NHSA Completes 2025 Drug Negotiation Review; CAR‑T Therapies Clear the Hurdle

NHSA Completes 2025 Drug Negotiation Review; CAR‑T Therapies Clear the Hurdle

The National Healthcare Security Administration (NHSA) announced today that the expert review for the 2025 drug negotiations has been finalized. Companies that have confirmed participation in the negotiations, bidding, and price discussions are urged to submit the required documentation to the National Healthcare Service Platform by 5 p.m. on September 30.

Review Outcomes

  • Selective Pass Rate – Internal estimates suggest that fewer than half of the total applications advanced past the expert review, underscoring the stringent pricing and value criteria applied by the NHSA.
  • CAR‑T Breakthrough – All five CAR‑T products—previously excluded from the national reimbursement list due to their steep cost (≈ 1 million yuan per dose)—successfully cleared the review. This marks a significant shift in the agency’s stance toward high‑price, high‑impact therapies.

Implications for Stakeholders

  • Pricing Dynamics – The inclusion of CAR‑T therapies may prompt a recalibration of price negotiation strategies for other advanced biologics.
  • Market Access – Companies that meet the documentation deadline will gain expedited access to the national reimbursement system, potentially unlocking substantial commercial opportunities.
  • Regulatory Focus – The high stringency of the review highlights the NHSA’s continued emphasis on cost‑effectiveness and evidence‑based value assessments.-Fineline Info & Tech