In Depth: New Innovative Drug List Could Expand Access to Costly Breakthroughs

[para. 1]

[para. 5]

[para. 10]

[para. 13][para. 14][para. 15][para. 16] The initiative took shape in late 2024, with the NHSA drafting what became known as the “commercial insurance innovative drug list”—first referenced as "Category C." Announced in January and rebranded in July, the plan targets highly innovative and clinically valuable drugs too costly for the NRDL. An initial 121 drugs made the candidate list in August, with the final version expected by the end of 2025 and implementation set for early 2026. The NHSA, while not an insurance regulator, is leading this effort to facilitate negotiations and leverage its data for better pricing but stresses the voluntary and commercial nature of the new list to distinguish it from state-run insurance.

[para. 17][para. 18][para. 19][para. 20] Industry perspectives are mixed. Some see potential in greater public awareness and risk control, while others see business opportunity backed by government support, but the list is divisive, particularly as high-premium plans have operated without formal drug lists historically.

[para. 21][para. 22][para. 23][para. 24][para. 25][para. 26][para. 27] The new system aims to offer drug manufacturers access to the market under different terms than the NRDL, which balances sharp price cuts with high patient volumes. The market remains small: in 2024, commercial health insurance premium income was 977.3 billion yuan, far below the 2 trillion yuan projected for 2025, with most "Huiminbao" programs relatively small and slow-growing. CFR-T therapy manufacturers have split strategies—some applying for both commercial and NRDL lists, others choosing only the commercial option. Price negotiations, led by NHSA-appointed groups, present complexity since insurers, not the government, are ultimate payers, creating uncertainties in pricing and actuarial calculations.

[para. 28][para. 29][para. 30] A further obstacle is hospital adoption: even if a drug is listed and insurance is available, strict hospital budgets and payment controls may still prevent widespread access, leaving patients in limbo.

[para. 31][para. 32][para. 33][para. 34][para. 35][para. 36] Meanwhile, the NFRA is developing its own, broader drug catalog via the Insurance Association of China, aiming for over 100 drugs (versus NHSA’s 20-30 candidate medicines) and standardizing coverage tiers. The NFRA system offers a "floor" of mandatory medicines for insurance plans, while NHSA’s model acts more as a "cap," prioritizing negotiation leverage. This dual-track approach could cause confusion unless the regulators collaborate, particularly since commercial insurers lack access to NHSA health data crucial for accurate risk and pricing.

[para. 37][para. 38] In conclusion, China’s efforts to expand access to expensive but critical new drugs through commercial insurance face both structural economic constraints and complex industry dynamics. Success will depend on regulatory cooperation, transparent data sharing, and balancing cost pressures with market incentives to serve patients most in need.