The proportion of more than 400 auxiliary drug catalogues flowing out of traditional Chinese medicine injection should not be underestimated

Step pharmaceutical received the inquiry letter from Shanghai Stock Exchange: to explain the efficacy of traditional Chinese medicine injection, self-examination quality Is it inevitable? Since the beginning of the year, since Jiangxi released the first batch of provincial key monitoring directories, there have been many official release or online circulation of key monitoring directories (auxiliary drug directory) nationwide According to incomplete statistics, more than 400 drugs have been published on the Internet, such as 40 key monitoring directories in Qingdao, Shandong Province, 120 auxiliary drug directories in 6 places of Hebei Province, 80 key monitoring directories in Luoyang, Henan Province, Jiangxi Province (Jiujiang City, Dazhou City, Anyuan County), the fifth people's Hospital of Dazhou city and Anyuan County People's Hospital, a total of 141 key monitoring directories, Anhui 46 Key production monitoring directories After a simple review, more than 400 key monitoring (auxiliary drugs) drugs are almost all injections, of which the proportion of traditional Chinese medicine injections should not be underestimated From the list of auxiliary drugs (key monitoring catalogue) published by the above regions, the injection is the first to be strictly controlled First, the clinical value of some products is controversial, and second, the policy orientation In terms of the latter, the State Administration has issued several policies to deal with the plight of tight medical insurance funds, such as 4 + 7 centralized procurement, anti-cancer drug access negotiations, auxiliary drug catalog, DRG payment, etc On the other hand, according to the data disclosed by Xinkangjie, the compound annual growth rate of domestic injection market was 6.7% in 2013-2016, and by 2016, the scale of domestic injection reached 757.7 billion yuan, an increase of 8.1% year on year According to the growth, the injection drug market in 2018 has exceeded trillion yuan And the share of traditional Chinese medicine injection is about 12%, that is to say, the market scale of traditional Chinese medicine injection may have exceeded 100 billion yuan But how many of the important members of the "hundred billion kingdom" are based on their own security and effectiveness? For example, even if a drug has been warned (strictly monitored), restricted in use for at least 26 times in 11 provinces (cities), or even faced the risk of discontinuation at any time, its sales volume in 2018 is also "among the best" in the field of cardio cerebrovascular The controversial and huge volume of traditional Chinese medicine injection Market is bound to usher in a top-down "rectification wind" The space reserved for traditional Chinese medicine injection by medical insurance is not large In February 2017, the Ministry of human resources and social security released a new version of the national directory of drugs for basic medical insurance, work injury insurance and maternity insurance (2017 version) (hereinafter referred to as the "drug directory"), in which 49 varieties of traditional Chinese medicine injection were selected, but the "drug directory" strictly restricted the use of traditional Chinese medicine injection, with 39 restricted varieties, such as Shuanghuanglian injection and Qingkailing injection Injection, Shuxuetong injection and many other best-selling varieties are limited to medical institutions above the second level, and at the same time, they are also limited to severe and disease types, that is, the grass-roots medical institutions use the preparation, and the medical insurance will not be reimbursed Some people in the industry have said that doctors in the top three hospitals basically do not use traditional Chinese medicine injections because the ingredients of the drugs are not clear Most of the traditional Chinese medicine injections are actually sold in the grass-roots market, including county hospitals, township hospitals, etc After previous restrictions on the use of traditional Chinese medicine injections in various provinces and cities across the country, the sales volume of some manufacturers did not decline, because it was limited to the use of secondary hospitals or above, but this level of hospitals did not use this medicine At the same time, the drug catalog stipulates that the intelligent monitoring system for medical services of basic medical insurance and the monitoring and analysis system for the use of drugs in social insurance should be established and improved, focusing on the monitoring of drugs with large consumption, high expenditure and possible unreasonable use, and the monitoring results should be released to the society in an appropriate way This regulation will directly strengthen the monitoring of the restricted drugs in the new catalogue In addition to the overall restriction of "one size fits all" in medical insurance, each province (District, city) shall adjust the category B of medical insurance catalogue implemented in this region, and the adjusted quantity (including transfer in, transfer out and adjustment of limited payment scope) and the national category B drug shall be limited to 15% That is to say, on the basis of the implementation of the drug catalogue, there are very limited opportunities for enterprises to keep (open) the market by attacking the provincial medical insurance In addition, the adjustment mechanism of the medical insurance catalogue is more flexible, some of which can not prove that it is safe and effective or fall into the "difficult to enter and easy to exit" situation Although 2019 medical insurance catalogue is coming out soon, there is little space reserved for traditional Chinese medicine injection Before the catalogue of national auxiliary drugs was published, the enterprises of traditional Chinese medicine injection suffered from the difficulty of "cold winter" medical insurance, which had an impact on the sales volume of traditional Chinese medicine injection, but did not "harm the key point" And the formulation of auxiliary drug catalogue and key monitoring catalogue is the important factor that causes its weak sales For example, kunyao group disclosed its 2018 semi annual report While its revenue grew rapidly, its net profit declined slightly The main reason for the decline was the limited medical insurance of its leading product Xuesaitong for injection (freeze-drying) According to treasure island's 2018 annual report, due to the impact of industry policies and market environment, the injection sales volume has declined The sales volume of Shuxuening injection decreased by 35.59% year on year, that of osteopeptide for injection decreased by 29.15% year on year, and that of Xuesaitong (freeze-dried) for injection decreased by 27.09% year on year In the 2018 annual report, Cr Sanjiu disclosed that under the environment of medical insurance and fee control, the sales of Shenfu injection, Honghua injection, Shenmai injection, Cinobufacin injection and other traditional Chinese medicine injection varieties fell In addition, there are also regular customers in the catalogue of key monitoring (auxiliary drugs), the core products of Wuzhou pharmaceutical company, such as Xueshuantong for injection (freeze-dried), Xingnaojing injection and Shenmai injection of Dali pharmaceutical, all of which have seen sales decline It can be seen that the national catalogue of auxiliary drugs has not yet been published, and various key local monitoring (auxiliary drugs) catalogues have caused great losses in some traditional Chinese medicine injections Before that, the national health and Health Commission issued the notice on the management of clinical application of auxiliary drugs (hereinafter referred to as the notice), which made clear provisions on strengthening the management of auxiliary drugs and improving the level of rational use of drugs According to the notice, each provincial health administrative department organizes the medical institutions above the second level within its jurisdiction to rank the auxiliary drugs in the common name and according to the annual use amount (from December 1, 2017 to November 30, 2018), form the catalogue of auxiliary drugs, and report it to the provincial health administrative department However, this "notice" makes the insiders have many puzzles First, "auxiliary drug use" should have a scientific definition, formulate corresponding measures and management systems under the premise of fuzzy standards and rules, and require the auxiliary drug use catalogue at all levels to be increased at all levels, the quantity can only be increased, not reduced, or even ranked by the total amount of use, which is random and lack of science Second, many medical institutions and local health authorities lack objective evaluation on the efficacy and clinical value of Chinese patent medicine, and mistakenly identify the therapeutic Chinese patent medicine with definite efficacy, safety, reliability and clinical needs as auxiliary medicine It can be seen from the above that traditional Chinese medicine injections are impacted to varying degrees along with the policies of medical insurance cost control, limited use and auxiliary drug use Why does its traditional Chinese medicine injection suffer such "discrimination"? There is no scientific definition of "auxiliary drug", no clear evaluation standard for the clinical efficacy and safety of traditional Chinese medicine injection, and the unreasonable use of drugs by doctors However, the frequent occurrence of drug safety events in traditional Chinese medicine injections is a fact that can not be ignored, which is the fundamental for pharmaceutical enterprises to innovate technology and ensure the safety and effectiveness of drugs under the premise of complying with policies Reevaluation of traditional Chinese medicine injections, repeated "dystocia"? It is said by enterprises that it is necessary to re evaluate the traditional Chinese medicine injection after it is put on the market Since 2006-2010, the former State Food and drug administration has repeatedly mentioned the safety re evaluation of traditional Chinese medicine injection According to the policy at that time, the safety of traditional Chinese medicine injection was mainly evaluated However, the safety re evaluation has not been implemented Until October 8, 2017, the central office and the State Office issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of pharmaceutical medical devices, proposing that in the future, the review and approval of pharmaceutical injections will be strictly enforced, and the re evaluation of the marketed pharmaceutical injections will be carried out at the same time, striving to basically complete in about 5 to 10 years In March 2018, the State Food and Drug Administration issued the 2017 annual drug review report, which mentioned in the "2018 key work arrangement" part of the report that the re evaluation of traditional Chinese medicine injection will be studied and initiated, and the technical guidelines for re evaluation will be formulated However, by March 28, 2019, CDE released the list of reference preparations for the 21st batch of generic drugs, involving 327 drugs (by serial number), 242 of which are injections, involving 88 varieties (by generic name) This is the first time the injection has appeared in the list of reference preparations, and the industry speculates that the injection consistency evaluation is finally coming The re evaluation of traditional Chinese medicine injection has not been reported yet, but it is related to the lack of reference standard of traditional Chinese medicine injection If enterprises are required to complete the work in a scientific and practical manner, the re evaluation of the safety of traditional Chinese medicine injection will undoubtedly be successful Only those manufacturers with strength, good product quality and effective varieties can pass the clinical trial and research, so as to pass the re registration of drugs That is to say, the production enterprise is the main body to evaluate the safety of its own products, and self certification of its safety and effectiveness is bound to have great drawbacks Therefore, the repeated "dystocia" of traditional Chinese medicine injection is closely related to the lack of re evaluation criteria Recently, at the Symposium on auxiliary drug monitoring and clinical comprehensive evaluation held by China Pharmaceutical Enterprise Management Association, some industry figures thought that "in fact, many traditional Chinese medicine injection enterprises are doing re evaluation work, but they are" crossing the river by feeling the stone ", there is no clear evaluation standard, but in fact, their investment in re evaluation of traditional Chinese medicine injection is not low, no less than The scale of investment in generic conformity assessment " Therefore, "it is hoped that the state can clarify the re evaluation criteria of traditional Chinese medicine injection." There are also people in the industry who say that they hope to be able to make clear whether their injection varieties can work based on the re evaluation criteria If they can't, they will eliminate and give up the relevant varieties If there is still room for improvement in the result, the enterprise can adapt through production process improvement and so on "The key is to have evaluation criteria, which is responsible attitude at the policy level." Information source: yaozhi.com, e-medicine manager, cypress blue, pharmaceutical economic news, pharmaceutical cloud studio, etc