Recently, the General Office of the National Health Commission issued a notice on the "Regulations for the National Key Monitoring and Reasonable Use of Drugs Catalogue Adjustment" (Guoweiban Medical Letter [2021] No.474, hereinafter referred to as the "Regulations"). On the 1st, after the National Health Commission issued the first batch of national key monitoring and rational use of drugs, the National Health Commission will strengthen the management of clinical rational use of drugs, continuously standardize clinical use of drugs, and promote this work to be standardized and normal. Another important step in globalization. As a Pharmaceutical company, you must pay enough attention, because once it is included in the monitoring catalog, it will have a great impact on the corresponding drugs, and the extent is no less than that of centralized procurement.
Which drugs will be included in the key monitoring?
The "Regulations" clearly stipulates that chemical drugs and biological products that have many unreasonable clinical use problems, abnormally high amounts of use, and greater impact on the rationality of medication should be included in the monitoring catalog management, focusing on auxiliary drugs, anti-tumor drugs, and anti-tumor drugs. Six types of drugs including microbial drugs, proton pump inhibitors, glucocorticoids, and parenteral nutrition drugs. In principle, the time for catalog update and adjustment is not less than 3 years, and the number of drug varieties included in catalog management is generally 30. The adjustment of the catalog is carried out in four stages: start-up adjustment, local selection and recommendation, expert summary, and announcement of results. The initial adjustment stage is when the National Health Commission issues a notice of catalog adjustment, clarifying the time schedule, materials to be submitted, and work requirements. In the local selection and recommendation stage, general hospitals above the second level will be based on comprehensive factors such as clinical unreasonable use of drugs, usage amount, clinical value and other comprehensive factors. The recommendation level is ranked from strong to weak, and the information of the top 30 varieties with the strongest recommendation is stamped with the official seal of the hospital and submitted to the provincial health administrative department. The provincial health administrative department assigns corresponding scores to the 30 varieties recommended by each hospital. That is, the first-ranked variety is assigned a value of 30, and the second-ranked variety is assigned a value of 29 points. The 30th place is assigned 1 point. On the basis of the generic name of the drug, the provincial health administrative department sums up the assignments of all the varieties submitted by general hospitals above the level of jurisdiction to obtain the total recommended score for each variety, and then follow the scores from high to low. Sorting (if the scores are the same, they can be sorted in parallel and occupy the subsequent rankings), and the information of the top 30 drugs (including other drugs with a score of 30) will be stamped and submitted to the National Health Commission. Ha. The National Health Commission entrusted the National Pharmaceutical Affairs Commission to conduct a formal review of the materials submitted by various regions and adopt the same calculation method as that of the provincial health administrative departments to obtain the top 30 varieties, which are summarized by experts. The National Health Commission announces the results of catalog adjustments, publishes a new version of the catalog, and puts forward management requirements, that is, the results are announced. All provincial health administrative departments shall, based on the 30 drug varieties submitted by the province, include them in the new version of the list of drug varieties, form a provincial-level key monitoring and rational use drug list, and report to the National Health Commission for the record in a timely manner. On the basis of the provincial catalog, all medical institutions at all levels, combined with the actual use of drugs, form a list of drugs that the institution focuses on monitoring the rational use of drugs. The provincial and medical institutions’ key monitoring and rational use drug catalogs shall be announced to the public in the form of government affairs disclosure, hospital affairs disclosure, and official website announcements as required. For the drugs adjusted out of the original catalogue, the local health administrative department should continue to monitor for at least one year, and grasp the prescription review, usage, usage amount, etc., to promote the continuous improvement of the level of clinical rational drug use.
The consequences will be no less than centralized procurement
On July 1, 2019, in order to implement the "Opinions on Strengthening the Performance Appraisal of Three-level Public Hospitals" by the General Office of the State Council and the "Notice on Doing a Good Job in the Management of the Clinical Application of Auxiliary Drugs", the National Health Commission Together with the State Administration of Traditional Chinese Medicine, on the basis of the provincial-level recommended catalogs submitted by various localities, the "First Batch of National Key Monitoring and Rational Use Drugs Catalog (Chemical Drugs and Biological Products)" was formed. The catalog covers gangliosides, cerebroside-carnosine, oxiracetam, creatine sodium phosphate, calf serum deproteinized, alprostadil, troxerutin hydrolysate, complex coenzyme, salvia miltiorrhiza, ligustrazine, inverted glycoelectrolyte 20 It also requires the health administrative departments at all levels, the competent departments of traditional Chinese medicine, and medical institutions to establish and improve the clinical use of drugs and abnormal early warning systems. Focus on the clinical use of drugs included in the catalog as the assessment content of medical institutions and their main persons in charge, combined with medical institution verification, review and evaluation, and performance appraisal, and the assessment results will be announced in a timely manner. For drugs that have not been included in the catalogue management, do a good job of routine clinical use monitoring. If problems such as abnormal increase in use, no indication, overdose use, etc., are found, early warning should be strengthened and the cause should be found. Those who violate laws and regulations must be dealt with seriously. Obviously, those included in the key monitoring catalogue will also "enjoy" the same or even stricter "treatment". The inclusion of these in key monitoring will also have a huge impact on pharmaceutical manufacturers. The market may plummet. It is understood that the first batch of 20 varieties included in key monitoring involves more than 200 companies. In 2018, the sales of public medical institutions nationwide were 65 billion yuan, of which ganglioside, oxiracetam, alprostadil, and Darabong has exceeded 5 billion yuan. The largest number of companies involved are thymopentin (52 companies), cerebroprotein hydrolysates (44 injections), vinpocetine (38 injections), and alprostadil (32). The injection formulations of 20 drugs account for a relatively large proportion. . Since the first quarter of 2019, except for the only positive growth of edaravone in the second quarter of 2019, it has been declining every quarter in other periods, such as the sales growth rate of ganglioside 20mg, which has been ranked first in sales for a long time. From -22% in 2019Q1 to -58% in 2020Q2, cinepazide maleate 80mg/2ml dropped from -21% in 2019Q1 to -89% in 2020Q2. Compared with the sales of 2018 before the publication of the catalog, the whole year of 2020 in 2020 shows that both sales and sales volume have declined. Among them, the sales and sales of cinepazide maleate 80mg/2ml have fallen by 80% respectively. And 79%. According to industry analysts, once it is included in the catalog, a sharp decline in sales will be inevitable. Although this adjustment does not involve Chinese medicine, it is still unknown whether it will be included in the local version in the future. Judging from the "Regulations for the Regulation of the List of Drugs for Key Monitoring and Reasonable Use", since it is a "procedure", it means that it has been institutionalized. In terms of actual operational effects, while the implementation of the key monitoring drug catalog plays an important role in improving the rationality of medications, it will inevitably have an impact on related companies, and it may even be catastrophic for companies that rely on certain drugs to live their lives. The level of destruction is no less than that of centralized procurement. Because these drugs have a negative effect on saving money for medical institutions, and after the reform of the medical insurance payment system is generally implemented, it is also the unreasonable medical cost that medical institutions must focus on reducing. Therefore, as enterprises, they must pay attention to the implementation of this procedure. Make corresponding adjustments to your own strategy as soon as possible, and be prepared.
September 08, 2021
