Presentation (CTI)

OBJECTIVES: To develop and validate a structured MCDA framework that integrates multidisciplinary evidence to support transparent, evidence-based, and reproducible global launch prioritization for innovative oncology medicines.
METHODS: A multi-phase methodology:
First, a targeted literature review was conducted to identify published MCDA frameworks, oncology value HTA assessment methodologies. Second, candidate decision criteria were identified and organized into thematic domains. A modified Delphi process involving international experts in HEOR, medical affairs, clinical development, epidemiology, and regulatory affairs was designed to evaluate the relevance, completeness, and practical applicability of each criterion through iterative consensus rounds.
Third, relative criterion importance will be quantified using structured weighting methodology (e.g., swing weighting or Analytic Hierarchy Process). Finally, the framework will be retrospectively evaluated using selected innovative oncology medicines approved across multiple global markets to assess consistency, validation, and ability to differentiate launch prioritization compared with historical launch sequences.
RESULTS: The preliminary framework from the first step comprises six evidence domains:
• Disease burden and unmet medical need
• Clinical differentiation and therapeutic value
• Health economic evidence and readiness
• Pricing and reimbursement opportunity
• Healthcare system environment
Each domain contains multiple predefined assessment criteria with standardized scoring definitions. The Delphi process is expected to refine criterion selection and improve content validity, while the weighting exercise will establish the relative contribution of each domain to the overall prioritization score. Retrospective validation will evaluate framework robustness, transparency, reproducibility, and agreement with expert judgement across representative oncology case studies.
CONCLUSIONS: This research proposes a structured, evidence-based MCDA methodology for global launch of innovative oncology medicines. By integrating clinical, epidemiological, economic, HTA, and healthcare system evidence into a transparent, improve consistency and reproducibility of innovative oncology decision making. Validation through expert consensus and retrospective case studies will provide evidence supporting its potential application in strategic planning, and value-based decision making.