Behind the "soul bargaining": how did the bargain floor price come about?

Recently, the National Medical Insurance Bureau and the Ministry of Human Resources and Social Security and other departments organized the results of the 2021 national medical insurance drug list adjustment results announced, this adjustment, a total of 74 drugs were added to the catalog, 11 drugs were transferred out of the catalog. Judging from the negotiation situation, 67 kinds of exclusive drugs outside the list were successfully negotiated, with an average price reduction of 61.71%. After the adjustment, the total number of drugs in the national medical insurance drug list is 2860, including 1486 western medicines and 1374 chinese proprietary medicines. There are still 892 kinds of Chinese medicine tablets.

On December 7, the National Medical Insurance Bureau disclosed the contents of the interviews he gave to the relevant person in charge of the Department of Pharmaceutical Administration on the 2021 National Medical Insurance Drug Catalogue Access Negotiations (hereinafter referred to as the Drug Negotiations). During the interview, the National Medical Insurance Bureau deeply interpreted many issues related to drug negotiations.

According to the National Medical Insurance Bureau, in addition to the "bargaining" link that has attracted much attention, the adjustment of the national medical insurance drug list is a systematic work. The adjustment of the national medical insurance drug list in 2021 began in May and ended at the end of November, which took more than half a year. From the perspective of the process, it is mainly divided into five stages: preparation, declaration, expert review, negotiation, and announcement of results. Therefore, on-site negotiations are only one part of the catalog adjustment process. Before the "soul bargaining", the medical insurance party and the enterprise must carry out a lot of preparatory work, repeatedly arguing, reviewing, calculating, and communicating to ensure that the negotiation work is scientific, standardized, fair and just, and the whole process leaves traces.

How did the negotiated reserve price come about?

According to the National Medical Insurance Bureau, the negotiated reserve price is calculated by experts organized by the medical insurance department. On the one hand, for drugs that have obtained negotiation qualifications, the medical insurance department organizes relevant enterprises to submit calculation materials according to a unified template, mainly including: basic information of drugs, relevant safety, effectiveness, economy and other information, intentional prices, and corresponding evidentiary materials. On the other hand, the medical insurance department organizes experts in pharmacoeconomics and medical insurance management to carry out scientific calculations from the perspectives of drug cost effect, budget impact, and medical insurance fund burden, etc., forming the highest price that the medical insurance fund can bear, that is, the negotiated reserve price, as the basis and bottom line for negotiators to carry out negotiations.

The National Medical Insurance Bureau stressed that in the calculation process, experts fully draw on pharmacoeconomic guidelines and the latest international technical methods, and fully consider factors such as The positioning of China's medical insurance and market environment. At the same time, according to the work plan, we will fully communicate with relevant enterprises one by one, and do our best to improve the scientificity, rationality and standardization of calculations, so as to lay a solid foundation for the smooth development of negotiations.

Why is the base price directly revealed by experts at the negotiation site?

According to the current negotiation rules, the on-site negotiation is jointly participated by the enterprise side and the medical insurance party, and the enterprise party is presided over by the authorized negotiator and the medical insurance party is presided over by the leader of the negotiation team, and the negotiation result is determined on the spot. First quoted by the enterprise side, the enterprise side has two opportunities to quote and confirm. If the price after the second confirmation of the enterprise is higher than 115% (exclusive) of the negotiated reserve price of the medical insurance party, the negotiation fails and is automatically terminated. For example, the price after the second confirmation of the enterprise is not higher than 115% of the negotiated reserve price of the medical insurance party, and it enters the negotiation link between the two sides. The price finally agreed upon by the two parties must not be higher than the negotiated reserve price of the health care provider. During the negotiation process, the authorized representative of the enterprise can ask for instructions by telephone or other means, but should give a clear opinion on the spot. After the negotiation, regardless of whether an agreement is reached, the two sides sign the confirmation of the result on the spot.

The ultimate success of the negotiation depends on whether there is an intersection between the bottom line of the health care provider and the corporate side. From a practical point of view, the responsibility of the negotiator of the medical insurance party is to use the negotiation mechanism to guide the enterprise to quote the lowest price it can accept. The National Medical Insurance Bureau said that negotiators strive to obtain more preferential prices for the people within the scope that the fund can afford and the enterprise can accept, which is the charm and value of "soul bargaining".

Why can individual OTC drugs be included in the Medicare list?

Article 36 of the Interim Measures for the Administration of Drugs in Basic Medical Insurance stipulates that in principle, OTC drugs will not be added to the Drug Catalogue. 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 procedure. Therefore, in the adjustment of the national medical insurance drug list in 2020, OTC class A essential drugs such as "bovine yellow qinggan capsules" and "racemic scopolamine tablets" are included in the scope of medical insurance payment; in the adjustment of the national medical insurance drug list in 2021, the OTC essential drug "clotrimazole vaginal expansion plug" is included in the scope of medical insurance payment.

There are two main considerations for including essential drugs (including OTC essential drugs) in the scope of medical insurance payment: First, the implementation of legal and policy requirements. Article 59 of the Law of the People's Republic of China on Basic Medical Care and Health Promotion stipulates that essential drugs shall be included in the list of drugs in basic medical insurance on a priority basis in accordance with regulations. The Opinions on Improving the National Essential Drugs System (Guo Ban Fa [2018] No. 88) issued by the General Office of the State Council require that for therapeutic drugs in the essential drug list, the medical insurance department will give priority to the eligible drugs in the scope of the catalogue according to the procedures when adjusting the medical insurance catalogue. Second, it is conducive to reducing the burden on the insured masses. The Opinions of the General Office of the State Council on Further Ensuring the Supply and Stabilizing the Price of Shortage Drugs (Guo Ban Fa [2019] No. 47) stipulates that it is necessary to promote the priority use and rational use of essential drugs, and increase the proportion of basic drugs used. Strengthening the coordination with the essential drug system and management measures is conducive to reducing the burden on patients and improving the level of benefits for the masses.

How to grasp the effectiveness of the drugs to be included in the list in the adjustment process? What's next?

According to the National Medical Insurance Bureau, according to the current rules, in order to ensure the effectiveness of drugs, it mainly starts from the following aspects:

First, the drug must pass the review of the drug regulatory department and be approved for listing. In recent years, the national medical insurance drug list has been adjusted, mainly for drugs newly approved for listing in recent years. Second, enterprises must submit information that can prove the effectiveness of drugs. Third, drugs can pass expert review. According to the adjustment rules, drugs that meet the declaration conditions and declare success need to accept multiple rounds of arguments from experts in pharmacy, clinical medicine, pharmacoeconomics, medical insurance management and other aspects.

In the 2021 review, the National Medical Insurance Bureau studied and formulated the evaluation index system, and the experts reviewed Western medicines and proprietary Chinese medicines from the aspects of safety, effectiveness, economy, innovation (inheritance and innovation), and fairness. Taking Ganlutna capsules as an example, the drug was included in the scope of support for the "Major New Drug Creation National Science and Technology Major Project". In 2020 and 2021, they were successfully declared and successfully passed the expert review. The failure of the 2020 negotiations was not included in the catalogue. In this year's adjustment, after 32 expert reviews, an average score of 70.47 was obtained, and the drug was given the negotiation qualification according to the rules. Through negotiations, 66.92% of the price reduction was included in the catalogue. Through negotiated price cuts and Medicare reimbursement, the burden of medication on patients will be significantly reduced.

The National Medical Insurance Bureau stressed that since most of the drugs currently included in the scope of adjustment are newly approved and listed drugs, and many are even listed drugs in the same year, expert reviews rely on most of the information collected during the clinical trial stage of drugs. In the future work, enterprises will be encouraged to carry out real-world research on drugs, and more real-world research data will be relied on in the adjustment of the catalog. (Reporter Han Lu)

Source: China Economic Network