Regulations on Assessment Criteria and Procedures, etc. for Medical Care Benefit Eligibility, etc. of Medicines.
For the pre-announcement, the major provisions were as followed;
- Amend processing times for medicines that have conditions to be fulfilled by the manufacturer, etc. and are evaluated as falling under subparagraph 2, item B and C in [Table 2] of the “Determination and Adjustment Criteria for Medicines”'
○ Expand the scope of medicines exempt from submitting economic evaluation data (Article 6-2, paragraph 1, subparagraphs 1 and 2)
- Amend provisions to allow the omission of economic evaluation data in the case of medicines used in pediatric patients for which there are no other therapeutically equivalent products or treatments and that has demonstrated a clinically significant improvement in quality of life, or where otherwise approved by the Committee
For more details, please visit the website of Health Insurance Review & Assessment Service; https://www.hira.or.kr/eng/main.do