How China’s Layered Access System and Real-World Evidence Are Changing Market Access
China is evolving beyond a single public reimbursement model toward a layered access system that combines national coverage, commercial funding, and early access programs. In 2025, these changes began to reshape how manufacturers think about pricing, evidence, and launch sequencing. In Trinity’s webinar “Around the World in Market Access 2026: Global Trends Life Sciences Leaders Need to Watch,” the section on China examined how the National Reimbursement Drug List (NRDL), Category C, real-world evidence (RWE), and early access are coming together to define the next phase of market access.
NRDL Remains the Anchor – Trading Price Concessions for Scale
As China’s primary public coverage channel, NRDL remains the primary access route for large patient populations. It continues to mature, with more systematic, value-focused negotiations. At the same time, some fundamentals have not changed. There is a fixed annual per-patient cost ceiling for high-cost therapies that is not expected to move in the near term. Manufacturers still face steep price-for-volume trade-offs, and budget impact remains central to payer decisions.
For products that fit NRDL criteria, public reimbursement offers scale and volume. But for some high-cost, novel therapies, the required discounts can be difficult to absorb while maintaining global pricing objectives. This tension is one reason why new mechanisms have started to emerge.
Category C and Dual Funding Pathways
In 2025, China introduced a Commercial Innovative Drug List, often referred to as Category C. Nineteen drugs were listed in its first year, including five CAR-T therapies, three orphan drugs, and two Alzheimer’s treatments. Category C is designed to support early market access, preserve prices closer to global levels, and enable data generation and value demonstration.
Category C, however, is not compulsory for insurers. Market uptake depends on whether commercial insurers choose to cover a product, whether hospitals include it on formularies, how it competes with other therapies, and what patients can afford. Hospital formulary inclusion remains a significant challenge, and access may increasingly occur through alternative channels such as direct-to-patient pharmacies, online pharmacies, and direct procurement by insurers. As a result, China is evolving toward dual funding pathways: NRDL as the primary public channel with volume, and Category C offering a more flexible commercial route to preserve value.
The strategic task for manufacturers is to decide when to pursue NRDL, when to use Category C, and how to sequence or combine these options across the product life cycle and broader portfolio.
The Growing Role of Real-World Evidence and Early Access
Real-world evidence is becoming more important in China’s access decisions. Regulators and payers are increasingly open to RWE, public insurance claims data are gradually opening, and policies now allow RWE in payer negotiations and coverage decisions. The availability of claims data is expected to improve the precision and evidence base of health economics decisions. Given the scale of the data and the policy focus on using it, China may move quickly to adopt RWE as a standard element of market access.
Early access programs, especially the Hainan Boao pilot zone, add another layer. Boao offers a platform for early patient access, RWE generation, demand testing, and brand building. It also provides a way to engage with key clinicians and payers ahead of broader coverage decisions. These programs are not designed for volume, but they can be powerful tools to de-risk access and shape perception before NRDL or Category C negotiations.
What Manufacturers Should Do Next
China’s shift to value-anchored, multi-tier access demands careful planning and coordination. Manufacturers should:
- Build cross-functional China access playbooks that map scenarios across NRDL, Category C, and early access
- Engage NRDL payers, commercial insurers, third-party administrators, and local experts early
- Demonstrate incremental clinical benefit and budget manageability and decide when to prioritize NRDL versus Category C
- Design payer-relevant clinical and RWE studies focused on long-term outcomes, adherence, and budget impact
Companies that can navigate both funding pathways effectively and capitalize on the growing role of RWE will be best positioned to maximize access and value for its pipeline in China.
To explore these themes in more detail, watch the replay of “Around the World in Market Access 2026: Global Trends Life Sciences Leaders Need to Watch.” Our third annual State of Global Market Access white paper, which expands on what was shared in the webinar, will be released soon, and you can sign up to receive it by visiting TrinityLifeSciences.com. Other blogs summarize the US, Europe, and Latin America/MENA sections of the webinar.
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Author: Wenting Zhang