Country: CHINA | Region: ASIA & SOUTH PACIFIC | Type: Policy | Keywords: #basicmedicalinsurance #bidding #negotiations #nhsa #nmpa #nrdl #pricingandreimbursement
- The National Healthcare Security Administration (NHSA) of China has issued its official work plan for revisions to the 2020 National Reimbursed Drug List (NRDL), including application guidelines for revision of the list
- Some criteria for inclusion in the 2020 NRDL include: the drug must intend to treat respiratory diseases related to COVID-19; the drug must be included in the list of foreign, clinically urgently needed new drugs, the list of encouraged generics, or the list of pediatric medicines encouraged for development and application; or the drug must be a new generic name or a product with a new indication approved by the National Medical Products Administration (NMPA) in accordance with new drug application procedures from the time period of January 1, 2015 to August 17, 2020
- In October and November, enterprises will be called on to submit negotiating/bidding materials for the inclusion of their medicines and experts from China will determine which drugs will win inclusion, based on negotiations and BMI standards, etc.; at which point, the revision results of the NRDL will be published (by the end of December 2020)
THE DETAILS
BEIJING, China – The National Healthcare Security Administration (NHSA) of China has issued its official work plan for revisions to the 2020 National Reimbursed Drug List (NRDL), including application guidelines for revision of the list.
As noted during feedback and consultation periods on the list, the scope of the 2020 NRDL revisions will consider what the burgeoning Basic Medical Insurance (BMI) scheme can afford, and the clinical demand for drugs.
Eligible drugs must meet provisions outlined in Articles 7 and 8 of the “Interim Measures for the Administration of BMI Medicines.” Besides the medicines that meet the aforementioned provisions, all western-made and formulated traditional Chinese medicines that fall into one of the following categories will be considered for inclusion:
- Drugs for the treatment of respiratory diseases related to COVID-19
- Drugs included in the 2018 National Essential Drug List (NEDL)
- Drugs included in the list of foreign, clinically urgently needed new drugs, the list of encouraged generics, or the list of pediatric medicines encouraged for development and application
- Prevailing drug products in the second batch of nationally, centralized procured medicines
- New generic name drugs approved by the National Medical Products Administration (NMPA) in accordance with new drug application procedures from the time period of January 1, 2015 to August 17, 2020
- Drug products with major changes in indication or function based on clinical trial outcomes whose applications were approved by the NMPA from the time period of January 1, 2015 to August 17, 2020
- Products that were included in five or more provincial-level reimbursed drug lists (RDLs), excluding those with main active ingredients which are controlled under the first batch of the “List of Drugs Subject to State Rationalization Surveillance and Control”
Going forward, eligible enterprises need to submit the necessary information to the National Medical Insurance Center as required. Then, the database for drugs under review will be established, and experts will be consulted on which drugs should be added, removed, etc.
In October and November, enterprises will be called on to submit negotiating/bidding materials for the inclusion of their medicines, and experts from China will determine which drugs will win inclusion, based on negotiations and BMI standards, etc.
Finally, the revision results of the NRDL will be published by the end of December 2020.
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