The base medicine is "embarrassing"...

A new message has been updated with the Essential Medicines Catalog.
October 15, the National Health and Health Commission held a symposium on the basic drug system, organized relevant enterprises to participate in the symposium to discuss the basic drug policy.
13 companies participated in the discussion.
it is learned that the main purpose of this meeting is to understand the implementation of the national basic drug system in various places and units, and to solicit the revised recommendations of the National Basic Drug Catalog Adjustment Management Measures (Trial) (hereinafter referred to as the "Basic Drug Management Measures").
July this year, the industry has been out of the base drug catalog adjustment of the relevant meeting content, mentioned that the Health and Health Commission is discussing the revision of the "base drug management measures", "base drug management measures" will be introduced only after the adjustment of the catalog accordingly.
meeting also mentioned that the adjustment cycle for the essential drugs catalogue remained unchanged, i.e. three-year adjustments, and that the adjustment for the last edition of essential medicines was in 2018, and that the adjustment of essential drugs was not expected to start this year on schedule.
addition, essential medicines are likely to be subject to a small annual dynamic adjustment, as is the medicare catalog.
held on October 15, 2020, means that the adjustment of the national base drug catalogue is about to start.
01 base drug is currently the industry's most concerned about two directories: the base drug catalog and the health insurance catalog.
simple understanding, the base drug catalog is the health care industry for the leading units set up by the directory, the health insurance directory is the health insurance sector for the leading units set up a directory.
, the list of base drugs has been updated three times since it was established.
formulated the base drug system immediately after the new medical reform was launched in 2009.
August 2009, the Ministry of Health promulgated the National Essential Medicines Directory (a total of 307, the industry's 307 catalogue), since then China has started to launch the basic drug system.
addition, the nine ministries have simultaneously issued the Measures for the Administration of the National Essential Medicines Directory (Temporary) and the National Essential Medicines Directory (The Use Section of Primary Health Care Institutions) (2009 edition).
September 21, 2012, the National Essential Medicines Directory (2012 edition) (a total of 520 drugs, the industry's 520 list of essential drugs) was discussed and adopted by the Ministry of Health Minister's Meeting, effective May 1, 2013.
Of the Ministry of Health of the People's Republic of China, issued on August 18, 2009, was repealed at the same time.
September 30, 2018, the National Essential Medicines Directory (2018 edition) was reviewed by the Leading Group on Medical Reform of the State Council and called for consideration and adoption by the Executive Meeting of the State Council, effective November 1, 2018.
increased from 520 to 685, of which 417 were Western medicine, 268 were traditional Chinese medicine (including ethnic medicine), and 685 drugs involved more than 1110 dosage forms and more than 1810 specifications.
the basic drug catalogue basically covers the requirements of 800 to 1500 standards of the hospital drug catalogue.
until the Establishment of the National Health Insurance Administration in 2018, drug procurement was the responsibility of the Health Care Commission.
health care commission is responsible for the eligibility of drugs to enter the hospital and the use of drugs, the market policy tilted towards the list of essential drugs.
the 2012 edition of the list of essential drugs (520 base drug species), drug tenders are basically the initiation of basic drugs tender procurement.
No. 7 of 2015, "Guidelines of the General Office of the State Council on improving the centralized procurement of drugs in public hospitals", clearly for clinical use of large quantities, high procurement amount, a number of enterprises to produce basic drugs and non-patented drugs, to give full play to the provincial centralized bulk procurement advantages, by the provincial drug procurement agencies to adopt a double envelope system of open tender procurement, hospitals as the main procurement body, according to the winning price of drugs.
this document as a starting point for generic drugs with a high purchase amount of non-essential drugs in the non-essential drug catalogue to be expected to be tendered for procurement.
, can not participate in the public hospital drug tender procurement can not enter the hospital sales.
can thus be seen as a good entry into the 2012 list of essential drugs products.
In 2014, the State Health and Planning Commission issued the Opinions on Further Strengthening the Administration of the Use of Medicines in Primary Health Care Institutions and in February 2015 the State Health and Planning Commission issued the Notice on the Administration of Basic Medicines, which explicitly requires all primary health care institutions organized by the Government to be equipped with and use essential drugs, and all other types of medical institutions must also use essential drugs in accordance with the regulations.
Primary health care institutions also require that the "100% equipped" policy undoubtedly stimulates the market, driving the profitability of basic drug manufacturers, the market for essential drugs to stimulate manufacturers to enter the basic drug catalog, which led to a surge in the 2018 catalog.
, with the establishment of the National Health Insurance Administration, access to the essential drugs catalogue is no longer the key to tender procurement.
The question of whether Medicare pays for the Essential Medicines Catalog, until the 2020 National Health Care Drug Catalog Adjustment Work Programme mentions that drugs included in the National Essential Medicines Catalog (2018 edition) could be included in the 2020 drug catalog to be added to the scope of the proposed new drugs, which is a solution, but whether they are successfully included in the pending health care negotiations.
the actual use of base drugs in medical institutions? The results of the 2018 three-level hospital assessment issued by the General Office of the National Health and Health Commission show that the number and proportion of basic drug procurement have increased year by year, and the proportion of prescriptions for essential drugs for outpatients has reached 52.25% (this indicator refers to the proportion of prescriptions with essential drugs to total prescriptions), and the proportion of prescriptions for basic drugs for outpatients has increased year by year. Refers to the proportion of prescriptions with a base drug to the total prescription, that is, as long as a prescription is prescribed the base drug, regardless of the quantity and amount are included in the indicator, then this 52.25% of the data can only show that more than half of the prescriptions have the base drug, but can not reflect the more important quantity of the proportion, the amount of the proportion.
The use rate of essential drugs among inpatients reached 95.38 per cent (this indicator refers to the proportion of patients who were discharged from hospital with essential drugs as a percentage of the total number of discharges), but again, the more important proportion of quantities and the proportion of amounts cannot be reflected.
basic drugs because it is mostly non-exclusive products, the bid price is low, many basic drugs in large hospitals do not want to use, 520 version of the basic drugs catalog accounted for about 19% of the market share of medical institutions.
The basic drug system is a system of effective management of the catalogue of essential drugs, production and supply, procurement and distribution, rational use, price management, payment reimbursement, quality supervision, monitoring and evaluation, etc., with the aim of improving the drug supply guarantee system and ensuring the safety of the people's drug use.
the implementation of the system, has achieved significant results, but also let the primary medical institutions have been guaranteed the safety of drug use.
, due to the low bid price, distribution costs may be much higher than the total sales of the distribution of goods, grass-roots commonly used drugs out of stock from time to time.
Basic drugs in small hospitals are not enough is reflected in many primary medical institutions need the types of drugs are not listed, restricting primary medical institutions can only use the basic drugs caused by the obstruction of clinical drug use, which is contrary to the original intention of the establishment of the basic drug system.
The Notice on Further Strengthening the Administration of the Use of Essential Medicines in Public Medical Institutions (National Health and Drug Administration No. 1) liberalizes the restrictions on the percentage of basic medical institutions that must be equipped with essential drugs: provincial health administrative departments, taking into account local actual and public medical institutions' functions and scope of diagnosis and treatment, reasonably determine the requirements for the variety and amount of medicines provided by the State basic drugs in public medical institutions and strengthen the examination.
the use of similar drugs in the course of clinical drug treatment, priority should be given to the selection of national essential drugs under the premise of ensuring their stability.
So many provinces have formulated similar "provincial third, second and primary medical institutions of the proportion of basic drug use varieties not less than 30%, 40%, 50%, and the amount of the proportion is not less than 30%, 40%, 60% "basic drug use standards", further weakening the "basic drug catalog" for clinical drug use guidance status.
the impact of the Essential Medicines Directory is becoming less and less important.
is about to see a fourth change in the Essential Medicines Directory, leaving only essential drugs in the 1 plus X model.
Until October 11, 2019, the General Office of the State Council issued the Opinions on Further Doing a Good Job of Keeping The Price of Shortage Drugs (State Office Issued No. 47 of 2019), in particular, it was pointed out that the basic drugs of government-run primary health care institutions, secondary public hospitals and third-level public hospitals should be gradually realized. In principle, the proportion of the number of varieties equipped is not less than 90%, 80% and 60%, respectively, to promote medical institutions at all levels to form a "1 plus X" ("1" as the national list of essential drugs, "X" as non-essential drugs, determined by the local according to the actual) drug use model, optimize and standardize the drug use structure.
this is the first time that the "1-X model" has been presented in a document at the national level, and the first time that data on the proportion of the use of base drugs have been made clear at the national level.
On February 26, 2020, the National Health and Safety Commission and six other departments issued the Opinions on Strengthening the Administration of Pharmaceuticals in Medical Institutions to Promote Rational Drug Use (National Health Care Administration No. 2) to promote the formation of a "1 plus X" drug model dominated by basic drugs at all levels of medical institutions, and once again raised the basic drug 986 system to the policy level.
From the market level analysis, the current 685 base drug catalog has 349 exclusive base drug regulations (including exclusive dosage forms, specifications) of which 134 Western medicine, Chinese medicine 215, but really can make large varieties (annual sales of more than 1 billion) no more than 20, and more than 100 million yuan scale, is expected to not exceed 50.
This means that the market size of large varieties of basic drugs will not exceed 50 billion yuan, basic drugs want to reach the market size of 30% at least 200 billion, basic drugs are mainly basic, the collection is usually not high prices such as PD-1 mono-resistant large varieties, if limited in the scale of drug use, implementation is very difficult to achieve.
02 The dynamic adjustment period of 3 years will be 2009 "National Basic Medicines Directory Management Measures (Temporary)" refers to the national basic drug catalogue on the basis of maintaining a relatively stable number of dynamic management, in principle, once every three years;
In view of the 2012 edition of the basic drug catalogue to supplement more provinces, including Guangdong, Jiangxi, Shanxi, Chongqing, Qinghai, Hubei, Gansu, of which Guangdong added nearly 300 varieties, the addition of the catalog of exclusive varieties, local enterprise varieties accounted for a relatively high.
In 2014, the State Health and Planning Commission issued the Opinions on Further Strengthening the Administration of drug Use in Primary Health Care Institutions, referring to the addition of non-catalog drugs as a unit of provinces (districts and municipalities) as a phased measure in the initial stage of the implementation of the basic drug system, and the 2012 edition of the National Essential Medicines Catalog basically adapts to the needs of primary drug use and does not encourage new additions.
In the Opinions of the General Office of the State Council on Improving the National Basic Drug System in 2018, for the dynamic adjustment and optimization of the catalogue, based on the norms of diagnosis and treatment, clinical guidelines and expert consensus, Chinese and Western medicines are equally important, selecting the appropriate number of basic drug varieties to meet the major clinical needs of common diseases, chronic diseases, emergency rescue and other major clinical needs, taking into account the special population such as children and the needs of public health prevention and treatment.
strengthen evidence-based decision-making, highlighting the clinical value of drugs, standardized dosage form specifications, can oral non-muscle injection, can muscle injection not infusion.
the newly approved and marketed drugs, the efficacy is significantly improved than the listed drugs and the price is reasonable, the transfer process can be initiated in due course.
Priority is given to the transfer of drug varieties with clear evidence of effectiveness and safety, with a significant cost-benefit ratio, to larger and more severe adverse reactions occurring when the market has been withdrawn, where it has been assessed that it is not appropriate to be used as a basic drug, and to replace the drug with a risk-benefit ratio or a more cost-effective alternative.
in principle, there are no additions to medicines, and ethnic minority areas may add a small number of ethnic medicines.
, priority is given to the inclusion of generic drug varieties that have been evaluated through consistency.
to the generic drugs that have been included in the list of essential drugs, enterprises are encouraged to carry out a consistent evaluation, not through the consistent evaluation of the variety of essential drugs, and gradually transferred out of the catalogue.
15, 2020 meeting mentioned that the base medicine does not represent low-cost drugs, there is clinical value of high-priced drugs can also be considered for inclusion in the list of base drugs.
, the adjustment of the base drug will not consider the enterprise's active declaration method, or the selection of clinical experts mainly.
03 Base drugs overlap low-cost drugs 2012 version of the base drug catalog a total of 520 drugs, 2018 version of the base drug catalog has 685, the current official low-cost drug catalog of 533 versions.
in the National Development and Reform Commission "on improving the price management of low-cost drugs related issues notice" can be seen that the average daily cost standard of low-cost drugs is: Western medicine does not exceed 3 yuan, Chinese medicine does not exceed 5 yuan.
April 2014, the National Development and Reform Commission issued a notice to lift the maximum retail price limit for 283 low-cost Western medicines and 250 low-cost Chinese medicines to encourage pharmaceutical companies to produce low-cost drugs.
2012 version of the national base drug catalog of 520 varieties of 280 low-cost drug catalog products, plus the launch of the basic drug catalog products tender in 2012, for low-cost pharmaceutical products are allowed to hang the network procurement, in fact, the tender procurement of products less than the low-cost drug list procurement products, the basic drug catalog is equal to the stereotype of low-cost drugs was established at that time.
, however, in 2019 for the centralized procurement of drugs through consistency evaluation, once entered the low-cost drug products finally bid price into the "sub" unit of the era.
These low-cost drugs if the use of low-cost drug network procurement, as long as not more than 3 yuan a day to take the price can be purchased, hanging net list price can be much higher than the centralized procurement of the winning price, which means that as long as low-cost drugs into the centralized procurement catalog can not use low-cost drug hanging network procurement methods, low-cost drug price protection may disappear with more and more products into the volume of procurement.
note that the price of centralized procurement has made many low-cost pharmaceutical companies reluctant to initiate consistent evaluations.
Individual low-cost pharmaceutical manufacturers do not have a trial preparation unless it belongs to clinical recognition does not require consistent evaluation of varieties, otherwise, according to the current regulations do not have the participation of preparations may not declare imitation and start consistent evaluation, these products will be difficult to start a consistent evaluation and continue to enjoy the "national minimum price application directly hanging online" "low-cost drug" policy dividends.
04-in-one paradox-based drugs and health-care directories can't be combined.