보건의료기술평가를 위한 병용요법의 가치 배분 모델 탐색: 체계적 문헌고찰

Abstract

Objectives: Combination therapies are widely adopted across therapeutic areas to enhance treat- ment effectiveness, particularly playing a critical role in oncology due to their ability to target multi- ple tumorigenic pathways. However, these regimens often extend treatment duration and raise cost- effectiveness concerns, even when the added drug is priced at zero. This study aims to review and categorize existing frameworks for attributing value among component drugs in combination ther- apies. Methods: A systematic review was conducted to identify literature that discusses value attri- bution methodologies within combination therapy contexts. Searches were performed in PubMed and Ovid-MEDLINE, using multi-term query strategies to capture terminology variants of “value attribution.” Additional sources included grey literature, technical reports, and policy documents from international organizations. Key articles were further identified via reference tracking and au- thor-based snowballing. Results: Two key frameworks were identified. Briggs et al. propose a ne- gotiation-based model that categorizes scenarios based on the availability of monotherapy efficacy data and the balance of market power between manufacturers. While offering practical flexibility, the model relies on stakeholder negotiations, which—if not supported by formal guidelines or arbitra- tion mechanisms—may result in inconsistent or suboptimal value allocations. Towse et al. presents an outcome-based model that allocates value proportionally to each drug’s contribution to overall health gains. Its fairness is supported by principles of universal applicability, neutrality, and full val- ue allocation, but implementation may be limited by data availability and legal constraints. Conclu- sion: These contrasting models highlight the need for structured value attribution frameworks ap- plicable across therapeutic areas. Real-world adoption requires policy reform, including legal flexibility for price negotiation, indication-based pricing, improved clinical data access, and a neutral body to mediate value-sharing.