Presentation (CTI)

OBJECTIVES: Health technology assessment (HTA) is widely used for drug inclusion in China’s National Reimbursement Drug List (NRDL). However, no standardized methodology exists for selecting comparator drugs, leading to inconsistencies among stakeholders. This study aims to provide methodological guidance for comparator drug selection to improve research design, implementation, and reporting, ensuring both evaluation and decision-making needs are met.
METHODS: A systematic review summarized comparator selection criteria from international HTA agencies. Based on this, interviews with key informants and surveys of stakeholders were conducted, followed by Delphi and consensus techniques to finalize recommendations. The study involved 4 rounds of expert consultation (72 inputs), interviews with 14 pharmaceutical companies, and 4 survey rounds (222 responses).
RESULTS: Ten consensus statements were developed, addressing definitions, principles, and processes for comparator drug selection. Comparator drugs should be clinically substitutable therapies within the same indication and treatment line as the evaluated drug, preferably those listed in the NRDL. Standard treatment is prioritized, followed by conventional treatments. Evidence level, availability, and mechanism of action are critical. If multiple drugs meet these criteria, 1-3 comparators are recommended. For first-in-class therapies, a placebo or no-treatment comparison is acceptable. Early determination of comparator drugs during or before the evaluation process is recommended, along with a multidimensional selection framework. The framework also emphasizes categorizing drugs into high-value and other categories based on characteristics of the evaluated and comparator drugs. Relative benefit comparisons should guide willingness-to-pay thresholds, higher thresholds are recommended when benefits are demonstrated against high-value comparators.
CONCLUSIONS: This study provides a structured framework for comparator drug selection, ensuring consistency and transparency in NRDL inclusion and supporting rigorous HTA practices.