The latest news about the adjustment of the basic medicine catalog is coming out!

Draft for adjustment of the basic medicine catalogue is brewing

According to industry sources, at a recent meeting, the first draft of the basic medicine catalog adjustment related comments has been reviewed in a small range, and the 2021 edition of the basic medicine catalog adjustment may be completed in September.

In fact, some experts said earlier that the adjustment of essential medicines would not consider adopting the method of enterprise active declaration like the medical insurance catalogue, or the method of selecting clinical experts.

As we all know, the basic medicine list management method is a guiding document for the adjustment of the basic medicine list.

As early as September 19, 2018, the General Office of the State Council proposed in the "Opinions on Improving the National Essential Drug System" that the catalog should be dynamically adjusted and optimized.

The most recent adjustment of the essential medicines catalogue was from 2018 to October 25, 2018.

According to the rule that each round of basic medicine catalogue adjustment does not exceed 3 years, the new round of basic medicine catalogue adjustment may start this year.

It is worth noting that the previous version of the basic medicine catalog management method was issued by the former National Health and Family Planning Commission on April 14, 2015.

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There have been many news of catalog adjustments before

Earlier, the main points of work of relevant departments in 2020 were announced, and the main points of work were clear and will start the adjustment of the basic medicine list in due course.

When explaining part of the essential medicine system, the document mentioned that “a national survey and evaluation of the implementation of the 2018 edition of the National Essential Medicines List, collection and analysis of the use of medicines in medical institutions at all levels.

In fact, since the second half of last year, the industry has repeatedly reported the adjustment of the basic medicine catalogue.

In October 2020, relevant departments organized a symposium on the basic medicine system, and organized relevant companies to participate in the meeting to discuss basic medicine policy issues.

In November 2020, a discussion meeting for soliciting opinions on the National Essential Medicine Catalogue Management Measures was held.

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It mainly depends on the value of the product.
The improvement of clinical endpoint indicators can improve the patient's long-term quality of life, with cure as the standard.

On March 1, 2021, the National Health Commission convened the 2021 National Pharmaceutical Administration Video and Telephone Conference.
It is understood that the meeting has clarified the seven key points of this year's pharmaceutical policy work, namely, essential drugs, stable supply and price protection, centralized procurement of drugs, use monitoring, comprehensive clinical evaluation, pharmaceutical services, and policy research.

The key aspects of essential medicines include: prioritizing the allocation and use of essential medicines; strengthening the evaluation and publicity of the essential medicine system; and optimizing and adjusting the national essential medicine list.

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Possible Standards for Import and Export of Essential Medicines List

In accordance with the requirements of the current "National Essential Drug List Management Measures", the adjustment of the essential medicine list mainly refers to the selection procedures and principles of the World Health Organization Essential Medicine List and the drug list of relevant countries (regions), according to the disease spectrum and drug characteristics of my country, and fully consider the current situation.
Stage the basic national conditions and guarantee capabilities, summarize the previous practical experience in the formulation and adjustment of the catalog, and clarify the standards for transferring into and out of the essential medicine catalog.

As for the specific number of products that are dynamically adjusted in the list of essential medicines each time, the National Health Commission stated that it will comprehensively consider the clinical application of drugs, changes in drug standards, adverse drug reaction monitoring, comprehensive clinical evaluation of drugs, etc.
, based on changes in the disease spectrum and clinical diagnosis and treatment needs in my country.
The factors are determined.

Standards for drug transfer:

The first is to combine the order of disease spectrum, incidence, disease burden, etc.
, to meet the basic drug needs of common diseases, chronic diseases, heavy burdens, serious diseases and critical illnesses, and public health.
From the drugs that have been on the market in my country, Select an appropriate number of essential medicines.

The second is to support the development of traditional Chinese medicine, support the development and innovation of the pharmaceutical industry, and favor traditional Chinese medicine (including ethnic medicine) and domestic innovative medicines.

The "Opinions of the General Office of the State Council on Improving the National Essential Drug System" also requires strengthening evidence-based decision-making and highlighting the clinical value of drugs.
Standardized dosage form specifications, can be taken orally without intramuscular injection, and can be injected intramuscularly without infusion.
Support the development of Chinese medicine and encourage R&D and innovation in the pharmaceutical industry.
For drugs that are newly approved for marketing, have significantly improved efficacy compared with those already on the market, and are reasonably priced, the transfer procedure can be initiated in due course.

Standards for drug recall:

The first is that the drug standard is replaced; the second is that the national drug regulatory authority revoked its drug approval certificate; the third is that adverse reactions have occurred and it is not suitable to be used as a national essential drug after evaluation; the fourth is that it can be risked based on pharmacoeconomics evaluation Replaced by varieties with better benefit ratio or cost-benefit ratio; Fifth, other situations that the National Essential Medicines Working Committee believes should be transferred.

The "Opinions of the General Office of the State Council on Improving the National Essential Drug System" requires that the focus is on those that have been delisted, have more serious adverse reactions, are not suitable for use as essential drugs after evaluation, and have a better risk-benefit ratio or cost-benefit ratio The variety of alternative medicines.
In principle, medicines are not supplemented in various places, and minority areas can supplement a small amount of ethnic medicines.

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The advantages of basic medicine equipment still exist

The key points of the above-mentioned documents also propose to promote the management of the provision and use of essential medicines in public medical institutions and further increase the proportion of essential medicines used.

In accordance with the requirements of the "Opinions of the General Office of the State Council on Further Doing a Good Job in Guaranteeing Supply and Stabilizing Prices of Drugs in Shortage", promote the priority allocation and use of essential medicines and rational use of medicines.

"Promote the priority allocation and use of essential medicines, increase the proportion of essential medicines used, and timely adjust the national essential medicine list, and gradually realize that the number of essential medicines equipped with basic medicines in government-run primary-level medical and health institutions, secondary public hospitals, and tertiary public hospitals account for in principle.
No less than 90%, 80%, 60%, respectively, to promote the formation of “1+X” dominated by essential medicines in medical institutions at all levels (“1” is the national essential medicine list, and “X” is non-essential medicine.
According to actual determination) medication mode, optimize and standardize medication structure".

In addition, the main points of the document require local governments to carry out comprehensive pilot programs for essential medicines, encourage urban medical groups and county medical communities to establish a unified medicine catalog and supply guarantee mechanism, and promote the connection of medicines between higher and lower medical institutions.

Recently, the National Pharmaceutical Administration Work Conference was held in Nanjing, Jiangsu.
At the meeting, the relevant leaders of the National Health Commission pointed out that all localities should fully understand the functional positioning of essential drugs in ensuring clinical necessity, promote medical institutions at all levels and various types to accelerate the establishment of a "1+X" clinical drug model, and steadily expand the clinical use of essential drugs .

Judging from the national sample survey in 2019, basic medicines used by primary medical and health institutions and second- and third-level public hospitals accounted for 59%, 45%, and 39%, and the amount of basic medicines used by tertiary hospitals has increased significantly.

According to news from the industry, on April 11, the Pharmaceutical Affairs Division of the National Health and Medical Commission held a meeting to interpret the policy of the "National Essential Drug System Drug Supply Guarantee".

It was proposed at the meeting to gradually increase the use ratio of 90%, 80%, 60%, and the amount of 60%, 50%, and 40% of the basic medicines in public medical and health institutions at all levels, with a compound annual growth rate of not less than 4%.
Compared with medical institutions at the same level, the types of essential medicines in Chinese medicine hospitals can be reduced by 5%, and specialized hospitals can be reduced by 10%.

Some opinions point out that the medical insurance catalog is a reimbursement qualification catalog, and the basic medicine catalog is a recommended guide.
With the adjustment of the medical insurance catalog, the medicines in the basic medicine catalog are basically in the medical insurance catalog.
In addition, with the normalization of the basic drug catalogue and the medical insurance catalogue, drugs that meet the requirements of safety, effectiveness and economy will usher in favorable policies.