On November 26, 2021, the first special collection of insulin with doses hosted by the National Medical Insurance Bureau kicked off. The collection involves an annual demand of about 200 million insulins, involving an amount of about 17 billion yuan, which is related to the well-being of more than 10 million diabetic patients across the country, which is eye-catching.
In the end, 42 selected varieties were produced, with an average price reduction of 48% and a maximum reduction of 74%, and the collection effect was remarkable.
The significance of this special collection of insulin is not only the first national collection of insulin, but also the first time to collect the amount of biological drugs at the national level.
As we all know, after the establishment of the National Medical Insurance Bureau, it has carried out multi-party policy exploration in the collection and collection of drugs with quantity, and has achieved obvious results in the field of chemical drugs.
Now, the work of collecting with quantity has also continued to the field of biological drugs. Although due to the complexity of biopharmaceuticals, the difficulty of collection and procurement, there have been many discussions in the society, but from the perspective of this collection, the promotion of this reform is clear.
For biological drugs with strong innovation and complex technology, whether they are suitable for collection and collection, what risks will occur, and how to prevent and deal with them, it is necessary to establish a clear theoretical system and comprehensive institutional arrangements.
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The practical significance of promoting the collection of biological drugs
At present, with the expiration of many patents for original biological drugs, the number of biosimilars on the market is also increasing. According to reports, there are nearly 500 biosimilars in China, and nearly 50 are expected to be listed by 2022.
Compared with chemical drugs, the pricing of biological drugs is generally higher. Due to the complexity of production and application technology, the pharmaceutical community generally believes that biosimilars and original drugs are not exactly the same, and there will be differences in efficacy and safety.
However, if each biosimilar is considered an exclusive product, its price will remain high, placing a heavy financial burden on patients and health insurance.
At present, domestic pharmaceutical companies such as Haizheng, Cinda, Fuhong Henlin, etc. have biosimilar products, imitating well-known original drugs such as Meiluohua, Herceptin, and Humira, etc., and their prices are not significantly different from the original research products, and an obvious "patent cliff" has not yet been formed.
In this sense, based on the experience of chemical drug collection, it is of practical significance to promote the collection of biological drugs with quantity to promote market competition and price return.
Two major obstacles: efficacy and productivity
The essence of drug collection is to put the clinically replaceable drugs together, and the low price wins the market, so as to prompt the manufacturer to quote the low price as much as possible to achieve the value pursuit of the buyer.
It can be seen that the key to the implementation of the collection with volume is that the drugs bid in the same group must be clinically replaceable. That is to say, the winning product should be able to replace the unsolicited product for clinical use.
It is understandable that if the drugs that are collected and bid for cannot be replaced by each other, then the winning drugs will not fully meet the clinical needs and will form an obstacle to medical work.
At the same time, if drugs of different quality can be bid in the same group, low-quality products are likely to eliminate high-quality products at low prices, forming a "bad currency elimination of good money", and eventually those who survive on the market will be low-quality drugs.
Due to the high technical content and complex process of biological drugs, it is increasingly important to ensure clinical substitution in the collection of biological drugs. Many experts have pointed out that due to the complexity of biopharmaceuticals, biosimilars often cannot fully reproduce the manufacturing process of the original drug, and there may ultimately be differences in efficacy and safety.
This concern is the main obstacle to the collection of biological drugs, and it is also the confidence of the pharmaceutical industry to invest in the research and development of biological drugs and set a higher market price. Obviously, if this difficulty cannot be overcome, it is difficult for the collection of biological drugs to be smoothly promoted.
Another important factor in the collection of drugs is the capacity supply of the winning drugs.
The core concept of volume collection is "volume for price", where buyers offer huge future sales in exchange for the lowest possible offer from manufacturers.
There may be a contradiction in this: the lower the offer, the easier it is to win the bid, and the greater the cost pressure of the manufacturer, the higher the supply that needs to be completed, and the greater the risk of supply difficulties.
In the biopharmaceutical field, due to the complexity of the process, the pressure on its production capacity and supply will be greater than that of chemical drugs, and the risk will be more obvious.
Therefore, the capacity problem will also be one of the factors hindering the collection of biological drugs.
Proven experience is being reused
Of course, although there are some difficulties and risks in the collection of biological drugs, relevant policy considerations and institutional design have also been advancing.
First of all, there has been policy progress on the issue of the fungibility of collective bidding drugs.
As we all know, the "consistency evaluation" method is used in the collection of chemical drugs with quantities, that is, bioequivalence studies are carried out in chemical generic drugs and reference preparations, which proves that equivalence can be qualified for collection.
Because biosimilars are difficult to conduct such evaluation studies, it is considered difficult to cross this barrier. However, in reality, the consistency evaluation is mainly applied to the national collection level of chemical drugs, and it often exceeds this scope in the local collection pilots, and is the collection of unappraised drugs.
In the pilot projects in various places, a variety of technical means such as expert review, quality scoring, and comprehensive evaluation are used to set the shortlisting criteria for collected drugs, and the promotion of collective procurement has also been achieved. This shows that the collection of quantities does not necessarily have to follow a strict "consistency evaluation", and other evaluation tools can also be used in due course.
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 the Evaluation of Similarity of Biosimilar Drugs and Extrapolation of Indications (Draft for Comment)" in early 2021, in which the concept of similarity evaluation of biological drugs is proposed, that is, based on evidence from pharmaceutical research, non-clinical research, clinical comparison studies and other aspects, to conduct a comprehensive evaluation of biological drugs, so as to determine the overall similarity of biosimilars and original research (reference) drugs.
The publication of this document lays the foundation for the alternative evaluation of biosimilars and further collection of bands.
In the future, based on the comprehensive evaluation of experts to prove that there are similar biological drugs and biosimilars, they can replace each other clinically, and the work of collecting with quantity can be carried out smoothly.
Based on the experience of chemical drug collection, in addition to consistency (or similarity evaluation), the management department of the winning drug will also strictly supervise its production, storage, use and other aspects to ensure the quality and safety of drugs, and the adverse drug reaction monitoring platform will also closely monitor the adverse reactions related to the collection of drugs, and the problems will be warned in time. These management measures can also be applied to the collection of biological drugs with quantity to ensure the quality and reliability of the collection of drugs and the safety of medication.
For the production capacity supply of biological drugs, there are also policy ideas to learn from in the work of collecting and collecting with quantity.
In the collection of chemical drugs and medical consumables, the managers have clear provisions on the qualifications of the shortlisted products, especially in the pilot collection of medical consumables (coronary stents), mature products and manufacturers with large sales volume on the market are selected.
For the collection of biopharmaceuticals, it is expected that there will also be a comprehensive consideration of the qualifications and supply capabilities of the shortlisted products and manufacturers to ensure the continuous supply after winning the bid.
On the other hand, the winning bidder needs to sign a strict supply contract with the management department in order to obtain the qualification for winning the bid. The contract will make it clear that the winning bidder must supply in quality and quantity, otherwise it will be punished based on the agreed terms. This also standardizes that manufacturers must do what they can to collect and bid, and must ensure supply after winning the bid.
These contractual constraints are also expected to be applied to the collection of biological drug belts to ensure the guaranteed supply of the winning products.
Consider the feasibility of separate collection measures
In this special collection of insulin, because the policy design is more pragmatic and takes into account the benign development of the industry, the participation of relevant pharmaceutical manufacturers is more active.
Domestic brands and joint venture brands are actively involved in and quoted, so that the purchase price of insulin, which has been relatively firm, has dropped significantly, and it is reported that the price of insulin products of some foreign-funded enterprises has ranked at the lowest level in the world, which fully reflects the attractiveness of the "volume price linkage" policy.
At the same time, due to the use of factory reporting, basic volume and allocation of the same method, so that most of the bidding manufacturers can obtain a certain market share, both the market pattern and a certain continuity, but also reduce the cost and risk of brand conversion of medical institutions. This also ensures the diversification and equalization of China's insulin market to a certain extent and the long-term benign development of the industry.
Of course, due to the complexity of biological drugs, their collection and collection work also needs to have a more flexible and pragmatic policy design. Although we say that the core of the theory of collection is "the same group of bidding for homogeneous and replaceable products", some experts believe that there are always differences between different brands and manufacturers' products, and simple bidding is not appropriate, so they put forward the policy idea of "one product and one policy".
Due to the large variety of drugs, the cost of developing a separate method for each product is too high, but it is possible to consider a specific procurement method for some specific products.
For biological drugs, if some varieties are more specific and their biosimilars are insufficiently replaceable, they may also be considered for separate negotiation and pricing, and separate collection measures may be formulated.
In this way, while carrying out collection, we can more effectively avoid risks and protect the interests of patients and clinical drug needs.
In short, with the advancement of chemical drug collection, the collection of biological drugs with quantity will also be gradually carried out. Although there are certain risks and obstacles to the collection of biological drugs due to their complexity, it is necessary to promote this work in order to use the medical insurance fund more effectively and achieve valuable purchases.
At present, the field of biological drugs has established the idea of similarity evaluation, and there are previous experiences in the collection of chemical drugs and medical consumables with quantity for reference, and I believe that the collection of biological drugs with quantity will also establish a suitable system system to carry out smoothly.
Written by | Tao Libo (Peking University School of Medicine)
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