After more than 20 days of soliciting opinions, the documents related to the national medical insurance negotiation in 2024 (hereinafter referred to as "national negotiation") were recently released, and the seventh adjustment of the national medical insurance catalog since 2018 officially started. In terms of product structure, the operating income of 10-30 billion yuan products is 401/1288/60 million yuan respectively, with an overall sales volume of 18,000 kiloliters, a year-on-year increase of +28.10%, showing significant growth.
Industry experts told reporters that compared with the draft for comments and the national negotiation documents in recent years, the detailed rules and bidding rules of this year's national negotiation documents have changed very little. This indicates that the operating rules of the national negotiation have become mature, gradually standardized and standardized, and have been recognized by enterprises, experts, and leaders. For enterprises, it is more predictable and operable.
It has been noted by reporters that this year's medical insurance negotiation involves more than 300 varieties, more than half of which are Chinese products. There is no lack of heavyweight varieties from well-known innovative pharmaceutical companies such as Hengrui Pharmaceuticals, Simcere Pharma, Sino Biopharm, Akeso, and CMS. In addition, some pharmaceutical companies have been approved for listing before negotiations, or have directly started to actively lower prices in order to be included in the negotiations.
The rules of national negotiation are becoming more and more mature, and the landing of "national negotiation drugs" has reached 430 channels.
Recently, the National Medical Insurance Bureau officially issued an announcement on the publication of the "Work Plan for the Adjustment of the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogs" (hereinafter referred to as the "Plan") and the Declaration Guide, totaling four Documents. The 2024 national negotiation application process will take place in July and August, and expert evaluations will be conducted in August and September. Negotiations and bidding will take place from September to November, and the results will be announced in November with the publication of the new version drug catalog.
According to the above documents, this year’s national negotiation extends the time requirements for drugs that have been approved for sale or have modified indications, and these drugs can be submitted for review if they have been approved for listing or modification from January 1, 2019, to June 30, 2024. In addition, conventional catalog drugs that have not supplied designated medical institutions for medical insurance and negotiation drugs that have not guaranteed market supply according to the agreement within the past three years may be removed from the medical insurance catalog.
It has been noted by reporters that compared with previous years, the "Non-exclusive Drug Bidding Rules" and the "Negotiation Drug Renewal Rules" of this year's national negotiation were not subjected to external opinions during their release and were not delayed compared to previous years, but were released together with the other four documents.
"Compared with the national negotiation documents in recent years, the changes to this year's documents are not significant except for the addition of the statement for drugs that have entered the routine catalog management after being evaluated by experts with expired payment standard validity periods." Wuhan Harui Pharmaceutical's general manager Lu Chuanyong told reporters from Cai Lian She that since the national negotiation started in 2018, it has been successfully operated for six years. Through continuous accumulation of experience, problems discovery and problem solving, the national negotiation rules have been iterated continuously. They have gradually matured and become standardized.
Zhang Tingjie, a medicine access expert and founder of Fengyun Youtang, also agrees with the above view. He told reporters that from the fact that bidding rules and renewal documents were not solicited for opinions like last year, the national negotiation rules have become relatively mature and have been recognized by enterprises, experts and leaders.
"This is a good thing for enterprises. The predictability of national negotiation has increased, and enterprises have more information to follow if they want to promote their varieties. "Lu Chuanyong added.
Public information shows that 744 drugs have been included in the medical insurance catalog after the national medical insurance negotiation. However, in practice, some negotiation drugs for the treatment of major diseases have not really entered the hospital even though they are included in the medical insurance drug catalog, becoming one of the issues of concern to insured people.
In order to promote the solution to this problem, the National Medical Insurance Department and the Health Commission jointly launched the "dual-channel" mode of including retail pharmacies in the negotiation drugs. The National Medical Insurance Bureau recently stated that since its implementation three years ago, the "dual-channel" national negotiation drugs have increased from 221 to 430 kinds, and the sales amount of "national negotiation drugs" in Jiangsu alone has increased from less than 4 billion yuan in 2020 to more than 12 billion yuan in 2023.
According to the Pharmaceutical Information Cloud database, more than 320 drugs meet the application conditions for participation in the 2024 national negotiation, of which more than 160 are domestically produced drugs, involving enterprises including Hengrui Pharmaceuticals, Sichuan Kelun Pharmaceutical, SSY Group, and Humanwell Healthcare.
As the approval deadline for participating in national negotiations is June 30th this year, many products were approved for sale at the last minute. The drug approval certificate information released by the National Medical Products Administration on June 18th shows that innovative drugs such as Jingyi Ruiti's trametinib hydrochloride tablets, Positive Dayclear's citrate afatinib capsules, and CMS' methylene blue enteric-coated modified-release tablets have all been approved for sale.
In addition, Simcere Pharma's innovative anti-cancer drug company, Simcere Zenming, has partnered with Mai Bo Pharma (02181.HK) to launch a new generation of EGFR antibody drug cetuximab beta injection, which has recently been approved for listing by the National Medical Products Administration.
Previously, Professor Hu Shanlian of Fudan University School of Public Health published an article analyzing that in recent years, the average price reduction of drugs negotiated by medical insurance has been around 50%-60%, and the success rate of negotiations has been increasing year by year, exceeding 80% in 2022.
According to last year's national negotiation renewal situation, 70% of the 100 drugs up for renewal were renewed at the original price, and 31 varieties needed to be priced down due to sales exceeding expectations, but the average reduction was only 6.7%.
The above two experts in the industry unanimously told Cailianshe reporters that they expect the number and proportion of drugs that pass the formal review through national negotiations and finally enter the medical insurance list this year, as well as the renewal situation, to remain relatively stable. As the rules gradually mature, the attractiveness of drugs in the national medical insurance catalog is increasing year by year, and the desire of companies to participate in national negotiations to enter medical insurance is also continuously increasing. "Qualification for medical insurance catalog has become a compass affecting the future development of companies."
Cailianshe reporters learned that before June 30th, several well-known innovative drug companies took the initiative to reduce the prices of heavy-duty drugs that met the national negotiation conditions.
On June 18, Akeso Bio lowered the price of its dual-antibody new drug Calduline single-chain antibody from 13220 yuan/125mg/bottle to 6166 yuan/125mg/bottle, a decrease of 53.4%. Calduline single-chain antibody is an independently developed tumor immune bispecific antibody new drug, which was approved for listing on June 29, 2022.
Cailianshe reporters verified with Akeso Bio that the price reduction was to prepare for participation in medical insurance.
Multinational corporations seem to be more interested in national negotiations. On June 18th, the Office of the Hubei Provincial Medical Security Bureau announced the adjustment of the price information of some online drugs, and AstraZeneca's DS-8201 trastuzumab deruxtecan was reduced from the original 8860 yuan/dose to 6912 yuan/dose.
Cailianshe reporters learned that the drug is known as the "ADC super drug" with a usage fee of between 300,000 and 500,000 yuan before the price reduction. The drug participated in national negotiations last year but was not successful in negotiations. After attempting to reduce the price this year, it has made a comeback.
There is also Roche Pharmaceuticals, according to the Liaoning Province Drug and Medical Consumables Centralized Purchasing Network, its heavyweight ADC variety injection drug Enhertu was reduced from 10,400 yuan/30mg/bottle to 9,580 yuan/30mg/bottle, a reduction of about 7%. The variety similarly "failed" in national negotiations last year.
"There is a conventional rule in national negotiations that the annual treatment cost cannot exceed 300,000 yuan. If there is sincerity, it is a must to enter medical insurance, and the price reduction must be done before the application." Industry experts told Cailianshe reporters.