[Zhou Jun] Howson, the first domestic "Gleevec" generic drug, passed the consistency evaluation; 36 kinds of negotiated generic drugs will be included in the Beijing Medical Insurance catalogue

Last week, the movie "I'm not the God of medicine" swiped the screen in the circle of friends, and generic drugs became the focus of national attention Coincidentally, the movie's protagonist, the generic drug Lenin (officially known as Gleevec), was the first in the country to pass a consensus assessment this week On July 5, Jiangsu Haosen confirmed to receive the approval document for supplementary application of chemicals imatinib (Gleevec) approved and issued by CFDA, becoming the first enterprise that passed the consistency evaluation of the drug According to the data of pharmaceutical intelligence, at present, there are four domestic enterprises approved for listing, namely Novartis, hausen, Zhengda Tianqing and Sinopharm Ouyi Imatinib capsule declared by Zhengda Tianqing has also been accepted and is currently under review and approval In addition to the above hot spots, what are the new developments and policies of domestic generic drugs this week? Let's have a look According to the database of registration and acceptance of intelligent drugs, as of July 4, there are 237 acceptance numbers of consistency evaluation (calculated by acceptance number, the same below), involving 99 varieties of 96 enterprises, of which 48 have passed the acceptance number From June 30 to July 6, CDE undertook 5 acceptance numbers of consistency evaluation, involving 5 varieties of 5 enterprises Among them, levofloxacin lactate tablets and benhexol hydrochloride tablets were the first to be declared, and levofloxacin lactate tablets, benhexol hydrochloride tablets and montmorillonite powder were 289 varieties (details of CDE acceptance consistency evaluation varieties from June 30 to July 6) 11 generic drugs were accepted, and 7 reported production varieties entered the new state from June 30 to July 6 CED accepted 11 generic drug application records, all of which were reported for production It includes ketoprofen cataplasm, gligliptin metformin tablets, olanzapine tablets, voriconazole for injection, dextran iron injection, irinotecan hydrochloride injection, medium and long chain fat emulsion / amino acid (16) / glucose (16%) injection (from June 30 to July 6, 7 generic drugs were accepted by CDE) in addition, 7 varieties of 7 enterprises reported for production and entered into a new state Qianliedier injection has been approved - to be certified, and others are in an approved state (June 30-July 6, 7 status updates of generic drugs) Beijing issued the payment standard of generic drugs in medical insurance negotiation On July 3, Beijing Municipal Bureau of human resources and social security issued the notice on payment of generic drugs in negotiation, which clearly included 36 generic drugs in Beijing Medical Insurance catalogue At the same time, provisions are made for the generic drugs of these drugs: the negotiated generic drugs belong to the category B drugs in the drug catalogue of basic medical insurance, industrial injury insurance and maternity insurance of this city The limited payment content shall be implemented in accordance with the provisions of the HR & SDF [2017] No 54 document; if the Generic specifications are consistent with the negotiated drugs, the payment standard shall be temporarily implemented in accordance with the actual market price of the generic drugs, but shall not exceed the payment standard of the corresponding negotiated drugs; if the Generic specifications are inconsistent with the negotiated drugs, the payment standard shall refer to the notice of the national development and Reform Commission on printing and distributing the drug price difference rules 》Calculation: if the calculated payment standard is higher than the actual market sales price of generic drugs, the actual market sales price of generic drugs shall be taken as the payment standard After this notice was issued, it indicates that the battle between generic drugs and original research drugs in the national health insurance negotiation has begun According to the current data, although the original research drugs still occupy a dominant position, as Beijing, with 170 billion yuan, the second largest pharmaceutical market in China, it is unknown who will spend the next few years On July 3, the Department of human resources and social security of Henan Province and the health and Family Planning Commission of Henan Province jointly issued the notice on safeguarding the clinical use of national negotiated drugs It is clearly stipulated that the national negotiated drugs (including negotiated drug generic drugs) and special drugs for major and serious diseases will not be included in the drug proportion and total medical insurance control assessment of medical institutions temporarily According to statistics, up to now, 22 provinces, such as Tianjin, Hainan and Ningxia, have made it clear that the requirement of national negotiated drugs is not included in the drug proportion or separate accounting requirements It is expected that more provinces will implement the dividend in the context of vigorously promoting drug price negotiations The policy is not clear Most hospitals hold a wait-and-see status for conformity evaluation varieties Recently, Shanghai and Sichuan successively issued procurement notices for conformity evaluation varieties of quality and efficacy of generic drugs In terms of price limit, Shanghai clearly pointed out that: Sunshine platform provides price information of other provinces and cities, this city and the same varieties as a reference for negotiation Set up price negotiation reminders for varieties with large increase or high price Sichuan pointed out that: drug manufacturers must promise that the transaction price of the product passing the consistency evaluation in Sichuan public medical institutions shall not be higher than the provincial bidding price or online price newly formed in other provinces after the product passing the consistency evaluation In short, it can't be higher than the price of other provinces, in fact, it is to ensure the lowest price in the country In fact, in terms of drug price limit, Zhejiang Province, Jiangsu Province and many other provinces require the lowest price in China And according to media reports, just recently, in the procurement work of many provinces and cities, "priority procurement through consistency evaluation of varieties" is actually only a suggestion, not a mandatory implementation A large pharmaceutical company also said that in the past six months, there have been 10 product regulations passed the consistency evaluation, but in the process of drug delivery communication, most hospitals choose not to be the first to eat crabs, because the policy is not clear The price of the original research drug has been reduced, and generic drugs are no longer dominant On July 2, Gansu provincial drug and medical consumables centralized purchase network released the notice on adjusting the bid price of some drugs According to the notice, Xi'an YANGSEN Pharmaceutical Co., Ltd and Gansu heavy Pharmaceutical Co., Ltd actively applied to adjust the online price of the online products, and the new online price will be implemented from July 5, 2018 Among them, Xi'an YANGSEN's Dake (injection land of cetabine freeze-dried powder needle, 50mg) dropped from the original 10327.22 yuan to 4996 yuan, a drop of 51.6% Such a high drop makes the product a few drugs whose price is lower than that of domestic generic drugs in the market Content source: Yaozhi database, cypress blue, Yaozhi elite club, etc