Centralized procurement of biopharmaceuticals is imperative, two major difficulties VS five major countermeasures

After the establishment of the National Medical Insurance Bureau, it has carried out multi-party policy exploration in the centralized procurement of drugs, and has achieved obvious results in the field of chemical drugs

Biopharmaceuticals are the mainstream direction of the pharmaceutical industry in the future

status quo

Patients and medical insurance have a heavy financial burden

At present, with the expiration of patents of many original research biologic drugs, the number of biosimilar drugs on the market is also increasing

Compared with chemical drugs, biological drugs are generally priced higher

However, if each biosimilar drug is regarded as an exclusive product, its price will remain high, which will impose a heavy economic burden on patients and medical insurance

"Patent cliff" is not obvious

At present, domestic pharmaceutical companies such as Hisun, Cinda, Fuhong Henlius, etc.

In this sense, based on the experience of centralized procurement of chemical drugs, it is of practical significance to promote the centralized procurement of biological drugs in order to promote market competition and price return

difficulty

Clinical substitutability: the main obstacle to centralized procurement

The essence of centralized procurement of drugs is to put clinically replaceable drugs together for bidding, and the lower price wins the market, thereby prompting manufacturers to quote as low prices as possible in order to realize the value pursuit of buyers

It is understandable that if the centralized procurement and competitive bidding of drugs cannot be substituted for each other, the winning bidders will not be able to fully meet the clinical needs, which will hinder medical work

Due to the high technical content and complex process of biological drugs, it is more and more important to ensure clinical substitutability in the centralized collection of biological drugs

Supply problem: Biological medicine is more pressured than chemical medicine

Another important factor in the centralized procurement of pharmaceuticals is the production capacity and supply of the bid-winning pharmaceuticals

In the field of biological medicine, due to the complexity of the process, the pressure on its production capacity and supply will be greater than that of chemical medicine, and the risks will be more obvious

Countermeasure

Of course, although there are some difficulties and risks in the centralized procurement of biopharmaceuticals, relevant policy considerations and system design have also been advancing

[Countermeasure 1] Comprehensive evaluation of the similarity of biological drugs

First of all, there has been policy progress regarding the substitutability of centralized procurement and bidding drugs

However, in reality, consistency evaluation is mainly applied to the national centralized procurement level of chemical drugs.

In order to promote the research and development, procurement and prescription of biological drugs, the Drug Evaluation Center of the State Food and Drug Administration issued the "Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilar Drugs (Draft for Solicitation of Comments)" in early 2021.

The issuance of this document has laid the foundation for the alternative evaluation of biosimilar drugs and further centralized procurement with quantities
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In the future, based on the comprehensive evaluation of experts, biological drugs and biological analogues that have similarity can be replaced in the clinic, and the centralized collection work can be carried out smoothly
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[Countermeasure 2] Strict supervision of production, storage and use

Based on the experience of centralized procurement of chemical drugs, in addition to consistency (or similarity evaluation), the management department will also strictly supervise the production, storage, and use of the drugs that are selected for the centralized procurement to ensure the quality and safety of drugs; The reaction monitoring platform will also closely monitor the adverse reactions related to centralized procurement of drugs, and prompt early warnings when problems are found
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These management measures can also be applied to the centralized procurement of biological drugs to ensure the quality and reliability of centralized procurement of drugs and the safety of medication
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[Countermeasure 3] Specify the qualifications of shortlisted products and manufacturers

Regarding the production capacity and supply of biological drugs, there are also policy ideas that can be used for reference in the work of centralized procurement
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In the centralized procurement of chemical drugs and medical consumables, the managers have clear regulations on the qualifications of the shortlisted products.
In particular, the pilot centralized procurement of medical consumables (coronary stents) has selected mature products and products with a large sales volume on the market.
Vendor
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Therefore, for the centralized procurement of biological drugs, it is expected that the qualifications and supply capabilities of the shortlisted products and manufacturers will also be comprehensively considered to ensure continuous supply after winning the bid
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[Action 4] Sign strict supply contracts with manufacturers

On the other hand, the bid-winning manufacturer of centralized procurement needs to sign a strict supply contract with the management department to obtain the bid-winning qualification
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The contract will specify that the winning bidder must provide quality and quantity, otherwise it will be punished based on the agreed terms
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This also regulates that manufacturers must conduct centralized procurement bidding according to their ability, and supply must be guaranteed after winning the bid
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These contractual restraint measures are also expected to be applied to the centralized procurement of biological drugs to ensure the guaranteed supply of the bid-winning products
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[Countermeasure 5] Specific procurement methods for certain products

Taking into account the complexity of biological drugs, the centralized procurement of biopharmaceuticals also requires flexible policy design
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Although the core theory of centralized procurement is "same group bidding for homogenized alternative products", some experts believe that there are always differences in products of different brands and manufacturers, and bidding alone is not appropriate.
Therefore, a policy of "one product, one policy" is proposed.
Ideas
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Due to the large variety of drugs, the cost of formulating a separate method for each product is too high, but specific procurement methods for certain specific products can be considered
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For biological drugs, if certain varieties are highly specific and their biosimilar drugs are not sufficiently substitutable, they can also be considered for separate negotiation and pricing, and separate centralized procurement measures can be formulated
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In this way, it is possible to more effectively avoid risks and protect the interests of patients and the needs of clinical medication while carrying out centralized procurement
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Conclusion <<<  

With the advancement of the centralized procurement of chemical drugs, the centralized procurement of biological drugs will also be gradually carried out
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Although due to the complexity of biopharmaceuticals, there are certain risks and obstacles to the centralized procurement of biopharmaceuticals.
However, in order to use medical insurance funds more effectively and realize valuable purchases, it is necessary to advance this work
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At present, the similarity evaluation method has been established in the field of biological medicine, and there is past experience in the centralized procurement of chemical drugs and medical consumables for reference.
It is believed that the centralized procurement of biological drugs will also establish an appropriate institutional system and achieve success.
Unfold
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