Xu Yanjun, deputy director of the National People's Social Affairs Department: How to talk about drug price negotiations

Recently, the Ministry of Human and Social Affairs issued the Notice on the Inclusion of 36 Drugs in the Category B of the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs Directory (hereinafter referred to as the Notice), which included 36 drugs in the Category B scope of the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition) (hereinafter referred to as the Drug Catalog), and simultaneously published the standards for the payment of medical insurance for these drugs.
: Would you please tell us about the impact of the outcome of the negotiations on the scope of medication used by the insured persons?
Yanjun: A total of 44 drugs participated in the negotiations, of which 36 were successful, the success rate reached 81.8%, the successful negotiations of drugs unified into the scope of the drug catalog Category B. The negotiated payment criteria, compared with the average retail price in 2016, fell by an average of 44 percent, the largest drop of 70 percent, significantly reducing the burden of drug costs for insured personnel and effectively controlling health fund spending. The 36 drugs successfully negotiated included 31 Western medicines and 5 Chinese medicines.
15 of the 31 Western drugs are tumor therapy drugs, involving lung cancer, stomach cancer, breast cancer, colorectal cancer, lymphoma, myeloma and other common cancers, including the previous insured personnel reflected more of the curto-pearl monoanti, lytoxic, boron Zomi, lynadamine, etc.; five are cardiovascular drugs, such as tigrillo for acute coronary syndrome, recombinant human urase for acute heart attack, etc.; and the other drugs are kidney disease, ophthalmology, psychosis, anti-infection, diabetes, and rare diseases. Three of the five Chinese medicines are tumor drugs, and two are cardiovascular medications. This negotiation attaches great importance to innovative drugs and rare disease drugs, included in the "12th Five-Year Plan" since the national major new drug creation special Sidabenamine, Compaxip, Apatini, etc. all successful negotiations, the treatment of haemophilia recombinant human coagulation factor VII.a and the treatment of multiple sclerosis recombinant human interferon β-1b have also been successfully included in the drug catalog. Through negotiations, the treatment of major diseases such as cancer-targeted drugs, which reflect relatively strongly in society, is included in the drug catalogue, which greatly improves the level of protection of basic medical insurance, and also takes into account the affordability of the fund, and is conducive to guiding rational medical behavior, promoting the development and innovation of the pharmaceutical industry, and basically realizing the goal of "three wins" for medical insurance, enterprises and insured persons. Next, we will guide the local government to earnestly implement the outcome of the negotiations, to ensure that this important policy of benefiting the people can be implemented at an early time, so that the masses of the people can really benefit.
: Drug catalog negotiation access is a brand-new attempt, why should the Ministry of Human Resources and Social Affairs carry out this work?
Xu Yanjun: In the management of medical insurance drugs, we deeply feel that there are some patents, exclusive drugs, indeed high clinical value, the efficacy is accurate, if can be included in the list will greatly benefit the insured, but at the same time their prices are more expensive, according to the existing market price into the drug catalog is the health insurance fund is unbearable. In order to solve this problem, in accordance with the relevant requirements of the Opinions of the State Council of the CPC Central Committee on Deepening the Reform of the Medical and Health System, "Actively Explore the Establishment of a Negotiating Mechanism between Medical Insurance Agencies and Medical Institutions and Drug Suppliers", we have carefully studied the practices of some developed countries and regions in the world, and summarized the useful experience of the previous national drug price negotiations and the access negotiations of some local health insurance departments. In the process of formulating the 7-year drug catalogue, it is proposed that the clinical necessity, the efficacy is accurate, but the price is more expensive, according to the existing market price to be included in the catalogue may bring some risk to the fund patents, exclusive drugs, explore the establishment of negotiation access mechanism, by expert review to determine the scope of negotiations of drugs, organize clinical, pharmaceutical, health economics, insurance management and other fields of experts to negotiate. We hope to give full play to the advantages of the purchase of health insurance groups, on the basis of equal consultation between health insurance and enterprises, negotiate the appropriate medical insurance payment standards and then include these drugs in the drug catalog, taking into account the level of drug protection for insured personnel and the affordability of the fund.
: Could you tell me about the negotiation process?
Xu Yanjun: In February this year, the Ministry of Human Resources and Social Affairs issued the 2017 edition of the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalog (hereinafter referred to as the Drug Catalog), and through expert review identified some of the higher clinical value but relatively expensive patents, exclusive drugs as the drug to be negotiated, to be negotiated with pharmaceutical enterprises to determine the appropriate standards for payment of medical insurance drugs before being included in the scope of the catalog. In April, the Ministry of Human and Social Affairs published a list of 44 drugs to be negotiated, followed by the establishment of a special working group and monitoring group to undertake specific work and carry out the whole process of supervision, and organized experts to negotiate with the relevant enterprises.
negotiations have three main links: (a) the formulation of strict and careful negotiating rules. One is to clarify the subject of the negotiation. In accordance with the Opinions of the State Council of the CPC Central Committee on Deepening the Reform of the Medical and Health System, "actively explore the establishment of a negotiating mechanism between medical insurance agencies and medical institutions and drug suppliers", in order to give full play to the role of the purchase of medical insurance groups, the main body of the negotiations between the medical insurance parties was identified as the Social Security Center of the Ministry of Human and Social Affairs. Enterprises are generally negotiating pharmaceutical production enterprises, or by the production enterprises authorized Chinese mainland the total distributor to participate in negotiations. All negotiating subject qualifications are confirmed by the lawyer.
is to clarify the policy conditions for negotiations. Clearly negotiate successful drugs into the scope of the drug catalog Category B, the national unified implementation of the negotiated medical insurance payment standards.
is to clearly declare, evaluate and negotiate the separation of the three. The enterprise shall independently declare the basic information of the drug, the price of efficacy and other materials, the evaluation experts shall evaluate the information of all parties and make the evaluation opinions, and the medical insurance agency shall organize the negotiation experts to conduct specific negotiations with the enterprise. To achieve their own duties, relative independence, so as to ensure that the negotiations are fair, scientific and reasonable.
is to clarify the combination of objective evaluation and expert evaluation. Widely collect information on the efficacy, price, economy and medical insurance data of negotiated medicines, organize experts in clinical, pharmacology, pharmacoeconomics, medical insurance management, etc. to conduct comprehensive evaluations and put forward evaluation opinions.
is to clarify the specific negotiation process. According to the results of the expert evaluation, the medical insurance agency organizes negotiation experts and enterprises to negotiate one by one, on-site confirmation of the results of the negotiations. The company has two offers, and if the lowest offer is more than 15% higher than the expected payment standard for health insurance, the negotiations are terminated; The final payment criteria must not exceed the expected payment criteria for health insurance. In this negotiation, we have fully communicated with enterprises on all the rules, procedures and basic information of drugs, evaluation reference factors, etc., so that both sides agree with the rules and have a number in mind to ensure the smooth progress of the negotiations.
(ii) to organize experts to carry out assessment and calculations. Experts in clinical, pharmacy, economics, medical insurance management and other fields randomly selected from the pool of experts are divided into two completely independent evaluation expert groups, which evaluate and measure from the two aspects of drug economy and the affordability of health insurance funds. Among them, the drug economy assessment group mainly analyzes from the clinical value of drugs, international and domestic price comparison, similar drug comparison and other angles, and makes suggestions by using the method of drug economics, and the medical insurance fund measurement group mainly makes recommendations by calculating the impact of negotiating drugs into the catalogue through big data analysis and mathematical actuarial methods based on the relevant drug use and cost information extracted from the medical insurance operation database. The Working Group combined the findings of two groups of experts to determine the expected payment criteria for health insurance in accordance with pre-established rules.
(iii) to negotiate in accordance with the prescribed procedures. On 16 June, we negotiated all 44 medicines. The negotiations were conducted simultaneously in four groups, basically completed from 10:30 a.m. to 20 p.m., and the monitoring group monitored the scene, while videotaping the entire process of the negotiations and keeping audio and video materials for reference. All companies participating in the negotiations signed a confirmation of the outcome of the negotiations on the spot and endorsed the results in writing. Within a week of the completion of the negotiations, all the negotiating companies signed a formal agreement with us.
: Drug catalog access negotiations by enterprises and society's high concern, what has the health care sector done in terms of disciplinary requirements?
Xu Yanjun: In order to ensure that the drug catalog access negotiations in accordance with the law compliance and fair, just, open, we have carried out careful planning and arrangements:
First, the formulation of strict integrity and confidentiality measures. At the start of the negotiations, we developed a series of provisions on the collection, storage, management and use of information and data, such as the Staff Code, the Code of Assessment Experts, and required all staff involved in this work to sign a Confidentiality Commitment, while the Assessment Specialist signed a Confidentiality Commitment and a Declaration of No Conflict of Interest. At the same time, a special monitoring group has been set up to supervise the negotiations throughout.
, the expert evaluation process to implement two sets of experts parallel assessment, personnel do not cross each other, work independent of each other, the results are completely confidential. This means that any group of experts in the assessment will only know the assessment of this group at most, but not the results of the other group of assessments. At the same time, after the experts have completed the assessment, the results are strictly confidential and are not reported or disclosed to other personnel.
is to negotiate in strict accordance with the rules. On the morning of the negotiations, the members of the Working Group, based on the results of two sets of expert evaluations, determined on-site the expected payment criteria for health-care parties in accordance with established rules. The members of the previous working group were unaware of the results of the expert evaluation and, after the results had been determined, the members of the working group were closed until the conclusion of the negotiations; The negotiating group implements collective decision-making and negotiates in full accordance with the rules. The whole process of the negotiation is recorded, and the video materials are kept for reference.
: What are the requirements for negotiating the management of the use of drugs?
Xu Yanjun: The requirements for negotiating the management of drug use are mainly as follows: First, 36 negotiated drugs are explicitly included in the 2017 edition of the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalog Category B, and the provincial (district, city) social insurance authorities shall not transfer these drugs out of the catalogue, nor may they adjust the limited payment scope of these drugs.
Second, the standard of payment for medical insurance, which is clearly negotiated, includes all expenses paid jointly by the basic medical insurance fund and the insured persons, and the payment standard is valid until December 31, 2019, after which it shall be adjusted in accordance with the relevant provisions of the medical insurance drug payment standard. During the validity period, if a generic drug is listed, the medical insurance payment standard for the drug will be adjusted according to the price level of the generic drug, and if the actual price of the drug market is significantly lower than the current payment standard, the medical insurance department may negotiate with the enterprise to re-establish the payment standard.
third is to require all regions to strengthen the negotiation of drug management, promote rational drug use. For drugs that require "pre-review before use" or other drugs that need strict management, a unified pre-review provision should be established; drugs with large quantities and high costs should be included in the intelligent monitoring system of basic medical insurance medical services to focus on monitoring and cost analysis; and effective measures should be taken to encourage targeted retail pharmacies to provide medicines to insured persons, to give full play to the positive role of pharmacies in the supply of medical insurance drugs, and to actively support "the separation of medicines".
: The overall progress of this negotiation is relatively smooth, enterprises are also more cooperative, what do you think are the main reasons?
Xu Yanjun: Health insurance drug catalog access negotiations are a common international practice, there are some early exploration, so although at the national level is the first time, but we have carefully summarized the study, there are still a lot of experience for reference. At the same time, our country has achieved "medicare for all", the relevant enterprises attach great importance to China's huge market size, which is the biggest bargaining chip. In order to ensure the success of the negotiations, we have also taken note of several aspects in our work:
is clear and clear negotiating conditions. At the beginning of the negotiations, we have made clear the negotiation of drugs into the health insurance Category B directory, the local can not be transferred out, the negotiation of the validity of the payment standards and other important policies, the conditions and chips negotiated by the medical insurance side and the tray out, so that enterprises have the bottom of their hearts, can come up with the most favorable conditions to participate in the negotiations.
is to strictly follow established negotiating procedures and rules. From negotiating willingness to negotiate with companies to submitting negotiating materials, expert assessments, and specific negotiations, all processes are conducted in accordance with pre-determined rules and treat all businesses equally.
is to fully reflect equal consultation. Negotiation is a process in which both sides negotiate and strive for win-win results. In this negotiation, we asked enterprises to submit negotiating information, fully explain the value and advantages of drugs, at the same time, we have held a number of corporate symposiums, with enterprises to fully exchange and jointly study the specific issues of negotiations, listen carefully to the views and suggestions. In the expert evaluation link, but also specifically with each enterprise on the expert evaluation considerations of the factors to the enterprise to communicate, and the enterprise feedback expert reference, guide the reasonable expectations of the enterprise. (Official website of the Ministry of National People's Social Affairs)