Previously, CAR-T cell therapies priced at around one million yuan per dose were consistently excluded from China's national medical insurance reimbursement negotiations. However, a breakthrough has now been achieved in commercial health insurance coverage for these treatments.
On December 7, during the 2025 High-Quality Development Conference for Innovative Drugs, the inaugural "Commercial Health Insurance Innovative Drug List" was officially released. Five CAR-T cell therapies successfully made the list: - Axicabtagene ciloleucel injection (Fosun Kite) - Relmacabtagene autoleucel injection (JW Therapeutics) - Naxicabtagene autoleucel injection (Hengrui Therapeutics) - Ixicabtagene autoleucel injection (Xunlu Bio) - Zevorcabtagene autoleucel injection (CARsgen Therapeutics)
Among these, only Hengrui’s Naxicabtagene autoleucel is priced below one million yuan (¥999,000 per dose). The others exceed this threshold, with JW Therapeutics’ Relmacabtagene autoleucel being the most expensive at ¥1.29 million per dose.
**Significance of the Inclusion** These therapies primarily target hematologic malignancies, including large B-cell lymphoma, multiple myeloma, and acute lymphoblastic leukemia, offering potential cures for some patients. Despite their clinical value, CAR-T therapies have repeatedly failed to qualify for national medical insurance negotiations in recent years, largely due to pricing constraints—unofficial rules suggest drugs priced above ¥500,000 are excluded, while those over ¥300,000 face significant barriers.
A key cost driver is the lentiviral vector, a critical component in CAR-T manufacturing that enables gene delivery. Many CAR-T therapies rely on imported vectors, which inflate production costs and limit price reductions. Industry insiders note that further time is needed to reduce costs sufficiently for medical insurance inclusion.
At the conference, Fosun Kite Chairman Zhang Wenjie emphasized that drug innovation extends beyond efficacy to patient accessibility, calling the commercial insurance negotiation mechanism a "milestone" for China’s innovative drug ecosystem.
Xia Sujian, a researcher at Jinan University and director of the Medical Insurance Big Data Institute, highlighted the broader implications: "This marks a major breakthrough in establishing a multi-tiered, institutionalized payment system for high-value innovative drugs. It creates a sustainable pathway for premium-priced therapies, providing a reference list for all commercial health insurance programs, including regional 'Huiminbao' plans and corporate supplemental insurance."
**Implementation Challenges** While inclusion in the list is a step forward, practical hurdles remain, particularly in hospital adoption. To address this, China’s National Healthcare Security Administration (NHSA) and National Health Commission introduced measures on July 1, 2025, granting "three exemptions" for listed drugs: exclusion from basic insurance cost-control metrics, volume-based procurement monitoring, and diagnosis-related group (DRG) payment caps.
Xia Sujian noted that these policies alleviate hospitals’ financial concerns, "fundamentally removing barriers to the 'last mile' of drug accessibility." However, a CAR-T company representative pointed out that hospital performance evaluations still discourage uptake: "We urge further coordination to exempt these 19 listed drugs from tertiary hospital assessments and expand dual-channel pharmacy coverage."
Zhang Wenjie added that Fosun Kite plans to deepen collaborations with insurers and regulators to broaden patient access, enhance reimbursement processes, and advance real-world research in cell therapy.