Presentation (CTI)

OBJECTIVES: Traditional health technology assessment (HTA) frameworks primarily focus on clinical and economic outcomes, often failing to capture broader dimensions of value associated with innovative therapies - particularly those offering extended survival, such as oncology medications. Real Option Value (ROV), an extension from the ISPOR value flower, is increasingly proposed as a complementary concept to capture the value of extended survival that enables access to future promising therapeutic innovations. This study critically explores ROV’s conceptualization, including its definition, core criteria, and methodological approaches for its incorporation into pharmaceutical value assessment and HTA methods.
METHODS: A qualitative study was conducted using semi-structured interviews with senior stakeholders from HTA entity, health policy, formulary management, pharmacy and therapeutics committees, physicians, and the pharmaceutical industry in Saudi Arabia. Interviews were audio-recorded and transcribed verbatim and analyzed manually using six-step thematic analysis approach.
RESULTS: Findings indicate ROV is primarily conceptualized as a time-dependent value arising from extended survival and the opportunity to access and benefit from future treatment advances. However, stakeholders consistently described ROV as conceptually ambiguous, methodologically underdeveloped, and lacking clear guidance for its practical operationalization in practice. The dominance of traditional HTA frameworks was identified as a key barrier, with substantial gaps in capturing non-clinical value dimensions. Major concerns included uncertainty in estimating future innovation trajectories, feasibility of robust ROV quantification, and practical challenges of incorporating ROV into existing frameworks and assessment processes.
CONCLUSIONS: ROV highlights a critical gap in current HTA frameworks by capturing value elements linked to future treatment opportunities. Yet, its conceptual ambiguity and methodological limitations currently hinder its practical application. This underscores the urgent need for clearer unified definition and robust HTA methods and processes.