National Health Insurance Administration: Launching real-world health insurance comprehensive value evaluation pilot work

The Zhitong Finance App learned that on September 23, the National Health Security Administration issued a notice to launch a pilot project to evaluate the comprehensive value of real-world health insurance. Among them, it was mentioned that the pilot work should adhere to unified standards, coordinate deployment by the National Health Insurance Administration, explore and practice locally, and gradually establish a unified national evaluation system. We must insist on data empowerment, focus on real-world data and evidence, and ensure scientific, objectivity, and transparency of evaluations based on reliable, usable, and trustworthy real-world data. We must adhere to comprehensive integration, and comprehensively evaluate the comprehensive value of pharmaceutical products from multiple dimensions such as clinical efficacy, safety, economy, fairness, accessibility, innovation, and patient experience based on the entire medical life cycle before and after marketing, before and after entry, before and after contract renewal, and before and after project establishment. We must adhere to practical application, strengthen the application of evaluation results, improve the efficiency of the use of health insurance funds, improve the effectiveness of health insurance management services, and enable the high-quality development of the pharmaceutical industry.

The original text is as follows:

Notice of the Office of the National Health Security Administration on Launching the Real World Health Insurance Comprehensive Value Assessment Pilot Work

Beijing, Liaoning, Jiangsu, Zhejiang, Fujian, Guangdong, Hainan, Chongqing, Sichuan, Shaanxi, and Gansu Medical Security Bureaus:

Carrying out a comprehensive value evaluation of real-world health insurance is an important part of the health insurance system studying and implementing Xi Jinping's ideology of socialism with Chinese characteristics in the new era and advancing the modernization of the health insurance governance system and governance capacity. It is an inevitable requirement for advancing scientific health insurance, promoting high-quality medical and pharmaceutical development, and better serving the collaborative development of the “Three Medicines” under the new situation. Since July 2025, the National Health Insurance Administration has focused on implementing “Certain Measures to Support the High-Quality Development of Innovative Drugs”, focusing on real-world data to support the comprehensive value evaluation of pharmaceuticals and health insurance, publicly solicited research results and ideas on ten selected topics, and made work arrangements at the National Health Insurance Mid-Year Symposium in August. In order to promote the implementation of the ten selected topics and complete the comprehensive value evaluation of real-world health insurance, it was decided to carry out pilot work in some pioneering regions (see Annex 1). The relevant matters are now notified as follows:

I. General principles

The health insurance department will cooperate with relevant parties to understand the health insurance department's concerns that have not been answered or fully answered based on various circumstances during decisions such as drug review and approval or drug catalogue negotiations. At the same time, pay attention to whether the actual clinical benefits and risks of patients after the drug is applied in the real world and the evidence submitted when entering health insurance decisions such as the medical insurance catalogue. Real world research includes, but is not limited to, interventional studies, non-interventional studies, or observational studies (including prospective studies, retrospective studies).

The pilot work should adhere to unified standards, coordinate deployment by the National Health Insurance Administration, explore and practice locally, and gradually establish a unified national evaluation system. We must insist on data empowerment, focus on real-world data and evidence, and ensure scientific, objectivity, and transparency of evaluations based on reliable, usable, and trustworthy real-world data. We must adhere to comprehensive integration, and comprehensively evaluate the comprehensive value of pharmaceutical products from multiple dimensions such as clinical efficacy, safety, economy, fairness, accessibility, innovation, and patient experience based on the entire medical life cycle before and after marketing, before and after entry, before and after contract renewal, and before and after project establishment. We must adhere to practical application, strengthen the application of evaluation results, improve the efficiency of the use of health insurance funds, improve the effectiveness of health insurance management services, and enable the high-quality development of the pharmaceutical industry.

II. Pilot tasks

Under the unified deployment of the National Health Insurance Administration, pilot pilot regions should promote the implementation of ten selected topics by the end of 2027, according to the working idea of “top-level design, practical verification, decision application”, and expand the construction of evaluation standards, technical methods, application scenarios, and related data and talent support systems, to form a value-oriented comprehensive health insurance value evaluation system based on real-world research, and promote it nationwide. Specifically, it is carried out in three stages:

(1) Initiation phase (before the end of 2025). The first is to promote standard-setting. Pilot pilot regions actively participated in the preparation of a nationally unified real-world health insurance comprehensive value evaluation technology path and standard specification, and further clarified the evaluation process, evaluation points, and quality control standards around the implementation of the standard system. The National Health Insurance Administration will take into account the operation of various pilots, sort out experiences and practices, and initially establish a comprehensive health insurance value evaluation framework and standards. The second is to promote data governance. Focus on real-world data and evidence. On the basis of data mining and development of existing health insurance information platforms, the focus is on fully managing clinical data such as medical insurance-related cases, tests, medication devices, and surgical records from major (or all) designated medical institutions in the region, especially evidence reflecting the efficacy, quality and safety of patients. The health insurance department will allocate relevant policies to designated medical institutions that standardize the upload of pharmaceutical data, and allocate price policies to designated medical institutions that actively participate in data collection in accordance with the requirements of relevant documents. The third is to promote team formation. The pilot regions should actively recruit experts and technicians who are fair and decent, proficient in business, and have a strong sense of responsibility, covering multidisciplinary talents in medical treatment, medicine, medical insurance, statistical information, etc., to form talent support that can independently undertake the comprehensive value evaluation of real world health insurance.

(2) Implementation phase (2026). The first is to build a database. Pilot pilot regions develop and form local databases in accordance with unified national requirements to strengthen hierarchical data management. The National Health Insurance Administration did a good job of collecting and sharing data from pilot regions. The second is task-based evaluation. Each pilot pilot region undertakes evaluation tasks specified by the National Health Insurance Administration and verifies and perfects evaluation methods and systems according to the fields of pharmaceuticals, consumables, and medical services, organizes relevant teams to carry out evaluations according to the technical framework and specifications of comprehensive health insurance evaluations, and actively expands application scenarios (see Annexes 1 and 2). Regions that are in a position to do so can carry out additional evaluation tasks in other or all fields, and actively create favorable conditions conducive to the first use of drugs, consumables, and medical services. At the same time, some medical institutions were selected as monitoring sentinels to verify the evaluation results. The third is to establish a database of achievements. By the end of 2026, the pilot regions will produce a batch of preliminary evaluation results, submit them to the National Health Insurance Administration, and include them in the research results database if eligible. The National Health Insurance Administration will combine the advantages and shortcomings of the different pilot regions, strengthen dispatch guidance, focus on solving existing blockages and difficult problems, and continuously improve the evaluation standard system.

(3) Application phase (2027). The first is to support health insurance decisions. Pilot pilot regions are encouraged to prioritize the application of real-world health insurance comprehensive value evaluation research results for supporting evidence of new or adjusted billable medical consumables catalogues, new medical service project establishment, and payment catalogues at the provincial level. Higher priority is given to admissibility of evidence under the same conditions. The National Health Insurance Administration is strengthening the dynamic tracking and application of real-world health insurance comprehensive value assessments. The second is to improve the operation mechanism. Pilot pilot regions continue to explore, improve and summarize experiences, and establish a full-chain health insurance comprehensive value evaluation operation mechanism through “standard specification - data platform - evaluation method - scenario application”. The third is to select the country's credible evaluation points. According to the pilot situation, the National Health Insurance Administration will select regions that have carried out good work as credible evaluation points before and after negotiations on the medical insurance drug catalogue and in decisions such as centralized procurement, medical service price guidelines, price policy formulation, and payment method reform, etc., to carry out related tasks on a regular basis.

III. Organizational Guarantee

The National Health Insurance Administration coordinates the national pilot work, and the National Health Insurance Administration's Pharmaceutical Price and Bidding and Procurement Guidance Center specifically undertakes daily work. Pilot pilot regions are managed dynamically, with both entry and exit. Provincial health insurance departments should fully understand the importance of real-world health insurance comprehensive value evaluation, strengthen pilot guidance for pioneering regions under their jurisdiction, and provide support for necessary policies, data, personnel, funding, and working conditions. Health insurance departments in pilot regions should strengthen organizational leadership, improve working mechanisms, clarify implementation plans, do a good job in data security management, and carry out pilot work in accordance with the unified deployment of the country. If important situations are encountered during the pilot work, they should be promptly fed back to the Pharmaceutical Price and Bidding and Procurement Guidance Center of the National Health Insurance Administration.

National Health Security Administration Office

September 23, 2025

This article was edited by the National Health Security Administration, Zhitong Finance Editor: Chen Wenfang.