The National Healthcare Security Administration (NHSA) has unveiled a draft Notification on “Establishing a Price Formation Mechanism for Newly Listed Chemical Drugs to Encourage High-Quality Innovation.” The document, currently open for feedback from industry associations, outlines a proposed framework that aims to balance market determination of drug prices with government influence to enhance the efficiency of new drug listings and incentivize developers of innovative drugs.
The NHSA’s proposed mechanism suggests a self-assessment model that classifies drugs into three pricing tiers—low, medium, or high—based on factors including pharmacology and clinical value, supported by evidence. Developers of newly listed chemical drugs can opt for an evaluation using a scale published by the NHSA to determine their product’s pricing category. The higher the self-assessment score, the greater the perceived innovative value of the drug and the more pricing freedom it enjoys.
Drugs with high self-assessment scores are promised preferential treatment in online procurement and a “stable price protection period.” High and medium scores qualify for a stable pricing period of 1-5 years, contingent upon their approval status. Prior to the stable period’s expiration, drug enterprises must submit a reevaluation report unless negotiations for National Reimbursement Drug List (NRDL) inclusion have been initiated. Drugs with low self-assessment scores must provide comprehensive information disclosure to substantiate their price points.
The NHSA proposes a centralized online model for accepting the initial prices of newly listed drugs, allowing for one-time acceptance and nationwide implementation. This model would streamline the process, enabling drug companies to conduct a single self-evaluation and file with one provincial bureau, benefiting from a unified price across all provinces, thus eliminating the need to engage with individual procurement platforms nationwide.- Flcube.com
