NHSA Releases Guide on Volume-Based Procurement Drug Equivalents

The National Healthcare Security Administration (NHSA) has reportedly released a reference guide for industry players, outlining which drugs are equivalent to volume-based procurement (VBP) winning drugs. The guide specifies which products can be clinically “replaced” by a particular VBP product. The aim is to guide drug usage monitoring, prioritize VBP products over alternatives, and prevent irrational drug replacement in clinical settings.

Drug Categorization and Replacement Guidelines
According to the data, drugs are divided into three categories: “completely replaceable,” “mostly replaceable,” and “replaceable to a certain degree.” The list covers all 286 winning VBP bids across seven rounds, excluding products with different administration routes. The majority of drugs fall into the “mostly replaceable” category, while the smallest category is “completely replaceable,” with only 56 products listed. For example, tenofovir alafenamide oral normal release dosage form can completely replace adefovir dipivoxil, lamivudine, and telbivudine. Similarly, insulin aspart 50 injection can completely replace protamine human insulin mixture injection (50R) and protamine zinc recombinant insulin lispro mixture injection (50R). Up to 159 drugs can be “mostly replaced” by others, such as ezetimibe oral normal release dosage form replacing hybutimibe and sunitinib oral normal release dosage form replacing pazopanib.

Previous NHSA Actions and Industry Concerns
The NHSA has previously released similar lists for the first five VBP rounds, though these were not publicly distributed. Industry observers have warned of unintended consequences resulting from the publication of these lists. The NHSA conducts big data monitoring of drug use through digital coding of clinical drugs. There is concern that unconventional increases in the sales of similar competing products, especially those listed as replaceable, could lead to unintended consequences. However, provinces have introduced matching measures to encourage non-winning bids to “proactively lower prices below the levels of the winning prices (including winning prices),” allowing them not to be restricted by priority procurement or impacted by the evaluation after the corresponding winning bids complete the agreed procurement volume.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry