4 + 7 non winning enterprises are in a hurry! 17 varieties have been evaluated and 3 of them have become the second batch of hot spots for centralized purchase

According to the data of mienei.com, at present, 17 generic varieties have passed or deemed to pass the consistency evaluation, and 3 or more enterprises have reached, among which 7 varieties are expected to be included in the second batch of volume purchase Recently, many provinces and cities have suspended the online purchasing qualification of drug manufacturers, involving multiple "4 + 7" varieties, which are "failed to pass the consistency evaluation, and 3 other enterprises have passed the consistency evaluation" Under the condition that the implementation effect of "4 + 7" with quantity procurement is better than expected, the bidding procurement and clinical use of "4 + 7" drugs that are not selected, not evaluated, with the same indication and mechanism are affected to different degrees According to the statistics of mienei.com, as of May 24, 2019, 130 varieties have passed or deemed to pass the consistency evaluation, involving 281 specifications Among them, 17 generic varieties have passed or deemed to have passed the consistency evaluation, reaching 3 or more enterprises From the perspective of treatment categories, there are 2 varieties of enterprises with over evaluation in 4 categories: diabetes medicine, systemic antibacterials, systemic antiviral drugs, and hypolipidemic drugs In terms of the number of evaluated enterprises, metformin, tenofovir dipivoxil, amlodipine and entecavir are the most evaluated enterprises, with 10, 8, 8 and 7 enterprises respectively Among the 17 varieties, 10 are "4 + 7" with quantity purchased, and 7 are expected to be included in the second batch of with quantity purchased, namely metformin, amoxicillin, glimepiride, sodium bicarbonate, polyethylene glycol, levocetirizine and isoniazid The related evaluated drugs are all national medical insurance drugs, among which metformin hydrochloride sustained release tablets and levocetirizine hydrochloride tablets are class B drugs, Others are class a drugs Among the 25 "4 + 7" varieties in the first batch, none of them were included in the centralized collection According to the data of MI Nei net, there are six generic varieties of diabetes drugs that have passed the consistency evaluation Among them, acarbose, metformin, repaglinide, glimepiride and other four varieties were the main drug varieties for diabetes patients, with the terminal sales of more than 2 billion yuan in China's public medical institutions in 2017 It can be predicted that diabetes drugs will be the focus of the purchase of the second tire volume Metformin and glimepiride have been evaluated by 10 and 4 enterprises respectively, and only one enterprise of acarbose, repaglinide, saggliptin and wiggliptin has passed the consistency evaluation It can be seen that metformin and glimepiride will face a fierce price war in the second batch of belt purchase According to the data of mienei.com, in 2017, the sales volume of metformin in the terminal of public medical institutions in China was 3.659 billion yuan, and Squibb, the original manufacturer, accounted for 48.66% of the market share At present, there are 1, 24 and 7 enterprises applying for conformity assessment in three products, including metformin hydrochloride capsule, metformin hydrochloride tablet and metformin hydrochloride sustained-release tablet In 2017, China's public medical institutions terminal metformin brand pattern in 2017, China's public medical institutions terminal glimepiride sales volume was 3.659 billion yuan, the original research manufacturer Sanofi accounted for 58.69% of the market share Among the top 5 enterprises, the products of Yangzijiang pharmaceutical, Wanbang biochemical and Xinhua Pharmaceutical have passed the consistency evaluation The market share of the product is 12.96%, but the conformity evaluation of the product is not declared In 2017, the consistency evaluation of the brand pattern of glimepiride in China's public medical institutions was just needed, and the non evaluated drugs were "abandoned" According to the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs, the drug varieties that pass the consistency evaluation shall be properly supported in the aspect of medical insurance payment, and medical institutions shall give priority to purchasing and selecting in clinical practice If there are more than three manufacturers that have passed the consistency evaluation for the same kind of drugs, no more varieties that have failed the consistency evaluation will be selected for centralized purchase of drugs Under the circumstances that the implementation effect of "4 + 7" volume procurement is better than expected, and the second batch of volume procurement varieties are about to be announced, the enterprises that have not been evaluated and have not been selected are facing more and more resistance in the bidding procurement of medical institutions and the sales in the retail market Recently, drug procurement platforms in Jiangxi, Guangxi, Jiangsu and other provinces have released announcements successively, suspending the online procurement qualification of drug manufacturers who "failed to pass the consistency evaluation and have passed the consistency evaluation" According to incomplete statistics, of the 17 evaluated enterprises, only four evaluated enterprises, including glimepiride, sodium bicarbonate, isoniazid and irbesartan, have not been suspended Among them, glimepiride, sodium bicarbonate and isoniazid are the three varieties that have just passed the evaluation in April and may this year In the future, some provinces will suspend the online purchasing qualification of drug enterprises that have not passed the evaluation With more and more enterprises' products passing the consistency evaluation and over evaluation up to 3, the non evaluated product enterprises are not only not able to purchase in volume at the national level, but also gradually lose the purchasing qualification in various regions The shuffling of the generic pharmaceutical industry in China is accelerated and the concentration degree is further improved At the same time, the process of suspending online purchase or online transaction is dynamically adjusted, and the enterprises that have not been evaluated need to pass consistency evaluation in order to resume online purchase or online transaction Failed to select enterprise drugstore to reduce price and push "4 + 7" exclusive package? In the "4 + 7" volume purchase, AstraZeneca, the original manufacturer of rosuvastatin calcium tablet (trade name can be determined), dropped the bid at the declared price of 6.65 yuan / tablet, and rosuvastatin calcium tablet of Jingxin tablet was selected at the price of 0.78 yuan / tablet Risuvastatin is the main product sold by AstraZeneca in China After the "4 + 7" volume purchase, AstraZeneca selected Zhikang of LVYE pharmaceutical to supplement the product line in cardiovascular field After the "4 + 7" volume purchase, AstraZeneca began to take further "rescue" methods for the company Recently, AstraZeneca has launched a "4 + 7" city exclusive package for rosuvastatin calcium tablets (10mg * 28 tablets) In addition, AstraZeneca significantly reduced the price of rosuvastatin calcium tablets (10mg * 7 tablets * 4 tablets) in a pharmacy in Guangzhou, with a discount as low as 50%, i.e from 3 yuan per tablet According to the data of minenet, in 2017, the sales volume of rosuvastatin tablets at the terminals of public medical institutions in China was 5.019 billion yuan, with the original research manufacturer AstraZeneca accounting for 56.71% of the market share, lunambert pharmaceutical accounting for 13.70% and Jingxin pharmaceutical accounting for 13.37% In recent years, AstraZeneca's market share of this product has declined from 69.64% in 2013 to 56.71% in 2017 At present, there are 6 enterprises that have passed the consistency evaluation of rosuvastatin calcium tablets, including lunanbert pharmaceutical, Haizheng pharmaceutical, Xiansheng Dongyuan pharmaceutical, Nanjing Zhengda Tianqing, Jingxin pharmaceutical and Novartis Lek In 2017, the price reduction of the brand pattern of rosuvastatin tablet in the terminal of China's public medical institutions was not in place! On March 5, 2019, when the "4 + 7" variety was refused to be put on the Internet, the state health insurance bureau issued the opinions on supporting measures for centralized drug procurement and use pilot medical insurance, which clarified the medical insurance payment standards for related drugs, and encouraged non selected enterprises to take the initiative to reduce their prices and make the same payment standards For generic drugs that fail to pass the consistency evaluation under the same generic name, no transition period will be set, and the payment standard in 2019 will not be higher than the price of selected drugs In the executive documents of purchasing with volume issued by 11 cities, except Xiamen, Xi'an and Guangzhou which are not described in the documents, 8 other cities have proposed the gradient price reduction requirements for the non selected varieties This means that not only will the market share of unselected drugs shrink, but also the price reduction is inevitable On May 14, 2019, Shaanxi issued the notice on the handling results of complaints about the dynamic adjustment of public announcement period for the purchase of drugs through the generic drug conformity evaluation variety sunshine, which made it clear that the price of "4 + 7" related varieties in the evaluated varieties with application price higher than the price of "4 + 7" online products would not be suspended On May 20, Shaanxi issued the announcement on the dynamic adjustment results of purchasing drugs through generic drug consistency evaluation varieties sunshine, and nine drug manufacturers, including amlodipine besylate tablets, were not allowed to hang their networks in all public medical and health institutions in Xi'an Before the announcement form of "4 + 7" varieties in Xi'an was not put on the Internet, Xi'an Medical Insurance Bureau issued the reference range of similar alternative varieties of selected drugs, and 117 non "4 + 7" varieties were included in the reference range of alternative varieties Under the policy of "encouraging medical institutions to use the selected drugs and completing the centralized purchase of drug consumption" of the state health insurance bureau, the influence scope of volume purchase has been extended to the same indication and mechanism drugs of "4 + 7" varieties It can be seen that volume purchasing and consistency evaluation have three major impacts on generic pharmaceutical manufacturers First, for the "4 + 7" variety manufacturers, the market share of the unselected enterprises is shrinking and the product price reduction needs to be in place; second, the evaluated enterprises have reached three varieties, and the unselected enterprises will lose the opportunity to purchase online; third, the clinical use of drugs with the same indication and mechanism as the "4 + 7" variety will be replaced It's not hard to understand why some "4 + 7" medium-sized enterprises need to obtain the qualification of "4 + 7" medium-sized enterprises through a large reduction.