National Procurement Enlarged Moves! 257 drugs are at risk of "substitution"

A few days ago, the National Health Insurance Administration updated the reference monitoring scope list of the first seven batches of nationally sourced alternative drugs, aiming to strengthen the monitoring of clinical dosage and price changes of alternative drugs, and ensure the priority use of selected drugs in centralized procurement and the fairness of
the online market.
According to statistics, 257 countries have included alternative drugs in selected drugs into the monitoring list; In addition, 30 alternative drugs of selected drugs are temporarily "vacant", among which pemetrexed injection, gemcitabine injection, lipoic acid injection, etc.
will exceed 1 billion yuan
in terminal sales in China's public medical institutions in 2021.
With the normalization of national procurement, the number of included varieties has surged, and measures to improve the "quantity and price" monitoring of alternative drugs have been put on the agenda
.

 

The implementation of "volume and price" monitoring, the national procurement "alternative drug list" came into being

 

With the normalization of national procurement, it is inevitable that some problems will occur when the selected drugs are implemented in hospitals, such as: overdose, underdose, over-reporting, under-reporting, and being replaced by similar varieties
.
Therefore, it is necessary
to monitor the clinical dosage and price changes of related products.

 

In April 2019, Xi'an City, Shaanxi Province issued the "Emergency Notice on the Implementation of the National 4+7 Pilot Work Monitoring Task", implementing the national 4+7 pilot work monitoring task, including the similar alternative drugs of 25 selected drugs into the key monitoring scope, and if there is a surge in consumption, it is necessary to analyze the reasons and take control measures
.

 

　　

Source: Shaanxi Provincial Pharmaceutical Equipment Centralized Procurement Platform

 

In October 2021, the Henan Provincial Medical Insurance Bureau issued the "Notice on Matters Related to the Reference Monitoring Scope of Alternative Drugs Centrally Purchased by the State and Our Province", which pointed out that when medical institutions are required to use the first five batches of state-sourced completely alternative drugs and the province's centralized procurement of standard varieties, they must explain the reasons in the medical records, and if the reasons are not explained, the medical insurance fund will not pay
.

 

　　

Source: Henan Provincial Medical Insurance Bureau

 

In order to continuously monitor the implementation of the results of centralized drug procurement organized by the state, and prevent unreasonable clinical alternative use
.
Recently, the Department of Pharmaceutical Price and Bidding and Procurement of the National Medical Insurance Bureau updated the reference monitoring scope list of the first to seventh batch of alternative drugs in the national collective procurement variety according to the feedback of the actual situation, aiming to strengthen the monitoring and analysis of drugs within the monitoring scope through the provincial drug procurement monitoring platform, and regularly publicize
the procurement of drugs within the monitoring scope of designated medical institutions in the jurisdiction.

 

257 selected drugs face the risk of "substitution", and 5 varieties of more than 1 billion are temporarily "spared"

 

In the first seven batches of national alternative drug monitoring list, the first batch has 25 varieties, the second batch has 32 varieties, the third batch has 55 varieties, the fourth batch has 45 varieties, the fifth batch has 57 varieties, the sixth batch has 15 varieties, and the seventh batch has 57 varieties, a total of 287 varieties
are included.
(Attached at the end of the article: List of the monitoring scope of alternative drugs of the first seven batches of nationally harvested varieties)

 

Among them, alternative drugs are divided into three categories
: "completely replaceable", "basically replaceable" and "replaceable to a certain extent".
Among them, 257 selected drugs have alternative monitoring drugs
.

 

Taking the fifth batch of nationally sourced varieties - oxaliplatin injection as an example, oxaliplatin mannitol injection is a basic alternative drug; Cisplatin, carboplatin, roplatin, and nidaplatin are substituted drugs
under certain conditions.

 

Oxaliplatin is the third generation of platinum anticancer drugs, with superior therapeutic effect and good safety, it is widely used in the treatment
of early/advanced colorectal cancer, gastric cancer, ovarian cancer and other malignant tumors.
According to data from Intranet, in 2021, the total sales of oxaliplatin injection and oxaliplatin for injection in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) exceeded 3 billion yuan, a year-on-year increase of 10.
49%.

 

Terminal sales trend of oxaliplatin injection and oxaliplatin for injection in public medical institutions in China (10,000 yuan)

Source: Intranet terminal competition pattern of public medical institutions in China

 

Because oxaliplatin injection can not be matched with sodium chloride injection, but can only be matched with 5% glucose injection (250~500ml), some tumor patients with diabetes are limited in the treatment of the drug, and oxaliplatin mannitol injection uses 5.
07% mannitol as a solvent, which greatly reduces the impact of chemotherapy on patients' blood sugar, and can be called the best alternative to
oxaliplatin injection.

 

Therefore, for such products that are easy to replace the drugs selected in the country, they should be used.
Volume price? Dynamic monitoring is a key measure
to prevent over-adoption and maintain the balance of the pharmaceutical market.

 

In the latest monitoring list, there are 30 varieties of irreplaceable monitoring drugs, among which pemetrexed injection, gemcitabine injection, lipoic acid injection, temozolomide oral regular-release dosage form, methylprednisolone injection, etc.
will exceed 1 billion yuan
in sales in China's public medical institutions in 2021.

 

Terminal sales of state-sourced drugs selected by national procurement in 2021 in China's public medical institutions (100 million yuan)

Note: Sales of less than 100 million yuan are expressed with *

 

Source: Intranet database

 

Although no alternative drugs have been included in the monitoring list for the above-mentioned selected drugs, it is also necessary to pay attention to daily monitoring of the clinical dosage and price changes of similar products to ensure the fairness of the priority and use of selected drugs in centralized procurement
.

 

There is no "dividend" dead end in collective procurement, and it is "too difficult" to find growth for non-selected drugs

 

At present, the state has opened eight rounds of seven batches of drug procurement, the average reduction rate of each batch has basically reached 50%, and the cumulative cost saving is close to 300 billion yuan.

 

There are views that because after the selection of state-sourced drugs at low prices, there is no cost support, the vitality of the product shrinks, and it may be replaced by similar products and steal the market
.

 

Therefore, in the eyes of the industry, the simultaneous launch of the monitoring of alternative drugs by the state is to plug this problem; At the same time, if there is a supply cut of the selected drugs, the alternative drugs can also be supplemented in time to ensure clinical supply
.
After such a set of monitoring combination punches are played, it can be more ensured that the selected drugs can be used according to the agreed amount, and the management department can also fully understand some practical problems that may be faced in use, and gradually improve the procurement plan
through timely intervention.

 

Some experts have pointed out that restricting the use of alternative drugs is mainly to ensure the priority use
of selected drugs in collective procurement.
On the one hand, it can ensure the sense of gain and fairness of the selected pharmaceutical companies in the process of participating in collective procurement, and on the other hand, by restricting the use, it can increase the willingness of pharmaceutical companies to be selected, and prevent pharmaceutical companies from opening the market
through other unreasonable and illegal channels.

 

Now, the national procurement is about to usher in the eighth batch, and the range of monitored varieties has been further expanded
.
From the monitoring of alternative drugs by relevant departments, it can be seen that both collective procurement varieties and non-collective procurement varieties are on the
chessboard with quantity procurement.

 

Previously, many agents have said that because there is no space for collective procurement varieties, sales opportunities for drugs with clinical effects will follow
.

 

However, with the introduction of policies in turn, the actual situation is not as simple as
imagined.

 

In June this year, the National Health Commission, the Ministry of Industry and Information Technology and other nine departments jointly issued the "2022 Key Points for Correcting Unhealthy Trends in the Field of Pharmaceutical Purchase and Sales and Medical Services", which clearly emphasized the need to "prevent medical institutions and medical personnel from using high-priced non-centralized procurement or centralized procurement of non-selected drugs instead of centralized procurement of selected drugs", and at the same time strengthen the management of pharmaceutical affairs in medical institutions to promote rational drug use, standardize the development of pharmaceutical services, improve the level of pharmaceutical services, and implement the policy
of giving priority to the procurement and use of selected drugs in centralized procurement.

 

　　

Source: National Health Commission official website

 

It can be seen that it is not easy for enterprises to seek performance growth from non-centralized procurement or centralized procurement of non-selected drugs instead of centralized procurement of selected drugs, especially under the monitoring of big data, the "volume and price" management of the product market will become more and more standardized
in the future.

 

The monitoring scope of the first batch of selected drugs in the national procurement

 

The monitoring scope of the second batch of national drug selection

 

The monitoring scope of the third batch of selected drugs in the national procurement

 

The monitoring scope of the fourth batch of national drug selection

 

The monitoring scope of the fifth batch of national drug selection

 

The monitoring scope of the sixth batch of national drug selection

 

The monitoring scope of the seventh batch of national drug selection

Source: Intranet database, National Health Insurance Administration, etc

 

Note: Intranet's "Terminal Competition Pattern of China's Public Medical Institutions", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of October 8, if there are any omissions, welcome to correct!