Source | Cyberblue (unauthorized reproduction is prohibited)
Written by | Color Makiyuki
01 Biological drugs, proprietary Chinese medicines or inclusion
The results of the seventh batch of national procurement have been announced, and the industry has reported the concerns of the eighth batch of national procurement from time to time.
Looking back at the seven batches of national procurement that have been carried out, the first five batches of national procurement are all chemical drugs, the sixth batch of national collection is insulin special, and the seventh batch of national procurement is back to chemical drugs. It can be seen that chemical medicine is still the main force of national procurement. Six batches of chemical drugs have been included in the national procurement of 278 drugs, and the rules are becoming more and more mature, and major pharmaceutical companies are still actively doing the consistency evaluation of drugs.
Up to now, there are nearly 70 kinds of chemical drugs that have been evaluated by 4 companies. Looking at the previous batches of chemical drugs, the number of varieties included in the competition is the fifth batch of national collection - 62 species.
Under the combination of various factors, many people in the industry believe that the eighth batch of national mining may still be dominated by chemical drugs.
Different voices also exist, "Proprietary Chinese medicines and biological medicines may also have the possibility of national procurement?" ”
At the regular briefing on the progress of the reform of the centralized procurement of drugs and high-value medical consumables held by the Information Office of the State Council, Chen Jinfu, deputy director of the State Medical Insurance Bureau, said that in the next step, the procurement of drugs and high-value medical consumables will be carried out in a normalized and institutionalized manner. It is necessary to promote the acceleration and expansion of collection and collection, and the collection and collection of drugs will be carried out in an all-round way in the three major sectors of chemical drugs, proprietary Chinese medicines and biological drugs.
However, whether it is provincial or national procurement is still uncertain.
Fu Shuyong, an associate professor at Shenyang Pharmaceutical University, told Cyberlan that biological drugs also have the possibility of being included in national procurement. At present, there are 3 varieties of biological drugs that have been evaluated in 4 companies, including bevacizumab, trastuzumab and adalimumab. The market size of these 3 biological drugs alone is already about 10 billion, and the scale of the sixth batch of national mining (insulin special) is also 10 billion yuan.
The National Medical Insurance Bureau has publicly stated that the proposals for the negotiation and procurement of biological agents and a number of successful candidates will be fully considered in the next step.
Looking at proprietary Chinese medicines, although the first seven batches of national procurement were not involved, the alliance of proprietary Chinese medicines in 19 provinces such as Hubei and 6 provinces such as Guangdong has been completed. Recently, Shandong and Beijing have begun to collect proprietary Chinese medicines. Some analysts pointed out that under the background of the increasing maturity of varieties and rules, there is a certain basis for the collection of proprietary Chinese medicines into the country.
So in the end, these three types of drugs, who is more likely to enter the next batch of national procurement?
02 The logic of three types of drugs entering the country for procurement
From the perspective of rules, the rules for the national collection of chemical drugs have been very mature. By the seventh batch of national mining, enterprises still need to meet one of the three conditions of 1.8 times the circuit breaker mechanism, a reduction of more than or equal to 50%, and a unit comparable price of less than or equal to 0.1 yuan.
On the basis of meeting these circumstances, the seventh batch of national mining also put forward new requirements, which also need to meet:
The highest order of the same variety is calculated according to the "highest order of the same variety 'unit comparable price' / the lowest order of the same variety 'unit comparable price'", and the non-top 6 are not ranked in the descending order of the ratio results of all varieties in this collection. If the calculation ratio is equal to 6th place, it is tied for 6th place.
As for the rules of the cycle and the national weight, it is more stable: the national participation allows up to 10 enterprises to be selected, and the procurement cycle of the selected varieties of 4 or more enterprises is 3 years (1 or 2, 1 year; 3, 2 years; 4 or more, 3 years), 4 or more selected to share 80% of the agreed purchase volume (1 selected 50%, 2 selected 60%, 3 selected 70%).
Then to the collection of biological drugs, in addition to the sixth batch of national mining (insulin special project), Guangdong 11 provinces alliance diclofenac and other drugs centralized procurement, growth hormone was included.
The above experts believe that in the future, the collection of biological drugs may be carried out in a special form. There are many indications for each variety of biological drugs, and if they are collected, the market size of several varieties may exceed dozens of varieties of chemical drugs.
The China Commercial Industry Research Institute predicts that the size of the mainland biological drug market will reach 831 billion yuan in 2025.
With the continuous expansion of the market scale and the increase in the indications of biological drugs, under the conditions of large clinical use and sufficient competitive pattern, national and local collection has been "the first" attempt, and then there are more possibilities for re-entering the national procurement.
The other is proprietary Chinese medicine, which is rapidly expanding in the form of local alliance collections.
A few days ago, Tianjin, Anhui, Shandong, Beijing and other places have said that they will promote the collection of proprietary Chinese medicines, while the collection of proprietary Chinese medicines in 19 provinces such as Hubei and 6 provinces such as Guangdong has been completed, and the collection of the two major proprietary Chinese medicine alliances covers most provinces and cities in the country.
Taking hubei and other 19 provinces of proprietary Chinese medicine alliance as an example, it is composed of 19 provincial-level units of Hubei, Hebei, Shanxi, Inner Mongolia, Liaoning, Fujian, Jiangxi, Henan, Hunan, Hainan, Chongqing, Sichuan, Guizhou, Tibet, Shaanxi, Gansu, Ningxia, Xinjiang and Xinjiang Production and Construction Corps, involving 17 product groups and 76 varieties.
In the end, the selection rate of the traditional Chinese medicine collection alliance in 19 provinces such as Hubei reached 62%, the average price of the selection was 42.27%, and the maximum decrease was 82.63%.
Guangdong and other 6 provinces of proprietary Chinese medicine alliance collection, Guangdong united with Shanxi, Henan, Hainan, Ningxia, Qinghai to form a procurement alliance, the collection of 53 large varieties of proprietary Chinese medicine, involving 132 product specifications; 313 companies participated, and finally 576 products and 275 companies completed the offer. From the completion rate, 87.86% of enterprises participated, and 86.88% of products generated quotations. In the end, 361 products of 174 enterprises were selected/selected, and the exclusive varieties were planned to win the bid with a small decline, with an average of about 20%; The average decline in non-exclusive winning products was 67.8%.
Combining the experience of the two major Chinese patent medicine alliances, the important exploration is the group bidding and the reduction competition, and on the whole, the decline rate is relatively mild.
The above experts said that with the experience of the 19 provinces such as Hubei and other provinces of the Chinese proprietary medicine alliance collection and the Guangdong and other 6 provinces of the proprietary Chinese medicine alliance collection experience, the national procurement of proprietary Chinese medicines is not a difficult task. However, the collection of proprietary Chinese medicines still needs to comply with the conditions of large clinical amount and sufficient competition.
03 The possibility of three types of drugs entering the country for procurement
According to the first six rounds of national procurement of chemical drugs, 3 (or more) enterprises pass the consistency evaluation, which is an important condition for chemical drugs to be included in the national procurement. According to statistics, there are more than 70 products that have been comprehensively evaluated by 4 companies, including sitagliptin phosphate tablets, alogliptin benzoate tablets, lenalidomide capsules, cefotaxime sodium for injection, etc.
As for the collection of biological drugs, special collection of insulin has been carried out at the national level before, which has accumulated certain experience for the subsequent collection of special fields. At the same time, the National Medical Insurance Bureau has also repeatedly released signals to include biosimilars in centralized procurement.
On January 29, 2021, at a press conference held by the State Council's new office, Chen Jinfu, deputy director of the National Medical Insurance Bureau, pointed out that there are differences in the quality evaluation methods of biosimilar drugs and generic drugs of chemical drugs, but it has strict quality standards, and there is no doubt that the next step will be included in the collection. For the specific collection method, Chen Jinfu said that quality must be taken as a priority consideration, and the rules must also meet market requirements.
Industry insiders said that the direction of future collection and procurement may gradually become precise, or personalized customization. Biological drugs are not like chemical drugs, and it is difficult to standardize classification for the time being. PD1, for example, has different indications for each product. In this case, if the state wants to collect and collect, it may be more feasible to customize the collection policy through personalization.
From the perspective of the competitive landscape, the domestic biosimilar market has reached sufficient competitive conditions. And from the perspective of market size, it has also had a certain scale. It can be seen that it is not impossible for the eighth batch of national procurement to include biosimilars.
As for proprietary Chinese medicines, in January this year, the National Medical Security Work Conference listed the collection and procurement of proprietary Chinese medicines as an annual key project; At the regular policy briefing held by the State Council New Office on February 11, Chen Jinfu, deputy director of the National Medical Security Bureau, introduced that on the basis of the alliance procurement that has been organized in some provinces last year, the scope of collection and collection of proprietary Chinese medicines will be further expanded in an orderly manner this year.
A number of experts told Sai Bailan that because there are already many provinces participating in the collection of proprietary Chinese medicines, the coverage is also very large, and it is difficult to say whether the follow-up is included in the national procurement - according to the previous statement of Chen Jinfu, deputy director of the National Medical Insurance Bureau, the state cannot recruit all varieties, or a large number of them are recruited through the provincial alliance.
Will more categories be included in the national collection in the future? There are two situations: one situation, such as the success of interprovincial local recruitment exploration, it is possible that other provinces will follow up in coordination, if the purpose of selecting the best is achieved, the price is reasonable and the clinical needs are met, and it is not necessary for the state to organize the collection; If the inter-provincial alliance explores, but the competition pattern is not sufficient, the variety is not very much, the total amount is not very large, on the basis of the success of the exploration mechanism, it will promote the collection of national organizations.
Due to the particularity of proprietary Chinese medicines, it is challenging to carry out the collection and collection work, and the mode of chemical drug collection cannot be copied.
First of all, it is difficult to formulate standards for the consistency evaluation of the quality of proprietary Chinese medicines.
Different from the consistency quality evaluation of chemical drugs, the quality control indicators are clear and clear, the composition of proprietary Chinese medicines is complex, and the quality of proprietary Chinese medicines is affected by many external factors, and the current quality inspection items and data are difficult to fully represent the real product quality of a proprietary Chinese medicine.
In addition, there are a large number of proprietary Chinese medicines with exclusive products.
Generally speaking, the drugs that enter the collection are non-exclusive products, which can ensure that they are fully competitive and have room for price reduction. However, due to the characteristics of Traditional Chinese medicine "Thousands of People and Thousands of Directions", the classification and naming of proprietary Chinese medicines are complex, and the formula and process become new varieties with slight changes, so there are many exclusive products.
What varieties or categories will be included in the next round of national mining? With the gradual landing of the seventh batch of national procurement, it is expected that the answer will also be revealed.
Note: All subject to official information.