Interpretation of Ministry of Human Resources and Social Security's notice policy on printing and distributing the national basic medical insurance, industrial injury insurance and maternity insurance drug list.
In order to let all sectors of society know more about the adjustment of the national medical insurance drug list in 2020, the National Medical Insurance Bureau interpreted the Notice on Printing and Distributing the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List in 2020.
1.What is the general idea and goal of adjusting the national medical insurance drug list in 2020?
In order to implement the decision-making arrangements of the CPC Central Committee and the State Council, according to the relevant provisions of the Interim Measures for the Administration of Medication in Basic Medical Insurance, the National Medical Insurance Bureau, together with relevant departments, earnestly carried out the adjustment of the national medical insurance drug list in 2020. This adjustment has always adhered to the functional orientation of "ensuring basics", and established the adjustment idea of "highlighting key points, filling shortcomings, optimizing structure and encouraging innovation" in accordance with the requirements of "doing your best and doing what you can", giving full play to institutional advantages, policy advantages and market advantages, releasing reform dividends, and striving to achieve the goals of more optimized drug list structure, more efficient use of medical insurance funds and higher level of basic medical insurance drug support.
After this catalogue adjustment, 1 19 drugs were transferred into the catalogue, and 29 drugs were transferred out of the catalogue. Finally, there are 2800 kinds of drugs in the catalogue, including western medicine 1426 kinds and Chinese patent medicine 1374 kinds, and the proportion of Chinese and western medicine is basically the same.
Second, how to ensure the functional orientation of "guaranteeing the basics" in this adjustment?
For drugs out of the catalogue, in terms of the evaluation, calculation and determination of the payment scope of medical insurance fund, we should comprehensively consider the current level of China's economic and social development, the affordability of medical insurance fund and insured personnel, and formulate technical standards that meet the "basic" positioning to ensure that the payment standards formed through negotiations meet expectations. For the drugs in the catalogue, experts will be specially organized to review, and the varieties that have entered the catalogue without negotiation and have high prices or fees will be negotiated to reduce prices, so as to guide the drug payment standards in the catalogue to gradually return to rationality. At the same time, through measures such as drug dispensing with low clinical value, especially the centralized procurement of "exchanging quantity for price" in recent years, the water content of drug prices has been further squeezed, the "cage for bird" has been realized, and the safety of the fund has been ensured.
Three. What changes have been made in the scope and quantity of off-balance-sheet drugs included in this adjustment? What are your considerations?
Different from the previous rounds of adjustment, which included "all listed drugs" in the evaluation scope, the declaration system was implemented for the first time this year, that is, all drugs outside the catalogue that meet the conditions listed in this year's adjustment plan can be included in the adjustment scope. The adjustment range of drugs out of the catalogue changed from "sea election" to "optimization".
According to the "Work Plan for the Adjustment of the National Medical Insurance Drug List in 2020", there are seven main categories of off-list drugs adjusted this year: drugs for the treatment of respiratory diseases related to COVID-19; Drugs listed in the national list of essential drugs; Being listed by the relevant departments in the catalogue of urgently needed overseas new drugs, the catalogue of encouraged generic drugs, or the catalogue of encouraged drug research and development to declare children's drugs; Drugs that have won the bid are included in the national centralized procurement scope; Drugs approved for marketing after 20 15 1 10, and drugs with significant changes in indications and functional indications after 201510/0. At the same time, considering the continuity of the use of the original supplementary drugs in various provinces, the "drugs included in the list of five or more provincial-level medical insurance drugs" will also be included in the adjustment scope. According to the declaration conditions, 704 kinds of drugs outside the catalogue were successfully declared.
The main considerations for setting application conditions are: First, to better meet clinical needs. For example, drugs used for treatment in COVID-19, drugs urgently needed or encouraged to be copied in clinic, national essential drugs, drugs purchased centrally, etc. The second is to better connect with the approval of new drugs, realize the "seamless connection" between drug approval and medical insurance review, and reflect the orientation of encouraging the creation of new drugs. For example, newly listed drugs, newly approved drugs with modified functions or indications. The third is to take care of the continuity of clinical medication. For example, drugs included in the list of five or more provincial-level medical insurance drugs are also included in the adjustment scope.
4. What is the success rate of the national medical insurance drug list adjustment negotiation? What about the number, types, treatment fields and price reduction of drugs successfully negotiated?
Compared with previous years, an important feature of this adjustment is that the number of drugs transferred through negotiation at reduced prices is the largest, benefiting the most extensive treatment fields.
We negotiated 162 drugs and 1 19 drugs successfully, with a success rate of 73.46% and an average price reduction of 50.64%. This catalogue adjustment * * * newly introduced 1 19 drugs. These drugs * * * involved 3 1 clinical group, accounting for 86% of all clinical groups. Patients will benefit from a wide range and have a stronger sense of acquisition.
5. There are 29 kinds of drugs transferred from the list. Under what circumstances will drugs be transferred, and will it affect the medication of patients with related diseases?
After expert review, 29 kinds of drugs were transferred out of the list, mainly because their clinical value is not high and they can be replaced, or they have been revoked by the drug supervision department and become "zombie drugs" and other varieties. The transfer of these drugs has been repeatedly demonstrated by experts and determined in strict accordance with procedures. In the evaluation process, experts regard substitutability as an important indicator, and there are drugs with equivalent or better efficacy in the list of drugs that have been transferred. At the same time, the transfer of these drugs has made room for more new drugs and good drugs to be included in the catalogue.
6. We have noticed that some "old varieties" that have been in the catalogue for a long time have been included in the negotiation scope. What are your considerations?
Article 10 of the Interim Measures for the Administration of Medication in Basic Medical Insurance clearly stipulates that "drugs with high price or cost in the same treatment field without reasonable reason" and "drugs with uncertain clinical value and good substitution" can be transferred out of the drug list after expert review and other prescribed procedures. In this year's adjustment process, after repeated argumentation and strict evaluation, the evaluation experts included 14 drugs in the catalogue in the negotiation scope according to the above requirements. If the negotiation is successful, they will be kept in the directory, otherwise they will be transferred out of the directory. These 14 drugs are all drugs that were not negotiated when they entered the catalogue in the early stage, and their prices or expenses are obviously high after evaluation. After negotiation, 14 drugs were successfully negotiated and kept in the catalogue, with an average price reduction of 43.46%.
There are three main considerations for bringing the so-called "old varieties" that have not been negotiated in the catalogue into the negotiations. The first is to improve the economy of drugs. Drugs also have a life cycle, and the payment standard of drugs should be adjusted accordingly due to changes in the market competition environment and other factors. From the actual situation, after some drugs entered the catalogue, the payment standard was not adjusted for a long time, or the adjustment was not in place, and the economy declined significantly. Negotiation is an important means to improve the economy. The second is to improve fairness. Through the introduction of negotiation mechanism, some drugs newly listed in the catalogue in recent years have higher cost performance, and their prices are "upside down" compared with the "old varieties" in the original catalogue. In order to maintain the fairness of the use of medical insurance funds and the rights and interests of patients, the market mechanism is used to negotiate the "old varieties" and guide their payment standards to return to rationality. The third is to reduce the burden on patients and save fund expenditure. Practice has proved that through the negotiation of "old varieties", the burden on patients can be effectively reduced and the use efficiency of medical insurance funds can be improved.
In the future adjustment, we will also organize experts to review and negotiate with qualified "old varieties" to improve the economy of drugs in the catalogue.
7. After this year's adjustment, what changes have taken place in the protection of anticancer drugs?
The State Council of the CPC Central Committee attaches great importance to the protection of anticancer drugs. In 20 18, our bureau organized special access negotiations for anticancer drugs at the beginning of its establishment, and finally 17 drugs were successfully listed in the catalogue, and the agreement expired at the end of this year. 17 class of anticancer drugs, three drugs are classified as generic drugs and included in Class B management. 14 exclusive drugs were renewed or renegotiated according to the rules, with an average decrease of 14.95%, among which some first-line anticancer drugs decreased by more than 60%. It is estimated that reducing the price of 14 kinds of anticancer drugs will save more than 3 billion yuan for cancer patients in 20021year. At the same time, this adjustment also added 17 kinds of anticancer drugs, including new and good drugs such as PD- 1 and Ranvartinib, which significantly improved the level of cancer drug protection in the catalogue.
8. What is the impact of this medical insurance drug list adjustment on the medical insurance fund and patient burden?
According to preliminary estimates, we can make room for funds by negotiating price reduction and transferring catalogues. Because we strictly control the economy of drugs in the process of catalogue adjustment, most of the newly added 1 19 drugs are exclusive drugs with negotiated price reduction. It is estimated that the increased fund expenditure in 20021is basically equivalent to the space vacated by drug negotiation and transfer. At the same time, this drug negotiation agreement is valid for two years. Two years later, we will adjust the payment standard again according to the actual sales situation to ensure the smooth operation of the fund.
Judging from the burden of patients, it is estimated that through negotiation of price reduction and medical insurance reimbursement, the cumulative burden of patients will be reduced by about 28 billion yuan in 20021year.
9. What measures has the National Medical Insurance Bureau taken to strengthen supervision and ensure the fairness, justice, standardization and completeness of the adjustment of the medical insurance drug list?
The National Medical Insurance Bureau has always attached great importance to strengthening the construction of supervision mechanism in the adjustment of medical insurance drug list. Bureau leaders personally deployed in key links, defined work tasks, emphasized the requirements of clean government discipline, and ensured that the negotiation work was scientific, standardized, clean and orderly. The first is to improve institutional measures. In view of the risk points that are easy to appear in the catalogue adjustment, clear institutional measures have been formulated for experts, staff and enterprise personnel to prevent risks from the source. The second is to strengthen the supervision and management of experts. Strictly adhere to the principles of interest avoidance and arbitrariness in determining the list of experts, allocation calculation and negotiation tasks. All the experts were randomly selected. Experts are required to take up their posts, and each expert only participates in one link. Expert review, calculation and other links are completely closed. The third is to strengthen internal control management. We have formulated special work rules, defined the responsibilities of each post and personnel, improved system measures such as information confidentiality, interest avoidance and accountability, and strengthened education, supervision and management in honesty and confidentiality. The fourth is to strengthen normative constraints. All staff and experts have signed the promise of confidentiality and good faith and the declaration of no conflict of interest. All experts are recommended by the party organization of the unit where they work, and truthfully report matters related to the interests of the enterprise. Fifth, take the initiative to accept supervision from all parties. Accept complaints and reports from all walks of life. Invite the media and discipline inspection and supervision to participate in the catalogue adjustment work, and record and video the whole negotiation process, so that the evidence is well documented and all parties have complaints. According to the above requirements, the negotiation work is standardized and orderly, and is progressing steadily.
X. how to implement the payment standard for negotiated drugs?
The payment standard of drug negotiation is the medical insurance payment standard agreed by the pharmaceutical enterprise and the National Medical Insurance Bureau, and it is the sum of the expenses paid by the fund and the individual patient. The medical insurance payment standard determined through consultation is the benchmark for drug payment in all co-ordination areas. This year, the new payment standards for drugs are synchronized with the new catalogue, and will be implemented from March 1 day to February 3 1 day, 2022. After the expiration of the agreement, it will be adjusted according to the relevant provisions of the medical insurance drug payment standard. During the validity period of the agreement, the price of drugs supplied by the negotiating drug enterprises to the designated medical institutions and retail pharmacies of national medical insurance shall not exceed the payment standard of medical insurance. During the validity period, if drugs with the same generic name from other manufacturers are listed, they will be automatically classified into the catalogue. The medical insurance department has the right to adjust the medical insurance payment standard according to the price of generic drugs, and also has the right to include generic drugs in the scope of centralized procurement. In case of major adjustment of national policies or the actual market price has been significantly lower than the agreed payment standard within the validity period, the medical insurance department can negotiate with the enterprise to re-establish the payment standard. After the expiration of the validity period, the medical insurance department will adjust the payment standard in accordance with the relevant provisions of the medical insurance drug payment standard.
XI。 When and how to implement the new national medical insurance drug list after negotiation?
Due to the epidemic situation, this year's adjustment work ended in February. In order to reserve time for system adjustment, policy convergence and personnel training for local medical insurance departments and agencies, we decided to formally implement the new catalogue from March 2002/kloc-0 to March 2002/kloc-0. The National Medical Insurance Bureau will issue documents with relevant departments to strengthen guidance, promote the implementation of new catalogues in various places, strengthen monitoring and dispatching, and strengthen post-entry management to ensure that the new catalogue will benefit the broad masses of the people as soon as possible.
Twelve, after the release of the new catalogue, what measures is the National Bureau going to take to promote the landing?
After the publication of the catalogue, it will guide all localities to strengthen the transformation of information systems, adjust and refine payment management measures, and do a good job in policy convergence. First, implement measures such as directly hanging the negotiated drugs on the internet to ensure that the payment standard for negotiated drugs is adjusted as scheduled according to the agreement. The second is to guide the designated medical institutions to form a linkage, optimize and upgrade the drugs equipped and used by this institution in time, and improve the level of clinical medication. The third is to guide local innovation methods, and promote the landing of new catalogue drugs by improving outpatient support policies, opening designated pharmacies for medical insurance, and rationally adjusting total quantity control. The fourth is to strengthen monitoring and dispatching. Improve the mechanism, strengthen the monitoring of the use and payment of listed drugs, especially negotiated drugs, and solve the problems in the process of landing in time.
Attachment: List of National Medicines for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance.
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