The health and Health Commission may be adjusted out of the new policy

In terms of the content of the draft, the next theme selection mechanism to be established will focus on the dynamic adjustment of the demand for the basic drug catalog, taking into account the list of short drugs, the list of drugs urgently needed to be encouraged in clinical research and development (including generic drugs), the list of orphan drugs and so on On October 15, the national drug administration work conference was held in Xiyuan Hotel In addition to the arrangement of drug administration work, another key issue was to discuss the overall work plan of national drug clinical comprehensive evaluation (2018-2020) (Draft for comments) (hereinafter referred to as "draft for comments") At the meeting, carrying out comprehensive clinical evaluation of drugs was listed as one of the key tasks At the meeting, it was proposed to study and establish the related application mechanism of the output of comprehensive evaluation results, especially in the aspects of basic drug selection and dynamic adjustment, drug procurement, and clinical rational use, so as to make the evaluation results play a basic supporting role According to the content of the draft, it is necessary to organize the implementation of theme selection, comprehensive evaluation and transformation application, promote and improve the mechanism of clinical comprehensive evaluation of drugs, and constantly improve the system of medical governance and enhance the capacity of medical governance The evaluation results of the application and implementation of the national drug clinical comprehensive evaluation results will be used for the control of drug cost burden, the adjustment of clinical drug use structure, the selection and adjustment of basic drugs and drug shortage catalogue, the innovation and research and development of medicine, etc The expert committee will review the evaluation results of clinical evidence and the comprehensive value judgment results of drugs to form the application implementation opinions This means that in the future, there will be more detailed standards for the management and control of medical institutions, and the clinical medication structure will be more scientific Moreover, the dynamic adjustment of the base drug catalogue in the future will also be affected by the evaluation results In terms of the content of the draft, the next theme selection mechanism to be established will focus on the dynamic adjustment of the demand for the basic drug catalog, taking into account the list of short drugs, the list of drugs urgently needed to be encouraged in clinical research and development (including generic drugs), the list of orphan drugs and so on Previously, Zeng Yixin, deputy director of the national health and Health Commission, said at the regular policy briefing of the State Council that the list of basic drugs paid more attention to clinical needs, highlighted the clinical value of drugs, implemented dynamic adjustment of the list, and started the transfer in procedure in due time for the newly approved and marketed drugs with significantly improved efficacy and reasonable price In principle, the dynamic adjustment of the list of base drugs shall not exceed three years For some new drugs that have definite curative effect, reasonable price and better curative effect than the existing drugs, the adjustment procedure shall be started timely and included in the list of base drugs According to the requirements of the draft, about 10 selection topics are produced each year, and the results of these selection will directly affect the dynamic adjustment of the base drug catalog 1 How to judge the adjustment? According to the draft, a scientific and standardized evidence method system should be established to comprehensively evaluate the multi-dimensional evidence of drug safety, effectiveness, economy, innovation, suitability and accessibility This will have a positive impact on the structure of clinical medication For example, for the drug proportion assessment, the criticized one size fits all method will have detailed requirements Industry insiders said that this will promote the control of drug proportion back to the law of medicine For the dynamic adjustment of base drug list, first of all, considering the drug safety, it means that some products with more clinical adverse reactions will be out of the market In fact, in the drug monitoring catalogue issued by many provinces, in addition to the auxiliary drugs, it is also clear that the products with high clinical adverse reactions should also be monitored Secondly, effectiveness means that another part of the product will be out of the market, and the most likely one will be adjuvant According to the adjusted list of base drugs obtained by e-drug managers, most of the products transferred out are of high side effects, low safety or auxiliary drugs At the expert seminar on the adjustment of the base drug catalog, the products listed in the auxiliary drug catalog by provinces and regions will be difficult to be included in the national base drug catalog, which has also been recognized by the participating experts From the economic point of view, price will be an important factor Although in the initial discussion meeting of experts on basic drug catalog, under the principle of giving priority to clinical value, the price factor and whether it is in the medical insurance catalog are behind, because it is important to link the basic drug catalog adjustment with the medical insurance payment and reimbursement policy, the price factor in the dynamic adjustment of the former will also be an important reference in the future When Zeng Yixin talked about the price and medical insurance reimbursement, he said that the national health insurance bureau is developing relevant working procedures to enable the drugs entering the basic drug catalog to enter the medical insurance reimbursement catalog Huang Xinyu, director of the medical service management department of the State Medical Insurance Bureau, also said that because the positioning and adjustment of the basic drug catalog was different from the previous several times, the medical insurance bureau was also comprehensively considering the connection with the basic drugs and included the therapeutic basic drugs out of the catalog into the medical insurance catalog according to the procedures In the new version of the basic drug catalogue, the new varieties include 12 kinds of anti-tumor drugs, 22 kinds of drugs urgently needed for children in clinical use, and the world's first and only new hepatitis C treatment drug with full oral, pan genotype and single tablet in China In the future, there will be more opportunities for therapeutic innovative products in product transfer On the other hand, a group of safe but ineffective "Chinese magic drugs" with boundless scenery in the past will also face major challenges 2 How? In accordance with the requirements of the draft, the national drug clinical comprehensive evaluation Coordination Committee will be established, which is expected to be completed by the end of 2018 The committee is responsible for the planning of the comprehensive evaluation system and the construction of the evaluation base, the formulation of evaluation management norms and policies At the same time, the national comprehensive evaluation center, sub center and evaluation base for drugs and health technology will be built At present, the National Comprehensive Evaluation Center for drugs and health technology has been established, and the national health and Family Planning Commission health development research center is responsible for the work of the center, and the most important theme selection mechanism is completed by the center In the sub centers and evaluation bases, priority will be given to the establishment of the national comprehensive drug clinical evaluation sub center and evaluation base in cooperation with the National Cancer Center, the national cardiovascular disease center and the National Children's medical center Relying on the National Medical Center, national clinical medical research center, national key clinical specialized medical institutions, and by the end of 2018, three pilot project engineering laboratories and five regional clinical drug evaluation bases for children's drug use, cardiovascular disease drug use and anti-tumor drugs were selected and determined Secondly, the national drug clinical comprehensive evaluation expert committee, including the national drug clinical comprehensive evaluation advisory expert committee and the review expert committee, should be established by the end of 2018 to be responsible for the selection of evaluation topics and external quality control of comprehensive evaluation At the same time, the national drug clinical comprehensive evaluation advisory expert committee will cooperate with the national drug and health technology comprehensive evaluation center to complete the selection of conventional topics for comprehensive evaluation In addition, in terms of specific organization and implementation, it is planned to be divided into three steps: first, complete the basic conditions and pilot construction by the end of 2018; second, carry out the basic capacity and demonstration construction in 2019; and finally, complete the system improvement and extension promotion from 2020.