Policy Interpretation of the Circular of the Ministry of Human Resources and Social Security of the National Health Insurance Bureau on the Issuance of the National Catalog of Medicines for Basic Medical Insurance, Workers' Compensation Insurance, and Maternity Insurance
In order to let all sectors of the society further understand the work of adjusting the drug catalog of the national health insurance in 2020, the National Health Insurance Bureau has made an interpretation of the "Notice on the Issuance of the Drug Catalog of the National Basic Medical Insurance, Workers' Compensation Insurance, and Maternity Insurance for the Year 2020". of the Notice on the Publication of the 2020 National Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance Drug Catalog.
I. What are the general ideas and goals of the 2020 National Health Insurance Drug Catalog adjustment work?
In order to implement the decision-making and deployment of the CPC Central Committee and the State Council, and in accordance with the relevant provisions of the Interim Measures for the Administration of Medicines for Basic Medical Insurance, the State Medical Insurance Bureau, together with the relevant departments, will earnestly carry out the adjustment work of the 2020 National Medical Insurance Drug Catalog. The adjustment has always adhered to the functional positioning of "guaranteeing the basics", and in accordance with the requirements of "doing the best we can and living within our means", it has established the idea of "highlighting the key points, making up for shortcomings, optimizing the structure, and encouraging innovation", and has given full play to the principle of adjustment. It has established the idea of "highlighting the key points, making up for the shortcomings, optimizing the structure, encouraging innovation", given full play to the advantages of the system, policy and market, released the dividends of reform, and strived to achieve the goals of a more optimized structure of the drug catalog, more efficient use of the health insurance funds, and higher capacity and level of protection of the basic medicines under the Basic Health Insurance, so as to better satisfy the basic medication needs of the majority of the insured people, and to help solve the worries of the masses about medical treatment, and to enhance the sense of gain of the masses. The masses of people's sense of obtaining.
After the adjustment of the catalog, 119 kinds of medicines were transferred into the catalog and 29 kinds of medicines were transferred out of the catalog, and finally there were 2800 kinds of medicines in the catalog, including 1426 kinds of western medicines and 1374 kinds of proprietary Chinese medicines, and the ratio of Chinese and western medicines was basically the same.
Second, the adjustment, how to ensure that the "basic" functional positioning?
On the drugs outside the catalog, in the evaluation, calculation, and determine the scope of payment of the medical insurance fund, etc., are comprehensively considered at this stage of China's economic and social development level, medical insurance fund and the affordability of the insured, etc., to set the technical standards in line with the positioning of the "basic", to ensure that the negotiation of the formation of the standard of payment is in line with expectations. The technical standards were set to ensure that the negotiated payment standards were in line with expectations. For medicines in the catalog, experts were specially organized to evaluate and negotiate price reductions for varieties that had not been negotiated into the catalog and whose prices or costs were on the high side, so as to guide the payment standards for medicines in the catalog to gradually return to a reasonable level. At the same time, through the transfer out of the clinical value of the drugs and other measures, especially in recent years, centralized volume purchasing "in exchange for price" to further squeeze the water of drug prices, to achieve the "cage for the bird", to ensure the safety of the fund.
Three, this adjustment, the scope of the adjustment into the scope of the catalog of drugs and the number of changes, what considerations?
Different from the previous rounds of adjustment, which included "all listed drugs" in the scope of evaluation, this year, for the first time, a declaration system has been implemented, i.e., only those off-list drugs that meet the conditions listed in this year's adjustment program can be included in the scope of adjustment. The scope of the adjustment of off-catalogue drugs has realized the change from "sea selection" to "preferential selection".
According to the 2020 National Health Insurance Drug Catalog Adjustment Work Program, this year's adjustment of off-catalog drugs are mainly in seven categories: medicines for the treatment of respiratory diseases related to new coronary pneumonia; medicines included in the National Essential Drugs Catalog; medicines included in the list of urgently needed overseas new medicines by the relevant departments, encouraging the generic drug catalog or encouraging research and development of children's medicines to declare the list of medicines; medicines that were successfully purchased through the centralized volume purchasing scope of the country; medicines that were successfully purchased through the centralized volume purchasing scope of the country. The drugs that have been successfully collected in the scope of national centralized banded purchasing; the drugs that have been approved and listed after January 1, 2015, and the drugs that have undergone significant changes in indications and functional mainstays after January 1, 2015. At the same time, taking into account the continuity of the original self-supplementation of drugs in each province, this time will also be "included in five or more provincial health insurance drug catalog drugs" into the scope of adjustment. According to the conditions of declaration, *** counted 704 kinds of drugs outside the catalog declared successful.
The main considerations for setting the declaration conditions are: first, to better meet clinical needs. For example, the new crown pneumonia treatment drugs, clinical urgency or encourage the imitation of drugs, the national essential drugs, the collection of selected drugs, etc.. The second is to better connect with the approval of new drugs, to realize the "seamless connection" between drug approval and medical insurance evaluation, and to reflect the orientation of encouraging the creation of new drugs. For example, newly listed medicines and medicines with newly approved modifications to their functional main treatment or indications. Third, to take care of the continuity of clinical use of drugs. For example, the inclusion of five or more provincial health insurance drug catalog drugs, also included in the scope of adjustment.
Four, this national health insurance drug catalog adjustment negotiation success rate? What are the number, types, therapeutic areas and price reductions of successfully negotiated drugs?
Compared with previous years, an important feature of this adjustment is that the negotiated price reductions transferred the largest number of drugs, benefiting the widest range of therapeutic areas.
We *** negotiated 162 kinds of drugs, negotiated 119 kinds of success, the success rate of 73.46%, the average price reduction of 50.64%. This catalog adjustment *** new 119 kinds of drugs, these drugs *** involving 31 clinical groups, accounting for 86% of all clinical groups, patients benefit from a very wide range of patients will have a stronger sense of access.
Fifth, there are 29 kinds of drugs transferred out of the catalog, what are the circumstances under which the drugs will be transferred out of the catalog, and whether it will have an impact on the use of drugs for patients with related diseases?
After the expert evaluation, *** counted 29 kinds of drugs were transferred out of the catalog, mainly for the clinical value is not high and can be replaced, or by the drug regulatory department to revoke the document number to become "zombie drugs" and other varieties. The transfer of these medicines, after repeated arguments by experts, in strict accordance with the procedures to determine. Experts in the evaluation process, the substitutability as an important indicator, were transferred out of the drug catalog are comparable or better efficacy of the drug can be replaced. At the same time, the transfer out of these drugs, for more new drugs, good drugs into the catalog to make room.
Sixth, we note that this time, some of the "old varieties" that have been in the catalog for a long time will be included in the scope of negotiations, what are the considerations?
Article 10 of the Interim Measures for the Administration of Medicines for Basic Medical Insurance clearly stipulates that "medicines with high prices or costs in the same therapeutic area without reasonable justifications" and "medicines with inaccurate clinical value that can be replaced by better alternatives" can be included in the scope of negotiation after expert evaluation and other prescribed procedures. expert evaluation and other prescribed procedures, they can be transferred out of the Drug List. In this year's adjustment process, the evaluation experts, after repeated arguments and strict evaluation, included 14 drugs in the catalog into the scope of negotiation according to the above requirements, and if the negotiation was successful, the drugs would be retained in the catalog, or else they would be transferred out of the catalog. These 14 medicines were not negotiated at the time of the previous access to the catalog and were assessed to be significantly higher in price or cost. After negotiations, all 14 drugs were successfully negotiated and retained in the catalog, with an average price reduction of 43.46%.
The so-called "old varieties" that were not negotiated in the catalog were included in the negotiation, with three main considerations, the first being to improve the economy of drugs. Drugs also have a life cycle, affected by changes in the competitive environment of the market and other factors, the payment standard of drugs should also be adjusted accordingly. From the actual situation, after some drugs entered the catalog, the payment standard has not been adjusted for a long time, or the adjustment is not in place, and the economy has obviously decreased. Negotiation is an important means to enhance economy. Second, it is to enhance fairness. Through the introduction of negotiation mechanism, in recent years, some of the new access to the catalog of drugs more cost-effective, compared with the original catalog of "old varieties" appeared in the price "upside down" phenomenon, in order to safeguard the use of health insurance funds and the fairness of patients' rights and interests, we use the market mechanism, the "old varieties" of drugs. We use the market mechanism to negotiate with the "old varieties" and guide their payment standards to return to a reasonable level. Third, reduce the burden on patients and save the fund expenditure. Practice has shown that through the negotiation of "old varieties", can effectively reduce the burden on patients, enhance the effectiveness of the use of health insurance funds.
In the future adjustments, we will also organize experts to evaluate and negotiate with the eligible "old varieties", and strive to improve the economy of the drugs in the directory.
Seven, after this year's adjustments, what are the changes in the protection of anti-cancer drugs?
The Party Central Committee and the State Council attach great importance to the protection of anti-cancer drugs.In 2018, at the beginning of the establishment of the Bureau, we organized a special access negotiation on anti-cancer drugs, and finally 17 kinds of drugs were successfully negotiated into the directory, and the agreement expired at the end of this year. Among these 17 anti-cancer drugs, 3 drugs had generic drugs listed to be included in Category B. 14 exclusive drugs were renewed or renegotiated according to the rules, with an average reduction of 14.95%, among which individual first-line anti-cancer drugs were reduced by more than 60%. It is estimated that the price reduction of 14 anti-cancer drugs is expected to save more than 3 billion yuan for cancer patients in 2021. At the same time, this adjustment also added 17 new anticancer drugs, including PD-1, lenvatinib and other new drugs good drugs, the level of protection of cancer drugs in the catalog has been significantly improved.
VIII. What is the impact of the adjustment of the medical insurance drug catalog on the medical insurance fund and patient burden?
According to preliminary calculations, through negotiating price reductions and transferring out of the catalog, a certain amount of space can be freed up for the fund. As we strictly grasp the economics of drugs in the process of catalog adjustment, the 119 new drugs, most of which are exclusive drugs that have been negotiated to achieve price reductions, are expected to increase the fund's expenditure in 2021, which is basically comparable to the space freed up by the negotiation and transfer out of drugs. At the same time, the agreement for the negotiated drugs is valid for two years, and after two years we will adjust their payment standards again according to the actual sales situation to ensure the smooth operation of the fund.
From the patient burden situation, through the negotiation of price reductions and health insurance reimbursement, it is expected that in 2021, a cumulative burden reduction of about 28 billion yuan for patients.
Nine, for the adjustment of the medical insurance drug catalog, what measures has the State Medical Insurance Bureau taken to strengthen supervision and ensure the fairness, impartiality, standardization and integrity of the adjustment of the medical insurance drug catalog?
The NHPA has always attached great importance to strengthening the construction of the supervision mechanism in the adjustment of the Medicare drug list, and the leaders of the NHPA have personally deployed in the key links, clarified the work tasks, and emphasized the requirements of honesty and discipline, so as to ensure that the negotiation work is scientific, standardized, clean, and orderly. First, improve the system measures. In view of the risk points prone to catalog adjustment, experts, staff and business personnel, have formulated clear institutional measures 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 randomization in determining the list of experts, allocating measurements, negotiating tasks, etc., and all experts are randomly selected. Experts are required to be on duty, and each expert only participates in one session of work. Expert evaluation, calculation and other aspects of the implementation of the full closure. Third, strengthen internal control management. Special work rules have been formulated to clarify the responsibilities of various work positions and personnel, improve information confidentiality, avoidance of interests, accountability and other institutional measures, and strengthen education, supervision and management of integrity and confidentiality. Fourth, strengthening the normative constraints. All staff and experts have signed the Confidentiality and Integrity Commitment and Declaration of No Conflict of Interest. All experts are recommended by the party organization of their units, and truthfully report matters related to corporate interests. Fifth, take the initiative to accept supervision by all parties. Accept complaints and reports from all walks of life. Catalog adjustment work to invite the media and discipline inspection and supervision and other parties to participate in the negotiation process throughout the audio-video recording, so that all the evidence can be traced, all parties can complain. In accordance with the above requirements, the negotiation work is standardized and orderly, steady progress.
Ten, the negotiation of drug payment standards how to implement?
Negotiated drug payment standards are drug companies and the National Health Insurance Bureau **** with the agreed health insurance payment standards, is the fund to pay the sum of the cost of payment and personal payment of patients, the coordinated areas to negotiate the health insurance payment standards as a benchmark for the payment of drug costs. This year, the newly determined payment standard of the drugs, its payment standard and the new version of the catalog synchronization, since March 1, 2021, as of December 31, 2022 implementation. After the expiration of the agreement period, it will be adjusted in accordance with the relevant provisions of the health insurance drug payment standards. During the validity period of the agreement, the price of the negotiated drugs supplied by the negotiating drug enterprises to the designated medical institutions and designated retail pharmacies of the national health insurance shall not exceed the payment standard of the health insurance. During the validity period, if other manufacturers' drugs with the same generic name are listed on the market, they automatically belong to the scope of the catalog, and the health insurance department has the right to adjust the payment standard of health insurance according to the price of the generic drug, and also has the right to include the generic drug into the scope of centralized purchasing. During the validity period, if there is a major adjustment of national policy or the actual market price is significantly lower than the agreed payment standard, the health insurance department can negotiate with the enterprise to reformulate the payment standard. After exceeding the validity period, the health insurance department will adjust the payment standard in accordance with the relevant provisions of the health insurance drug payment standard.
Eleven, after the completion of negotiations on the new version of the national health insurance drug list when to start and how to implement?
Due to the epidemic, this year's adjustment work will only be completed in December. In order to allow time for local health insurance departments and agencies to make system adjustments, policy convergence, and personnel training, we have decided to officially implement the new version of the catalog from March 1, 2021 onwards. The State Medical Insurance Bureau, together with relevant departments, will issue documents, strengthen guidance, promote localities to do a good job in implementing the new version of the catalog on the ground, as well as strengthen monitoring and scheduling, and enhance post-access management, to ensure that the new version of the catalog can benefit the general public as early as possible.
Twelve, the new version of the catalog issued, the State Bureau is prepared to take what measures to promote the landing?
After the release of the catalog, we will guide localities to strengthen the transformation of information systems, adjust and refine payment management measures, and do a good job of policy convergence. First, the implementation of negotiated drugs directly on the network and other measures to ensure that the negotiated drugs as scheduled in accordance with the agreement to adjust the payment standard. The second is to guide designated medical institutions to form linkages, optimize and upgrade the drugs equipped and used by their own institutions in a timely manner, and improve the level of clinical use of drugs. Third, guiding localities to innovate ways to promote the landing of medicines in the new version of the catalog by improving outpatient protection policies, opening access to designated medical insurance pharmacies, and reasonably adjusting the total amount of control. Fourth, strengthening monitoring and scheduling. Improve the mechanism to strengthen the monitoring of the use and payment of the drugs in the catalog, especially the negotiated drugs, and solve the problems in the process of landing in a timely manner.
Attached: National Catalog of Medicines for Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance
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