According to multiple sources in the industry, from October 16 to 18, the National Medical Insurance Administration conducted pre-negotiations with companies that passed expert reviews. As in last year, "pre-negotiations" give companies ample opportunities for communication. Before the formal negotiations, the National Medical Insurance Administration specially organized experts and companies that intend to participate in the negotiations to fully communicate around the payment standard calculations for the intended negotiated products. The medical insurance party and the enterprise party first go through a round of "pre-negotiations" before the formal negotiations, which can facilitate the enterprise party to more fully understand the negotiation rules, and when the formal negotiations are held, the results will be relatively ideal.

Previously, the National Medical Insurance Administration had organized fund calculations and pharmacoeconomic calculations in Xiaotangshan, Beijing. On September 19, the National Medical Insurance Administration held an on-site communication meeting for companies to negotiate/bid in Beijing. Last month, the National Medical Insurance Administration organized experts to review the drugs submitted for the formal review of the 2024 national medical insurance catalog adjustment and completed the review work.

This year, a total of 445 drugs passed the formal review, including 249 outside the catalog and 196 in the catalog. Among them, many drugs have actively applied for price reductions, including cardunilizumab, detrastuzumab, vepotuzumab, anti-osteophyte tablets, etc., with a reduction of 53.4%, 22%, 7%, and 6% respectively. According to the "2024 National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalog Adjustment Work Plan", this year's national medical insurance catalog adjustment is expected to complete the negotiation/bidding stage from September to November and announce the results.

In recent years, "115%" and "envelope price" have become the key to the negotiation. According to the rules of previous negotiations, the on-site negotiations are quoted by the enterprise, and there are generally two opportunities to quote and confirm. If the price confirmed by the enterprise after the second confirmation is higher than 115% (not included) of the medical insurance negotiation floor price, it means the failure of the negotiation and the termination of the negotiation; otherwise, it enters the stage of negotiation between the two parties, and the price finally agreed upon by the two parties-cannot be higher than the medical insurance envelope price.

During the on-site negotiation/bidding, the negotiation/bidding will be organized according to the evaluation opinions, and the negotiation/bidding result confirmation will be signed on-site. For drugs that have successfully negotiated/bid, a unified national medical insurance payment standard will be determined. At the same time, the National Medical Insurance Administration will organize companies that have successfully negotiated and simplified renewals to sign agreements, which will clearly define the terms for guaranteeing drug supply and include them in the assessment management, and urge companies to take practical measures.

In terms of overall rules, this year's medical insurance negotiation/bidding and renewal rules are basically the same as last year. So far, my country has conducted 8 rounds of medical insurance drug negotiations for innovative drugs, and the average price reduction of innovative drugs selected for the first time is basically between 40% and 62%. Southwest Securities pointed out in a research report that from the average price reduction of new varieties in medical insurance negotiations from 2019 to 2022, they were 61%, 51%, and 62%, respectively; the average sales reduction in the first year of medical insurance reached 2692%, 5697%, and 15367%, respectively.

In recent years, the rules for medical insurance negotiations have become more stable, and the success rate of medical insurance negotiations has shown an upward trend from 2019 to 2023. In particular, the possibility of innovative drugs being included in the medical insurance catalog due to policy bias has increased significantly. First, in the review stage, support innovative drugs to be included in the catalog first, organize experts to conduct graded evaluations on the degree of drug innovation and clinical benefits, so that the innovative advantages of drugs can be transformed into access advantages; second, for renewal varieties, for innovative drugs that trigger the simplified renewal price reduction mechanism, companies are allowed to apply for renegotiation, and the reduction determined by the renegotiation can be smaller than the reduction of the simplified renewal, so that innovative drugs with large clinical usage can continue to renew with medical insurance with a relatively small price reduction.

In this round of national negotiations, PD-1, third-generation EGFR-TKI, autoimmune, and ADC drugs are all the focus of attention. Guotai Junan Securities pointed out in a research report that the overall pattern of PD-1/PD-L1 monoclonal antibodies is stable, and indications continue to expand; in the field of bispecific antibodies, two domestic bispecific antibodies, Cardunili and Ivosi, have passed formal review; in the field of ADC, many imported products have passed formal review, and the prices of non-catalog varieties have been actively reduced; in the field of EGFR-TKI, befortinib has added a single-drug first-line indication, and osimertinib has added a first-line indication of combined chemotherapy; in the field of autoimmune, the overall competitive pattern is stable, and many products have expanded new indications.

It is worth noting that in the national negotiations over the years, in addition to whether the drugs can enter the national negotiation drug catalog, the landing and hospital entry are also the focus of industry attention. It has been more than ten months since the 2023 medical insurance catalog was implemented. According to incomplete statistics from Cyber Blue, as of now, 21 provinces have clearly defined the time limit for holding drug affairs meetings. For example, according to the requirements of Zhejiang Province, tertiary hospitals are required to hold drug affairs meetings every quarter in principle. In addition, the Zhejiang Provincial Medical Insurance Bureau also regularly publishes the allocation of national negotiated drugs in tertiary medical institutions, and discloses the number of national negotiated drugs entering hospitals and the allocation of various cities. With the 2024 national negotiations approaching, the pharmaceutical market will undergo a new round of reshuffle.

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