The National Healthcare Security Administration (NHSA) has officially released the “Negotiation Drug Renewals” and “Non-exclusive Drug Bidding” guidelines for the annual update to the National Reimbursement Drug List (NRDL). These guidelines outline the processes for drug negotiations and bidding, ensuring transparency and efficiency in the management of drugs included in the NRDL.
Negotiation Drug Renewals: Official Rules and Updates
The “Negotiation Drug Renewals” rules propose adding all drugs that have been continuously included in the NRDL negotiations for 8 years or more to the regular catalog management. For negotiated drugs that have not reached 8 years, and varieties with a continuous agreement period of 4 years or more that trigger a price reduction due to simple renewal or new indications, the reduction rate will be halved. This approach provides a structured framework for the management of long-standing drugs within the NRDL.
Updates to Renegotiation Circumstances
Compared to the draft proposal, the official versions have updated two circumstances in relation to renegotiations. Firstly, if the manufacturer does not agree to adjust the payment standards according to the rules, it can apply for renegotiation and submit corresponding documents. If the negotiation fails, the original payment scope can be renegotiated or simply renewed according to the procedures determined by the rules. This provides manufacturers with a clear path for addressing payment standard adjustments.
Secondly, for Class 1 chemical drugs, Class 1 therapeutic biological agents, and Class 1 and Class 3 traditional Chinese patent medicines and simple preparations approved in accordance with the current registration management measures, if the ratio A (the ratio between the actual fund expenditure and the fund expenditure budget during the term of this agreement) is more than 110% and not more than 200% when renewing the contract, the manufacturer can easily renew the contract according to an automatic price cut as set out within the guidance, or can apply to determine the reduction ratio through renegotiation. The negotiated renewal will not produce a more significant price cut than under the automatic reduction rules. However, if that negotiation process fails, the drug will be removed from the list.
Non-Exclusive Drug Bidding: Exploring New Mechanisms
The “Non-exclusive Drug Bidding” rules have added an item called “Explore the establishment of payment standards, online pricing, and payment management linkage mechanisms.” Specific implementation details for this will be formulated separately, indicating a forward-looking approach to drug pricing and payment management within the NRDL.-Fineline Info & Tech
