PURPOSE: Since 2018, China has adopted a centralized drug review and price negotiation process to inform national coverage decision making. Quality-adjusted life year (QALY) is a recommended outcome measure for this process. However, all existing patient-reported outcome measures (PROMs) were developed in western countries. There was a need for PROMs that measure important aspects of health perceived by Chinese populations. The China Health-Related Health Outcome Measures (CHROME) were developed for this purpose. CHROME is a system of preference-based PROMs that consists of a core module for generic use and a series of disease-specific modules for measuring disease or condition-specific impact. This system has a novel design in which both generic and disease specific measurement needs are integrated throughout the conceptualization, validation, and valuation. Therefore, they can be used in clinical and economic evaluations with consistency and transitivity, while maintaining independence. The primary goal of this workshop is to introduce the development and validation of the CHROME system and its application to support drug price negotiation in China.

DESCRIPTION:

This workshop will start with an introduction of health technology assessment (HTA) and drug price negotiation process in China (10 minutes, by Dr. Kun Zhao). Dr. Feng Xie will provide an overview of the design, concept and structure of the CHROME system (15 minutes). Dr. Xue Li will present the development of CHROME instruments and their validations using both classic testing theory and item response theory in large representative samples (n=2,929) in China (20 minutes). The workshop will be concluded by discussion on the implications of the CHROME systems for HTA and drug price negotiation in China (10 mins by Dr. Qiang Fu), followed by a Q&A session (5 minutes).

This workshop may benefit the audience who is interested in the PROMs development and validation for HTA and drug coverage decision making in China.