China Emphasizes Rare Disease & Pediatric Drugs in Adjusting the 2022 National Reimbursement Drug List (NRDL)

by Grace Wang Jul 04, 2022

On June 29, 2022, China National Healthcare Security Administration (NHSA) issued the Work Plan for Adjusting the 2022 National Reimbursement Drug List (NRDL) (hereafter referred to as NRDL). NRDL is a list of drugs covered by the basic national insurance for healthcare, employment injury, and maternity.

1. Which Drugs Can Apply for Entering NRDL

The Work Plan specifies the six conditions1 that drugs can apply for entering NRDL:

  1. Drugs approved by National Medical Products Administration (NMPA) with new generic names between January 1, 2017, to June 30, 2022.

  2. Drugs with major indication changes approved by NMPA between January 1, 2017, to June 30, 2022.

  3. Drugs in the latest version of COVID-19 Pneumonia Diagnosis and Treatment Plan.

  4. Drugs in the 2018 National Essential Drug List.

  5. Drugs in the Encouraged Generic Drug List / List of Pediatric Drugs Encouraged for R&D and Application and approved by NMPA before June 30, 2022.

  6. Rare disease drugs (orphan drugs) approved by NMPA before June 30, 2022.

* The six conditions above only apply to drugs currently outside the NRDL. For NRDL-listed drugs which have major indication changes or seek contract renewal to stay in NRDL, they should submit applications to NHSA as well.

2. Procedures for Adjusting the NRDL

The NRDL adjustment has five phases:

2.1 Preparation (May-June 2022)

NHSA released the rules for the new round of NRDL adjustment, including application scope, bidding, and contract renewal.

2.2 Application (July-August 2022)

  • Pharmaceutical companies submit applications to NHSA from July 1, 2022 →

  • NHSA conducts format review of the applications →

  • NHSA publishes the information (except the business information) of the drugs that pass the format review →

  • NHSA re-reviews the application documents based on the public opinions collected during the publicity period in the last step →

  • NHSA publishes the list of drugs that pass the format re-review.

2.3 Expert Evaluation (August 2022)

Experts specializing in pharmacology, clinical use, pharmacoeconomics, medical insurance management, and employment injury will evaluate the drugs. After the evaluation, the experts will release four lists:

  1. list of drugs that are planned to be directly admitted into NRDL;

  2. list of drugs that are planned to be admitted into NRDL after negotiation/bidding;

  3. list of drugs that are planned to be directly removed from NRDL;

  4. list of drugs that are planned to be handled as per contract renewal stipulations.

For drugs ready to go through negotiation/bidding, the experts will decide on their main strength, reference product, and insurance coverage scope.

2.4 Negotiation/Bidding (September-October 2022)

Pharmaceutical companies submit documents for negotiation/bidding. The company's representatives will lower drug prices to bid for places in NRDL and negotiate with NHSA. The companies that win the bid or succeed in renewing the contract will sign agreements with NHSA.

2.5 Publishing the Result (November 2022)

The new version of NRDL will be released, and is expected to take effect on January 1, 2023.2

3. BaiPharm Comments

Compared to the previous NRDL adjustments, this round of adjustment emphasizes more on rare disease drugs and pediatric drugs by waiving the application prerequisite of "getting NMPA approval after Jan 1, 2017".

Meanwhile, the primary trend for NRDL adjustment remains basically the same. The companies still need to lower their prices in the bidding. Besides prices, NHSA will also evaluate whether the drugs have high clinical value and meet the basic medical needs.

Read articles about previous NRDL adjustments:

Grace Wang
ChemLinked Regulatory Analyst
+ FOLLOW
Copyright: unless otherwise stated all contents of this website are ©2022 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com