This week, China’s National Healthcare Security Administration (NHSA) released two draft documents detailing a plan to adjust the national basic medical insurance, maternity insurance, and work-related injury insurance drug lists and to establish a commercial health insurance innovative drug list for the first time in 2025. The consultation on the plan is open until July 7.
Establishment of Commercial Health Insurance Innovative Drug List
In 2025, China will establish the first edition of the Commercial Health Insurance Innovative Drug List. This list will primarily include innovative drugs that exceed the basic coverage scope and cannot yet be incorporated into the National Reimbursement Drug List (NRDL) but demonstrate high innovation, significant clinical value, and substantial patient benefits. These drugs will be recommended for reference and use by multi-tiered healthcare security systems, such as commercial health insurance and medical mutual aid programs.
Negotiated Drug Renewal Rules
Drugs under current negotiation agreements may be transferred to the regular NRDL if they meet either of the following conditions: 1. Non-exclusive drugs (determined by the number of generic versions approved by the National Medical Products Administration, NMPA) as of June 30 of the adjustment year (inclusive). 2. Drugs that have been continuously listed in the “negotiated drugs under agreement” section of the NRDL for eight years as of December 31 of the adjustment year. For example, drugs newly negotiated between 2017 and 2024 will have been listed for 8, 7, 6, 5, 4, 3, 2, and 1 year(s), respectively, as of December 31, 2025.
Negotiation Criteria
The criteria for new drugs outside the NRDL to enter negotiations and for in-list drug renewals remain largely consistent with previous years. Drugs approved for market by the national drug regulatory department from January 1, 2020 (inclusive) to June 30, 2025 (inclusive), and rare disease treatment drugs approved before June 30, 2025, can separately be applied for the commercial insurance innovative drug list or simultaneously for the commercial insurance innovative drug list and NRDL.
Renewal Rules Adjustment
Renewal rules remain unchanged from previous years. Starting from 2025, for exclusive drugs with adjusted coverage scope that have been in the negotiated drug list for less than four consecutive years, the sales revenue cap will be adjusted to 1.5 times the previous year’s level. Drugs with an annual average incremental budget impact of ≤RMB 300 million (USD 42 million) will undergo simplified renewal with tiered price cuts. For incremental impacts between RMB 300 million (USD 42 million) to RMB 1.5 billion (USD 209 million), RMB 1.5 billion (USD 209 million) to RMB 3 billion (USD 419 million), RMB 3 billion (USD 419 million) to RMB 6 billion (USD 873 million), and more than RMB 6 billion (USD 873 million), an additional price reduction of 2%, 4%, 6%, and 6% respectively will apply. Drugs listed in the “negotiated drugs under agreement” section for four or more consecutive years (as of December 31 of the adjustment year) will have their price reduction rates halved from the calculated values above.-Fineline Info & Tech
