Compared with the previous two years, the number of drugs participating in this medical insurance negotiation has increased significantly. According to the list previously published by the National Medical Insurance Bureau, 343 drugs passed the formal examination this year, including 198 new drugs out of the catalogue and 145 new drugs in the catalogue. In addition, there are a number of drugs for serious diseases such as anticancer drugs and high-value rare diseases to participate in this year's national medical insurance negotiations.
There is no special change in the rules of this medical insurance negotiation. After two rounds of quotation, pharmaceutical companies will be out if they exceed the medical insurance reserve price 1 15%. If they fall into the scope, they will continue to negotiate and eventually form a negotiation price. However, two new regulations initiated by the national medical insurance negotiations this year-"simple contract renewal" and "non-exclusive drug bidding" have attracted much attention.
For the first time, two new regulations, "simple contract renewal" and "non-exclusive drug bidding", were implemented.
Due to the epidemic and other reasons, the national medical insurance negotiation in 2022 was postponed to June 5-8, 2023. During the negotiation, at around 8: 00 every morning, the negotiators of pharmaceutical companies waiting to enter the market gather outside the negotiation meeting. They are carrying bags and holding file bags with draft paper and calculators. They gather together and queue up to sign in.
The reporter learned from the scene that in the four-day national medical insurance negotiations, the focus of each day is different. The first day of negotiations focused on antiviral, respiratory and narcotic drugs; 65438+10.6 focused on drugs for cardiovascular, orthopedic and immune diseases; 65438+10.7 focusing on rare diseases and tumors is one of the focuses of this negotiation. On the last day of the negotiation, Chinese patent medicine was the main one.
Usually, the negotiation time of each pharmaceutical company is about 20-30 minutes. After the negotiation, many representatives of pharmaceutical companies who participated in the negotiation said that they felt good and the pressure was not great, and the decline was expected. Some representatives of pharmaceutical companies said that the state has great support.
In addition to the representatives of pharmaceutical companies, many people from the pharmaceutical industry gathered outside the negotiation meeting. A pharmaceutical industry analyst told reporters at the scene: "I am particularly concerned about the situation of' simple renewal' this year."
"Simple renewal" is one of the new highlights of this year's medical insurance negotiations. On June 29th, 2022, the National Medical Insurance Bureau issued the "Negotiated Drug Renewal Rules", which clarified the simple renewal rules for exclusive varieties. According to the regulations, the agreement is valid until June 5438+February 3, 20221.For drugs that meet five conditions at the same time, such as exclusive drugs, the actual fund expenditure during the agreement period does not exceed 200% of the fund expenditure budget (the enterprise's estimated value, the same below), and the fund expenditure budget is reasonably increased in the next two years, so it can be simply renewed, and the renewal period is valid for two years.
Some insiders have analyzed that "simple renewal" will help simplify the negotiation process, improve the efficiency of renewal, and ease the pressure of administrative examination and approval and enterprise declaration. Some innovative drugs with new indications are expected to be directly included in medical insurance through the "simple continuation" rule without renegotiation. This is an important positive for pharmaceutical companies.
A representative of a pharmaceutical company who participated in the "non-exclusive drug bidding" told reporters that their negotiations were not smooth: "Everyone has been bidding, depending on how low the price can be."
"Non-exclusive drug bidding" is another new regulation of this medical insurance negotiation. The Bidding Rules for Non-exclusive Drugs points out that if drugs are included in the drug list through bidding, the lowest quotation of each enterprise will be used as the payment standard for generic drugs. If the quotation of the enterprise is lower than 70% of the willingness to pay for medical insurance, 70% of the willingness to pay for medical insurance will be used as the payment standard for the drug. This means that if the quotation of pharmaceutical companies participating in "non-exclusive drug bidding" is lower, other pharmaceutical companies will passively enter medical insurance at this low price.
Anticancer drugs and rare diseases have become the focus of negotiations.
According to the list previously published by the National Medical Insurance Bureau, in 2022, 343 kinds of drugs formally passed the formal examination in the national medical insurance negotiations, including 198 kinds of western medicines and Chinese medicines out of the catalogue and 145 kinds of western medicines and Chinese medicines in the catalogue. Pacciclovir, an oral drug of Pfizer COVID-19, CAR-T drugs with millions of yuan per injection, PD- 1/PD-L 1 antineoplastic drugs and high-value drugs for rare diseases have attracted much attention.
65438+1 On the evening of October 8, the National Medical Insurance Bureau announced that the negotiation of paciclovir failed because Pfizer Investment Co., Ltd. quoted too high ... Previously, Paxlovid was conditionally approved by the State Pharmaceutical Products Administration on February12022, and it was also included in the temporary medical insurance in Beijing and Shanghai. According to the Notice of the National Medical Insurance Bureau and relevant departments on Optimizing the Relevant Policies of novel coronavirus Infected Patients' Medical Insurance after the Implementation of Class B Tube and novel coronavirus Infection Diagnosis and Treatment Scheme (Trial Tenth Edition), all therapeutic drugs, including paciclovir, azithromycin tablets, Danlawei capsules and Sanhan Chushi granules, will not be paid until March 3, 20231day.
The negotiation was the highlight of the second and third days, during which the enterprises participating in the negotiation included Bayer Pharmaceuticals, Baiyang Pharmaceuticals, Xi 'an Janssen, Yang Zijiang Pharmaceuticals, Hairong Pharmaceuticals, Jichuan Pharmaceuticals, Baekje Shenzhou, simcere and Junshi Bio. The list of drugs that passed the preliminary examination published by the National Medical Insurance Bureau shows that the drugs that these enterprises participated in the negotiations involved a variety of anticancer drugs, as well as some rare diseases and high-value drugs.
There are 0/9 kinds of drugs for rare diseases, including drugs for treating spinal muscular atrophy (SMA), Castleman disease, Fabray disease, Gaucher disease, multiple sclerosis and other rare diseases. For example, risperidone oral solution powder, an SMA drug of Roshi Pharmaceutical, participated in the national medical insurance negotiation last year, but failed in the end. Shandong medical device purchasing platform shows that Roche Pharmaceuticals has previously lowered the price of Lipron oral solution powder from 10000/ tablet to 10000/ tablet.
Since 20 18, the national medical insurance bureau has included 19 rare diseases in the medical insurance drug list through negotiations, with an average decline of up to years. During the medical insurance negotiation, the SMA therapeutic drug Nose Sodium Injection developed and produced by Bojian Company was reduced from 700,000/needle to 1 10,000/needle. At that time, Zhang, the negotiator of the National Medical Insurance Bureau, touched many people with his speech that "every small group should not be abandoned".