Policy Updates on Access to and Affordability of Innovative Medicines in China

Abstract

Introduction: In China, efforts to qualify innovative medical products for reimbursement used to be subject to substantial delays after regulatory approval due to fiscal and bureaucratic barriers. In this review, we surveyed the Chinese government's most recent initiatives to improve access to innovative medicines from both the regulatory and the reimbursement aspects, which not only accelerated the launching of drugs in the Chinese market but also expanded the reimbursement coverage of such products. We also provided a discussion of the current challenges.

Areas covered: We provided a comprehensive review of the updates in China's national reimbursement listing policies of medicines.

Expert opinion: As the most recognized regulatory shortcuts, priority and conditional approvals have expedited the authorization of many innovative medicines. In addition, the national negotiation process was institutionalized to enable timely access to innovative medicines through the National Reimbursement Drug List, leading examples of which were new anticancer drugs. Other impactful reimbursement policies in recent years included dynamic updates of the National Reimbursement Drug List, manufacturer-initiated reimbursement coverage applications, and parallel fund robustness tests and pharmacoeconomic analyses for price estimation. Recent administrative efforts have substantially improved the access to and affordability of innovative medicines in China. Nevertheless, standardized and transparent evidence appraisal processes need to be established for informed decision making in the future.

Keywords: China; National Reimbursement Drug List; access to innovative medicines; affordability; conditional approval; price negotiation.