China Strengthens Regulations for Clinical Use of Oncology Drugs
Minhua Chu ·1 months ago

Writer: Minhua Chu

Editor: Justin Fischer

On June 28, the National Health Commission (NHC) issued the The Management Indicators for the Rational Clinical Application of Oncology Drugs (2021 Version), which covers six indicators.


Previously, in December 2020, the NHC issued a document to implement a grading system for oncology drugs and launch a national clinical application monitoring network.

The document classifies oncology drugs into two categories: restricted-use grade and general-use grade. Restricted-use grade drugs meet one of the following characteristics: (a) highly toxic side effects, improper use may have serious health risks; (b) new to the market minimal use cases; (c) expensive and economically burdensome.


This time, NHC set six indicators for the restricted-use grade and general-use grade oncology drugs when they are used in inpatient or outpatient settings:

1.     Percentage of prescription

2.     Percentage of cost

3.     Percentage of qualified prescriptions

4.     Number of reported adverse reactions

5.     Percentage and number of pathological diagnosis and testing

6.     Percentage of off-label uses


One month later, Guangdong Province took the lead in determining the specific criteria for restricted-use oncology drugs and published a list of 78 drugs. The Guangdong Pharmaceutical Association's issued a document stating that the 78 restricted-use oncology drugs all meet at least one of the following criteria:


·      Highly toxic side effects, seriously damaging if used improperly, must be prescribed by physicians with rich clinical experience.


·      Sold in China for less than three years (launched after January 1, 2019), has new mechanisms with less clinical use.  


·      High price — an average monthly cost of RMB 15,000 ($2,318) or more for monotherapy.


·    Immune checkpoint inhibitors, cellular immunotherapy drugs (CAR-T, NK), monoclonal antibodies (CD20, CD30, BCMA, BiTE, CD33, CD52, etc.), and tumor vaccines.


·      Any drug that obtained market approval after January 1, 2019, and not on the list of drugs.

According to Menet, one Chinese well-known healthcare database company, the sales of oncology drugs has risen rapidly in recent years, increasing from a rate of 12.44% in 2016 to 21.30% in 2019 while the market value is up to RMB 96.1 billion ($14.9 billion). In the first half of 2020, despite the impact of the pandemic, the anti-tumor and immunomodulator categories, achieved a market share of 16.95%. Year-on-year growth reached 13.81%.


With the issuance of the documents, it is foreseeable that Chinese government is strengthening the regulations on clincial use for oncology drugs, especially the off-label uses. This means potential new challenges for oncology drug developers in the future.  

Additionally, the fifth batch national volume-based procurement (VBP) was completed. 61 of 62 generic drugs were procured. 251 brand-name products from 148 manufacturers won bids. Procured products saw an average price reduction of 56%. Among all the procured products, 11 products are from 10 multinational companies — a new record. Additionally, 240 products are from 138 domestic companies.


Keywords: National Health Commission (NHC) Oncology Drugs volume-based procurement (VBP) The Management Indicators for the Rational Clinical Application of Oncology Drugs (2021 Version)
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