China targets hospital formulary barriers for eligible innovative drugs

A four-agency notice addresses formulary limits, hospital performance metrics and payment exceptions for eligible innovative drugs. Uptake remains to be demonstrated.

China’s health and insurance authorities are targeting hospital-level obstacles that can keep innovative medicines out of routine use after approval. A joint notice publicized on November 10 addresses formularies, prescribing conditions and performance measures rather than granting new drug approvals.

The notice reproduced by China Pharmaceutical Information, signed October 30, calls on secondary-level and higher institutions to improve formulary procedures. Provincial and prefecture-level hospitals should list Class 1 new drugs in the negotiated national reimbursement list or the commercial health-insurance innovative-drug list when they have the capabilities and conditions to use them.

For these eligible drugs, the policy removes the usual “one generic name, two specifications” restriction. It also excludes them from specified public-hospital performance measures, including growth in average outpatient and inpatient drug expenditure. The text bars regional product lists from being used to restrict non-local products.

That changes some administrative incentives around stocking and prescribing. It does not make every newly approved medicine eligible, compel every hospital to supply it immediately, or turn commercial-insurance listing into public-insurance coverage.

Payment exceptions also retain a review step. For appropriate use of innovative medicines within the national reimbursement catalogue that does not fit a disease-based payment standard, hospitals may apply for case-by-case consideration. Authorities are asked to review such cases monthly or quarterly and adjust payment where warranted.

For manufacturers, the practical follow-through is whether hospitals add eligible products to formularies and information systems, and whether payment exceptions are processed. The notice sets a route to easier use; actual uptake and resulting sales still require evidence.

AI-assisted reporting based on the published policy text. Industry information only—not medical or investment advice.