Frankly speaking, the first step is to negotiate a new drug into the catalog. What matters most to enterprises is how much sales and profits it can generate in the end.

The implementation of nationally negotiated drugs concerns the vital interests of insured patients and is of great significance for better meeting clinical needs and enhancing the efficiency of fund utilization. As the national negotiation has become routine, it is imperative to implement the spirit of the "Notice on Adapting to the Regularization of National Medical Insurance Negotiations and Continuously Promoting the Implementation of Negotiated Drugs" issued by the National Healthcare Security Administration and the National Health Commission, improve supply assurance levels, and promote rational use of negotiated drugs. In August 2024, the China Pharmaceutical Association organized 380 multidisciplinary experts from 110 tertiary medical institutions nationwide to compile the "China Expert Consensus on National Medical Insurance Negotiated Drug Management in Medical Institutions". The initiative aims to comprehensively address the entire process of implementing negotiated drug policies in medical institutions, focusing on current practices in the selection, introduction, and clinical application management of negotiated drugs. By pooling expert wisdom and resources, it provides recommendations to ensure rational clinical medication and achieve comprehensive lean management across the entire negotiation drug chain.

1. Construction of relevant working systems or implementation plans for medical institutions to implement the policy on negotiated drugs

Medical institutions should formulate relevant work systems or implementation plans for implementing the negotiated drug policies in accordance with national medical insurance drug negotiation policy requirements, combined with specific directives from superior authorities such as local medical security bureaus and health commissions, while fully considering practical circumstances. This will strengthen the whole-process lean management of negotiated drugs.

Medical institutions shall implement relevant work systems or implementation plans for national medical insurance drug negotiation policies, covering but not limited to the following seven aspects: ① Drug List Development and Management; ② Procurement and Supply Assurance Management; ③ Rational Use Management; ④ Quality and Adverse Reaction/Event Monitoring and Management; ⑤ Comprehensive Clinical Evaluation Management; ⑥ Policy Promotion and Risk Prevention Management; ⑦ Management of Information Technology System Construction and Administration.

2. Construction and management of drug list negotiated by medical institutions

In accordance with the regulatory requirements of the National Healthcare Security Administration (NHSA) and National Health Commission regarding negotiated drugs, medical institutions must rationally allocate and utilize these medications. They shall not restrict their distribution or usage due to total medical insurance budget constraints, limitations on the number of drugs in institutional medication catalogs, or drug cost-to-revenue ratios. Negotiated drugs listed in the national medical insurance catalog are exempt from the "dual regulations" (one product with dual pricing) policy. Within three months after the NHSA publishes the negotiated drug list for the agreement period, institutions should establish a coordinated mechanism linking drug allocation with catalog adjustments. This involves promptly convening pharmaceutical affairs meetings to select and introduce relevant negotiated drugs, ensuring full coverage of all eligible medications.

2.1 Construction and management of the regular negotiated drug list for medical institutions

2.1.1 Basic principles: clinical necessity, economy and dynamic management

2.1.2 Workflow

2.1.2.1 Preliminary assessment of the need for introduction (safety, effectiveness, economy, innovation and suitability)

2.1.2.2 Re-justification of Need for Introduction

2.1.2.3 Review of the introduction list: Medical institutions shall hold a pharmaceutical council in time to review the negotiated drug list recommended for introduction, and determine the negotiated drug list introduced by the institution based on comprehensive consideration of clinical necessity and economy.

2.1.2.4 Procurement to Ensure Supply: After the implementation of the negotiated drug list, the pharmacy department shall purchase drugs according to the imported drug list decided by the pharmaceutical council and clinical needs to ensure clinical medication; for non-exclusive negotiated drugs, such as competitive bidding drugs, it is recommended to conduct public inquiry and prioritize the purchase of high-quality and inexpensive varieties.

2.1.2.5 Dynamic monitoring and timely evaluation: Medical institutions should establish a regular monitoring and evaluation mechanism for the clinical efficacy and safety of newly introduced negotiated drugs, and dynamically track the rationality of drug use.

2.2 Construction and management of temporary procurement negotiation drug list in medical institutions

For negotiated drugs that cannot yet be included in the hospital's routine medication list but have genuine clinical needs, they may be temporarily procured after passing multidisciplinary expert review or procedural approval, forming a provisional procurement list. A green channel will be established for drugs listed in this provisional procurement list to streamline procedures, shorten processing cycles, and ensure timely procurement to meet clinical treatment needs. The pharmacy department should conduct regular specialized analyses and evaluations of the procurement and rational use of these negotiated drugs, promptly reporting relevant findings to the Pharmaceutical Affairs Committee. Drugs with large procurement volumes and no instances of irrational use may be considered for inclusion in the hospital's routine medication list. For temporarily procured drugs showing abnormal usage patterns or irrational medication practices, interventions will be implemented according to the institution's rational drug use management regulations.

2.3 Construction and management of the "dual-channel" negotiation drug list in medical institutions

For negotiated drugs that cannot be routinely stocked or included in temporary procurement programs, medical institutions are advised to establish their own "dual-channel" negotiated drug lists in accordance with regional medical insurance authorities' regulations on drug directory management, while considering institutional specific conditions. These lists may serve as essential components of external prescription drug catalogs to enhance rational medication use management. Notably, negotiated drugs classified as prohibited for retail sales by national regulations shall not be included in this directory.

Medical institutions should establish and improve the prescription circulation mechanism, transfer "dual-channel" prescriptions through the prescription center, and implement specific traceability management requirements such as "three fixed", "four fixed" or "five fixed" according to the regulations of superior administrative departments in each region, so as to strengthen the whole-process supervision and traceability of patients' medication behavior.

When constructing the "dual-channel" negotiated drug list, medical institutions should fully weigh the possible risks of drugs purchased and used outside the hospital, establish corresponding risk prevention and control measures, and ensure the safety of patients' medication.

2.4 Dynamic adjustment management mechanism of drug list negotiated by medical institutions

To enhance medical service quality, meet clinical medication needs, and optimize healthcare resource allocation, medical institutions should implement a dynamic adjustment mechanism for the negotiated drug list. In accordance with medical insurance policies and requirements, healthcare providers should comprehensively evaluate clinical demands, cost-effectiveness, and compliance standards. Based on their actual clinical practices, they should regularly update the list to ensure its timeliness and rationality.

3. Management of drug procurement and supply guarantee through negotiation among medical institutions

Medical institutions should establish a comprehensive system for negotiating drug procurement and supply assurance to ensure patients can promptly access negotiated medications. This system, guided by patients' rational medication needs and actual conditions of negotiated drugs, adopts multiple approaches including routine procurement, temporary procurement, and "dual-channel" mechanisms to guarantee drug availability. Additionally, they should strengthen internal management, implement relevant policies and regulations, utilize information technology to enhance operational efficiency, and ensure full traceability throughout the procurement and supply process while maintaining quality and safety standards.

Medical institutions should select the negotiated drugs suitable for inclusion in the "dual-channel" management according to the evaluation indicators such as clinical value and economy of drugs.

It is believed that with the gradual implementation of consensus, the implementation of national negotiation drugs in various terminals will be more down-to-earth, which will also provide enterprises with willingness and enthusiasm to participate in national negotiation.

Note: Excerpt from China Expert Consensus on the Management of National Medical Insurance Negotiated Drugs in Medical Institutions (Draft for Comments)

Disclaimer: This article is only for the purpose of knowledge exchange and sharing, and does not involve commercial publicity, and does not serve as relevant medical guidance or medication advice. If there is any infringement, please contact us for deletion.

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