Expert interpretation . . . 3 aspects, a comprehensive analysis of the medical insurance drug catalog formulation and adjustment of ideas.

Wen . . . Sun Xin's team's formulation of the Basic Medical Insurance Drug Catalog is an important measure for the state to safeguard people's lives and health, promote health equity and medical accessibility, and realize the outline of the "Healthy China 2030" program, which plays a key role in China's medical security system.
the efficient selection, adjustment, use, management and supervision of basic medical insurance drugs is the core content of ensuring the smooth implementation of the Basic Medical Insurance Drug Catalog.
, the development and adjustment of the drug catalogue, as a key component of the implementation of the Basic Medical Insurance Drug Catalog, has been widely concerned by the industry and the public.
a new version of the Interim Measures for the Administration of Drug Use in Basic Medical Insurance (the "Temporary Measures") was officially issued by the State Administration of Medical Security recently, in which the second chapter of the "Basic Medical Insurance Drug Catalog" was formulated and adjusted.
The author interprets the second chapter of the interim measures, "conditions for transferring in and out of the Drug Catalog" and "dynamic adjustment mechanism", with a view to helping readers better understand the relevant contents of this part and promoting the implementation of the interim measures.
1. How to understand the basic conditions for inclusion in the catalogue How to understand the basic conditions for drug integration The interim measures (Article 7) on the basic conditions for drug integration, continue the 2019 National Health Insurance Drug Catalog Adjustment Work Programme, in addition to drugs (including chemicals, biological products, traditional Chinese medicines (ethnic medicines) and Chinese medicine tablets) should be approved by the state drug regulatory authorities and obtain a drug registration certificate, at the same time should meet the "clinically necessary, safe and reasonable price" basic conditions.
This reflects the functional positioning and multi-dimensional value assessment of drug catalog development, based on clinical needs, clinical effectiveness, safety, economic value, access and payment and other multi-dimensional comprehensive assessment.
addition, in the basic principles of drug management of basic medical insurance, it is also clearly stated that: do your best, but also do your best, the level of drug protection and health insurance funds and the affordability of the insured.
through scientific, standardized, fine, dynamic management, and effectively protect the reasonable drug demand of the insured population.
How to understand multi-dimensional value assessment To establish a multi-dimensional comprehensive assessment of "clinical necessity, safety and effectiveness and reasonable price", we need to establish a chain of evidence that includes clinical necessity, drug utilization, clinical effectiveness/comparative effectiveness, safety, economy and so on.
, led by pharmaceutical economics, integrates multidisciplinary methods such as epidemiology, statistics and evidence-based medicine, which can play an important role in building an integrated evidence chain.
addition, with the diversification of value assessment elements and the need for evidence, there are limitations to a single data resource and research model.
Based on different problems and evidence needs, based on multi-source data system (e.g. real-world data, literature data, etc.), the use of a variety of research methods (e.g., traditional clinical trials, real-world data research, system evaluation, economic evaluation, etc.) is an important way to build a multi-dimensional evidence system.
clinical necessity of clinical necessity refers to the drug in the prevention and treatment of diseases play an important role in clinical urgent needs.
clinically necessary manifestations can be multi-necessary, for example, whether clinical treatment is urgently needed, whether first-line treatment is used, whether it is irreplaceable or not completely replaceable, whether it is a major disease burden of medication, etc.
Often, there is a need to have a full understanding of the clinical and economic burden of the disease, the existing clinical mode of diagnosis and treatment, and the actual needs of drugs in clinical treatment can be clarified by reference to evidence-based clinical practice guidelines and expert consensus based on evidence-based methodology systems.
epidemiological surveys (e.g. disease prevalence, morbidity surveys), treatment patterns and disease prognosis can be used to assess the burden of disease, analyze clinical applications, and provide evidence guarantees for the evaluation of clinical necessity.
clinical value assessment of clinical effectiveness is a key indicator of the clinical value of drugs.
medical insurance decision-making process, the evaluation of clinical effectiveness, in addition to the therapeutic effectiveness of the product itself, but also pay attention to the actual effectiveness and comparative effectiveness in the actual medical environment.
traditional clinical research model, clinical effectiveness evaluation is usually based on pre-market clinical trials of new drugs.
these trials provide key evidence to confirm the therapeutic efficacy of the product, but there are limitations in confirming the actual efficacy of the drug in real diagnosis and treatment, as well as in comparing the effectiveness of other products with the same adaptive disorders.
through the comprehensive use of traditional clinical trial evidence, real-world evidence, and based on the systematic evaluation of evidence, comprehensive evaluation of drug effectiveness and comparative effectiveness in the actual diagnosis and treatment environment, can be more comprehensive evaluation of clinical effectiveness.
consideration of drug safety is an important assessment dimension and basic index for the development of medical insurance drug catalogue.
high risk of adverse reactions not only cause additional harm to patients, but also increase the medical and financial burden.
drug safety assessment is mainly aimed at the common adverse reactions and serious adverse reactions of drugs to conduct a comprehensive assessment.
adverse reactions to drugs on the market are usually mildly controllable and the risks are less than those that benefit, and more evidence is available through traditional clinical trials and Meta analysis.
but severe rare adverse reactions, due to the limitations of pre-market clinical research, the drug needs to be further long-term safety monitoring and evaluation after the market.
for the latter, the safety warnings, safety monitoring data, and research evidence based on real-world data and systematic evaluation provided important support for responding to severe and rare adverse reactions to drugs.
price reasonable interpretation of reasonable price is an important index of medical insurance drug selection, the significance of which is through the reasonable setting of drug prices, and finally reflects the economic value and affordability of drugs.
covers the assessment of the cost-effectiveness (effectiveness) of medicines through the means of pharmaceutical economics and the budgetary impact on the Fund, reflecting that the efficiency, sustainability and security of the use of health insurance funds are fully taken into account on the basis of the overall level of funding for health insurance, with maximum efficiency and fairness at the group level.
of economic value and affordability as the focus of medicare drug selection, usually on the basis of proven clinical necessity, clinical value and safety.
Assessment of the reasonableness of drug prices can be reflected in three aspects: first, the global price situation of similar drugs (e.g., what is the minimum international price and what is the price that patients are willing to pay for them); Based on clinical trial data and real-world data, the corresponding parameters can be generated, and the cost-effect (utility) can be reasonably evaluated by means of economic model, and thirdly, the number of drug users, the location of the drug in the whole treatment process, the estimated impact of the duration of the drug, market share, etc. on the use of the fund.
, how to interpret the transfer conditions of the Drug Catalog 1. Clear the criteria for drug transfer until 2019, the adjustment of the National Health Insurance Drug Catalog only announced the transfer of drugs, no mention of drug transfer out.
but with the change and innovation of drugs, some products have no advantage in terms of clinical value, safety and price.
it is necessary to transfer such drugs in order to improve the efficiency of the use of health insurance funds.
2019, 150 drugs from the National Health Insurance Drug List will be removed.
The Interim Measures further clarified the call-out criteria and determined the "direct transfer out of the directory" and "can be called out of the directory" two types of situations.
will facilitate the efficient use of health insurance funds and provide space for clinically urgently needed and cost-effective innovative medicines.
, it is also conducive to pharmaceutical enterprises to speed up the transformation and upgrading.
2. How to understand the conditions for the transfer of the catalogue is that, in the two cases mentioned above, drugs entering the national medical insurance drug catalogue still need to be subject to rigorous monitoring.
drug companies that have misbehavior or are listed by the relevant state departments as prohibited from producing, selling and using drugs are strictly regulated, reflecting the strictness of the management of health insurance drugs.
from the perspective of the conditions of the adjustable catalogue, the Interim Measures are implemented by the "survival of the fittest" mechanism.
When there are multiple medicines to choose from in the same therapeutic field, a list of drugs that are significantly more expensive or expensive and have no reasonable justification may be considered, and for drugs of less clinical value, alternatives with better clinical value may be considered for the catalogue.
this will introduce competition mechanism in the same treatment field, through the same way of dynamic adjustment, can promote enterprises to continuously optimize and upgrade, but also conducive to the pharmaceutical market benign and sustainable development.
note that the clinical value of medicines often changes with disease and medical patterns and drug life cycles.
therefore, attention still needs to be paid to assessing the extent to which drugs meet clinical needs from the perspective of doctors, patients, etc.
, the establishment of dynamic adjustment mechanism, further activate the drug catalog transfer and transfer out of the organic cycle in 2018 after the establishment of the National Health Insurance Administration, the continuous adjustment of the health insurance catalog, has achieved periodic dynamic adjustment.
Interim Measures further clarified the establishment of a sound dynamic adjustment mechanism by the administrative department of national medical security, which in principle is adjusted once a year.
this dynamic adjustment mechanism has many advantages, which has laid an important mechanism guarantee for the transfer and transfer of drug catalogues, and is a major institutional innovation, reflecting the significant improvement of the level of governance in the field of national medical security.
first of all, dynamic adjustment can be quickly and effectively incorporated into clinically urgently needed, clinically effective, safe and reasonably priced products, and can also effectively eliminate products that are at a disadvantage in multi-dimensional value assessment.
this dynamic mechanism is conducive to the efficient use of health insurance funds, while meeting the growing health needs of the people.
, it is also of great significance to promote the development of China's pharmaceutical industry, encourage innovation and enhance the competitiveness of China's pharmaceutical industry.
to achieve efficient dynamic adjustment mechanism, we need to have a sound overall organization.
procedures established by the Interim Measures provide institutional guarantees for the implementation of the Measures.
From the production and evaluation of drug evidence, the establishment of dynamic evidence production mechanism, timely updating of newly generated multi-dimensional evidence, the use of high-quality research evidence for dynamic adjustment, will better promote the basic medical insurance drug evidence-based selection and decision-making.
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