Guangdong Union pilots new rules?

According to the "Opinions of the General Office of the State Council on Promoting the Normalized and Institutionalized Development of the Centralized and Volume Procurement of Drugs" (Guobanfa [2021] No.
2), "Pharmaceutical Net, August 13 Market expectations, stable price levels, stable clinical use, comprehensive consideration of factors such as reliable quality, stable supply, good credit, and clinical demand, adhere to the integration of recruitment and procurement, link volume and price, and determine supply companies, agreed procurement quantities and procurement agreements in accordance with laws and regulations Period: When there are major changes in the supply-demand relationship and the market structure, the selected companies, the selected prices, the agreed purchase quantity, and the purchase agreement period can be generated through bidding, bargaining, negotiation, inquiry, etc.
"
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This year is the big year for the renewal of centralized procurement.
How the provinces purchase through bidding, bargaining, negotiation, inquiry, etc.
will have a major impact on the pharmaceutical market structure and arouse strong attention from the industry
.
In July 2021, Guangdong issued the "Amoxicillin and other 45 Pharmaceutical Alliance Regional Groups' Volume Procurement Documents (Draft for Comment)".
There are many new rules and highlights, and they are even considered by the industry to be a pilot or become a future province.
A weather vane for the centralized drug procurement of the Union
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The situation of "renewal" and new issues
automatically renew the contract, which is beneficial to the original selected companies.
The author found that after the expiration of the national centralized procurement agreement, many provinces chose to automatically renew the contract .
For example, Shanghai in the "4 + 7" purchase agreement expires, the merger results in order to select Jicai, renewal Union rules areas: (a) "4 + 7" pilot areas were selected drugs and alliances, selected companies agreed to the city If the selected price is adjusted to the selected price for centralized drug procurement in the enterprise alliance area, the procurement cycle will be extended by 1 year .
(2) If the drug is selected in the "4+7" pilot but the alliance area is not selected, and the selected company agrees to adjust the selected price in this city to the average selected price of the product in the alliance area, the procurement cycle will be extended by 1 year


.
(3) If the enterprises selected in the "4+7" pilot do not accept the above rules (1) and (2), among the selected varieties in the inquiry alliance area, the enterprises with large purchases in the city in the first two years will be the newly selected enterprises, and the selected price will be the new The selected price is selected in the alliance area of ​​the selected company, and the procurement cycle is 1 year
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(4) For varieties with relatively sufficient competition (more than (including) 3 companies that meet the eligibility requirements for declaration), the selected enterprises that meet the above (1), (2) and (3) rules agree to adjust the selected price in this city to the lowest selection in the alliance area of ​​the variety Price, the procurement cycle will be extended to 2 years
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From the perspective of rules, the renewal of Shanghai's “4+7” contract is most beneficial to the original selected companies, and secondly, it is beneficial to the selected companies in the alliance region
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New focus: What will happen to those who are approved after the launch of the National Procurement?
Shanghai’s contract renewal policy is aimed at "4+7" and the renewal method for products that the same batch of drugs are purchased in different stages and concentrated in the alliance area
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For products that have only been recruited by the national centralized procurement once and then turned into a provincial recruitment, if they learn from the Shanghai policy and continue to renew the contract at the original price, it will be beneficial to the original selected companies; but it will not be conducive to the unselected manufacturers that have passed the consistency evaluation.
, Especially the manufacturers that have been approved after the national centralized procurement started
.
After the expiration of the National Drug Centralized Purchase Agreement, which method will each province adopt for bidding, bargaining, negotiation, or inquiry? Has caused controversy in the industry
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　　Guangdong Union Six Aspects and Six Trends
The "Amoxicillin and Other 45 Drug Union Regional Groups Procurement Documents (Draft for Comment)" issued by Guangdong in July 2021 is another national initiative initiated by Guangdong after cephalexin capsules.
Centralized procurement by the provincial alliance after the expiration of the purchase agreement
.
01.
The competitive situation has not changed, and there is also a chance to be included in the provincial alliance list.
Guangdong’s 45 products this time include all the 25 products in the first batch, 2 products in the second batch, and 24 products in the third batch.

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The second batch of 30 generic-name products other than cephalexin collected by the provincial alliance, and the third batch of 31 generic-name products are not included in this renewal list
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Only 2 products in the second batch were selected.
It is very likely that Guangdong has already issued the "Notice on Doing a Good Job in the Renewal of the Second Batch of State-Organized Drug Centralized Procurement of the Second Procurement Cycle" in April, and most of the products have been renewed
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The industry is concerned about whether after the expiration of the national centralized procurement agreement, if the competitive situation changes, it is likely that the provincial alliance will lead the purchase? From the product point of view, it is not necessary that the product competition situation changes before entering the provincial alliance with volume procurement
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For example, when "4+7" was launched, there were only 2 manufacturers of flurbiprofen injection, and now there are only 2 manufacturers.
The competitive situation has basically not changed, but it still entered the list of provincial alliances with volume procurement
.

　　02.
The selected price of the provincial alliance has the opportunity to be higher than the national
procurement price .
The list of purchased products is divided into over-evaluated and non-over-evaluated products.
Sub-provincial alliance procurement is not simply the procurement of products that have expired under the National Pharmaceutical Centralized Procurement Agreement.
The more important point is: How does the price of products that have expired under the National Centralized Procurement Agreement affect other products that have not passed the consistency evaluation? The last time the final price of cephalexin (oral regular-release dosage form) in Guangdong Province was higher than the previous national centralized procurement price, because the “unit comparable price” in Guangdong did not have a rigid requirement to be lower than the original national centralized procurement price.

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The “comparable unit price” that stipulates the specific price is the sustained-release controlled-release dosage form: the proposed price of the 0.
25g cephalexin sustained-release controlled-release dosage form that has not passed the consistency evaluation shall not be higher than 0.
42 yuan
.
This means that if the country with the amount of purchase selected products do not participate in the provincial coalition with the amount of procurement tender , the provincial coalition with the amount of purchase of selected price may exceed the same common name selected countries with the amount of purchase price
.
This time, amoxicillin and other 45 drug alliance regional groups have volume procurement regulations: in the clear list of products supplied by the same applying company, the price of the purchase order for the same product under evaluation is not higher than the national minimum price; the same product is not under evaluation The selected price of the purchase order is not higher than the national minimum price (or the price after the same product specification difference) and is lower than the national minimum price of the reviewed purchase order (or the price after the same product specification difference)
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The national lowest price shall be the lowest price of the same variety and specifications in the list of products supplied by the same enterprise after the comparison
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In the list of products clearly specified by the applicant enterprise, the original country’s central procurement regulations are not filled in, but the original selected company’s other specifications of the same species have been eligible for the proposed selection in this group’s procurement, the original country’s central procurement prices are still included in this The calculation scope of the national minimum price of the enterprise
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In view of the fact that the price of Guangdong is compared with the price of its own products, instead of referring to the lowest price of the original national centralized procurement price of the common name, as long as the selected products purchased by the country do not participate in the competition, the price of the provincial alliance with the volume procurement is still there.
The opportunity is higher than the national centralized procurement price
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03.
The same generic name and different routes of administration are combined, but the price may not be subject to bidding.
Price comparison, combining different dosage forms, specifications, packaging, and purchase quantities of the same generic drugs with similar clinical efficacy in the same route of administration to promote competition
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" The different routes of administration of the same generic drug in Guangdong this time are all placed under one serial number
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For example, flurbiprofen injections, sustained-release and controlled-release dosage forms and patches correspond to three different administration routes: injection, oral, and external use
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However, the bidding is based on the combined type of dosage forms that have a difference in price relationship of the same variety.
According to the published price difference rules, there is no difference in price relationship between the three dosage forms, and no bidding will occur
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　　04.
Combination of the same indications: the bidding principle is based on daily treatment costs
Guangdong even mentioned in the "Opinions of the General Office of the State Council on Promoting the Normalized and Institutionalized Development of Centralized Drug Purchases" (Guobanfa [2021] No.
2), "It is necessary to explore differences in indications or similar functions and indications.
Common name drugs are merged to carry out centralized and volume procurement", and a trial of combined bidding of different generic drugs is started, and the price is calculated based on the same principle as the average daily treatment cost (average daily treatment cost = price of the declared product specification × daily treatment volume of the declared product specification) , Such as placing flurbiprofen patch and loxoprofen patch in the same group of bids
.
The problem with the daily cost of treatment is that in the future, if the same indication is different according to the severity of the disease, the frequency of medication and the dosage each time are different, how should the prices of different products be compared? 05.
Provincial-level alliances are getting bigger and bigger and become a new "national procurement" in disguise.
From the perspective of procurement areas, more and more provinces have joined the provincial-level alliances to purchase products from the national centralized drug procurement agreement
.
This time, amoxicillin and other 45 pharmaceutical alliance regions have participated in the volume procurement of the alliance regions including Guangdong, Shanxi, Jiangxi, Henan, Hunan, Guangxi, Hainan, Guizhou, Gansu, Qinghai, Ningxia, Xinjiang, and Xinjiang Production and Construction Corps.
Compared with the last renewal of cephalexin capsules, four provinces including Shanxi, Hunan, Guizhou and Gansu have been added
.
According to this development trend, if all provinces in the country join the provincial alliance, they will become a new "national procurement" in disguise
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　　06 , "more than successful" when: Guangdong Union rules?
Whether it is the national centralized procurement or the centralized procurement of cephalexin in Guangdong Province in March 2021, a scheme has been adopted in which only one manufacturer of each generic name and category in each province has won the bid
.
In response to this, 45 pharmaceutical alliance regional groups such as amoxicillin and other regional groups have changed their procurement plans: according to the order of quotations, and the reported volume of the company, combined with a certain percentage of the annual pre-purchasing volume of the same medical insurance dosage form of the product (but the specific proportion Not yet announced) to determine the A purchase order of the reviewed product, and the rest will be included in the reviewed B purchase order
.
All non-over-assessed categories are included in the non-over-assessed B purchase order
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In addition, the qualification of the company to be selected in the A purchase order is based on the "comparable unit price" ≤ the highest effective declared price.
If there are less than 2 (including the number), it will not be eliminated; if the number is more than 3 (including the number), the "comparable unit price" will be used.
Sort from high to low, and eliminate the company with the highest "comparable unit price"
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This means that the purchase order of A may be selected by more than one but the price is undetermined
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It is also unknown whether the highest effective declared price is linked to the lowest winning bid price for centralized purchases of quantities in the country
.
The rules for determining the companies to be selected in the B purchase order are as follows: In the over-evaluated and non-over-evaluated B purchase orders, the companies in the order of "comparable unit price" are determined in order from low to high, and a certain percentage of the companies (the ratio has not yet been announced) will be obtained.
To be eligible for selection, the maximum number of shortlisted companies is 6
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In other words, a maximum of 12 B-type purchase orders can be won
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　　Talk about exclusive successful VS over bid: Where is the most appropriate scale in?
The advantage of multiple winning bids is that they can avoid the greater risk of supply interruption caused by exclusive bids
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The main difficulty for many bids is the complexity of the hospital reporting, but it is expected to solve the supply risk of the exclusive product after winning the bid, and also to ensure the unique clinical habits of medical institutions
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But in the long run, hospitals will use more and more standards of quality
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If multiple coexistences become a new trend of centralized procurement, it means that companies still have to spend the cost to promote their own products for more medical institutions to use, which in turn will flow naturally with the state’s expectations of centralized procurement, without the need for companies to promote and use them.
His will is against
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