Key Proposal to Include NRDL Category C for Innovative Therapies
Strategic Implications for Launching Pharmaceuticals in China
Key Proposal to Include NRDL Category C for Innovative Therapies: Strategic Implications for Launching Pharmaceuticals in China
Article written by Steven Lin and Amy Morgan, Windrose Consulting Group
The National Reimbursement Drug List (NRDL) has long been a critical vehicle for pharmaceuticals in China, providing patient access to treatments through centralized public insurance. Historically, the NRDL has included two categories (see Table 1): Category A, which includes essential medicines that are fully reimbursed and subject to stringent inclusion criteria, and Category B, which covers a broader range of therapies with flexibility in determining reimbursement levels by the provinces. Together, these categories form the basis of China’s publicly funded drug coverage framework.
Table 1: Overview of NRDL Category A & B
In early 2025, the National Healthcare Security Administration (NHSA) proposed the creation of Category C within the NRDL — a new market access channel specifically for drugs that do not qualify for Categories A or B. These are typically high-cost or recently launched innovative therapies that fall outside the “basic coverage” criteria of the Basic Medical Insurance (BMI) scheme but offer meaningful clinical benefits [1-3]. This initiative, introduced during a January press conference and reinforced at the March “Two Sessions” (Lianghui) as a national priority, aims to accelerate patient access while managing budgetary constraints. The NRDL application process for Category C opened on April 1, with the launch targeted for September 2025. Draft guidelines outlined a fast-track review mechanism and indicated a limited initial list of high-impact therapies for inclusion [2].
This move aligns with China’s broader healthcare policy objectives: fostering innovation, improving affordability, and enabling faster patient access. The proposal reflects key lessons from past NRDL negotiations, where authorities navigated the challenge of balancing increasing demand for breakthrough therapies (e.g., cell/gene therapies, rare disease drugs) against fiscal sustainability [1-3].
Key Proposed Features of Category C [4-6]:
Purpose and Scope: Category C is designed for therapies that fall outside the Basic Medical Insurance (BMI) scheme’s “basic coverage” criteria, often due to high costs or recent market entry, yet deliver substantial clinical value; these innovative treatments could also be subject to special pricing arrangements or conditional reimbursement terms
Funding Model and Access Pathways: Commercial insurance will be the primary funding source for Category C medicines, creating new reimbursement routes for patients to access advanced therapies, including CAR-T treatments, gene therapies, and rare disease interventions
Multi-Tiered Coverage Structure: The commercial insurance market is developing a tiered access framework and implement innovative payment models such as risk-sharing agreements or outcome-based contracts, allowing for coverage differentiation based on clinical need, therapeutic value, and drug costs
Implementation and Impact: The Category C drug list is expected to be launched in September 2025; manufacturers may use Category C as a fast track to commercialize novel therapies to bypass the stringent price negotiations and drive faster market entry and expanded patient access for new therapies
Windrose’s Take
The introduction of NRDL Category C marks a structural change in China’s drug reimbursement landscape, creating both opportunities and operational challenges for global pharmaceutical companies. By establishing a dedicated access pathway for therapies that do not qualify for Categories A or B, Category C will reshape market dynamics and compel manufacturers to re-evaluate how they design and execute drug access strategies in China
New Access Pathway for High-cost Innovations: Category C opens reimbursement, via commercial insurance-led funding, to advanced modalities such as CAR-T, gene therapies, and rare disease treatments that have been excluded from NRDL coverage due to high cost or cost-effectiveness challenges
Accelerated Market Entry in CN: By bypassing the protracted NRDL negotiation cycle, Category C has the potential to shorten time-to-access by months, potentially allowing manufacturers to generate early sales and collect real-world data sooner; this could serve as a launch bridge before pursuing full NRDL inclusion, offering a phased approach to market access in CN
Changes to Pricing and Negotiation Dynamics: The rise of standardized commercial insurance formularies and collective bargaining is shifting pricing leverage to private insurers. Manufacturers will face more coordinated negotiation pressure, requiring advanced contracting strategies, including discounting and engagement in value and performance-based agreements; in addition, as commercial insurers gain scale and negotiating experience, their pricing decisions may influence broader market trends, potentially affecting the prices of similar drugs outside the Category C list as well
Portfolio Implications: Larger manufacturers may bundle assets or leverage portfolio breadth to secure favorable coverage terms, while smaller players can remain competitive by focusing on high-value products or differentiating through innovative contracting
Local Variations: City-specific commercial insurance plans and group supplemental policies are becoming more common and can provide substantial reimbursement for Category C drugs. However, coverage levels, deductibles, and eligibility rules vary widely between cities and plans; manufacturers should focus on regions where plan designs are most favorable and coordinate patient-support programs to help reduce the out-of-pocket costs patients may face
In summary, the NRDL Category C framework is poised to address long-standing barriers — including inflexible pricing mechanisms, limited industry collaboration, and insufficient risk management. By bridging these gaps, it has the potential to establish a more sustainable and dynamic access model for innovative therapies that do not meet the traditional NRDL requirements, in China’s rapidly evolving market landscape.
Steven Lin (Left) and Amy Morgan (Right), Windrose Consulting Group