The General Office of the National Healthcare Security Administration (NHSA) has recently issued the Circular on Launching a Pilot Program for Real-World Comprehensive Value Assessment for Health Insurance (the "Circular").
The Circular stipulates that the healthcare security authorities will collaborate with relevant stakeholders to address issues of concern that were not fully resolved or remain unanswered in processes such as drug review and approval, drug reimbursement negotiations and other decision-making procedures. At the same time, emphasis will be placed on assessing whether the actual clinical benefits and risks observed on patients in real-world drug use cases differ from the evidence submitted during health insurance decision-making processes, such as the decision to include drugs in the reimbursement list. Real-world studies include, but are not limited to, interventional studies, non-interventional studies, and observational studies (including both prospective and retrospective studies). According to the Circular, by the end of 2027, a value-oriented, real-world study–based comprehensive value assessment system for health insurance is to be established and promoted nationwide.