On October 27, the 2024 National Medical Insurance Negotiations officially began at the National People's Congress Conference Center in Beijing. The entrance to the venue was crowded. Some companies said that "the talks will not start until tomorrow, but we came in advance to check out the atmosphere." This year, a total of 162 generic drugs will participate in the negotiations/bidding. The negotiations will be conducted by 25 negotiation experts from medical insurance departments selected from all over the country and divided into 5 groups. The negotiations will last until October 30, and the final results are expected to be announced in November.

It is reported that the varieties of negotiations on the first day involve antiviral, anesthetic analgesic, antihypertensive and other fields. Hengrui, Merck, Kangyuan, Zhengda Tianqing, Renfu, Hisense, Xinlitai, Daiichi Sankyo, Baxter and other companies have entered the venue. Companies on the scene revealed that their Chinese medicine varieties will be negotiated on October 29.

Some enterprise representatives expressed their hope to "talk about it upwards, and don't push it too low overall", while representatives of peer enterprises said frankly that "the ceiling is there". In recent years, the industry generally believes that the national negotiations have an "invisible ceiling" of "no negotiation at 500,000 yuan, no entry at 300,000 yuan", and many pharmaceutical industry practitioners expect this ceiling to be raised, but some experts believe that in the context of limited medical insurance funds, the "ceiling" may not change in the short term.

In addition, "115%" and "envelope price" have become the key to the quotation of participating enterprises. According to previous rules, the on-site negotiations are made by enterprises, and there are generally two opportunities to quote and confirm. If the price confirmed by the enterprise for the second time is higher than 115% (not included) of the negotiation floor price of the medical insurance party, the negotiation will be terminated directly; if it is lower than 115%, it will enter the negotiation stage, and the final price reached by both parties is not higher than the envelope price of the medical insurance bureau, which means that the negotiation is successful.

Some enterprise representatives recalled the scene of their first participation in the negotiation - due to reasons such as lack of familiarity with the rules, the price after confirmation exceeded the upper limit of the medical insurance bureau, and at that time "I was anxious and wanted to talk again (with the medical insurance bureau) with the door closed". This year marks the seventh consecutive year that the National Medical Insurance Administration has adjusted the medical insurance drug catalog since its establishment. Many representatives on the scene revealed that "we (the scale of the enterprise) are small, and this time all employees are mobilized" and "(we are talking about) our most important varieties this year". Although they all attach equal importance to the attitude, it can be seen that the mentality of each enterprise is different after the negotiation.

Representatives of enterprises who have participated in on-site negotiations many times mentioned easily before entering the venue: "I am not nervous, we don't have much pressure", and they also showed joy after the negotiation, saying "very good, very good". At the same time, the negotiation results of some enterprises were not as expected. On the first morning of the national negotiation, a representative of an enterprise walked out of the venue with a solemn face after 12 o'clock. Not far away, he stopped on the sidewalk to review the negotiation process just now. Standing in the cold wind, he read the materials and said that the price was "far worse", and began to summarize the experience and lessons for the next negotiation.

Since last year, the medical insurance department has introduced a new drug classification method in drug review, which is divided into four types based on clinical value: breakthrough therapy, improved new drugs, equivalent efficacy, and inferior drugs. This round of national negotiations has stricter requirements on the authenticity and reliability of clinical data and test data, which also means that the threshold for innovative drugs to enter the catalog is higher. According to the Dingxiangyuan Insight database, 249 drugs outside the catalog passed the formal review this year, 162 varieties participated in the negotiation and bidding, and the pass rate of the expert review stage was less than 50%, which was significantly lower than the pass rate of 74.2% in 2022 and 63.8% in 2023.

In this round of national negotiations, CAR-T, PD-1, third-generation EGFR-TKI, autoimmune, ADC drugs, etc. are all the focus of the industry. Among the 162 participating varieties, there are many high-value innovative tumor drugs and new drugs for rare diseases that are on the market for the first time. For example, Kangfang Bio's cardunilizumab and ivocizumab are both on the preliminary review list for the first time. The two drugs were approved in June 2022 and May 2024, respectively, and are both world-first dual antibodies. In addition, Hisun Pharmaceutical's cligabalin, Zelgen Biopharma's recombinant human thrombin, Beijing New Pharmaceutical's didacidinib, Dizhe Pharmaceutical's suvotinib and golixitinib are also "negotiated" for the first time.

Southwest Securities pointed out that in the previous eight rounds of medical insurance drug negotiations for innovative drugs, the average reduction of innovative drugs selected for the first time was basically between 40% and 62%. After entering the medical insurance, most innovative drugs achieved price-for-volume exchange and sales increased significantly. Take the domestic PD-1 anti-tumor drug sindilimab as an example. It was included in the medical insurance in 2019, and its sales in 2020 increased by 954% to 273 million yuan; the imported atopic dermatitis new drug dupilumab injection was included in the medical insurance in 2020, and its sales increased by 47486.2% the following year.

Before the on-site negotiations were officially launched, the National Medical Insurance Administration had organized fund calculations and pharmacoeconomics calculations, and conducted pre-negotiations with companies that passed expert reviews. A person in charge of an innovative pharmaceutical company once said: "From the previous communication, the adjustment rules of the medical insurance catalog this year are basically the same as last year. It is estimated that the overall tone will not change much, but this year will place more emphasis on high-quality and cost-effective innovation."

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