The latest policy release Biosynthic drugs to replace the original research into the inevitable innovative drugs face new challenges.

On July 31, 2020, the Interim Measures for the Administration of Drug Use in Basic Medical Insurance and the Interim Measures for the Administration of Drug Use by the State Medical Security Administration (No. 1) were issued, and the Interim Measures for the Administration of Drug Use in Basic Medical Insurance were an important measure to promote the construction of a healthy China and realize the outline of the "Healthy China 2030" plan. The basic drug use needs of personnel, the improvement of the scientific and fine management level of basic medical insurance drugs, the improvement of the efficiency of the use of basic medical insurance funds, the modernization of the governance system and governance capacity, the promotion of health fairness and medical accessibility, in accordance with the Social Insurance Law of the People's Republic of China and other laws and regulations and the Cpc Central Committee of the State Council on deepening the reform of the 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 efficient selection and adjustment of basic medical insurance drugs in the Interim Measures for the Administration of Drug Use in Basic Medical Insurance is largely based on changes in the Work Programme for the Adjustment of the National Health Insurance Drug Catalog for 2019, and a draft for comments was issued in April 2020.
With the heavy responsibility of medical procurement under the responsibility of the State Administration of Medical Security, the State Administration of Medical Security has become the "buyer' side" of medical insurance drugs: by the end of 2019, the total amount of orders taken by 31 provinces (districts and municipalities) through the provincial centralized drug procurement platform network is 991.3 billion yuan.
, orders for Western medicines (chemicals and biological products) amounted to 811.5 billion yuan, and orders for traditional Chinese medicine amounted to 179.8 billion yuan.
832.7 billion yuan, accounting for 84% of the total amount of medical insurance drug orders.
that basic medical insurance drugs account for a very high proportion of the total purchase of medicines.
therefore, the impact of the Essential Health Insurance Drug Catalog (hereinafter referred to as the Drug Catalog) on the industry is described as a source of income on which it depends.
At present, there are five trends worthy of industry attention: 1 generic drugs automatically belong to the basic medical insurance fund payment scope "drug catalog" implementation of generic name management, "drug catalog" of drugs of the same generic name drugs automatically belong to the basic medical insurance fund payment scope.
The recent debate over whether Chinese medicine and biological products can be replaced by each other can basically subside, which also means that in the provincial volume procurement pilot, "the same generic name" background biological similar drugs to replace the original biological products is inevitable, but this also means that biological similar drugs manufacturers more, the product will have the possibility of a price war.
to circumvent the generic name, perhaps biosimilars could refer to Sansheng Guojian's newly approved injection of Initumma in 2020.
is also a biologically similar drug for the joint treatment of HER2-positive metastatic breast cancer with chemotherapy, but there are many innovations and upgrades in Inito's monotherapy compared to queto bead monotherapy, such as production process optimization, Fc segment modification, and innovative anti-HER2 monoantigen with stronger ADCC.
In addition, the constant region of Inito monoto resistance is further optimized, and the 359th and 361st amino acid optimization modifications of the Fc segment heavy chain constant zone (Initonic monoto resistance is D359, L361, quritobe mono resistor is E359, M361), which enhances the body's immune system.
in addition, in terms of glycosylation modification, a 60 per cent increase in intensification of intransigenic acidification levels helped to prolong the half-life, while high glucosaccharization levels were reduced by 40 per cent and the risk of immunogenicity was reduced.
In view of Inito monoto is based on the innovation and upgrading of Quto zhu mono resistance, obtained a different generic name, this product into the health insurance may be and Quto zhu mono resistance to negotiate the price together, but in the procurement tender, may not be replaced by the same generic name of the product, relatively speaking, the maintenance price is less difficult.
2 Class B OTC, Broken Wall And Refined Drink tablets escaped the disaster Although it is not clear which products are not included in the Drug Catalog in the 2019 National Health Insurance Drug Catalog Adjustment Work Programme, the 2019 National Health Insurance Drug Catalog Adjustment Work Programme policy The interpretation is clear: "According to the basic principles of health care system to ensure functional positioning and medical insurance use, some drugs can not be included in the scope of the catalog: such as the main tonic drugs, including the national endangered wildlife medicine drugs, preventive vaccines and contraceptives and other public health drugs, for weight loss, beauty, smoking cessation and other drugs."
some of these are to improve the quality of life, some are preventive, some belong to the scope of public health protection, are not included in the scope of directory adjustment.
for over-the-counter drugs (OTC), the international general non-reimbursement, this adjustment in principle will not be added."
Interim Measures for the Administration of Medications for Basic Medical Insurance refer to the following drugs not included in the Drug Catalog :(1); Drugs that are not available for separate charges due to inclusion in medical treatment projects, (7) alcohol preparations, tea preparations, all kinds of fruity preparations (except for children's medication in exceptional cases), oral oral dosing agents and oral foaming agents (except in special cases); and (8) other drugs that do not comply with the provisions of basic medical insurance.
In addition to the draft for comments on the "Class B OTC drugs" and "broken-walled drink tablets, refined beverage tablets and other standard drink tablets reprocessed drink tablets" were not mentioned, other categories of "basic medical insurance drug management interim measures" are basically consistent with the draft for comments.
means that both types of drugs are retained, but that does not mean that the new two types of drugs will be able to enter health insurance.
If a drug in the Drug Catalog has one of the following circumstances, it shall, after expert review, directly transfer out of the Drug Catalog :(1) the drug whose approval documents have been revoked, revoked or cancelled by the drug regulatory department; (2) the drug that has been included in the negative list by the relevant department Drugs; (3) drugs that, taking into account clinical value, adverse reactions, drug economy and other factors, have been assessed as making a risk greater than the benefits; (4) drugs that have entered the Drug Catalog through illegal means such as fraud; and (5) other circumstances prescribed by the State that should be transferred directly.
"Drugs prohibited from being produced, sold and used by the relevant departments" in the draft for comments are deleted and are expected to be duplicated by "drugs that have been revoked, revoked or cancelled by the drug regulatory authorities".
2019 has been the national focus on monitoring the drug catalog products out of the drug catalog.
It is worth noting that individual provinces will be the top sales of products into the province's key monitoring drug catalog, but not all of the top sales of products are not therapeutic drugs, if the focus of monitoring drug catalog is a negative list, then these products are very likely to be called out of the "drug catalog."
The three types of products that can be transferred out of the catalogue, whether it is the draft for comments or the Interim Measures for the Administration of Medications for Basic Medical Insurance, are three categories: (1) drugs with significantly higher prices or costs in the same field of treatment and no reasonable reason;
It is worth noting that the current health insurance sector has mastered the national drug procurement prices, experienced the national drug production procurement, high blood pressure, high blood lipids of the first-line drug prices have fallen to the "floor price", individual exclusive or competitive manufacturers 2 products may be significantly higher prices and bear the pressure to be kicked out of the "drug catalog" or negotiate price reduction.
3 The edgy drug economics of innovative drugs embodies the basic conditions for their inclusion in the Drug Catalog, and the Interim Measures for the Administration of Drugs for Basic Medical Insurance only retain the basic conditions of "drugs included in the Drug Catalog" which are consistent with the draft for comments, and shall be chemicals, biological products, traditional Chinese medicines (national medicines) that have obtained the certificate of drug registration approved by the State Drug Regulatory Department, and which are made according to standards.
support for eligible essential medicines", but "supporting eligible innovative drugs with independent intellectual property rights to be included in the Drug Catalog in accordance with prescribed procedures" was deleted.
, for domestic innovative drugs, to be included in the Drug Catalog, only eligible national organizations to centrally purchase selected drugs or government-priced drugs can be directly included in the Drug Catalog.
government-priced products often refer to narcotic drugs and the first category of psychotropic drugs, as well as the national unified procurement of preventive immunologic drugs, the national free antiviral treatment drugs for AIDS.
State organizations focus on the procurement of selected drugs usually refers to the manufacturer of drugs above, innovative drugs in the short term usually only one, which means that domestic innovative drugs and domestic and foreign therapy with the same adaptive PK pharmacoeconomics can enter the "drug catalog."
For innovative drugs, the 2019 hepatitis C health-care negotiations are likely to repeat history, which means that innovative drugs piled up in the therapeutic field are likely to face the prospect of not being included in the Drug Catalog in the future because of the inability of pharmaceutical economics research to be in place.
is necessary to add research on pharmaceconomics for innovative drugs that are being developed.
4 Decisions in and out of the catalog: The clinical necessity of drug economics is the basic criterion for screening throughout the Drug Catalog, and the 2019 National Health Insurance Drug Catalog Adjustment Work Programme also mentions giving priority to the treatment of major diseases such as basic drugs, cancers and rare diseases, chronic disease medications, children's medications, emergency medicines, etc.
the need to consider clinically necessary, safe and effective circumstances, and also to consider reasonable prices, then pharmaceutical economics is the best tool for judging.
The Interim Measures for the Administration of Medications for Basic Medical Insurance mention that, in addition to the "drugs recommended in the original Drug Catalog", direct transfers are made.
A drug of this type is transferred directly from the Drug Catalog" and "The drug recommendations in the original Drug Catalog adjust the limited payment scope, where the scope of limited payment is narrowed or the scope of payment is limited but the impact on the basic medical insurance fund is small, the drug may be directly adjusted" without the need for pharmaceutical economics, Access to and from the catalogue basically requires the economics of drugs: (1) it is recommended that new drugs incorporated into the Drug Catalog be submitted to the Pharmaceutical Economics and other information in accordance with the provisions, in addition to the centralized procurement of selected drugs by qualified national organizations or government-priced medicines.
(2) the original "Drug Catalog" recommended that can be transferred out of the drug, such drugs in accordance with the provisions of the submission of drug economics and other information.
(3) The drug recommendations in the original Drug Catalog should be adjusted to limit the scope of payment.
to expand the scope of payment and have a greater impact on the basic medical insurance fund, according to the provisions of the submission of pharmaceutical economics and other information.
expected to spur exclusive drugs in the Drug Catalog to conduct drug economics studies of their products to prevent them from being restricted or kicked out.
5 generic drug market 2 even health insurance negotiation products to enter the collection has a policy basis in addition to how to enter the "drug catalog", how to set the price of health insurance is also the industry's concern.
The Interim Measures for the Administration of Drug Use in Basic Medical Insurance proposed the establishment of a mechanism for linking access to the Drug Catalog with the Standard for payment of Medical Insurance Drugs (hereinafter referred to as the Payment Standard).
addition to Chinese medicine tablets, in principle, the new drugs included in the "Drug Catalog" to determine the payment standards simultaneously.
criteria for the payment of exclusive medicines through access negotiations.
agreement in principle is valid for two years.
during the term of the agreement, if a generic drug of the same generic name (generic) is listed, the health insurance department may adjust the payment standard for the drug according to the price level of the generic drug, or it may include the generic name in the scope of centralized procurement.
After the expiry of the agreement, if the negotiated drugs are still exclusive, the prices of neighboring countries and regions and other market environment has not changed significantly and no adjustment of the limited payment scope or although the limited payment scope has been adjusted but the impact on the basic medical insurance fund is small, according to the actual expenditure of the basic medical insurance fund during the agreement period (whichever is based on the statistics of the medical insurance sector) and the budget impact analysis submitted by the enterprise before the negotiation, adjust the payment criteria according to the relevant rules, and renew the agreement.
specific rules will be formulated separately".
meanwhile, "negotiated medicines are purchased directly online in principle in accordance with payment standards during the agreement period."
period of the negotiation agreement, the generic name of the drug under negotiation shall be purchased online in accordance with the provisions if the price is not higher than the negotiated payment standard.
medicines shall be carried out in accordance with the relevant policies on drug recruitment". The
draft does not explicitly reduce prices based on the price level of generic drugs, or even can be included in the scope of centralized procurement, which means that when only one generic drugs are on the market, enjoy the "price is not higher than (expired original drug prices) negotiated payment standards", expired original drugs because the price of generic drugs is basically similar to their own without adjusting the level of payment, the biggest challenge comes from the generic replacement.
Once the two listed and expired original research drugs together three may enter the volume procurement and face a price war - generic drugs after the market price "cliff drop" phenomenon may appear faster than the current phenomenon.
addition, "all negotiated medicines in the draft for comments are, in principle, renewed only once for a period of two years."
E-contract period allows medical institutions to negotiate drugs", which means that the health insurance negotiating catalog does not involve secondary bargaining, and as long as the generic product is not on the market, it is very likely that indefinitely in the health-care negotiation catalog.
non-exclusive drugs, the State organizes the centralized procurement of selected drugs and determines the payment standards in accordance with the relevant provisions of centralized procurement;
if the negotiation or access bid is successful, it shall be included in the Drug Catalog or the scope of payment shall be adjusted, or if the negotiation or entry bid is unsuccessful, it shall not be included or transferred out of the Drug Catalog, or the scope of payment shall not be adjusted.
This big probability will refer to the current lowest bid price or the lowest of several provinces of the average bid standard, recent news that the provinces to organize provincial and municipal-level volume procurement, and it is understood that the health care sector provided 500 catalogs, the price of these products may be the bid standard reference value.
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