외국의 약제 사용범위 확대 정책의 현황: 호주, 영국 및 일본

Current Policies on the Expansion of Drug Indications in Australia, the UK, and Japan

In this study, we attempted to examine foreign cases of how prices are differentiated when the scope of drug use expands in foreign countries. The targeted countries were Australia, the UK, and Japan. A comprehensive search was conducted utilizing each country’s institutional websites and relevant articles. The UK and Australia conducts an economic evaluation for each indication, the risk-sharing and the rebate rate for each indication differ despite the single price. If there is uncertainty in clinical effectiveness in the new indication, additional data will be collected for approximately 2 years with the managed access contract and then the benefit is reevaluated. Japan added indications without consideration for economic evaluation and repeatedly cut drug prices if sales of high-priced drugs increased, resulting in the cumulatively 78.8% cut for Opdivo®. We found that each country uses a distinct approach. In South Korea, value-based pricing for multi-indication drugs should be contemplated from the long-term perspective considering drawbacks and benefits of such system.