 Home > Active Ingredient News > Drugs Articles > In 2022, the performance evaluation of public hospitals will be launched, and the centralized procurement of biosimilars needs to fully consider the characteristics of biological drugs, and especially expensive rare disease drugs cannot be included in medical insurance for the time being

In 2022, the performance evaluation of public hospitals will be launched, and the centralized procurement of biosimilars needs to fully consider the characteristics of biological drugs, and especially expensive rare disease drugs cannot be included in medical insurance for the time being

 Last Update: 2022-11-01
 Source: Internet
 Author: User

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Table of Contents

record

Policy interpretation

1.
The "national examination" for the performance of public hospitals in 2022 was launched

2.
China took the lead in formulating and issuing the world's first international standard for stem cells

3.
National Health Insurance Administration: Particularly expensive drugs for rare diseases cannot be included in medical insurance for the time being

4.
Medical Insurance Bureau: The centralized procurement of biosimilars should fully consider the characteristics of biological drugs

5.
The 15 provincial alliances started the procurement with quantity and carried out the centralized procurement of orthodontic brackets

6.
Innovative devices are directly hung on the net, or are not included in the centralized procurement

7.
Hunan: Continuous enrollment can increase the reimbursement rate

8.
Encourage enterprises to participate in centralized procurement, with a maximum reward of 3 million

Industry dynamics

1.
The national average price of 6 shortage drugs was announced

2.
67 varieties passed the consistency evaluation, and 11 new drugs were announced on the network

Retail category data insights

1.
Traditional Chinese Medicine: Analysis of the retail market of internal medicine

2.
Traditional Chinese Medicine: Retail Market Analysis of Surgical Medicines

Policy interpretation

1.
The "national examination" of public hospital performance in 2022 was launched

In order to implement the Opinions of the General Office of the State Council on Strengthening the Performance Assessment of Tertiary Public Hospitals and the Notice on Strengthening the Performance Assessment of Secondary Public Hospitals issued by the General Office of the National Health Commission and the Office of the State Administration of Traditional Chinese Medicine, and to continue to promote the performance appraisal of national public hospitals, the National Health Commission issued a notice
on the performance appraisal of secondary and tertiary public hospitals (excluding traditional Chinese medicine hospitals, the same below) in 2022.

Continue to promote the performance evaluation of national public hospitals,

The National Health Commission has set requirements
for the work from the aspects of determining the directory of hospitals participating in the performance appraisal, collecting data on the first page of inpatient cases, completing other relevant tasks on time, and dynamically adjusting the relevant surgical catalogues used in the performance appraisal.

All relevant hospitals that require participants in the assessment shall, in accordance with the requirements, uniformly use the Notice on Printing and Distributing ICD Codes Related to Novel Coronavirus Infection, the Notice of the Medical Administration and Hospital Authority of the National Health Commission on Adjusting the International Disease Classification Codes Corresponding to the National Restricted Technologies, the National Clinical Edition 2.
0 of the Disease Classification Code, the National Clinical Edition of the Surgical Operation Classification Code and the adjusted catalogue of some surgical operation classification codes.
Standardize the filling in the homepage of inpatient cases (relevant materials can be downloaded on the performance appraisal management platform of public hospitals), and upload the data on the homepage of inpatient cases in 2022 to the national hospital quality monitoring system ( _istranslated="1"> in accordance with the "Performance Appraisal and Medical Quality Management Inpatient Case Homepage Data Collection Quality and Interface Standards (2020 Edition)".

2.
China took the lead in formulating and releasing the world's first international standard for stem cells

The 3rd China Collaborative Innovation Platform Conference and Standard Release Conference for Stem Cell and Regenerative Medicine was held in Beijing on September 24, officially releasing a series of relevant standards in the field of stem cells, including the world's first international standard for stem cells led by China ISO 24603 "General Requirements for Human and Mouse Pluripotent Stem Cells", 1 national standard "General Principles for Cell Sterility Testing" and "Technical Specifications for Ethical Review of Human Stem Cell Research", "Human Natural Killer Cells", "Human Midbrain Dopaminergic Neural Precursor Cells", "Human Neural Stem Cells" 7 group standards
.

The world's first developed by China

ISO 24603 "General Requirements for Human and Mouse Pluripotent Stem Cells" is the first stem cell standard in the ISO system of the International Organization for Standardization, which specifies the requirements for the
establishment of pluripotent stem cells, biological characteristics, quality control, information management, distribution and transportation.
China released the world's first international standard for stem cells, which has received wide attention and high praise
from experts in the field of stem cells and standards.

China released the world's first international standard for stem cells, which has received wide attention and high praise
from experts in the field of stem cells and standards.

In recent years, China has been stepping up the formulation of relevant standards in the field of stem cells, and the Standards Working Committee of the Chinese Society of Cell Biology has led a total of 16 international standard proposals, 42 national standard proposals, and 24 group standard proposals; He has participated in 19 international standards and 13 national standards under research, and has played an important role
in the standardization construction of stem cell field, standardizing the development of stem cell industry, protecting the rights and interests of subjects, and promoting the transformation and application of stem cells.
China takes the lead in formulating relevant standards in the field of stem cells and leading the formulation of international standards, which can not only standardize scientific research practices and ethical standards, but also be crucial
to the transformation of scientific research achievements and the development of the industry.

China takes the lead in formulating relevant standards in the field of stem cells and leading the formulation of international standards, which can not only standardize scientific research practices and ethical standards, but also be crucial
to the transformation of scientific research achievements and the development of the industry.

3.
National Medical Insurance Bureau: Particularly expensive rare disease drugs cannot be included in medical insurance for the time being

Recently, the National Medical Security Administration issued a reply
to the Fifth Session of the 13th National People's Congress No.
1426 on exploring the drug security mechanism for rare diseases.
The National Health Insurance Administration said that particularly expensive rare disease drugs cannot be included in medical insurance for the time being, and does not support local governments to explore the guarantee mechanism
for high-value rare disease drugs alone.

However, the national medical security department attaches great importance to the drug protection of
patients with rare diseases.
First, accelerate the frequency of adjustment to timely include eligible drugs for rare diseases in the medical insurance catalog: the "Interim Measures for the Administration of Drugs for Basic Medical Insurance" was issued to clarify the conditions and procedures for the adjustment of the catalogue, and the cycle of catalog adjustment was shortened from a maximum of 8 years to 1 year, so as to achieve regular adjustment
every year.
At present, more than 40 of the more than 60 rare disease drugs listed in China have been included in the national medical insurance drug list
.
The second is to promote the access negotiation of the medical insurance catalogue and improve the accessibility of drugs for rare diseases: for four consecutive years, the access negotiations for exclusive drugs have been carried out, and the drugs for rare diseases such as norcinaxen sodium, magastat, and deuterium butbenazine have entered the catalogue after price reduction, with an average reduction of more than 50%, greatly reducing the drug burden of
patients with rare diseases.
However, there are also a few particularly expensive drugs for rare diseases, which cannot be included in the scope of medical insurance payment because they are significantly beyond the level of
basic medical insurance protection.
In response to the suggestion of exploring the establishment of a drug security mechanism for high-value rare disease drugs at the provincial level and below, the National Medical Insurance Administration said that on the one hand, the diseases of high-value rare disease drugs are small diseases with a very low incidence or a very low number of patients, and the bargaining power in local areas is limited, and it is difficult to form an effective scale effect; On the other hand, local exploration is easy to cause the insured people to compare, which is not conducive to enhancing the fairness and coordination between
regions.

The first is to accelerate the frequency of adjustment to include eligible rare disease drugs in the medical insurance catalogue in a timely manner: the second is to promote the negotiation of medical insurance catalogue access and improve the accessibility of rare disease drugs: on the one hand, the diseases of high-value rare disease drugs are small diseases with very low onset/prevalence or extremely low number of patients, and the bargaining power in local areas is limited, and it is difficult to form an effective scale effect; On the other hand, local exploration is easy to cause the insured people to compare, which is not conducive to enhancing the fairness and coordination between
regions.

4.
Medical Insurance Bureau: The centralized procurement of biosimilar drugs should fully consider the characteristics of biological drugs

Under the dividends of various favorable policies, the pace of innovative drugs entering medical insurance has been accelerating
.
With the experience of special centralized procurement of insulin, the rules for collective procurement of biological drugs will become more and more perfect, and more biological drugs will inevitably be included in the national centralized procurement
.

The National Health Insurance Administration said it would accelerate access to medical insurance for
innovative drugs.
At present, the adjustment cycle of the medical insurance catalogue has been shortened to one year, and the scope of catalogue access focuses on new drugs listed in recent years, and the pace of newly listed innovative drugs entering medical insurance is accelerating, and some innovative drugs are included in the national medical insurance in the year of listing.

In addition to medical insurance access, entering centralized procurement is also one of the
important ways for innovative drugs to obtain the market.
However, because bioproducts cannot be tested for bioequivalence (BE), there will be more
factors to consider than the inclusion of chemical drugs in centralized procurement.

The National Health Insurance Administration said it would accelerate access to medical insurance for
innovative drugs.
At the same time, the scope of catalog access focuses on new drugs listed in recent years, and entering the centralized procurement is also one of
the important ways for innovative drugs to obtain the market.
However, because bioproducts cannot be tested for bioequivalence (BE), there will be more
factors to consider than the inclusion of chemical drugs in centralized procurement.

Although biosimilars started late in China, progress has accelerated
in recent years.
However, compared with chemical drugs, biological drugs have no consistency evaluation as support, the naming is complex and diverse, and the ramp-up of production capacity is slow, so it is necessary to further adjust and improve
the rules on the basis of centralized procurement of chemical drugs.
The National Medical Insurance Administration said that it will continuously improve the rules for collective procurement of biological drugs on the basis of the existing successful experience of collective procurement and the characteristics of
biological drugs.
In fact, before that, the National Medical Insurance Administration has repeatedly issued news that it intends to release "biosimilars into centralized procurement"
.
At present, after insulin has been explored and practiced in Wuhan, the national special organization has collected and gained certain experience
.

Compared with chemical drugs, biological drugs have no consistency evaluation as support, the naming is complex and diverse, and the ramp-up of production capacity is slow, so it is necessary to further adjust and improve
the rules on the basis of centralized procurement of chemical drugs.

5.
The 15 provincial alliances started the procurement with quantity and carried out the centralized procurement of orthodontic brackets

Recently, Shaanxi, Shanxi, Inner Mongolia, Liaoning, Heilongjiang, Anhui, Henan, Guangxi, Hainan, Guizhou, Tibet, Gansu, Qinghai, Ningxia, Xinjiang and other provinces (autonomous regions, production and construction corps) issued announcements, announcing the centralized procurement of orthodontic brackets, which will be organized and implemented
by the Shaanxi Provincial Public Resources Trading Center.

The announcement states that the procurement cycle is 2 years, and public medical institutions (including military hospitals) carrying out orthodontics in the alliance provinces (autonomous regions and corps) should participate, and medical institutions designated by medical insurance designated social medical institutions should voluntarily participate
.

The scope of centralized procurement varieties is brackets, invisible braces without brackets, and buccal tubes
that have obtained China's medical device registration certificate.
Specifically, it is divided into ordinary metal brackets (two groups A and B), ordinary ceramic brackets (two groups A and B), self-locking metal brackets (two groups A and B), self-locking ceramic brackets (two groups A and B), bracketless appliances (two groups A and B), buccal tube (negotiation).

According to the order of the procurement demand of medical institutions of the inter-provincial alliance from most to least, the enterprises covered by the top 70% (inclusive) of the cumulative procurement demand of each product category are group A bidding units, and the rest are group B bidding units
.
If the number of valid reporting enterprises entering the group A bidding unit is less than 5, it will be supplemented in descending order according to the procurement demand of inter-provincial alliance medical institutions, until the number of valid declaration enterprises of group A bidding unit reaches 5; If there are less than 5 declared enterprises in the same product category, all of them will enter Group
A.

According to the order of the procurement demand of medical institutions of the inter-provincial alliance from most to least, the enterprises covered by the top 70% (inclusive) of the cumulative procurement demand of each product category are group A bidding units, and the rest are group B bidding units
.

6.
Innovative equipment is directly hung on the net, or not included in the centralized procurement

Recently, the Heilongjiang Provincial Public Resources Exchange Center issued the "Announcement on the Maintenance Information Results of Related Innovative and Clinically Urgently Needed Medical Consumables Hanging Network Enterprises"
.
It was learned from the announcement that 16 innovative medical devices from four machinery companies, Medtronic, Zhuo Ruan Medical, Jianwei Medical and Panorama Hengsheng, met the requirements of
hanging network.
Among them, the final price of the transcatheter implantable leadless pacing system produced by Medtronic is 173600, which was reviewed by the State Food and Drug Administration in May this year and approved for the registration of
innovative products.
Nowadays, in Heilongjiang Province, it can be purchased directly on the network, and the speed of products entering the market has been further accelerated
.
At present, Heilongjiang Province is the first province in the country to announce that innovative medical devices can be directly purchased on the network, but it will not be the only one
.
With the completion of the establishment of the national unified pharmaceutical hanging network and trading rules, the network channel of innovative devices may be opened
nationwide.
While accelerating the listing of innovative medical devices in various provinces, the state has issued a series of relevant policies, such as exempting innovative medical devices from DRG and not including centralized procurement, which is beneficial to a large number of enterprises and agent dealers
.

The speed of product entry to market is further accelerated
.
With the completion of the establishment of the national unified pharmaceutical hanging network and trading rules, the network channel of innovative devices may be opened
nationwide.
For example, innovative medical devices are exempt from DRG, not included in collective procurement, etc.
,

In September this year, the National Medical Insurance Administration clearly pointed out that it is difficult to implement the quantitative method
because the clinical use of innovative medical devices is not yet mature and the amount of use is temporarily difficult to estimate.
Therefore, in the process of centralized volume procurement, the National Medical Insurance Bureau will reasonably determine the proportion of volume according to factors such as clinical use characteristics, market competition pattern and the number of selected enterprises, and leave a certain market in addition to centralized volume procurement to provide space
for innovative products to open up the market.
The National Medical Insurance Administration also further clarified that it will improve the market-oriented price formation mechanism, promote the high-quality development of the medical device industry, and provide more innovative products
for the people at reasonable prices.

Since the clinical use of innovative medical devices is not yet mature, and the amount of use is temporarily difficult to estimate, it is still difficult to implement the quantitative method
.
According to the clinical use characteristics, market competition pattern and the number of selected enterprises and other factors, the proportion of belt volume is reasonably determined, and a certain market is set aside in addition to centralized volume procurement to provide space
for innovative products to develop the market.

7.
Hunan: Continuous enrollment can increase the reimbursement ratio

On October 18, the Hunan Provincial Medical Insurance Bureau issued the "Implementation Measures for Basic Medical Insurance for Urban and Rural Residents in Hunan Province (Draft for Comments)" (hereinafter referred to as the "Draft for Comments"), which formulated measures
to standardize and improve the unified basic medical insurance for urban and rural residents (hereinafter referred to as resident medical insurance) system in the province and combine it with the actual conditions of Hunan Province.

In order to standardize and improve the unified basic medical insurance system for urban and rural residents (hereinafter referred to as resident medical insurance) in the province, measures
are formulated in combination with the actual conditions of Hunan Province.

The Draft requires that the resident medical insurance system should follow the following five basic principles: adhere to full coverage, basic protection, multi-level and sustainable; Adhere to the level of financing, security standards and the level of economic and social development; Adhere to mutual assistance, combining individual contributions and government subsidies; Adhere to the combination of rights and obligations, and residents can enjoy basic medical insurance treatment fairly; Insist on determining income and expenditure, balance income and expenditure, and have a slight balance
.
The Draft for Comments clarifies that resident medical insurance implements a financing method
based on a combination of individual contributions and government financial subsidies.
Townships, neighborhoods, collectives, or other socio-economic organizations with the capacity are encouraged to support or subsidize
individual residents' contributions.
Before the end of July each year, the provincial medical insurance administrative department together with the financial department shall reasonably determine the financing standards
for the province's resident medical insurance for the next year in accordance with relevant national policies.
The Draft proposes to increase the corresponding payment ratio by 2 percentage points for those who have participated in domestic medical insurance for more than 5 consecutive years (inclusive); If you have participated in domestic medical insurance for more than 10 years (inclusive), the corresponding payment ratio will be increased by 5 percentage points
.
Then, according to the new measures, if you have been insured for 10 consecutive years, and seek medical treatment in medical and health institutions at the grass-root, first, second, third, and provincial and ministerial levels, the reimbursement rates within the policy scope will be as high as 95%, 90%, 85%, 70%, and 65%
respectively.

Domestic medical insurance implements a financing method
based on the combination of individual contributions and government financial subsidies.
Before the end of July each year, the provincial medical insurance administrative department together with the financial department shall reasonably determine the financing standards
for the province's resident medical insurance for the next year in accordance with relevant national policies.

8.
Encourage enterprises to participate in centralized procurement, with a maximum reward of 3 million

Recently, many cities have introduced policies
to support the pharmaceutical industry.
In order to accelerate the construction of a biomedical innovation highland, improve the industrial ecosystem, consolidate high-quality industrial support, build an advanced manufacturing industrial cluster, and accelerate the high-quality development of
the biomedical industry.
On the evening of October 15, Hangzhou announced the "Several Measures on Accelerating the High-quality Development of the Biomedical Industry", focusing on supporting the research and development, production and services
in the fields of drugs, high-end medical devices, advanced pharmaceutical equipment, new service outsourcing, digital medical care and medical cosmetology.

In order to accelerate the construction of a biomedical innovation highland, improve the industrial ecosystem, consolidate high-quality industrial support, build an advanced manufacturing industrial cluster, and accelerate the high-quality development of
the biomedical industry.

Among them, the most concerned is the measures
to support enterprises to participate in centralized volume procurement.
The "Document" mentions that enterprises are encouraged to actively participate in the centralized procurement of drugs and equipment at the national and provincial levels, and will be rewarded at 3% of the total price of the winning bid, and the maximum reward for a single variety shall not exceed 3 million yuan
.

Measures
to support enterprises to participate in centralized volume procurement.

The Measures also focus on consolidating the foundation of innovation sources, strengthening core drug technology research and achievement transformation, supporting the R&D and production of innovative drugs, supporting the R&D and production of improved new drugs, supporting the R&D and production of medical devices, establishing a working mechanism for ethical collaborative review, improving the support platform system for drug clinical research, strengthening incentives for the transformation of clinical research results, improving the ability of medical enterprises to integrate and innovate, exploring the establishment of biomedical industry alliances and professional clinical research alliances, encouraging the development of drug clinical trial services, The promotion of industrial agglomeration development and other aspects are explained in detail
.

Industry dynamics

1.
The national average price of 6 shortage drugs was announced

According to the relevant documents of the National Medical Security Bureau, in order to implement the spirit of the "Opinions on Further Doing a Good Job in Guaranteeing Supply and Stabilizing the Price of Shortage Drugs" (Guo Ban Fa [2019] No.
47), Shanghai Sunshine Pharmaceutical Procurement Network announced the national average price of some shortage drugs in August 2022, and medical institutions purchase drugs
with reliable quality and suitable prices on the basis of ensuring supply and stable prices according to market supply and demand.

On the basis of ensuring supply and stable prices, we will purchase drugs
with reliable quality and suitable prices.

China attaches great importance to the work of guaranteeing the supply of shortage drugs, establishing and improving the legal system guarantee system, accurately implementing the measures to ensure supply and price stability of shortage drugs, and establishing an operating mechanism
for the work of ensuring supply and price stability of shortage drugs 。 In the next step under the national linkage mechanism, we will accelerate the process of listing varieties on the national shortage drug list in combination with the actual situation of supply guarantee of shortage drugs, give full play to the important role of national medical reserves, and continue to strengthen the normalization of drug price supervision, price monitoring and early warning; Give full play to information technology to promote the sharing and sharing of information such as drug production and supply, production suspension reports, price anomalies and procurement, reporting by medical institutions, and local verification and response; Strengthen policy publicity and guidance, carry out in-depth publicity and popularization of policy measures, and reasonably guide social expectations
.

Establish and improve the legal system guarantee system, accurately implement the measures to ensure supply and price stability of shortage drugs, and establish an operating mechanism
for the work of ensuring supply and price stability of shortage drugs.
，

National average price list for partial shortage drugs in August 2022

2.
67 varieties passed the consistency evaluation, and 11 new drugs were announced on the network

On October 18, 2022, the Zhejiang Provincial Pharmaceutical and Medical Device Platform issued a notice that, in accordance with the spirit of the "Zhejiang Province Reform Plan for Improving the Function of the Centralized Drug Procurement Platform to Promote the Full Coverage of Medical Insurance Drug Payment Standards", after enterprise declaration, sorting and other procedures, 67 enterprises applied for online procurement of generic drugs and 11 Class 1 new drugs through quality and efficacy consistency evaluation were made public
.

"Zhejiang Province Improves the Function of Centralized Drug Procurement Platform and Promotes the Reform Plan of Full Coverage of Medical Insurance Drug Payment Standards"

01 Involving the procurement varieties to be prioritized on the net: agomelatine tablets, olmesartan medoxomil tablets, rabeprazole sodium enteric-coated tablets, cefixime granules, enoxaparin sodium injection, adenosylmethionine succininium sulfonate for injection, somatostatin for injection, teicoplanin for injection, cefazolin sodium for
injection.

01 Involving the procurement varieties to be prioritized on the network:

02 Procurement of varieties through consistency evaluation: cefoperazone sodium sulbactam sodium for injection (1:1), ticagrelor tablets, valsartan hydrochlorothiazide tablets, metformin hydrochloride sustained-release tablets, atorvastatin calcium tablets, ondansetron oral dissolved film, olmesartan medoxomil hydrochlorothiazide tablets, citicoline injection, sodium valproate injection concentrated solution, febuxostat tablets, pantoprazole sodium for injection, apixaban tablets, agatroban injection, acarbose tablets, azithromycin dry suspension, delaroxir tablets, iopromide injection, Acetaminophen mannitol injection, fluconazole tablets, fluorouracil injection, compound amino acid injection (17AA-II.
), glycerol fructose sodium chloride injection, glipizide controlled-release tablets, vildagliptin tablets, ipratropium bromide solution for inhalation, ambroxol hydrochloride oral solution, ambroxol hydrochloride injection
, etc.

02 Procurement of varieties through consistency evaluation:

Retail category data insights

1.
Traditional Chinese medicine: analysis of the retail market of internal medicine

According to the common name, Pudi blue anti-inflammatory, ejiao, liuwei rehmannia, compound salvia, and angong beef yellow have the highest
sales in Chinese medicine internal medicine.

Figure 1: Overall retail market for internal medicine

Figure 2: Internal Medicine Pharmaceutical Segment Retail Market*Source: China Pharmaceutical Industry Information Center China Drug Retail Database RPDB sample pharmacy data

2.
Traditional Chinese medicine: analysis of the retail market of surgical drugs

According to the generic name, Fuxin, Ma Yinglong Musk Hemorrhoids, Tai, Anti-inflammatory Choleretic and Moist Burn have high sales in Chinese medicine surgery
.

Figure 3: Overall retail market for surgical drugs

Figure 4: Surgical Drug Segment Retail Market*Source: China Pharmaceutical Industry Information Center Data from RPDB sample pharmacies in China Drug Retail Database

Source: Pharmaceutical Geography, WuXi AppTec, Sina Pharmaceutical News, Cyberblue, BioValley, Bioexploration, E Drug Manager, Health News, Chinese government website, arterial network, etc
.

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