Pharmacoeconomic Evaluation Exemption and Deferral in Korea – Impact on Patient Access?

OBJECTIVES: Since the introduction of the positive listing system(PLS) in Korea, only new drugs that have proven cost-effectiveness may be listed. However, due to the strict pharmacoeconomic evaluations(PEs), the number of non-reimbursed drugs continued to increase, and to address this problem, a system that enables exemption from PE was introduced in 2015. Although it was initially introduced as a relief measure for certain drugs, a report has been published suggesting that the system needs to be changed as the number of drugs listed through this track has increased. This study analyzed the impact of the proposed system on the accessibility of new drugs.

METHODS: We analyzed whether the proposed revised system could be applied to the 33 products that were listed through PE exemption(PEE). Additionally, we examined which criteria of the revised PEE were more difficult to meet compared to the current standards.

RESULTS: Among the 33 products, 23(69.7%) were anti-cancer drugs, 6(18.2%) were orphan drugs, and 4(12.1%) were others. Under the current criteria, most drugs listed through PEE were based on the criteria that there be no alternatives or drugs with equivalent therapeutic position and that it be difficult to produce evidence. However, under the revised criteria, none of the 33 products meet the requirements for PEE. The most difficult criteria to satisfy are the requirement for lack of PE abroad and the less than 200 patient requirement for a single disease.

CONCLUSIONS: The PEE was adopted to improve patient accessibility following the implementation of the PLS. While there has been criticism of the system as the number of drugs being listed through the system has steadily increased, if the proposed reforms are introduced, there is high likelihood that the system will lose its original purpose as a relief measure and instead serve only as a regulatory barrier.