From today (July 1), the adjustment of the 2024 medical insurance drug list will be officially launched. Compared with the draft for comments and the national negotiation documents in recent years, the detailed rules and bidding rules of the 2024 national negotiation documents have changed less, and the operating rules of the national negotiations have gradually matured, so the predictability of the national negotiations has also improved.
Which drugs are expected to be included in the list? What are the key points of this year's adjustment of the medical insurance drug list? According to the analysis and collation of Xinkangjie, there are more than 300 varieties that meet the conditions for 2024 medical insurance negotiation, and more than half of them are Chinese-made varieties, including Hengrui Pharmaceutical, Simcere Pharmaceutical, China Biopharmaceutical, Akeso Biologics, and CMS Pharmaceutical.
01
70% of the drugs are renewed at the original price
This year, the adjustment of the medical insurance drug catalogue has been postponed according to the rules for the time requirements for drug approval and modification of indications. Drugs that have been approved for marketing or have modified indications after January 1, 2019 can be declared. This means that more new drugs will be included in the National Reimbursement Drug List.
At the end of June, some pharmaceutical companies were approved before the national talks. On June 25, according to the official website of the State Food and Drug Administration, a total of 130 product acceptance numbers were approved, including 26 new drugs. For example, Haisco's Class 1 new drug copagliptin tablets, Luye Pharma's rotigotine microspheres for injection, and Nanjing Youke's clevidipine emulsion injection.
A partial list of products that are expected to be included in the 2024 medical insurance catalog
Source: Public information, compiled by Xinkangjie
Copagliptin is the first biweekly formulation of hypoglycemic drugs in mainland China. The product has just been approved, and the first year of listing is in the new product development period, and due to the influence of factors such as the development progress of the hospital, it is not possible to accurately estimate the sales volume in the first year of listing. However, Haisco is currently actively participating in the national talks and striving to be included in the medical insurance, and it is predicted that the sales revenue of this product will gradually increase in the later stage.
Yesterday (June 30), Wu Qingyi, deputy general manager and chief commercial officer of Dizhe Pharmaceutical, said in an interview that striving to include the two approved products in the national medical insurance catalogue is the core goal of the commercialization of Dizhe Pharmaceutical Business this year.
It is reported that Dizhe Pharmaceutical's golixitinib (Gao Ruizhe) and suvotinib (Suvozhe) are eligible, of which golixitinib was approved for marketing on June 18, and the first batch of prescriptions in the country was issued on June 27. As an innovative product that has received priority review, it is expected to be included in the medical insurance catalogue through this year's medical insurance negotiations.
In addition, companies such as Roche and AstraZeneca are also poised to take off. According to the Liaoning Provincial Centralized Procurement Network for Drugs and Medical Consumables, recently, the price of Roche's blockbuster ADC variety vepotuzumab for injection dropped from 10,400 yuan/30mg/bottle to 9,580 yuan/30mg/bottle, a decrease of about 7%. This variety was also "folded" in last year's national talks.
Detrastuzumab, known as the "ADC super miracle drug", has also dropped from the original 8860 yuan/piece to 6912 yuan/piece, a decrease of more than 50%. Last year, AstraZeneca's drug participated in the national negotiations, but the negotiations were not successful, and this year it tried to reduce the price and "made a comeback".
It is not useless to increase the probability of entering health insurance by reducing prices. In recent years, the average price reduction of drugs negotiated by medical insurance is basically 50%-60%, and the success rate of negotiation has been increasing year by year, exceeding 80% in 2022. Judging from the renewal of the national talks in 2023, among the 100 renewed drugs, 70% of the drugs were renewed at the original price, and 31 varieties needed to be reduced because their sales exceeded expectations, but the average decline was only 6.7%.
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After entering insurance, it was reduced from 700,000 yuan to 30,000 yuan per injection
Sales surged 294%
Judging from the drugs transferred out of the catalog, the number of drugs transferred out of the catalogue has decreased year by year in the past five years. In 2019, a total of 150 varieties were transferred from the medical insurance catalog, and a total of 79 varieties were transferred except for drugs whose number was revoked by the State Food and Drug Administration.
In 2020, 29 drugs were transferred out of the catalog, mainly for varieties with low clinical value and can be replaced, or the drug regulatory department has revoked their document numbers and become "zombie drugs". From 2021 to 2023, a total of 15 drugs will be removed from the list.
From the perspective of drugs transferred to the catalog, at present, the proportion of newly listed drugs in the five years of newly enhanced medical insurance in the current year has increased from 32% in 2019 to 97.6% in 2023. Taking 2023 as an example, a total of 57 varieties will be "approved in the same year and included in the catalogue in the same year".
After the previous six rounds of adjustments, a total of 744 new drugs have been added to the National Medical Insurance Drug Catalogue, including 446 new drugs through negotiation, most of which are newly launched in recent years and have high clinical value, covering 31 therapeutic areas in the catalogue.
The most well-known to the Chinese public is nusinersen sodium, which has undergone "soul bargaining" and has been reduced from 700,000 yuan to 30,000 yuan per injection and entered the national medical insurance, with global sales reaching $1.7 billion in 2023, and it is also the best-selling small nucleic acid drug among the existing small nucleic acid drugs.
Nusinersen sodium injection is an important drug for the treatment of SMA (spinal muscular atrophy). According to the Zhongkang Kaisi system, the sales of nusinersen sodium injection increased by 293.8% year-on-year to 610 million yuan in the first year after being included in the medical insurance.
Coincidentally, as the world's first breakthrough innovative drug in the field of heart failure treatment, sacubitril-valsartan sodium tablets were included in the 2020 National Medical Insurance Catalog, and in 2021, the sales volume in the hospital exceeded 2 billion yuan in one fell swoop, a year-on-year increase of 170%.
Sacubitril valsartan sodium tablets - sales of national hospitals
Source: Zhongkang Kaisi system
In addition, under the influence of the gradual lifting of the restrictions on traditional Chinese medicine injections by medical insurance in 2022, traditional Chinese medicine injections will change the decline in 2023 and achieve significant growth. According to the Zhongkang Kaisi system, in 2023, all major categories of traditional Chinese medicine injections will achieve positive growth, and there will be 20 traditional Chinese medicine injections with terminal sales of > 1 billion yuan.
Compared with the adjustment plan of the medical insurance catalogue in the past four years, it can be seen that the drugs transferred to the catalogue in the 2020 version mainly highlight "urgent", emphasizing urgent clinical needs and epidemic prevention needs; The 2021 edition highlights a "new", a drug for the treatment of respiratory diseases related to the new crown pneumonia; The 2022 edition highlights a "leaning", with special emphasis on inclusion in the list of encouraged generic drugs or the list of children's drugs encouraged to be developed and declared.
The time from approval to entry of new drugs in 2023 has been shortened from more than 5 years to more than 1 year now, and 80% of innovative drugs can enter the NRDL within two years after listing. The 2024 edition emphasizes that 5 types of drugs outside the catalogue can apply for the adjustment of the 2024 medical insurance catalogue, including drugs for children, drugs for rare diseases, drugs with major changes in indications or functional indications, etc.