China’s NRDL: The World’s Largest Market Access Event Is Underway

Every year, one event stands out in the market access calendar like no other, China’s National Reimbursement Drug List (NRDL). With the 2025 application window now closed, the race is on for companies vying to secure access to the world’s largest single-payer market. Inclusion means reaching over 1.3 billion people making the NRDL not just a policy tool, but the largest market access opportunity on the planet. And in 2025, the rules are shifting again. The NRDL is no longer just a list; it's a dynamic platform driven by increasingly rigorous Health Technology Assessments (HTAs) and new dual-track reimbursement models that are transforming how and which innovations make it to Chinese patients.

This article explains why the NRDL process is more important than ever, what’s changing in 2025, and how companies should rethink their strategy to align with China’s evolving dual-track reimbursement model.

China’s Market: From Emerging to Essential

The strategic importance of the NRDL is rooted in China’s dramatic transformation into a pharmaceutical powerhouse. By 2023:

• 28% of global pharma R&D originated in China, up from 3% in 2013
• 29% of new drug launches occurred in China first, up from just 9% in 2017, driven largely by domestic innovation

This surge has made China the second-largest pharmaceutical market in the world, trailing only the U.S. Its HTA and reimbursement systems are evolving just as rapidly. For global life sciences companies, market access in China is no longer optional it’s mission critical. [1]

The NRDL: Expanding Reach, Deepening Impact

The NRDL continues to grow in scope and ambition. In 2025, the list includes 3,159 drugs, with an annual growth rate of about 5%. This reflects China's national effort to make innovative therapies more affordable and widely available through its Basic Medical Insurance (BMI) system. (See Figure 1.)

While both Traditional Chinese Medicines and modern medicines are included, modern medicines accounted for 94% of the NRDL’s growth between 2022 and 2024, a clear signal of where China’s priorities lie.

Figure 1. Number of drugs included in the NRDL 

Source: [2]

Since the introduction of formal HTA processes in 2017, the NRDL has evolved from a static listing to a sophisticated and competitive access platform. Assessments now include:

• Comparative clinical effectiveness
• Innovation scoring
• Economic modeling
• Budget impact analysis

It’s clear that companies must present robust, localised evidence to succeed. [3]

The Price of Access: Steep Discounts, But Big Rewards

Gaining entry to the NRDL requires significant price concessions. Discounts of 40–60% off list prices are common, but the trade-off can be worth it.

According to Trinity Life Sciences, revenues for 36 listed products nearly doubled between 2017 and 2019, from RMB 20.4 billion to RMB 38.6 billion. The sheer scale of the BMI-covered population (95% of Chinese citizens) makes up for lost margin through high volume. [4]

The results show that deep discounts buy access to unmatched scale, and for many therapies, especially in chronic or high-burden areas, this route remains commercially attractive.

What’s New in 2025: Enter the Commercial Innovation Catalogue (Cat C)

This year, China is rolling out a second access channel, the Commercial Insurance Innovation Catalogue, or Category C (Cat C).

This pathway was developed in response to the exclusion of high-cost, high-impact therapies (like CAR-T cell therapies or rare disease drugs) from the NRDL due to affordability constraints. Under Cat C:

• Drugs are still assessed by the NHSA via HTA
• But reimbursement is through commercial health insurance, not public funds
• Pricing negotiations occur between manufacturers and individual insurers

Cat C formalises a two-track reimbursement system:

• NRDL/BMI: public, centralised, volume-focused
• Cat C/commercial: flexible, innovation adopting

This structure not only broadens access to cutting-edge drugs but also serves as a potential model for developed markets grappling with rising costs and innovation backlogs. [5, 6]

Cat C in Practice: Opportunity, Not Guarantee

Commercial Insurers can negotiate the prices of the earmarked innovative drugs once negotiations with the NHSA on the reference price for Cat C drugs are complete:

• Each insurer decides whether to include the drug in their plans
• They negotiate with the manufacturer on rebates, patient caps, co-pay levels, and performance-based discounts

This means Cat C doesn’t guarantee reimbursement, but it opens the door to it, provided companies are willing to engage flexibly with insurers.

Paving the way to NRDL Access

Strategically Cat C coverage can be viewed as a stepping stone for future reimbursement via the NRDL:

• Generate real-world evidence (RWE) from actual clinical use
• Build local health economic models and value dossiers
• Establish pricing anchors and market value

This creates a data-rich foundation for future applications to the NRDL and may even improve negotiation positioning down the line.

Still a lot to improve in China’s HTA

Despite impressive progress, barriers persist, especially for foreign companies:

1. Lack of transparency in policies and outcomes of assessments: E.g., pricing criteria and comparator selection, willingness to pay thresholds for rare diseases, end of life care, paediatric conditions
2. Limited guidance on submissions and no early advice (unlike other HTA agencies)
3. Limited use of RWE (currently mainly economic evidence is used)
4. Potential to improve pricing for drugs with multiple indications
5. Perceived disadvantage for foreign manufacturers: lower listing rates, often due to pricing expectations or limited local data

These all present risks to any enterprise applying for reimbursement. Given China’s speed with which it has transformed HTA across the country, I expect more policies will be implemented to address these points over the next few years. [7]

Final Word: Engage Now, or Miss the Curve

With its vast scale, rapid innovation, and bold policy reforms, China is no longer a future market it’s a current imperative.

The days of treating China as a secondary launch market are over. With nearly one-third of global drug launches already happening first in China, life sciences companies need to prioritise China in their access planning, not after FDA or EMA approval, but in parallel with them.

Contact:

If you are interested in discussing any of the issues above for your company/drug development program, please contact me through my email address dniven@nivenbiopharma.com . Feel free to also visit my website at www.nivenbiopharma.com for more information. 

Sources:

[1] China on the Move: Lesson from China’s National Negotiation of Drug Prices in 2021, Greenberg Traurig, Feb 22, Lu et al

[2] 2024年全国医疗保障事业发展统计公报, Statistical Bulletin on the Development of National Medical Insurance in 2024, NHSA, July 25

[3] Access to innovative drugs and the National Reimbursement Drug List in China: Changing dynamics and future trends in pricing and reimbursement, Macabeo et al, Journal of Market Access and Health Policy, May 2023

[4] Is the Pricing Discount for Chinese NRDL Inclusion Worth it? NRDL Commercial Impact Assessment, Trinity, July 2021

[5] 2025 年国家基本医疗保险、生育保险和工伤保险药品目录及商业健康保险创新药品目录调整工作方案, Adjustment Plan for the National Basic Medical Insurance, Maternity Insurance and Work-Related Injury Insurance Drug-Lists and the Commercial Health Insurance Innovative Drug list in 2025, National Healthcare Security Administration, July 2025

[6] NRDL 2024: Rare Diseases Deep Dive, Trinity, July 25

[7] Key Issues of Economic Evaluations for Health Technology Assessment in China: A Nationwide Expert Survey, Liu et al, Value in Health, November 24