A Delphi Study to Identify Priority Indicators for Formulary Selection of Innovative Anticancer Drugs in China

OBJECTIVE: To develop a multi-stakeholder, consensus-based decision support framework for prioritizing innovative anticancer drugs in Chinese hospital formularies, balancing clinical benefit, patient access, and financial sustainability. METHODS: A two-round Delphi survey was conducted with a multidisciplinary expert panel (n = 62 in Round 1; n = 51 in Round 2, 82.3% retention rate) comprising clinicians, pharmacists, health administrators, and patient representatives. The initial set of 19 indicators across 9 dimensions, derived from a literature review, was iteratively refined based on panel feedback. Consensus was defined as ≥ 80% of respondents rating an indicator as 4 or 5 on a 5-point Likert scale, dispersion was summarized by interquartile range (IQR). RESULTS: The panel reached a clear consensus on a structured framework comprising seven key dimensions and 16 measurable indicators. The top three prioritized dimensions were clinical benefits, safety, and economic impact. The framework incorporates policy-sensitive indicators relevant to China's healthcare system, such as pharmaceutical access and access barriers of genetic testing. Five indicators from the initial list were discarded, and two new ones were added based on expert input, with specific metrics refined for enhanced objectivity and practicality (e.g., "patient out-of-pocket expenditure per year"). CONCLUSION: This study presents a transparent, standardized, and actionable decision-making framework to support formulary selection of innovative anticancer drugs in Chinese hospitals-particularly in resource-adequate settings. By incorporating diverse stakeholder perspectives and establishing clear evaluation criteria, the framework reduces subjectivity and supports consistent value assessment. It provides practical guidance for hospital pharmacy and therapeutics committees and contributes to more equitable, evidence-informed, and financially sustainable drug policy development in China. PATIENT OR PUBLIC CONTRIBUTION: Patient representatives participated in the first-round expert panel, where they rated candidate indicators, shared their lived experiences, and provided feedback on the interview guides and questionnaires.