Breakthrough for CAR-T Therapies in China's National Reimbursement Negotiation: Can the First Commercial Insurance Drug List Unlock a New Payment Paradigm?

Reporter Yan Shuo from the 21st Century Economic Report

From October 30 to November 3, 2025, the negotiation for the National Basic Medical Insurance Drug List and the price consultation for the Commercial Insurance Innovative Drug List were held at the Great Hall of the People in Beijing, lasting five days, becoming the longest negotiation in the eight rounds of medical insurance negotiations since the establishment of the National Healthcare Security Administration.

The biggest difference from the past lies in the fact that, for the first time, the Commercial Health Insurance Innovative Drug List (referred to as the "Commercial Insurance Innovative Drug List") has been incorporated into the policy framework. This becomes a key measure to expand the coverage of innovative drugs and build a multi-payment system for innovative drugs. Some innovative drugs can apply separately for inclusion in the Commercial Insurance Innovative Drug List or simultaneously apply for both the Commercial Insurance Innovative Drug List and the Essential Drug List.

According to data from the National Healthcare Security Administration, a total of 120 domestic and foreign-funded enterprises participated in this on-site negotiation and price consultation, including 127 off-list drugs involved in the negotiation and bidding for the National Basic Medical Insurance Drug List, and 24 drugs participating in the price consultation for the commercial insurance innovative drug list.

According to the relevant work arrangements, the price negotiation session for the commercial insurance innovative drug list will be concentrated on the afternoon of November 2nd and November 3rd, with products from domestic enterprises and multinational pharmaceutical companies being the main focus on each day respectively.

According to multiple media reports, compared with the negotiations for basic medical insurance, the atmosphere on the first day of price negotiations for the commercial insurance innovative drug catalog was relatively relaxed. Not long after the negotiations began that day, good news came about the CAR-T products, with Juventas' CAR-T drug successfully reaching an agreement. Additionally, several other products also showed promising signs.

The National Healthcare Security Administration revealed that the new edition of the National Basic Medical Insurance Drug List and the first edition of the Commercial Health Insurance Innovative Drug List are scheduled to be released both online and offline in Guangzhou on the first weekend of December, with official implementation starting from January 1st of the next year.

It should be noted that the commercial insurance innovative drug list is not mandatory. The National Healthcare Security Administration recommends it for reference by commercial health insurance products. Therefore, there is still a long way to go from successful negotiation to final implementation.

CAR-T Product Achieves Breakthrough

For the basic medical insurance catalog, the enthusiasm of innovative pharmaceutical companies for access continues to rise. According to incomplete statistics from relevant sources, among the new anti-tumor drugs approved for the first time in China in the first half of 2025, 20 have successfully passed the formal review. These include small molecule inhibitors, as well as CD38 monoclonal antibodies, CD3×CD19 bispecific antibodies, HER2, ADC, and more.Frontier BiotechMedicine, with indications covering multiple cancer types including multiple myeloma, prostate cancer, non-small cell lung cancer, and breast cancer.

However, the functional orientation of basic medical insurance is to "ensure the basics," allowing the limited medical insurance fund to play its maximum efficiency. Therefore, in the annual negotiations for the basic medical insurance catalog, the invisible threshold has become “nothing above 500,000 yuan will be discussed, and nothing above 300,000 yuan will be included.”

Some innovative drugs are not cheap, and may even far exceed 500,000 yuan, making it difficult for them to be included in the basic medical insurance. To address the payment challenges of innovative drugs, the National Healthcare Security Administration this year added a commercial insurance directory for innovative drugs. The focus is on including highly innovative drugs with significant clinical value and notable patient benefits, and recommending their use within multi-layered medical security systems such as commercial health insurance and medical mutual aid programs.

121 drugs in the commercial insurance innovative drug list passed the review, of which 24 eventually entered the price negotiation phase. According to the work schedule, the price negotiation for commercial insurance innovative drugs commenced after the national medical insurance catalog negotiation. On the afternoon of November 2, shortly after the negotiation began, news came that the "million-dollar anti-cancer drug" CAR-T product had successfully completed negotiations, marking a good start for high-value innovative drugs to reduce patient burden and improve clinical accessibility through commercial insurance channels.

CAR-T (Chimeric Antigen Receptor T-Cell) therapy is a revolutionary breakthrough in the field of cancer treatment in recent years. It genetically modifies the patient’s own T cells to enable them to precisely identify and attack cancer cells. In 2021, Fosun Kite's Axicabtagene Ciloleucel Injection was approved for marketing, becoming China's first CAR-T product. This product has attempted to be included in medical insurance for four consecutive years, but no substantial progress has been made.

Currently, a total of 7 CAR-T products have been approved for marketing in China, with 5 of them passing the preliminary review for this year's commercial insurance innovative drug list. Among these, 3 products are banking on being included in both the medical insurance and commercial insurance "dual lists." According to various sources, all 5 products have entered the price negotiation phase for the commercial insurance innovative drug list this year.

Among them, Juventas' Naciorlen Injection has reportedly been successfully negotiated. The product was approved for marketing in China in November 2023 and is indicated for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Priced at 999,000 RMB per dose, it is currently the only known CAR-T product priced below one million RMB.

Another report indicates that the negotiation for JW Therapeutics' Relmacabtagene Autoleucel Injection is proceeding smoothly. The product was approved for marketing in China in September 2021 and is suitable for certain types of lymphoma, priced at 1.29 million yuan per injection.

In addition to CAR-T products, several other innovative products are also worth looking forward to in the commercial insurance innovative drug catalog price negotiation. For instance, on November 3, in the "home ground" of multinational pharmaceutical companies, Bristol-Myers Squibb's "O+Y" combination therapy entered the price negotiation phase. This is currently the only dual immunotherapy regimen approved in China (referred to as O+Y), which involves the use of Nivolumab Injection combined with Ipilimumab Injection.

How to打通入院“最后一公里”？

Currently, the negotiations for the 2025 basic medical insurance catalog and the price consultations for the commercial insurance innovative drug list have concluded. The next issue to focus on is how the first commercial insurance innovative drug list will be implemented.

As an inclusive supplementary insurance,惠民保 (Huibao) serves as the primary platform for implementing commercial insurance coverage. According to Zhang Ziran, founder of the WeChat Official Account “Natural Medicine Review,” data from Yilian Tendering shows that as of August 31 this year, 164 Huibao products have incorporated special drugs. Among the top 30 innovative drugs included in Huibao products, more than half (16 drugs) have passed the expert review for inclusion in the commercial insurance innovative drug list. The high level of integration between Huibao and the commercial insurance innovative drug list clearly indicates the significant responsibility Huibao shoulders in paying for innovative drugs.

The development of inclusive insurance (Huimin Bao) varies across different regions in China, and there are some challenges in implementing the commercial insurance innovative drug list. "The commercial insurance drug list is not mandatory like the medical insurance drug list; it only serves as a reference for local inclusive insurance schemes. The final decision still rests with each region's Huimin Bao. Therefore, how many cities will include the drugs depends on the communication between each pharmaceutical company and the local Huimin Bao," said Zhao Heng, founder of the healthcare strategy consulting firm Latitude Health, in an interview with the 21st Century Business Herald.

ZHAO Heng further pointed out, "Commercial insurance also faces challenges in the 'last mile' of hospital entry. Since national medical insurance negotiated drugs have difficulties entering hospitals, commercial insurance will face the same issue. Commercial insurance is not capable of pushing this forward; hospitals hold much more power than commercial insurers. The specific developments will depend on the subsequent measures taken by the National Healthcare Security Administration."

Currently, in terms of policy, the National Healthcare Security Administration provides three exemptions for innovative drug listings by commercial insurance: not counting towards the drug ratio, not being included in DRG/DIP payments, and not being subject to procurement substitution monitoring.

On how to promote the integration of commercial insurance into hospitals, Zhong Chongming, former associate researcher at the National Health Insurance Research Institute of Capital Medical University, pointed out to the 21st Century Business Herald that the first step is to "build a clear path," which means valuing the already successful routes and cases of innovative drugs entering hospitals and learning from those who have succeeded. In view of the currently small total reimbursement pool for innovative drugs by commercial insurance, it is suitable to adopt a bottom-up development model, making some down-to-earth business attempts.

Secondly, "secretly advancing through a hidden path," which means examining what commercial insurance itself can bring to empower innovative drugs. How much money can be allocated from dimensions such as actuarial science, lean management, and refined management? How much business sincerity can be shown to medical insurance, pharmaceuticals, and the insured? Breakthroughs need to be made in these areas.

Another point is "resolute adherence." Whether it's the city-customized supplementary medical insurance, which follows a localized approach as the king of inclusive healthcare insurance, or the high-end medical insurance that covers middle- and high-income groups, both rely on product actuarial calculations and business operations to determine the types and quantities of innovative drugs needed.

The future dynamic adjustment of the commercial insurance innovative drug list needs to continuously match clinical demands with the pace of industrial innovation. Zhong Chongming pointed out that the implementation and operation of the commercial insurance innovative drug list must seize the starting time to truly empower innovative drugs, which in turn empowers itself. In the first year, the commercial insurance innovative drug list should start with a "small-scale breakthrough" to create a demonstration effect. For future sustainable development, it must closely focus on "what is new quality productivity" and "what counts as high-quality development," gaining positive evaluations from both the pharmaceutical industry and the insured.

"Regarding the dynamic adjustment of the commercial insurance innovative drug list, the most crucial aspect is to identify the direction and implementation measures for adjustment based on the situations and issues encountered during its operation. It is not inorganic or rigid, but rather organic and vibrant. Only in this way can the list keep pace with the times," said Zhong Chongming.