OBJECTIVES: This research aimed to assess the budget impact of introducing Non-Invasive Prenatal Testing (NIPT) into Korea's public health insurance, focusing on older women with high-risk pregnancies. Although NIPT is one of the most popular prenatal tests in Korea, it is not yet covered by KNHI. Given its widespread use as a non-covered service, this research aims to provide robust economic evidence to support reimbursement decisions for NIPT in Korea. Our analysis leverages real-world data to produce a reliable BI estimate, contributing to informed, evidence-based policymaking in prenatal screening coverage.

METHODS: To analyze the annual increase in medical expenses and budget impact of NIPT coverage, we categorized NIPT costs and target populations into two types and analyzed eight scenarios with insurance coverage rates of 70% and 30%. Using 2017 birth statistics, we estimated the total number of pregnant women at 351,019, with 29.4% aged 35 and above, and 70.6% below 35. NIPT costs were set at 357,000 KRW and 715,000 KRW.

RESULTS: When NIPT is covered by insurance, the annual financial burden on insurers is lowest when targeting high-risk groups among pregnant women aged 35 and above based on maternal serum screening, with an NIPT cost of 357,000 KRW and an insurance coverage rate of 30%, at 6,115,813,866 KRW. Conversely, the financial burden is highest when covering all pregnant women aged 35 and above, along with high-risk groups among those under 35 based on maternal serum screening, with an NIPT cost of 715,000 KRW and an insurance coverage rate of 70%, at 56,240,636,611 KRW.

CONCLUSIONS: Our analysis offers key insights into the financial implications of introducing NIPT into the KNHI. Without extensive cost-effectiveness studies on prenatal diagnostics in Korea, our results are crucial for setting reimbursement standards and facilitating evidence-based policymaking, especially for high-risk groups like older pregnant women.