A reporter asked why the negotiations on medical insurance drugs did not directly show low prices?

Recently, "700,000-a-dose of sky-high price drugs into medical insurance" has been on the hot search and has become a hot spot of concern from all walks of life
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In order for everyone to have a more comprehensive and objective understanding and understanding of the adjustment of the medical insurance drug catalogue, the relevant responsible comrades of the Medical Management Department of the National Medical Insurance Administration accepted an interview and in-depth interpretation of the 2021 national medical insurance drug catalog entry negotiation work arrangements and related considerations
.
1.
We usually observe that every time the catalog is adjusted, the classic "soul bargaining" will be reproduced
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In addition to simple "bargaining", what specific work does the adjustment of the national medical insurance drug catalog include? The adjustment of the National Medical Insurance Drug List is a systematic work
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In 2021, the adjustment of the national medical insurance drug catalogue started in May and ended at the end of November, and it took more than half a year
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From the perspective of the process, it is mainly divided into five stages: preparation, declaration, expert review, negotiation, and announcement of results
.
The preparation stage mainly studies and drafts adjustment plans, solicits opinions from all walks of life, improves relevant norms and mechanisms, establishes a team of experts, etc.
, and makes preparations for organization and technology
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In the application stage, the main organization and guidance companies are to make declarations and submit drug-related information in accordance with the procedures, organize expert teams to review and publicize the application information, and feedback the review results to the corresponding companies to form a list of successfully declared drugs
.
The expert review stage mainly organizes experts in clinical, pharmacy, pharmacoeconomics, medical insurance management, etc.
, to evaluate the successfully declared drugs from the aspects of safety, effectiveness, economy, innovation, and fairness, and determine the catalog to be transferred and included in the negotiation List of drugs such as bargaining prices
.
The negotiation stage includes two links: First, organize experts to use pharmacoeconomics methods, consider factors such as fund affordability, and scientifically calculate and determine the negotiated base price of each drug, that is, the highest price that the medical insurance fund can afford
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The second is to organize on-site consultations between experts and enterprises to confirm the results on the spot
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The successfully negotiated drugs are included in the catalog, and the negotiation result is determined to be the national unified medical insurance payment standard
.
Drugs that are not successfully negotiated are not included in the list
.
The results of the announcement stage are mainly to sign agreements with companies that have successfully negotiated, release new versions of the catalog, etc.

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Therefore, on-site negotiation is only one link in the catalog adjustment process
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Before the "soul bargaining", medical insurance providers and enterprises must carry out a lot of preparation work, repeated demonstration, review, calculation, and communication to ensure that the negotiation work is scientific, standardized, fair, and just, and leave traces throughout the process
.
2.
Why do we need to carry out negotiations on the access to the medical insurance drug catalogue? Drug negotiation is a negotiation between the medical insurance department and pharmaceutical companies on the payment standard of the drug (the payment standard of an exclusive drug is generally equivalent to its price), and the result of the negotiation directly determines whether the drug is included in the national medical insurance drug list and at what price
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According to Article 12 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" promulgated by the National Medical Insurance Administration, the payment standard for exclusive drugs is determined through access negotiations
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The main purpose of the drug negotiation is to give full play to the role of the medical insurance department’s strategic purchase.
For the drugs included in the negotiation, negotiate with companies on the "national medical insurance usage" to achieve the goal of improving the efficiency of fund use and reducing the burden on patients.
The use is limited.
Of medical insurance funds to maximize the effectiveness of protection
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At the same time, through the value purchase and strategic purchase of the medical insurance fund, the pharmaceutical industry is guided to take the path of innovative development
.
3.
How did the negotiating reserve price come about? The negotiated base price is calculated by experts organized by the medical insurance department
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On the one hand, for drugs that are eligible for negotiation, the medical insurance department organizes relevant companies to submit calculation data according to a unified template, which mainly includes: basic drug information, relevant safety, effectiveness, and economic information, intended prices, and corresponding evidence materials
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On the other hand, the medical insurance department organizes experts such as pharmacoeconomics and medical insurance management to carry out scientific calculations from the perspectives of drug cost effectiveness, budgetary impact, and medical insurance fund burden, forming the highest price that the medical insurance fund can bear, that is, the negotiation base price, which is carried out as a negotiation expert The basis and bottom line of the negotiation
.
It needs to be emphasized that in the calculation process, experts fully refer to the pharmacoeconomics guidelines and the latest international technology and methods, and fully consider factors such as my country's medical insurance positioning and market environment.

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At the same time, in accordance with the work plan, fully face-to-face communication with relevant companies one by one, and do their utmost to improve the scientific, rational, and standardized calculations to lay a solid foundation for the smooth development of negotiations
.
4.
At the negotiation site, companies are not allowed to make offers, and experts will directly show the reserve price.
Wouldn't it be more straightforward to see if the company can accept it? According to the current negotiation rules, on-site negotiations are jointly participated by the business side and the medical insurance party, the enterprise side is negotiated by the authorized negotiating representative, and the medical insurance side is led by the negotiation team leader, and the negotiation result is determined on the spot
.
First, the company will make a quotation, and the company will have two opportunities to make a quotation and confirm it
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If the price after the second confirmation of the company is higher than 115% (exclusive) of the negotiated base price of the medical insurance party, the negotiation fails and it will be automatically terminated
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If the price after the second confirmation of the company is not higher than 115% of the base price negotiated by the medical insurance party, it will enter the negotiation link between the two parties
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The price agreed by both parties must not be higher than the negotiated base price of the medical insurance party
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During the negotiation process, the authorized representative of the enterprise can ask for instructions by telephone, etc.
, but should give clear opinions on the spot
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After the negotiation, regardless of whether an agreement is reached, the two parties will sign the result confirmation on the spot
.
The ultimate success of the negotiation depends on whether there is an intersection between the bottom line of the medical insurance party and the enterprise side
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From a practical point of view, the responsibility of the medical insurance negotiator is to use the negotiation mechanism to guide the enterprise to quote the lowest price it can accept
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In other words, negotiation experts strive to obtain more favorable prices for the common people within the range that the fund can bear and the enterprise can accept.
This is the charm and value of "soul bargaining"
.
5.
Why can individual OTC drugs be included in the medical insurance catalog? Article 36 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" stipulates that in principle, OTC drugs will no longer be added to the "Drug List"
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However, in the adjustment of the National Medical Insurance Drug List, OTC drugs that belong to the National Essential Drug List can still be included in the National Medical Insurance Drug List according to the procedures.

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Therefore, in the adjustment of the National Medical Insurance Drug List in 2020, OTC essential drugs such as "Niuhuang Qinggan Capsules" and "Racial Anisodamine Tablets" will be included in the scope of medical insurance payment; in the adjustment of the National Medical Insurance Drug List in 2021, OTC essential drugs "Clontrimazole vaginal expansion suppository" is included in the scope of medical insurance payment
.
There are two main considerations for including essential medicines (including OTC essential medicines) into the scope of medical insurance payment: one is to implement legal and policy requirements
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Article 59 of the Basic Medical Hygiene and Health Promotion Law of the People's Republic of China stipulates that essential drugs shall be included in the list of basic medical insurance drugs with priority in accordance with regulations
.
The "Opinions on Improving the National Essential Drug System" (Guobanfa [2018] No.
88) issued by the General Office of the State Council requires that for the therapeutic drugs in the essential drug list, the medical insurance department shall comply with the conditions according to the procedures when adjusting the medical insurance list.
Prioritize inclusion in the scope of the catalog
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The second is to help reduce the burden on the people participating in the insurance
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The “Opinions of the General Office of the State Council on Further Doing a Good Job in Guaranteeing Supply and Stabilizing Prices of Drugs in Shortage” (Guobanfa [2019] No.
47) stipulates that the priority allocation and rational use of essential medicines should be promoted, and the proportion of essential medicines used should be increased
.
Strengthening coordination with the essential drug system and management measures will help reduce the burden on patients and increase the level of benefit for the masses
.
6.
How to grasp the effectiveness of drugs to be included in the catalog during the adjustment process? What are your plans for the next step? In accordance with the current rules, in order to ensure the effectiveness of drugs, we mainly proceed from the following aspects: First, drugs must pass the review of the drug regulatory authority and be approved for marketing
.
Article 7 of the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" stipulates that the drugs included in the national "Drug List" should be chemical drugs, biological products, and Chinese patent drugs (ethnic drugs) that have been approved by the national drug regulatory authority and obtained a drug registration certificate
.
In recent years, the national medical insurance drug catalogue has been adjusted, mainly for drugs newly approved for marketing in recent years
.
The second is that the company must submit materials that can prove the effectiveness of the drug
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In the reporting, review, and negotiation stages, relevant companies are organized to submit data and corresponding evidence in terms of validity and other aspects as required
.
In order to ensure the authenticity of the materials, the materials submitted by the enterprises shall be publicized during the declaration process and shall be supervised by the whole society
.
The drug administration, health and health departments are requested to provide drug support materials to provide support for the review
.
The third is that the drug can pass expert review
.
According to the adjustment rules, the drugs that meet the application requirements and are successfully declared need to undergo multiple rounds of demonstrations by experts in pharmacy, clinical medicine, pharmacoeconomics, and medical insurance management
.
In the review in 2021, we researched and formulated a review index system.
Experts reviewed Western medicines and Chinese patent medicines in terms of safety, effectiveness, economy, innovation (inheritance and innovation), and fairness
.
Taking Ganlu Turner capsules as an example, the drug was included in the scope of support for the “Major New Drug Creation and National Science and Technology Special Project”
.
In 2020 and 2021, the application was successful, and both passed the expert review
.
The failure of negotiations in 2020 was not included in the catalog
.
In this year’s adjustments, after 32 experts’ review, an average score of 70.
47 was obtained, and the drug was qualified to negotiate according to the rules
.
Through negotiation, a 66.
92% price reduction was included in the catalog
.
Through negotiation of price cuts and medical insurance reimbursement, the burden of medication for patients will be significantly reduced
.
It should be pointed out that since most of the drugs currently included in the scope of adjustment are newly approved drugs, and many of them are even marketed that year, the expert review mostly relies on the data collected during the clinical trial of the drug
.
In future work, we will encourage companies to carry out real-world research on drugs, and we will rely more on real-world research data in catalog adjustments
.
7.
How is the management of medical insurance drug payment restrictions considered? What do you plan to do? In 2004, the former Ministry of Labor issued the "National Basic Medical Insurance and Work Injury Insurance Drug Catalog", which began to limit the scope of medical insurance drug payment, and it has been used today
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Objectively speaking, limiting the scope of payment for medical insurance drugs played a certain role in maintaining fund safety and preventing drug abuse under specific historical conditions
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But at the same time, the fairness and rationality of the limited payment scope have also been repeatedly questioned
.
Since the establishment of the National Medical Insurance Administration, it has actively carried out national organization of centralized drug procurement and drug catalog access negotiations, fully promoted the reform of DRG, DIP and other payment methods, strengthened the supervision of medical insurance funds, and strived to improve the level of informatization and intelligent management of medical insurance.
The whole chain of the chain has exerted efforts, and the ability and level of drug use supervision and management have been significantly improved, and the need to limit the scope of drug payment outside the instructions has been greatly reduced
.
At the same time, more and more medical staff and patients report that the limitation of medical insurance drug payment has gradually become an important factor that affects clinical rational use of drugs and even triggers medical disputes
.
Therefore, from the perspective of maintaining fairness in patient medication, improving the relationship between doctors and patients, and facilitating reasonable clinical treatment, it is necessary to gradually restore the scope of drug payment in the catalog to the scope of the drug insert approved by the drug regulatory authority, and the right to choose medication and decision-making Return it to the clinician
.
For the 94 medicines successfully negotiated during the adjustment this year, the payment range has all been consistent with the instructions
.
For other medicines with original payment restrictions in the catalog, in view of the complexity and sensitivity of payment restrictions, involving fund safety, patient benefits, and corporate interests, in order to be stable, orderly, fair and just, after research, we decided to launch a pilot medical insurance payment standard
.
During the pilot process, according to the voluntary application of the enterprise, the payment scope of the drugs included in the pilot program will be restored to the drug insert simultaneously
.
In the early stage, we organized experts to repeatedly study and demonstrate the pilot work, solicited opinions and suggestions from finance, health, and drug supervision departments, as well as local medical insurance departments, and reached an agreement
.
At the same time, we also solicited opinions and suggestions from related companies
.
Some chemical drugs and proprietary Chinese medicines, such as Glycine Diazole Sodium for Injection, Irecoxib Tablets, Arbidol Hydrochloride Tablets, Danhong Injection, and other 30 drugs have been included in the pilot scope, and the medical insurance payment standards have been re-determined in accordance with the rules.
And restore the payment scope to the drug instructions
.
During the pilot period, we plan to include all pilot drugs in the key monitoring scope, strengthen supervision, ensure the rationality of drug use, and safeguard the interests of patients and the safety of funds
.
In the next step, we will gradually restore the scope of payment for more drugs in the catalog to the drug inserts based on the progress of the pilot, under the premise of ensuring the safety of the fund and the fairness of patients' medications, and in accordance with the principle of reducing increments and digesting stocks
.