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1. Overview of domestic innovative drug medical insurance negotiations in 222 Since 217, China's drug negotiation mechanism has gradually entered the normalization stage, basically maintaining the frequency once a year. Up to now, five batches of negotiations have been completed from 217 to 221, and the negotiation of medical insurance drugs in 222 is about to enter the negotiation/bidding stage.

1.1. Overall workflow: *** 5 stages, and it is expected to enter the negotiation/bidding stage in November. On June 29, 222, the National Medical Insurance Bureau announced the Work Plan for the Adjustment of the National Drug List of Basic Medical Insurance, Work Injury Insurance and Maternity Insurance in 222. According to the adjustment work plan, the work flow of the national drug list adjustment in 222 is divided into preparation, declaration, expert review and negotiation/bidding stages.

1.2. Changes in contract renewal rules: Innovating the negotiation policy of drug medical insurance contract renewal and improving it. On June 29th, 222, the National Medical Insurance Bureau issued the Contract Renewal Rules for Negotiated Drugs and the Bidding Rules for Non-exclusive Drugs, which made detailed provisions on the contract renewal procedures of medical insurance drugs for the first time. On October 12th, the National Medical Insurance Bureau issued the Reply of the National Medical Insurance Bureau to the No.1599 Recommendation of the Fifth Session of the 13th National People's Congress, which responded to the proposal of Sun Piaoyang, the chairman of Hengrui Pharma, on "improving the medical insurance access rules for new indications of innovative drugs with multiple indications". The reply mentioned that "it needs to be specially explained that in the process of negotiating drug renewal in 222, we fully considered the opinions and suggestions of relevant parties and included the new indications in the scope of simple renewal". Judging from the Rules for Renewing the Contract of Negotiated Drugs issued on June 29th, the added value of the fund expenditure budget in the next two years due to the adjustment of the payment scope (i.e. new indications) for new indications to be included in the simple renewal requires that the increase be no more than 1% compared with the higher of the fund expenditure budget of the original payment scope and the actual fund expenditure during this agreement period. This time, the medical insurance bureau replied that "the opinions and suggestions of relevant parties should be fully considered, and the new indications should be included in the scope of simple contract renewal", indicating that the relevant contract renewal rules may be further improved in the future.

( 1) Contract renewal rules for negotiated drugs At present, the contract renewal methods for negotiated drugs can be divided into three forms: being included in the regular catalogue management, simple contract renewal and renegotiation: 1) being included in the regular catalogue management: non-exclusive drugs, or exclusive drugs that entered the catalogue after negotiation in 218, and the payment standard and payment scope have not been adjusted for two consecutive agreement cycles; 2) Simple contract renewal: exclusive drugs, the actual expenditure of the fund during this agreement period does not exceed 2% of the estimated value, the increase of the fund expenditure budget in the next two years is reasonable, the market environment has not changed significantly, and it does not meet the conditions for inclusion in the regular catalogue management; 3) renegotiation: exclusive drugs, drugs that do not meet the conditions of being included in the regular catalogue management and simple renewal.

2) Simple contract renewal rules From the above conditions of drugs included in the simple contract renewal procedure, drugs whose medical insurance expenditure increases within 2% as a whole can be included in the simple contract renewal. Among them, simple renewal is mainly divided into two types: adjusting the payment scope and not adjusting the payment scope.

drugs whose payment scope is not adjusted: based on the ratio of actual fund expenditure to fund expenditure budget (ratio of actual fund expenditure to fund expenditure budget = ratio A), determine the decrease of payment standard;

drugs with adjusted payment scope: (1) calculate the decline of the original medical insurance payment scope to form a preliminary payment standard; (2) Compare the increased value of the fund expenditure budget caused by adjusting the payment scope with the higher of the fund expenditure budget of the original payment scope and the actual expenditure of the fund during the agreement period (the increased value of the fund expenditure budget caused by adjusting the payment scope in the next two years/the higher of the fund expenditure budget and the actual expenditure of the fund during the agreement period = ratio b), and adjust it according to the following rules on the basis of the preliminary payment standard to form the final payment standard. According to the current simple contract renewal rules, the price of innovative drugs will drop between % and 44% after the new indications are added (the scenario corresponding to the maximum drop of 44% is that the drugs whose payment scope is adjusted will be reduced by 25% on the basis of the original payment standard of medical insurance, and then reduced by 25% on the basis of the initial payment standard to form the final payment standard, which should be noted that this situation is extreme), and it is possible to renegotiate 5% ~.

2) The payment standards for drugs included in the regular catalogue management and renegotiation rules are as follows:

( 2) The bidding rules for non-exclusive drugs are compared with the willingness to pay for medical insurance. As long as one enterprise participates and the bidding price is not higher than the willingness to pay for medical insurance, the generic drug will be included in the B part of the drug catalogue, otherwise it will not be included; If the drug is included in the drug list through bidding, the lowest price quoted by each enterprise shall be taken as the payment standard of the generic drug. If the price quoted by the enterprise is lower than 7% of the willingness to pay for medical insurance, 7% of the willingness to pay for medical insurance shall be taken as the payment standard of the drug.

1.3. Negotiation trend of innovative drugs: innovative drugs are the mainstream, but not the only choice

1.3.1. Advantages and disadvantages of participating in the negotiation to enter the medical insurance catalogue: the advantage lies in accelerating the amount of hospital admission, and the disadvantage lies in the need to significantly reduce the price

The advantage of participating in the negotiation of innovative drugs to enter the medical insurance catalogue-accelerating hospital admission: innovative drugs are expected to improve the difficulty of access after entering the medical insurance, and achieve rapid penetration of hospitals and pharmacies. In the aspect of entering the hospital drug list, it is expected to lower the threshold of entering the hospital and accelerate the efficiency of entering the hospital after entering the medical insurance; In terms of entering the pharmacy, it is expected that drugs will enter the pharmacy through the "dual-channel" management mechanism of national medical insurance negotiations after entering the medical insurance, so as to accelerate the volume.

the advantage of innovative drugs entering the medical insurance catalogue through negotiation-accelerating sales growth: innovative drugs are expected to increase their volume after entering the medical insurance catalogue. Take the 17 drugs transferred to the medical insurance catalogue in 218 as an example, their average sales before being transferred to the medical insurance catalogue were 9 million yuan, and the average sales after being transferred to the catalogue reached 31 million yuan; In 219, the average sales of 7 drugs transferred to the medical insurance catalogue was 5 million yuan before being transferred to the medical insurance catalogue, and the average sales after being transferred to the catalogue reached 9 million yuan. The changes in sales of the varieties negotiated in the above two years before and after the transfer indicate that the inclusion of drugs in medical insurance can indeed accelerate the growth of product sales.

Disadvantages of innovative drugs entering the medical insurance catalogue through negotiation: Judging from the average price reduction range of related drugs in previous medical insurance negotiations, the average price reduction of drugs entering the medical insurance catalogue through medical insurance negotiations is about 5-6%, and it may be difficult for some products to exchange price for quantity.

1.3.2. Participation in the negotiation: At least 22 domestic innovative drugs participated for the first time, and 13 drugs chose innovative drugs that did not participate in the medical insurance negotiation for the first time: According to the List of declared drugs that passed the preliminary form review, at least 22 domestic innovative drugs (including imported products) participated in the medical insurance negotiation for the first time in 222.

According to enterprises, three innovative drugs participated in the medical insurance negotiation for the first time in Hengrui Pharma, Baekje Shenzhou and Zaiding Medicine both had two new drugs, and Kangfang Bio, Fuhong Hanlin, Corning Jerry/Sildi/Xiansheng, Yasheng Bio/Cinda Bio, and Huang Pharmaceutical all had new drugs to participate in the medical insurance negotiation.

According to the varieties, among the PD-1/PD-L1 drugs, Kangfang Bio's PD-1/CTLA-4 double antibody, Fuhong Hanlin's PD-1 monoclonal antibody, Kangning Jerry/Silodi/Xiansheng's PD-L1 monoclonal antibody participated in the medical insurance negotiation for the first time; In the aspect of CDK4/6 inhibitor, Dalsili of Hengrui Pharma participated for the first time; As for CAR-T drugs, Regiosai of Yaoming Junuo participated for the first time; Among non-tumor drugs, drugs such as azvudine are also participating in medical insurance negotiations for the first time.

Domestic innovative drugs that were eligible to participate in the 222 medical insurance negotiation but did not participate: At least 13 domestic innovative drug products were eligible to participate in this year's medical insurance negotiation in 222, but did not participate in the end. These drugs can be mainly divided into: (1) drugs with a wide range of indications, such as PD-1 drugs, whose prices have been reduced to a very low level by the listing of similar products; (2) Exclusive products and drugs without competing products.

for drugs with a wide range of indications corresponding to targets such as PD-1 monoclonal antibody, it has become the choice of some manufacturers to maintain high prices and not enter medical insurance. From the sales of PD-1 monoclonal antibody in sample hospitals in the first half of 222: Pabolizumab >; Karelizumab >: Trelizumab >: Cindilizumab, considering that the price of imported product Pabolizumab, which is not in the medical insurance catalogue at present, is much higher than that of domestic PD-1 monoclonal antibody, suggests that maintaining high price strategy may be one of the optional strategies for drugs with a wide range of indications such as PD-1.

2. Sorting out the negotiation of innovative drugs for key tumors

2.1. PD-1/PD-L1 drugs: 7 domestic drugs participated in this negotiation

(1) The participation of PD-1/PD-L1 drugs in this medical insurance negotiation. Among the domestic PD-1/PD-L1 drugs, Hengrui Pharma, Baekje Shenzhou and PD-L1 have participated in this medical insurance negotiation before. PD-1 monoclonal antibodies from four companies, including Junshi Bio, and PD-1/CTLA-4 monoclonal antibody from Kangfang Bio, PD-1 monoclonal antibody from Fuhong Hanlin, and PD-L1 monoclonal antibody from Kangning Jerry/Silodi/simcere, which passed preliminary examination; There are Kangfang Bio/Zhongsheng Pharmaceutical PD-1 monoclonal antibody, Cornerstone Pharmaceutical PD-L1 monoclonal antibody, Yuheng Bio-PD-1 monoclonal antibody and Lepu Bio-PD-1 monoclonal antibody that do not participate in this medical insurance negotiation. Among them, three products of Kangfang Bio/Zhongsheng Pharmaceutical, Cornerstone Pharmaceutical and Yuheng Bio are eligible to participate in this medical insurance negotiation (approved for listing on June 3, 222), but they have not passed the preliminary form review. As for the import of PD-1 monoclonal antibody or PD-L1 monoclonal antibody, all the four imported PD-1 monoclonal antibodies or PD-L1 monoclonal antibodies in this medical insurance negotiation are not on the list that passed the preliminary examination. Generally speaking, there are a large number of PD-1/PD-L1 monoclonal antibodies that have been approved for listing in China. * * Nine PD-1 monoclonal antibodies (7 made in China and 2 imported), four PD-L1 monoclonal antibodies (2 made in China and 2 imported) and one PD-1/CTLA-4 monoclonal antibody (made in China) were approved.

( 2) Current annual treatment cost (calculated according to the medication time of 12 months): 1) The annual treatment cost of Hengrui Pharma Karelizumab and Baekje Shenzhou Tilelizumab is about 52,-53, yuan, that of Cinda Bio-Cindilizumab is about 39, yuan, and that of Junshi Bio-Treprilizumab is about 34, yuan. 2) Products that are expected to participate in the medical insurance negotiation for the first time: the annual treatment fee of fuhong Hanlin siluzumab is about 268, yuan, and it is about 67, yuan after charitable assistance; The annual cost of Kangning Jerry/Sidi/simcere envolimab treatment is about 287, yuan, and it is about 72, yuan after charity assistance; The annual treatment fee of Kangfang Bio-cardonizumab is about 952, yuan, and it is about 198, yuan after charitable assistance. 3) Products that are not expected to participate in this medical insurance negotiation: the annual treatment fee of Kangfang Bio/Zhengda Tianqing Ampley monoclonal antibody is about 234, yuan, and it is about 39, yuan after charitable assistance; The annual treatment cost of Shuglimab is about 446, yuan, and it is about 99, yuan after charitable assistance. The annual treatment fee of Cepalimab is about 158, yuan.