Can Henan purchase normally after opening green light flow standard for Novartis, hausen and Ouyi?

On January 15, 2019, the office of the Joint Conference on centralized bidding and procurement of Henan Medicine issued a notice on regulating the procurement and use of some anticancer drugs The notice is very short and mainly conveys the following information: first, in the special centralized purchase and price negotiation of anticancer drugs just carried out in Henan Province, imatinib tablets (0.1g) produced by Novartis, Jiangsu Haosen and Ouyi, a stone drug company, are the whole group of flow standard due to "no expert price negotiation confirmed"; Second, in order to ensure the clinical use of drugs, the Joint Conference Office of Henan Provincial Pharmaceutical centralized bidding and procurement decided that imatinib (0.1g) produced by the above three enterprises could still be purchased and used by medical institutions; third, the policy basis for making this provision was the previous document of Yuwei Yaozheng (2018) No 15 and Yuyao Joint Office (2018) No 26 At the same time, this decision is made in combination with "medical institution application and enterprise appeal" Can we still ensure the normal purchase and use of drugs in the hospital after flow labeling? This seems to be in conflict with the original intention of the special centralized purchase of anticancer drugs and the supporting regulations when Henan Province formulated the detailed rules of purchase and price negotiation at that time According to the relevant regulations of Henan Province, the drugs that are not shortlisted for negotiation in the special centralized purchase of anticancer drugs and are not listed in the limited online purchase will be stopped from purchase and use after February 1, 2019 Although the reason given by Henan is to "guarantee the clinical use of drugs", such reason does not seem to be fully convincing After all, all anticancer drugs purchased through negotiation were also included in the scope of purchase negotiation through a unified standard at that time And the more crucial question is, what kind of medicine can belong to the category of "guarantee clinical medication" so as to make the bidding procurement rule exception? In the future, will other enterprises and varieties refuse the price of drug centralized purchase based on this? After setting a precedent, what should we do in the future? It is worth noting that up to now, the pharmaceutical purchasing platform of Henan public resource trading center has deleted the notice on its official website In order to clarify the key information, e-medicine manager combed the special centralized purchase of anticancer drugs in Henan Province in 2018 to restore its process 1 Not adopted expert bargaining: the whole group of flow standard On September 11, 2018, Henan provincial health and Family Planning Commission, Henan Provincial Department of human resources and social security, Henan public resources trading center and other three departments jointly issued the notice on printing and distributing the implementation plan for the special centralized procurement of anticancer drugs in public hospitals in Henan Province, marking that Henan Province has officially started to respond to last August, and the National Medical Security Bureau and the state The provincial special centralized procurement of anticancer drugs jointly promoted by the health committee In this notice, Henan Province made clear the implementation scope of its special centralized procurement of anticancer drugs Specifically, it is "based on the anticancer drug varieties involved in the announcement on reducing drug import tariff issued by the Tariff Commission of the State Council and the notice on value added tax policies for anticancer drugs issued by the Ministry of finance, the General Administration of customs, the General Administration of Taxation and the State Drug Administration, referring to the list of large drugs used in Henan Province, and excluding the 2015 national drug price negotiation, 2017 The anticancer drugs entered the national health insurance catalog negotiation in 2018 or other anticancer drugs not required to be included in the special centralized procurement according to the government's requirements " According to this standard, on December 11, 2018, Henan Public Resources Trading Center released the catalogue of special centralized procurement of anticancer drugs, which includes 31 anticancer drugs of different specifications, including imatinib 0.1g tablets At the same time, Henan public resources trading center also made clear the rules of bargaining According to the notice on doing a good job of price negotiation for special centralized purchase of anticancer drugs in Henan Province, all bidding enterprises shall log in to the drug bidding system of the pharmaceutical procurement platform of Henan public resource trading center within the quotation time of 9:00-11:00 on December and 13th, 2018, and report the price through CA log in In addition, the quotation requirements of the enterprises for the special collection of anticancer drugs have also been made clear: drug manufacturers (or the only authorized general agent in China for imported drugs) shall quote the actual quantity of drug specifications and packages according to the lowest price not higher than the national price, and the quotation shall be kept to two decimal places, and the drug quotation shall include the distribution cost Since then, an important link is the expert bargaining This is also the place where Novartis, Jiangsu Haosen, Sinopharm Ouyi and other three companies have problems The so-called expert price negotiation means that after the enterprise submits the relevant drug quotation, the health and Health Commission of Henan Province coordinates with the public resource trading center of Henan Province, invites the relevant experts to determine a "expert recommended price" According to the previous precedent, these experts are generally the heads of the pharmaceutical departments of Henan people's Hospital, Henan cancer hospital and other large-scale first-class hospitals in Henan Province, or the relevant tumors Professional experts The above notice requires, Experts shall conduct face-to-face negotiations with the enterprises according to the quotations of relevant pharmaceutical enterprises and the latest purchase prices of other provinces, in combination with the production scale, market reputation of the enterprises and other indicators that can reflect the product quality, such as the consistency evaluation, the state-level awards won, the marketing situation in developed countries (regions), etc., and confirm after the price evaluation of all negotiated drugs Set the price recommended by experts According to the requirements of the notice, if the enterprise accepts the expert's suggested price, the relevant varieties will be directly shortlisted; otherwise, they will not be shortlisted For the products that are not shortlisted, the experts shall evaluate according to the clinical needs, and the drugs that are not clinically necessary shall be eliminated directly; for the drugs that are clinically necessary and irreplaceable, they shall be listed in the limited online purchase catalogue Obviously, three companies, Novartis, Jiangsu Haosen and Sinopharm Ouyi, did not reach an agreement with the experts on the price of imatinib, nor did they confirm the price recommended by the experts, which led to the final result of "whole group flow standard" 2 According to the database information of imatinib, the only standard product of imatinib, currently there are only three domestic imatinib tablet manufacturers, one of which is imported by Novartis, Switzerland Its trade name is widely known by the outside world because I am not the God of medicine, that is, Gleevec As a representative of the heavyweight anti-tumor drugs and "TiNi" drugs launched by Novartis in 2001, the sales of Gleevec has been on the rise for many years due to its remarkable curative effect It was once known as "CML life-saving drug", and in recent years, it has also attracted more and more attention because of the increasing recognition of the disease The other two domestic manufacturers are Jiangsu Haosen and Sinopharm Ouyi Among them, Jiangsu Haosen is also the first enterprise in China to pass the consistency evaluation of quality and efficacy of generic drugs In addition, Novartis and Zhengda Tianqing also produce the dosage form of imatinib mesylate capsule At present, the market of imatinib is basically divided by the above four enterprises, among which, Novartis, the original research manufacturer, has the highest market share According to the data of insight, in 2016, its market share was 80.29%, followed by Haosen, Jiangsu, 10.97%, Zhengda Tianqing, 8.53%, while Ouyi, a stone medicine, only accounted for 0.21% Therefore, when imatinib tablets are only included in the scope of centralized procurement in Henan Province this time, if none of the three enterprises, Novartis, Haosen, and Ouyi, a stone drug, wins the bid, the clinical use will indeed be affected However, it is worth pondering that in the special centralized purchase of anticancer drugs in Henan Province, only imatinib's tablets were finally marketed, and the rest 30 drugs of the product specifications completed the negotiation process normally On December 27, the Joint Conference on centralized bidding and purchase of Henan Medicine issued the notice on the results of price negotiation for special centralized purchase of anticancer drugs and the results of price negotiation for special centralized purchase of anticancer drugs in the form of office documents According to the statistics of e drug managers, among the 31 specifications in the purchase catalogue, all the other varieties were shortlisted except octreotide 1ml: 0.2mg injection and imatinib 0.1g tablet Although octreotide 1ml: 0.2mg injection was not included in the list of successful negotiation, it was listed in the limited online purchase catalogue together with 33 other drugs According to the regulations, these varieties are not negotiated successfully, but they are "clinically necessary and irreplaceable drugs" These drugs can still be purchased through bidding, but the hospital shall negotiate the purchase price with the enterprise on its own, and stipulate that the purchase amount of all the drugs purchased through the limited amount of network shall not exceed 5% of the total annual drug purchase amount of the unit It is worth noting that imatinib has not appeared in the catalogue of "clinically necessary and irreplaceable" online limited purchase drugs If in strict accordance with the previous documents issued by Henan Province, imatinib tablets have not been shortlisted in the list of successful price negotiation, nor listed in the limited online purchase, "if the hospital purchases before December 30, 2018, it can continue to use until the end of January 2019, and the purchase and use will be stopped after February 1." However, on January 15, notice on regulating the purchase and use of some anticancer drugs gave Novartis, hausen and Ouyi imatinib tablets special treatment "Imatinib tablets (0.1g) produced by the above three enterprises can be purchased and used by medical institutions," the notice said 3 The national purchase price is basically stable Is Henan bidding too low? In fact, imatinib is a relatively well-known and widely used anti-tumor drug At the same time, with the gradual expiration of "Gleevec" patents, domestic imitation of imatinib is also a hot topic According to the information of drug clinical trial registration and information publicity platform, many domestic well-known enterprises, including xinlitai, Qilu, Chongqing Yaoyou, have carried out or are carrying out imatinib related clinical trials As a national action, the special centralized procurement of anticancer drugs has been actively implemented in all provinces The centralized procurement catalogue of each province is different from each other, but many provinces have listed imatini in the special procurement plan, only involving different specific enterprises For example, the special collection of anticancer drugs in Guangdong Province is only included in the products of Sinopharm Europe and Italy, while in the negotiation of 14 provincial Procurement Alliance, such as Shanxi Province, only Novartis products are included But there are also many provinces, like Henan, including the products of three enterprises at the same time, such as Anhui, Beijing, Jiangsu, and these provinces have also announced the shortlisted prices of several products, such as the price of imatinib tablets (0.1g * 60) of Ouyi, a stone medicine, in the above provinces ranges from 700.41 yuan to 729.6 yuan, and that of Haosen, Jiangsu Province ranges from 842 yuan to 850 yuan China's Gleevec is the same specification, ranging from 9959 to 9998 yuan It can be seen that the bidding price of these products in various parts of the country has been basically stable and there is no big difference due to the strategy of national lowest price linkage implemented in many places Therefore, if the expert price negotiation in Henan Province is also at this price level, several enterprises should not respond to the expert price negotiation without any reason Therefore, one of the possibilities is that the price given by experts in Henan Province is too low, even exceeding the expectation of enterprises This may also be why, Henan Province medicine centralized bidding procurement