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

Realizing the efficient selection, adjustment, use, management and supervision of basic medical insurance drugs is the core content to ensure 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 Basic Medical Insurance Drugs is largely based on changes made in the 2019 National Health Insurance Drug Catalog Adjustment Work Programme, and a draft for comments was issued in April 2020.
With the heavy responsibility of medical procurement under the responsibility of the State Health Insurance Administration, the State Health Insurance Administration has become the "buyer" of medical insurance drugs: by the end of 2019, the total amount of orders received by 31 provinces (districts and cities) through the network of provincial drug centralized procurement platforms was 991.3 billion yuan.
, orders for Western medicines (chemicals and biological products) amounted to 811.5 billion yuan and orders for Chinese medicines amounted to 179.8 billion yuan.
orders for medical insurance drugs on the Internet amounted to 832.7 billion yuan, accounting for 84%.
this shows that essential health insurance medicines account for a very high proportion of the total procurement of medicines.
, the impact of the Essential Medical Insurance Drug Catalog (hereinafter referred to as the Drug Catalog) on the industry is at the level of source of income on which to live.
There are currently five trends worthy of industry attention: 1 drugs with the generic name automatically belong to the scope of payment of the basic medical insurance fund "drug catalog" to implement generic name management, "drug catalogue" drugs of the same generic name of the drug automatically belong to the basic medical insurance fund payment scope.
The recent debate about whether Chinese medicine and biological products can be replaced by each other can basically be settled, which also means that in the provincial procurement pilot, "with the generic name" background of bio-similar drugs to replace the original biological products is inevitable, but this also means that when the number of manufacturers of bio-similar drugs more, the product will have the possibility of a price war.
in order to avoid the generic name, perhaps biosimilars can refer to Sansheng Guojian's newly approved injection of intransiviral monoantigen in 2020.
is also a combination of chemotherapy to treat HER2-positive metastasis breast cancer, "curto-bead monoantigen" biosynthetic drugs, but inito monoanti-resistance compared to curto-pearl monoantitor has a lot of innovation and upgrading content, such as production process optimization, Fc segment modification, with a stronger ADCC innovative anti-HER2 monoantitor.
In addition, the constant zone of inito monoantigen is further optimized, and the 359th and 361st amino acid optimization modifications of the Fc segment heavy chain constant zone (Inito monoantigen is D359, L361, cratural bead monoantigen is E359, M361), which enhances its ability to activate the body's immune system.
in addition, in the area of glycosylation modification, the level of intransimal acidification increased by 60%, which helped to prolong the half-life, and the level of high glyceride decreased by 40%, reducing the risk of immunogenicity.
Given that Inito monoantitor is based on the innovation and upgrading of quto pearl monoantitor, obtained a different common name, this product into health insurance may be and Quto zhu single resistance together to negotiate prices, but in the procurement of tenders, may not be replaced by products with the common name, relatively speaking, maintenance prices are less difficult.
2 Category B OTC, broken-walled drink tablets and refined beverage tablets escaped, although in the 2019 National Health Insurance Drug Catalog Adjustment Work Programme did not specify which products are not included in the Drug Catalog, but in the 2019 National Health Insurance Drug Catalog Adjustment Work Programme policy interpretation However, it is clear: "In accordance with the basic principles of the medical security system to ensure functional positioning and medical insurance drug use, some drugs can not be included in the scope of the catalog: for example, 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."
these are to improve the quality of life, some play a preventive role, some belong to the scope of public health protection, are not included in the scope of catalog adjustment.
for over-the-counter medicines (OTCs), which are generally not reimbursed internationally, and this adjustment is not new in principle."
The Interim Measures for the Administration of Drug Use in Basic Medical Insurance refer to the following drugs that are not included in the List of Medicines: (1) drugs that play a primary tonic role; (2) medicines containing national precious and endangered wildlife herbs; (3) health medicines; and (4) preventive vaccines and contraceptives; (5) Drugs that mainly enhance sexual function, treat hair loss, lose weight, beauty, quit smoking, abstipate alcohol, etc.; (6) drugs that cannot be charged separately for reasons such as being included in medical treatment programs; (7) alcohol preparations, tea preparations, all kinds of fruity preparations (except for children's medications in special cases), oral dosages and oral bubbly agents (except in special cases) and so on(8) other drugs that do not meet the requirements of basic medical insurance;
In addition to the "Class B OTC drugs" and "broken-wall drink tablets, refined drink tablets and other drink tablets for reprocessing of standard drink tablets" were not mentioned, other categories of "interim measures for the administration of basic medical insurance drug use" are basically consistent with the draft for comments.
means that both types of drugs are retained, but that doesn't mean that the new two types of drugs will be covered.
drugs in the Drug Catalog, if one of the following circumstances is reviewed by an expert, the Drug Catalog shall be directly called out: (1) the drug whose drug approval document has been revoked, revoked or cancelled by the drug regulatory department; (2) Drugs that have been placed on the negative list by the relevant departments; (3) drugs that have been assessed to be more risky than beneficial, taking into account such factors as clinical value, adverse reactions and drug economy; (4) drugs that have entered the Drug Catalog by means of fraud and other illegal means; and (5) other cases that should be directly transferred out as prescribed by the State.
"Drugs prohibited from production, sale and use by the relevant departments" from the draft is deleted, which is expected to duplicate the contents of "Drugs that have been revoked, revoked or cancelled by the drug regulatory authorities."
2019 has been the national focus on monitoring drug catalog products out of the "drug catalog."
It is worth noting that individual provinces will be the sales of the top products into the province's key monitoring drug catalog, but not all sales of the top products are not therapeutic drugs, if the focus of monitoring drug catalog is a negative list, then these products are very likely to be transferred out of the "drug catalog."
The three types of products that can be transferred out of the catalogue, whether they are drafts for comments or the Interim Measures for the Administration of Essential Medical Insurance Drugs, are three categories: (i) drugs with significantly higher prices or costs in the same therapeutic field and without reasonable justification;
It is worth noting that the current health care sector has mastered the national drug procurement prices, experienced the national drug belt 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 due to the price is significantly higher and under pressure to be kicked out of the "drug catalog" or negotiate price reductions.
3 The good drug economics of innovative drugs embodies the basic conditions for inclusion in the Drug Catalog, and the Interim Measures for the Administration of Drug Use in Basic Medical Insurance, which are consistent with the draft for comments, shall only retain the basic conditions of chemical drugs, biological products, traditional Chinese medicines (national medicines) approved by the State drug regulatory department, and Chinese medicine tablets made according to standards, and conform to clinical requirements, safety, effectiveness and reasonable price.
"Supporting eligible essential medicines", but "supporting qualified innovative drugs with independent intellectual property rights to be included in the Drug Catalog in accordance with the prescribed procedures" was deleted.
this is for domestic innovative drugs, to be included in the Drug Catalog, only qualified national organizations centralized procurement of selected drugs or government-priced drugs can be directly included in the Drug Catalog.
government-priced products often refer to narcotic drugs and psychotherapy class I drugs, as well as national procurement of immunization drugs, free national AIDS antiviral treatment drugs.
National organizations centralized 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 with the same adaptive therapy PK pharmaceutical economics can enter the "drug catalog."
For innovative drugs, the 2019 hepatitis C health care negotiations are likely to repeat history, meaning that innovative drugs piled up in the therapeutic field may in the future face a post-market failure to make the Drug Catalog because of a shortage of research into pharmacoeconomics.
is necessary to add research on pharmacoeconomics for innovative drugs that are being studied.
4 In and out of the catalog of the determination: pharmaceutical economics clinical necessity is throughout the "drug catalog" screening of the basic criteria, "2019 National Health Insurance Drug Catalog Adjustment Work Programme" has also mentioned the priority given priority to the national basic drugs, cancer and rare diseases and other major diseases treatment drugs, chronic diseases, children's drugs, emergency rescue drugs.
to consider clinically necessary, safe and effective, but also need to consider reasonable prices, then drug economics is the best tool to judge.
"Interim Measures for the Administration of Drug Use in Basic Medical Insurance" mentioned that, in addition to "the original Drug Catalog recommended direct transfer of drugs."
Three drugs are directly transferred from the Drug Catalog" and "The original Drug Catalog" suggests adjusting the scope of payment, which narrows the scope of limited payment or expands the scope of payment but has less impact on the basic medical insurance fund, it may be directly adjusted "without the need for pharmaceutical economics, " Drug economics is essentially required for entry and exit: (1) It is recommended that new drugs included in the Drug Catalog be added, and after expert evaluation, other drugs shall be submitted to the Drug Economics and other information in accordance with the provisions, in addition to the centralized procurement of selected drugs or government-priced medicines by eligible national organizations.
(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 pharmaceutical economics and other information.
(3) The drug recommendations in the original Drug Catalog are to adjust the scope of payment.
expand the scope of limited payment and have a great impact on the basic medical insurance fund, the drug economics and other information shall be submitted in accordance with the provisions.
is expected to spur exclusive drugs in the Drug Catalog to conduct drug economics research on their products in case they are restricted or kicked out of health insurance.
5 generic drug market 2 even health insurance negotiating products to enter the collection has a policy basis in addition to how to enter the "drug catalog", how to set health insurance prices is also the industry's concern.
"Interim Measures for the Administration of Drug Use in Basic Medical Insurance" proposed the establishment of a "Drug Catalog" access and medical insurance drug payment standards (hereinafter referred to as payment standards) interface mechanism.
addition to Chinese medicine tablets, in principle, the new drugs included in the "Drug Catalog" to determine the payment standards simultaneously.
exclusive medicines determine payment criteria through access negotiations.
" negotiated drug agreement in principle is valid for two years.
period of the agreement, if a generic name drug (generic) with a negotiated drug is listed, the health insurance department may adjust the payment criteria 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 end of the agreement, if the negotiating drug is still exclusive, the market environment such as prices in neighboring countries and regions has not changed significantly and the scope of payment has not been adjusted, or although the scope of payment has been adjusted to have less impact on the basic medical insurance fund, the actual expenditure of the basic medical insurance fund (whichever is based on the statistics of the health insurance sector) shall be compared with the budget impact analysis submitted by the pre-negotiation enterprises during the agreement period, and the payment standards shall be adjusted according to the relevant rules and the agreement shall be renewed.
specific rules are set separately."
, "negotiating drugs during the agreement period is, in principle, directly online in accordance with payment standards."
period of the agreement, the same generic name drug negotiating drugs shall be purchased on the Internet in accordance with the provisions, provided that the price is not higher than the negotiated payment standard.
other medicines shall be implemented in accordance with the relevant policies on drug recruitment".
The draft does not explicitly reduce prices according to the price level of generic drugs, or even can be included in the scope of centralized procurement, which means that only one generic drug on the market, enjoy the "price is not higher than (expired original drug price) negotiated payment standards" preferential treatment, expired original drugs because the price of generic drugs and their own prices are basically similar from the need to adjust the payment level, the biggest challenge comes from generic drug substitution.
Similars once the two listed and expired original drugs together three may have to enter the volume of procurement and thus face a price war - generic drugs after the market after the price of the original research drugs "cliff-edge decline" phenomenon may be faster and faster than the current phenomenon.
addition, "all negotiated medicines are renewed in principle only once and for a period of two years."
Resoly allowing medical institutions to negotiate drugs during the renewal period" means that the health-care negotiating list does not involve a secondary bargain, and as long as generic products are not on the market, it is highly likely that they will be in the health-care negotiating list indefinitely.
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 entry bid is successful, it shall be included in the Drug Catalog or the scope of payment shall be adjusted; if the negotiation or entry bid is not successful, 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 domestic lowest winning bid price or the lowest in several provinces of the average bid price as the bid standard, recently there is news that the provinces to organize provincial and municipal volume procurement, and it is understood that the health care sector provided 500 catalogs, the price of these products may be a reference value for the bid standard.
original title: Latest policy release! Biosynthic drugs replace the original research into inevitable, innovative drugs face new challenges, these categories of products or dodge a disaster!