The National Healthcare Security Administration (NHSA) has commenced the process for the annual update of the National Reimbursement Drug List (NRDL) by releasing the “NRDL Adjustment 2023 Work Plan” and associated documents. These documents are open for public feedback until June 15, ensuring transparency and stakeholder engagement in the update process. The “Negotiated Drug Renewal Rules” and “Non-Exclusive Drug Bidding Rules” will be released separately for public feedback.
Eligibility Criteria and Updates for 2023 NRDL
The update rules for this year are largely consistent with those used in 2022, with some minor adjustments. Innovative drugs approved from January 1, 2018, to June 30, 2023, are eligible for inclusion in the NRDL. Additionally, there are no restrictions on the approval date for children’s medicines and rare disease drugs.
Changes to the 2023 NRDL Update Rules
Minor alterations for the 2023 update include the eligibility of COVID-19 drugs that are no longer part of the latest COVID-19 Diagnosis and Treatment Plan but have received market approvals before June 30, 2023. There will also be enhanced supervision over pharmaceutical companies, with the establishment of integrity records. Any fraudulent, illegal, or irregular activities during the list adjustment process may jeopardize a drug’s ability to gain coverage.
Detailed Application Guidelines Provided by NHSA
The NHSA has provided more detailed guidance for applicants in several areas. Drugs with a simple change of generic name due to production transfer or re-registration are not considered new within the timeframe. Paper application materials do not need to be mailed again. Economic information in dossiers should no longer include insurance budget expenditure budgets but must include sales amounts in mainland China from January 1, 2021, to June 30, 2023, current price and cost situation, expected sales volume for the next three years, and the forecast impact on medical insurance funds. Companies must also clarify whether a molecule will address shortcomings within the NRDL and other clinical management difficulties. Price and cost information are required for drugs outside the list as well. Pharmaceutical companies must submit their dossiers by the end of July 14, 2023.-Fineline Info & Tech
