OBJECTIVES: As the price of a new drug should represent the value of the drug, various stakeholders have differing perspectives on Korea’s price levels. This study compares new drug prices in Korea at the time of initial listing with A7 prices, and further examines whether there are differences in price levels depending on drug characteristics or listing pathway.

METHODS: Among the evaluation results released by the Health Insurance Review and Assessment Service between 2011 and 2021, we excluded domestic drugs and reviewed only global new drugs. For drug characteristics, we included target disease, anticipated patient number and budget impact during the 1 year of listing, and for listing pathway, we compared the applicability of pharmacoeconomics evaluation(PE) and relevant listing pathways with the adjusted A7 average price(adjusted by domestic regulations).

RESULTS: A total of 174 new drugs were analyzed. These consist of 56(32.2%) oncology, 33(19.0%) rare disease, 49(28.2%) risk-sharing agreement and 24(13.8%) PE exemption drugs. There were 5 countries among the A7 for comparison and the target patient number and budget impact were 1500 and KRW 6 billion(median value). The median new drug price in Korea was 52.5%(range: 0.6-105.7) of the adjusted A7 average price. The median prices of oncology, rare and chronic disease drugs were 58.2%, 65.4% and 41.7%, respectively. The median prices of drugs that proved cost-effectiveness, those exempt from PE and essential drug pathway drugs were 48.3%, 69.5% and 91.8%, respectively. The larger the anticipated patient number in the first year, prices were lower (Pearson’s correlation: -0.25, p=0.0007), and prices were higher as the annual treatment cost per patient increased (Pearson’s correlation: 0.33, p<0.0001).

CONCLUSIONS: New drug prices in Korea are lower for those listed through PE evaluation, and higher for those listed based on A7 prices(Non-PE). And drugs with large target patient numbers (e.g., chronic disease) tend to have lower prices.