“Innovative drugs are about to take off, and this CAR-T product's sales will surge next year!” a seasoned pharmaceutical industry figure said today with barely concealed excitement upon hearing that the CAR-T cell therapy Relmacabtagene autoleucel had entered the basic medical insurance scheme. WuXi Juntuo's Relmacabtagene autoleucel injection has become another high-value star drug to “break through the circle” via medical insurance negotiation, following Nusinersen sodium. This person stated bluntly that as the million-yuan “sky-high” price barrier of CAR-T drugs is shattered, innovative drugs are ushering in a brand-new imaginative space for breaking the payment ceiling.

This year's medical insurance list adjustment established a “dual-list” linkage mechanism for the first time, allowing commercial insurance list products to apply for basic medical insurance inclusion. The National Healthcare Security Administration encourages high-value innovative drugs to first enter the commercial insurance list at the early stage of market launch, accumulate data and reduce costs through clinical use, and subsequently transfer to basic medical insurance. The effect of the “dual-list” linkage mechanism was immediate. This year, Relmacabtagene autoleucel injection and sapropterin hydrochloride tablets were the first to move from the commercial insurance innovative drug list into the basic medical insurance list. This became another landmark event in the history of China's medical insurance negotiations, indicating that the channel for commercial insurance list drugs to transfer into basic medical insurance has been officially opened.

These two drugs that dared to “eat the crab first” have provided a reference sample of medical insurance access for other similar high-priced drugs. Huang Xinyu, Director of the Medical Service Management Department of the National Healthcare Security Administration, said at a policy interpretation event on the afternoon of the 14th that in order to dispel companies' concerns about losing their original policy advantages after transferring from commercial insurance to basic medical insurance, the National Healthcare Security Administration has made it clear that transferred drugs will retain policies such as the “three exclusions” during two agreement periods, that is, within four years — they will not be included in the basic medical insurance self-payment rate indicator, will not be included in the monitoring of selected replaceable varieties in centralized procurement, and innovative drug application cases within the coverage of relevant commercial health insurance can be excluded from the diagnosis-related group payment scope, making clinical use more reassuring.

The dual-list linkage is not a one-time special arrangement but a normalized mechanism. Huang Xinyu said that this year a total of 7 drugs submitted applications, and ultimately 2 succeeded. As long as conditions are met, commercial insurance list drugs are welcome to apply for transfer to basic medical insurance at any time. Price is the most important condition for high-value innovative drugs to enter basic medical insurance. In recent years, the National Healthcare Security Administration has implemented a stricter price confidentiality mechanism for nationally negotiated drugs, no longer publicly disclosing specific transaction prices. Before entering medical insurance, Relmacabtagene was priced as high as 1.29 million yuan per infusion. If referring to the unwritten rule of national negotiation that “500,000 yuan is not discussed, 300,000 yuan is not included,” after this round of negotiation, industry insiders speculate that its price may have dropped below 300,000 yuan per infusion. Calculated at the ratio of 70% medical insurance payment for Class B drugs and 30% individual out-of-pocket payment, the million-yuan-level treatment cost that once deterred ordinary patients will see the individual out-of-pocket portion significantly reduced to below 100,000 yuan, effectively easing patients' medication burden.

“The value of pharmaceutical innovation lies not only in how cutting-edge the technology is, but more importantly in how many patients can truly benefit from it. Medical insurance has opened the door to accessibility for innovative drugs, while companies need to continuously reduce costs through sustained technological innovation,” said Tian Feng, Chairman and Chief Executive Officer of Shanghai WuXi Juntuo Biotechnology Co., Ltd. Ding Yilei, Director of the Medical Price and Tendering and Procurement Guidance Center of the National Healthcare Security Administration, said at the policy interpretation event that medical insurance access is a key amplifier for the commercialization of innovative drugs. According to procurement data from the national medical insurance platform, nationally negotiated drugs will see a significant volume expansion effect after entering medical insurance. Data shows that 84.2% of nationally negotiated drugs saw simultaneous growth in both procurement amount and procurement volume in 2025; among them, 152 nationally negotiated drugs had procurement amount growth rates exceeding 100%, and 167 nationally negotiated drugs had procurement volume growth rates exceeding 100%.

Ding Yilei said that the 2 drugs transferred into the medical insurance list this year will have a procurement amount of approximately 37 million yuan in 2026. Next year, the actual sales performance of these two products after entering basic medical insurance will be closely observed, so that the entire industry can verify whether it is appropriate for commercial insurance innovative drugs to enter basic medical insurance through price concessions.