In the case of pharmaceuticals for treatment of cancer or orphan diseases, however, economic evaluation may be omitted if certain criteria are met. By contrast, for medical devices, cost-effectiveness analysis plays only a limited and relatively minor role in determining eligibility for reimbursement and the level of reimbursement.
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