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collection policy innovation, biopharmaceuticals or entry

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At present, the centralized procurement of drugs and the negotiation of the national drug catalogue have become two carriages to reduce the disease burden of patients and improve the accessibility of drugs, which play a key role in ensuring the quality and supply of drugs and meeting the basic medical and drug needs of the people. For the centralized procurement of drugs with quantity, going back to the past, it originated from the centralized bidding and procurement of drugs initiated by the state around 2000, and developed from the subsequent provincial hanging network. Centralized procurement has experienced more than 20 years of ups and downs, and its rules are constantly being introduced according to market changes and policy guidance. The variety and scope of procurement are becoming wider and wider, which has become a normalized trading method. In addition to insulin, there are more calls for biological drugs to be included in centralized procurement.



1. The 20-year ups and downs of centralized mining

In 2000, the government's rectification office led by centralized bidding and procurement.collection is to solve the problem of "difficult and expensive medical treatment" and to correct the unhealthy trend in the field of drug purchase and sale. In Hainan, Henan, Xiamen and other places, the collection of hospitals or prefecture level cities was carried out. Since there was no specific management method at that time, the exploration was only based on the bidding law. Until November 2001, the former Ministry of Health issued the "Regulations for Centralized Bidding and Procurement of Drugs in Medical Institutions (Trial)", which is well-known in the industry, Document No. 308, which became my country's first departmental regulation on the operation mode and legal responsibilities of drug collection. In the same year, the State Council's Office of Rectification and other seven departments jointly issued the "Interim Measures for the Supervision and Administration of Centralized Bidding and Procurement of Drugs in Medical Institutions", marking the formal establishment of the centralized bidding and procurement system for drugs.

in the course of practice, the shortcomings of the system gradually show, the competent departments focus on bidding rather than procurement, the enterprise won the bid in the sales link workload did not reduce, but increased the bidding work. As a result, manufacturers and a number of industry associations have jointly requested termination, so various localities have carried out tentative policy improvements and pilots. For example, in 2008, Guangdong Province medical institutions sunshine procurement, Anhui's double envelope bidding model, Hebei Tangshan online three bidding model.

The provincial centralized procurement led by the former provincial health department began in 2010.In 2010, the Ministry of Health and other seven departments jointly issued the "Regulations for Centralized Drug Procurement in Medical Institutions", which stipulated: "Implement centralized drug procurement in medical institutions led by the government and based on provinces (regions, cities). Medical institutions and pharmaceutical production and marketing enterprises must purchase and sell drugs through the non-profit drug centralized procurement platform established by the provincial (autonomous regional and municipal) governments, and implement unified organization, unified platform and unified supervision." At this point, the centralized bidding and procurement system for drugs has come to an end, and the words of bidding are no longer reflected, and online centralized drug procurement with provincial units is carried out. At the same time, the system is improved, the provinces are compared horizontally, and the lower price or the median price is selected as the benchmark price.

2019 Health Insurance Bureau-led band procurement and limit price hanging network trading model.4 plus 7 drug collection after the establishment of the National Health Insurance Bureau, was tried to throw out, and then continue to expand the category and scope, from 4 plus 7 to expand the country, so far has held 7 batches of national collection. From the beginning, the exclusive over-evaluated products were negotiated, and now only four products must be included. From a price difference of 1.8 times for the same product is a necessary condition, to a price reduction of 50% or no more than 1.8 times to meet one requirement; From the 1.8-fold fuse of the same product to the top 6 fuse of the price difference between different products, we can see that the policy is constantly improving.

In the three stages of drug collection, through centralized bidding, the drug matching transaction is centralized; through provincial online centralized transactions, the matching transaction and procurement process are centralized; and through volume procurement, the matching transaction, procurement and procurement results of drugs are centralized, and finally the supervision of the whole process of circulation is realized. The scope of collection also ranges from drugs to equipment consumables, from chemical drugs to insulin to proprietary Chinese medicines, covering more and more widely, becoming a normal trading method.



2. Use of alternative mechanisms to implement "volume-price" monitoring

can replace the drug alternative mechanism, the implementation of "price" monitoring.along with the normalization of national procurement, selected drugs in the hospital end landing implementation will inevitably have some problems, such as: drugs over-dosage, less dosage, over-reporting, under-reporting, being replaced by similar varieties and so on. For the products that replace the selected drugs in the country, the dynamic monitoring of the quantity and price is a key measure to prevent excessive adoption and maintain the balance of the drug market.

,The National Health Insurance Bureau has updated the list of reference monitoring scope for the first seven batches of national alternative drugs, with the aim of strengthening the monitoring of clinical dosage and price changes of alternative drugs, ensuring the priority use of selected drugs in centralized procurement and the fairness of the online market. The use of alternative mechanisms can, on the one hand, hedge supply risks and, on the other hand, create a new market competition mechanism.this move can be seen in the use of the health insurance bureau in the collection of the use of the link to continue to optimize the policy. According to statistics, the first seven batches of national alternative drug monitoring list included a total of 287 varieties. Among them, alternative drugs are divided into three categories: "completely alternative", "basically alternative" and "alternative to a certain extent.

257 varieties are at risk of "substitution" and 5 blockbuster drugs are temporarily "spared".list have alternative monitoring drugs. Taking the fifth batch of national varieties-oxaliplatin injection as an example, oxaliplatin mannitol injection is a basic alternative drug; while cisplatin, carboplatin, lobaplatin, etc. are alternative drugs under specific conditions.

30 varieties have no substitute for monitoring drugs. Among them, pemetrexed injection, gemcitabine injection, lipoic acid injection, temozolomide oral regular release dosage form, methylprednisolone injection, etc. in 2021 in China's public medical institutions terminal sales scale are more than 1 billion yuan. Although no alternative drugs have been included in the monitoring list, the clinical dosage and price changes of similar products should also be monitored on a daily basis to ensure the fairness of the priority network and use of selected drugs.

the growth of alternative varieties is not easy., the country has already opened bids for eight rounds of seven batches of drug procurement, with an average drop of 50% in each batch, with accumulated cost savings approaching 300 billion yuan. The centralized procurement goal of "reducing costs, making room and adjusting structure" has achieved initial results.

, due to the lack of cost support after the national drug selection, the product vitality shrinks, may be replaced by similar products and take away the market. Therefore, in the view of the industry, the national monitoring of alternative drugs is to solve this problem and give competition opportunities for alternative products. However, it is not easy to grow rapidly.

In June this year, the nine departments jointly issued the "Key Points for Correcting Unhealthy Practices in the Field of Pharmaceutical Purchase and Sale and Medical Services in 2022", which clearly stressed the need to "prevent medical institutions and medical personnel from using high-priced non-centralized drugs or centralized drugs to replace centralized drugs." It can be seen that it is also very difficult for enterprises to seek performance growth from non-centralized drugs or centralized drugs to replace centralized drugs, especially under big data monitoring, in the future, the "quantity and price" management of the product market must be more and more standardized.



3. The rules are becoming more and more perfect, biological drugs or incoming collection.

, the National Medical Insurance Administration issued a letter on the reply to the proposal No. 03703 (Medical and Health 329) of the Fifth session of the 13th National Committee of the Chinese people's political Consultative Conference. I replied to the proposal put forward by member Zhu Yilong on the introduction of a new innovative drug access evaluation mechanism. The National Health Insurance Administration stated that entering the collection is one of the important ways for innovative drugs to gain market access. However, since biological products cannot be tested for bioequivalence (BE), there will be more factors to consider than the inclusion of chemical drugs in the collection."We will continue to improve the rules of collection of biological drugs based on the existing successful experience of collection and collection, combined with the characteristics of biological drugs."now, judging from the caliber of the National Health Insurance Bureau, the promotion of centralized procurement of biopharmaceuticals may have entered the agenda.

Compared with chemical drugs, biological drugs have no consistency evaluation as a support, and the naming is complex and diverse,Therefore, the Health Insurance Bureau on the basis of chemical drug collection, further adjust and perfect the rules, fully consider the characteristics of biological drugs to carefully formulate the rules of insulin collection.specifically includes three aspects: first, medical institutions shall submit the demand according to the manufacturer's license before centralized purchase, and after the successful selection results are produced, medical institutions shall select the selected products according to certain rules and respect clinical selection; The second is to combine and group products with similar treatment purpose and clinical mechanism but different common names, taking into account the clinical use demand and full competition. The third is to fully grasp the enterprise's production capacity through thorough investigation according to the characteristics of biological drug production capacity constraints, set the agreed purchase volume not to exceed 50% of the enterprise's maximum production capacity, and reserve sufficient production preparation time when landing, and take multiple measures to ensure supply.

the National Health Insurance Bureau said,the next step, the health insurance bureau will be based on the existing collection of successful experience, combined with the characteristics of biological drugs, and constantly improve the collection rules of biological drugs.

for the follow-up of the upcoming centralized mining change, how will biomedical companies respond? For companies, centralized mining is a double-edged sword. Whether to go to the car of centralized purchase or not, whether to make profits or sales; How to deal with the incremental uncertainty brought about by the price reduction; How to go about the market strategy after the dividend gradually disappears after the collection is what enterprises need to think about.

collection is to force biopharmaceutical enterprises out of the comfort zone, from the clinical needs, to avoid fighting in the field of oversupply. Centralized procurement of winning products can only exchange volume for price to gain more market share and cash flow, and companies can take advantage of the benefits of centralized procurement to seize opportunities for transformation and innovation,from the future direction, innovation is the only way out for enterprises.