On August 7, Caixin reported that this evening, the National Medical Insurance Bureau published the list and information of drugs that passed the preliminary review of the adjustment of the national medical insurance catalog in 2024 in a preliminary form, receiving 626 company application information and 440 drugs passed the preliminary review.

Caixin reporters noted that compared with last year, the number of drug applications submitted by companies has increased this year. Except for the igorolon injection of reindeer biology, almost all domestic CAR-T varieties have been brought together, and heavyweight innovative drugs such as Beigene's datuximab β injection, Simcere Pharma's new generation EGFR antibody drug situximab β injection, and Akeso's autonomous research and development of tumor immunotherapy bispecific antibody new drug candenilimab injection are all included.

Experts in the industry told Caixin that the attractiveness of the national medical insurance catalog is increasing year by year, and it has become a crucial threshold for the commercialization of innovative drugs. The increase in the number of drug applications this year is a powerful manifestation of the entire chain supporting the development strategy of innovative drugs. Some experts predict to reporters that this year may see the first CAR-T drug included in the medical insurance catalog.

As the enthusiasm of companies participating in negotiations has risen again, what will be the success rate and price reduction this time?

Today, the National Medical Insurance Bureau released the "Announcement on the Publicization of Drug Lists and Related Information for the Adjustment of the National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Lists in 2024 Passed the Preliminary Formal Review". According to the work arrangement, the formal review is mainly divided into four steps: preliminary review, preliminary review results announcement, re-examination, and re-examination results announcement. The content of this announcement is the preliminary review results for this year.

The National Medical Insurance Bureau revealed in the synchronous interpretation that from 9 am on July 1, 2024 to 5 pm on July 14, the National Medical Insurance Bureau received 626 company application information involving a total of 574 drugs (generic names, the same below) . After the audit, 440 drugs passed the preliminary formal review.

It is reported that in the 2023 national medical insurance catalog adjustment, a total of 629 company application information involving 570 drugs was received, and 390 drugs passed the preliminary formal review. Compared with 2023, the number of drug applications submitted this year has increased.

The National Medical Insurance Bureau emphasized that some drugs with high prices and obviously beyond the scope of basic medical insurance coverage have passed the preliminary formal review, only indicating that the drugs meet the application conditions and have obtained the qualifications to enter the next link. Whether such drugs can eventually be included in the national medical insurance drug list depends on the strict review procedure, and negotiation is required for exclusive drugs and bidding is required for non-exclusive drugs. Only after successful negotiation or bidding can they be finally included in the catalog.

Yang Tao, a senior executive of a listed innovative drug company and a senior expert in the pharmaceutical industry, told Caixin reporters that the increase in the number of drug applications this year is a powerful manifestation of the overall strategic deployment of the national support for the development of innovative drugs.

"Obviously, companies' enthusiasm for national negotiations has risen again this year!" Zheng Pei, general manager of Henan Dongxiao Enterprise Management Consulting Co., Ltd., told Caixin reporters that as the coverage of national medical insurance continues to increase and the scale of the insured population continues to expand, the national medical insurance catalog has become the most important channel for many companies to invest heavily in research and development of innovative drugs for commercialization and realization.

However, Xu Yucai, a senior medical reform expert, is more cautious, and he believes that because the price has been lowered, the clinical usage and the company may not benefit or achieve ideal benefits, so he can only be cautiously optimistic. "So I think that the average price reduction rate this year will be more gentle, but the success rate of the negotiation may not create a new high, but will be the same as in previous years."

Zheng Pei believes that the average price reduction rate this year may be larger. He analysis that the National Medical Insurance Bureau has increased its efforts in hospital admission, sales, and evaluation of medical insurance products, as well as the launch of DRG grouping 2.0. Coupled with the previous violations in the national centralized procurement and the anti-corruption measures in the pharmaceutical industry, the average price reduction rate of this year's national negotiations is expected to break historical records.

According to previous announcements from the National Medical Insurance Bureau, in the three years of implementation, the number of "two-way" state-negotiated drugs has expanded from 221 to 430. Only in Jiangsu, the sales amount of "state-negotiated drugs" has increased from less than 4 billion yuan in 2020 to more than 12 billion yuan in 2023.

According to the official account of the National Medical Insurance Bureau, in late July, the National Medical Insurance Bureau launched a flying inspection of the National Medical Insurance Fund in Qinghai and Hubei. According to the work arrangement, the inspection team will focus on inspecting the use, management, and related internal control system construction and implementation of medical insurance funds in the designated public medical institutions, designated social medical institutions, and designated chain pharmacies in Wuhan from 2022 to 2023.

Several heavyweight innovative drugs are listed, will there be breakthroughs in CAR-T this year?

According to the preliminary catalog review, the number of drugs outside the catalog that have passed the preliminary formal review is 196, which is slightly lower than the 226 products outside the national dialogue last year.

Many heavyweight innovative drugs are on the list of drugs that have passed the preliminary formal review. For example, AstraZeneca's blockbuster CAR-T variety, Enhertu injection under Fosun Pharma (600196.SH), is the earliest CAR-T therapy to be launched in China. It is the first CAR-T therapy in China to sprint for medical insurance. During the adjustment of the medical insurance catalog in 2021, Enhertu injection was reviewed by medical insurance for preliminary formal review, but ultimately failed to sit at the negotiating table. In 2022, this drug did not appear in the declared drug list that had passed formal review.

In terms of CAR-T varieties, there are also Rubiginous Injection under Pharmaron-B (02126.HK), Najin Injection under Heyuan Biological Technology (Tianjin) Co., Ltd., and Zvero Injection under Congenital Enterprise-B (02171.HK), which means that in addition to Iqvia Injection under Reindeer Biotechnology, other domestic CAR-Ts have all appeared in the list of drugs that have passed preliminary formal review this time.

It is worth mentioning that the CAR-T varieties of Fosun Kaitai and Pharmaron-B were both reviewed by preliminary formal review last year, but did not appear in the 2023 medical insurance catalog.

"This year may have a breakthrough in zero for CAR-T varieties." Yang Tao analyzed that the biggest problem restricting CAR-T drugs from entering medical insurance is that their annual treatment costs are all in the millions, but at present, there are more and more domestic CAR-T varieties, and who can be included in medical insurance first may become the most critical competition and commercialization process, especially Fosun Kaitai, under the support of the whole society for the full chain of innovative drug development, may be the "first to eat crabs."

In addition to CAR-T varieties, many innovative anti-cancer drugs also appeared in the list of drugs that passed preliminary formal review outside the catalog. For example, Beigene's Dutuximab beta injection, CSPC Pharma's (01093.HK) PD-1 variety Enrosova injection, and CMS's (00867.HK) methylene blue enteric-coated sustained-release tablets.

The new generation EGFR antibody drug Sicrituzumab beta injection under Xiansheng Pharmaceutical's anti-tumor innovative drug company Xiansheng Zaiming and Mayboshi Pharmaceutical (02181.HK) has also appeared in the preliminary review list. Previously, Xiansheng Pharmaceuticals' Sicrituzumab beta injection was approved on the line and obtained the qualifications to participate in the national dialogue.

Kangfang Biological's independently developed tumor immune bispecific antibody new drug Cardulinumab injection has also passed the preliminary review. On June 18, Kangfang biotech reduced the price of its bispecific new drug Cardulinumab to 6,166 yuan/125mg/bottle, a 53.4% decrease from 13,220 yuan/125mg/bottle.

Earlier, Caixin reporter verified from Kangfang Biological that the price reduction was to prepare for medical insurance participation.

There is also the "ADC super miracle drug"-AstraZeneca's Enhertu injection (DS-8201) also passed the preliminary review, and the intention to come back is obvious. In June, the Hubei Medical Insurance Bureau Office issued a notice to publicly adjust the price information of some ene meshed drugs. AstraZeneca's Enhertu injection (DS-8201) was reduced from the original 8,860 yuan/branch to 6,912 yuan/branch.

"Foreign companies may still consider being a little reserved in lowering prices in a 'price dip', but domestic companies relatively have no concerns or influence from global market prices, so this year's national dialogue will be a game for many domestic innovative drugs, very much looking forward to it!" Yang Tao said so.