Presentation (CTI)

OBJECTIVES: China’s pharmaceutical sector has shown an increasing emphasis on innovation alongside its established generic drug base. The National Healthcare Security Administration (NHSA) has recently updated processes governing patient access to innovative therapies. This summary outlines recent changes, and their implications for the market access landscape in China.
METHODS: A targeted review of publicly available information on reimbursement process since 2022 was conducted using PubMed and official sources, including NHSA.
RESULTS: In 2022, the NHSA issued formal guidelines standardizing the health economic evaluation dossier required for the National Reimbursement Drug List (NRDL) negotiations, demanding more structured HEOR data to justify the pricing of drugs under Categories A (essential drugs with 100% reimbursement) and B (other innovative and efficacious medicines, with partial reimbursement of 60-90%) via Basic Medical Insurance (BMI). In 2025, NHSA introduced the Commercial Health Insurance Innovative Drug Catalogue, also referred to as “Category C” (CHIIDL), as a complementary mechanism to the BMI drug catalogue. The pathway aims to identify selected innovative medicines that may exceed current scope of basic reimbursement while demonstrating high innovation, clinical value, patient benefit, and suitability for commercial insurance coverage via City Supplementary Insurances (CSIs). This development may support access to selected high-cost therapies, including oncology, rare disease, and advanced therapies such as CAR-T, and may facilitate future use of value-based access mechanisms where evidence and implementation infrastructure are sufficient. Managed entry agreements (MEAs) have been used in Europe (e.g. UK, Spain, Demark). However, the approach, frameworks and infrastructure demands remain heterogenous.
CONCLUSIONS: This hybrid of public and commercial ecosystem has opened Chinese market for newer, innovative, though expensive therapies which were a challenge earlier, benefiting both pharma industry and patients. The shift to risk-sharing with insurers also safeguards private insurers against reimbursement for high priced drugs. How China approaches MEAs is yet to be seen.