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A few days ago, the results of the 16 provincial alliance drug collection and procurement after 2 months were finally released, a total of 11 unevaluated varieties (28 drugs) were to be selected, involving 26 manufacturers, including the antispasmodic drug papaverine hydrochloride injection exclusively selected by Beite Pharmaceutical, the clinical commonly used hemostatic agent for calosesulfonate sodium injection of Shandong Luoxin Pharmaceutical and Beite Pharmaceutical, and the star single product of troposetron hydrochloride injection in the field of anti-vomiting of Hangzhou Minsheng Pharmaceutical
.
According to data from Minai.
com, the total sales scale of the terminals of 11 selected varieties in public hospitals in 16 provinces in 2021 exceeded 1 billion yuan
.
As a major supplement to national procurement, provincial procurement/provincial joint mining has accelerated its war to unevaluated, non-medical, exclusive and other varieties
.
The scope of centralized procurement has been expanded, and the "two-envelope" model has evolved again
In October 2022, the Jiangxi Provincial Medical Insurance Bureau organized and drafted a new round of consultation draft of the alliance collective procurement, which took two months after ups and downs and several changes, and finally the proposed selection results of this collective procurement were officially released
in December 2022 。
Source: Jiangxi Provincial Medical Insurance Bureau official website
Looking back at this collective procurement, the scope of collective procurement has been changed accordingly: (1) In the initial draft for comments, only 15 provinces formed an alliance to carry out a new round of collective procurement, and with the addition of Chongqing, the 15 provinces alliance collective procurement became a 16-province alliance collective procurement, including Jiangxi, Inner Mongolia, Jilin, Heilongjiang, Zhejiang, Henan, Hunan, Guangxi, Hainan, Chongqing, Guizhou, Shaanxi, Qinghai, Ningxia, Xinjiang and the Xinjiang Production and Construction Corps (hereinafter collectively referred to as "16 provinces").
(2) Since the product scope of this collective procurement is in principle unevaluated drugs, the two varieties of ambrobuterol oral liquid and lactulose oral solution have passed the consistency evaluation and are no longer included in this collective procurement
after verifying the registration certificate submitted by the enterprise.
In addition, the "double envelope" model has evolved again, and the scoring rules are more scientific
.
The 16 provincial alliances used the "double envelope" model for comprehensive evaluation, including economic and technical standard scores and business standard scores
.
Economic and technical standards focus on product quality, supply security, etc.
, with scores accounting for 60%, and commercial standards focusing on price reduction accounting for 40%.
In other words, this collective procurement not only requires enterprises to reduce prices, but also puts forward requirements
in drug quality and product supply.
The economic and technical standard is based on the drug name and the combined dosage form of medical insurance as the bidding group, and the highest economic and technical standard score of the product of each applicant enterprise is evaluated
.
Ranked from high to low, shortlisted for business standards and comprehensive judging according to the following proportions:
Economic and technical standard shortlisted ratio table
Source: Jiangxi Provincial Medical Insurance Bureau, compiled by Minai.
com
The score of economic and technical standards is roughly divided into the following parts: (1) quality indicators (70 points): distinguish the quality level, divided into 6 aspects such as original research, evaluation, European, American and Japanese listing, the score is not cumulative, and the highest score shall prevail; (2) Supply security index (12 points): Assign points according to the distribution rate index; (3) Comprehensive indicators (18 points): including several indicators such as untrustworthy recruitment records, national procurement selection, market share, coverage of medical institutions, industry rankings, etc.
, with different
scores.
It can be seen that for the collective procurement of unevaluated varieties, it is more fair
to distinguish the quality level and score it.
In addition, the full score of the business standard is 100 points, of which the quotation decrease accounts for 50 points, and the absolute value of the quotation accounts for 50 points, reflecting the hedging mechanism of the price score, which is more compatible
.
Commercial score is calculated as follows:
Business Score Table
Source: Jiangxi Provincial Medical Insurance Bureau, compiled by Minai.
com
Comprehensive evaluation score = economic and technical standard score× 60% + commercial standard score× 40%.
For the varieties selected by one enterprise, 50% of the agreed purchase volume base in the first year shall be taken as the agreed purchase volume in the first year; For the varieties selected by the two enterprises, 75% of the agreed purchase volume base in the first year is taken as the agreed purchase volume in the first year, of which 50% is used as the agreed purchase volume in the first year of the lowest price winning enterprise, and 25% is used as the agreed purchase volume
in the first year of the highest scoring selected enterprise.
On the whole, the scoring rules and selection requirements of the 16-province alliance are relatively mild and reflect humanity
.
More than 1 billion market reshuffle, Beite, Corun, Luo Xin.
.
.
The harvest was huge
A total of 13 unevaluated varieties were included in the collection and procurement of 16 provinces, including 2 varieties of vitamin D oral liquid agent and pancreatic kallikrein oral regular-release agent
, which were rejected due to less than 3 bidding enterprises.
From the perspective of treatment categories, the varieties to be selected are mainly digestive system and metabolic drugs, blood and hematopoietic system drugs, each occupying 3 or more seats
.
16 provincial alliances collect and collect the selected varieties
Source: Jiangxi Provincial Medical Insurance Bureau, compiled by Minai.
com
According to the rules of proposed selection, if the lowest quotation and the highest score are the same enterprise, only one enterprise will be selected; At the same time, enterprises with the second lowest quotation and the second lowest score are used as alternative enterprises to reduce the probability of supply interruption of selected drugs and set up "double insurance"
for supply.
Among the 11 varieties to be selected, Beite Pharmaceutical (Papaverine Hydrochloride Injection), Hangzhou Minsheng Pharmaceutical (Troposetron Hydrochloride Injection), Haisco Pharmaceutical (Compound Vitamin for Injection (3)), Shengtai Biopharmaceutical (Bone Peptide Injection), Kelun Pharmaceutical (Fructose Injection), Sinopharm Yixin Pharmaceutical (Adenosine Monophosphate for Injection), Shanxi Zhendong Taisheng Pharmaceutical (Oxacillin Sodium for Injection) are also the enterprises with the lowest quotation and the highest score, and will exclusively take the entire purchase volume
of the corresponding varieties 。
Papaverine injection belongs to the kidney, biliary or gastrointestinal and other visceral spasm treatment drugs, widely used in neurosurgery, vascular surgery, trauma orthopedics, urology and other clinical departments, is the "cerebral vasospasm prevention and treatment of neurosurgery expert consensus", "China ischemic cerebrovascular disease endovascular intervention diagnosis and treatment guidelines" and other authoritative guidelines recommended varieties
.
According to data from Minai.
com, the terminal sales of the drug in public hospitals in the above 16 provinces in 2021 exceeded 260 million yuan, a year-on-year increase of 62.
99%; In terms of market share, Northeast Pharmaceutical and Huatai Pharmaceutical are equally divided, each accounting for nearly 40%.
Beite Pharmaceutical was selected exclusively in this collective procurement, which is expected to further increase its market share
.
In 2021, the brand pattern of terminal papaverine injection in public hospitals in 16 provinces
Source: Competition pattern of drug terminals in public hospitals in key provinces and cities of Minai.
com
Caloxane sodium injection is a hemostatic drug, commonly used in urinary system, upper gastrointestinal, respiratory tract and obstetrics and gynecology bleeding diseases, has a significant effect on the urinary system, and can also be used for the prevention and treatment of surgical bleeding
.
According to the data of Minai.
com, there are currently 40 enterprises approved to produce sodium carrosulfonate for injection, and the 16 provincial alliances have 2 enterprises such as Shandong Luoxin Pharmaceutical and Beite Pharmaceutical to be selected with the qualifications with the lowest quotation and the highest score, and the competition is fierce.
What the subsequent product market trend will be still to be verified by time
.
Approval of sodium carrosulfonate for injection
Source: Minai.
com China Listed Drugs (MID) database
Tropasetron injection belongs to antiemetics and anti-nausea drugs, and is a national medical insurance class B drug (2021 version).
According to data from Minai.
com, the drug will have terminal sales of more than 90 million yuan in public hospitals in 16 provinces in 2021, and rank among the top 2
antiemetics and anti-nausea drugs with a market share of 22.
84%.
It is reported that toxitron injection has previously appeared in joint mining in 11 provinces such as Shaanxi, and joint mining in 16 provinces such as Hunan and Guangxi, which shows that its product status cannot be
underestimated.
In 2021, 16 provincial public hospitals terminal antiemetics and anti-nausea drugs TOP9
Source: Competition pattern of drug terminals in public hospitals in key provinces and cities of Minai.
com
According to data from Minai.
com, in the terminals of public hospitals in key provinces and cities, the total sales scale of the above 16 provinces in 2020 and 2021 will be more than
60 billion yuan.
This alliance collected a total of 11 drugs to be selected, and the total sales scale of public hospitals in 16 provinces in 2021 exceeded 1 billion yuan
.
Terminal sales scale of public hospitals in 16 provinces (: 100 million yuan)
Source: Competition pattern of drug terminals in public hospitals in key provinces and cities of Minai.
com
Accelerated the expansion of centralized procurement with volume, and "none of the varieties that have been evaluated are spared"
Accelerating the expansion of centralized procurement has become the general trend, and a number of official documents have clearly stated that it is necessary to promote the pilot procurement of unevaluated drugs and high-value medical consumables procurement in various places, and improve the linkage mechanism
between medical insurance payment and bidding procurement prices.
Provincial procurement/provincial joint procurement clarifies that for some drugs with large procurement amounts, sufficient competition, mature clinical use, and no generic drugs with the same generic name have passed the consistency evaluation, the provincial (municipal) medical insurance bureau, health commission, and drug administration will jointly organize experts to select and carry out centralized procurement
。 For example, in August 2021, the Gansu Provincial Public Resources Trading Center issued the "Notice on the Proposed Selection Results of the Ganxi-Shaanxi Alliance for the Centralized Procurement of Drugs in 2021", and 40 unevaluated varieties such as isosorbide mononitrate injection, mezlocillin sodium for injection, and thiopronin injection were among them, among which amoxicillin clavulanate potassium for injection was removed
from the batch of centralized procurement list because some enterprises passed the consistency evaluation at that time 。
Source: Gansu Provincial Public Resources Trading Center
In addition, in December 2022, the Jiangsu Provincial Medical Insurance Bureau announced the "Results of the Third Round of Centralized Drug Procurement in Jiangsu Province", which included flurbiprofen gel patch, leuprolide acetate sustained-release microspheres for injection, oxaliplatin mannitol injection and other 43 unevaluated varieties
.
It is worth noting that this collective procurement will no longer conduct quality group bidding for products, and after the bidding of non-exclusive varieties, a new round of bidding will be added, and all enterprises of the same variety will be re-quoted as a group, and the product competition is obviously becoming more and more fierce
.
Source: Jiangsu Provincial Medical Insurance Bureau with volume centralized procurement as a breakthrough in medical reform, the follow-up will become a norm, in addition to the national level responsible for the evaluation of chemical drug centralized procurement, other varieties of local pilot centralized procurement or become the mainstream
.
The leaders of the Medical Insurance Bureau have repeatedly proposed in the relevant interpretation meetings and interpretation documents of the national procurement: "The national procurement is mainly for the drugs that have been evaluated, and the provincial procurement/provincial joint procurement is a supplement to the national procurement, mainly for the drugs that have not been evaluated"
.
After 2023, eligible varieties may usher in "exhaustion"
.
In the context of the acceleration of centralized procurement expansion, the logic of consistency evaluation will also change, whether to do the evaluation application has become an important part of the strategic planning of the enterprise, the evaluated products have the opportunity to enter the country to share a larger market share, the unevaluated products will have the challenge of provincial procurement/provincial joint procurement, price linkage and the risk of
product approval being cancelled 。
epilogue
In general, provincial procurement/provincial joint mining is more like a supplement to national procurement, and the "baton" of market resource redistribution; The implementation and promotion of provincial procurement/provincial joint procurement reflects the guiding principle
of "adhering to volume procurement, ensuring quality, promoting innovation-driven, stable supply, ensuring clinical use, and setting bidding rules for specific varieties and competitive patterns" proposed by the state 。
Source: Minainet database, official website of provincial medical insurance bureaus, etc.
Note: The competition pattern database of chemical drug terminals of public hospitals in key provinces and cities of Minainet is based on the chemical drug procurement data of 20+ provinces and cities and nearly 700 sample provinces and cities public hospitals, and continuously monitors the sample provinces and cities of all categories of chemical drugs; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of December 30, if there are any omissions, welcome to correct!
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