Insight into the direction of medical insurance access from the eight points of view in the new catalogue!

In December 2021, the annual medical insurance catalogue adjustments will come as scheduled! The total number of drugs in the "2021 National Medical Insurance Drug List" is 2,860, an increase of 60 types from 2020
.
Among them, there are 1486 kinds of western medicines, 1374 kinds of Chinese patent medicines, and 892 kinds of Chinese herbal medicine pieces
.
There are 1273 types of Western medicines in the conventional catalog, 9 more than 2020; 1312 types of Chinese patent medicines, 3 less than 2020
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In the "2021 National Medical Insurance Drug List", a total of 74 new drugs were added to the list, 11 drugs were removed from the list, and 67 exclusive drugs outside the list were successfully negotiated, with an average price reduction of 61.
71%
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Among them, most of the finalists can be said to be expected, but there are still many surprises and eye-catching features
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So, what kind of product is recognized by the Medical Insurance Bureau and is willing to be reimbursed? The author summed up the eight aspects of the 2021 version of the medical insurance catalog, or can find some rules
.
01.
7 drugs are directly entered into the routine list of medical insurance.
A total of 7 drugs are directly entered into the routine list
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Among them, glycopyrrolate injections, ibuprofen injections, and bendamustine injections have all been collected in centralized collections and have not failed, and there are no restrictions on medication when they enter the medical insurance routine list
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Citicoline Sodium and Sodium Chloride Injection, Citicoline Sodium Glucose Injection, Isosorbide Dinitrate Sodium Chloride Injection, and Isosorbide Dinitrate Glucose Injection were directly transferred to the catalog based on the Essential Drugs List
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Among them, the medical insurance for Citicoline Sodium Chloride Injection and Citicoline Glucose Injection is "limited to patients with acute traumatic brain injury and brain surgery with impaired consciousness, and the payment shall not exceed 14 days
.
" At this point, only the compound potassium hydrogen phosphate injection and Tang grass tablets are left in the essential medicines list in 2018, which have not been included in the medical insurance list.

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02.
Among the 67 new negotiation catalog products that have entered the 2020 medical insurance catalogue form review, a total of 24 have entered the 2020 medical insurance catalogue formal review, namely alixizumab injection, apatamide tablets, Benzenecycloquinium Bromide Nasal Spray, Biconazole Tablets, Dacotinib Tablets, Daratumumab Injection, Danorevir Sodium Tablets, Mannote Sodium Capsules, Cyclosporine Eye Drops ( Ⅱ), Sodium Zirconium Cyclosilicate Powder, Criborrol Ointment, Nelatinib Maleate Tablets, Noxinassen Sodium Injection, Human Coagulation Factor Ⅸ, Sophosov Tablets, Uselumumab Injection , Ustinumab injection (intravenous infusion), Lavidavir hydrochloride tablets, Iloiuomab injection, Icilizumab injection, Remazolam besylate for injection, Toluene for injection Remazolam Sulfonate, Perfluorobutane Microspheres for Injection, Guanhuang Mother Granules
.
03.
Innovative drugs approved in 2020, 85% of them entered the medical insurance catalogue through negotiation and the drug review report of the 2020 CDE: A total of 20 domestic innovative drugs have been reviewed and approved by the Center for Drug Evaluation in 2020, and 8 have been included in the 2020 medical insurance catalogue; A total of 10 products have entered the 2021 medical insurance form review, and 9 have entered the 2021 version of the medical insurance; among the remaining 2 products, the new coronavirus inactivated vaccine (Vero cell) is not included in the medical insurance but is a reimbursement product for the whole people.
Alkali is the raw material medicine
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In other words, 85% of domestic new drugs approved for listing in 2020 entered the medical insurance catalog after medical insurance negotiations, so the guidelines for medical insurance negotiations to favor domestic new drugs are obvious
.
04.
Increasing speed of new drugs entering medical insurance VS less proportion of overseas original research drugs entering medical insurance In fact, new drugs are entering the medical insurance catalog faster and faster: in 2020, medical insurance will add 68 new drugs in 5 years, accounting for 68 new drugs on the market 71%; 66 of the 67 drugs out of the catalog in 2021 are drugs that have been on the market within the past five years, accounting for 99%
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However, 74 overseas-produced original research drugs approved by the Center for Drug Evaluation in 2020, of which 3 have entered the 2020 medical insurance catalog; a total of 29 have entered the 2021 medical insurance form review, and only 6 have entered the 2021 medical insurance catalog
.
05.
Twenty-six products will be listed in the medical insurance catalog for the first time in 2021.
According to the "2021 National Medical Insurance Drug Catalog Adjustment Work Plan" announced by the National Medical Insurance Administration on June 30, 2021, from January 1, 2016 to June 30, 2021 During the date, the new generic drugs approved for marketing by the State Drug Administration will be one of the new thresholds for inclusion in the 2021 medical insurance catalog
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According to the author’s statistics, in 2021 (as of June 30, 2021), there are 26 products that have entered the medical insurance catalogue for the first time in the country, including Hetropopaethanolamine Tablets, Risperidone Microspheres for Injection (II), and Chlorine Hydrate Aldehyde/syrup combination packaging, Haibo Maibu tablets, Mabaloxavir tablets, Smeglutide injection, Azilsartan tablets, Midazolam oral solution, Xuanfeibaidu granules, Tita for injection Cipro, icatibant acetate injection, vometinib mesylate tablets, amphotericin B cholesterol sulfate complex for injection, imitenofovir tablets, pamiparib capsules, dampness detoxification Granules, vedicitumumab for injection, enovirin tablets, lamivudine dotegravir tablets, donafenib tosylate tablets, fampridine sustained-release tablets, contizolamide tablets, darotata Amine tablets, levornidazole disodium phosphate for injection, nerofloxacin malate sodium chloride injection and otuzumab injection
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Among them, of the 23 major Chinese innovative drugs that entered the list of medical insurance negotiations, 22 were included in the list of medical insurance
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The more new drugs a domestic company lists, the more the company may enter the medical insurance catalog, such as Hengrui
.
06.
Two products entered the medical insurance catalog without entering the formal review.
Among the 67 newly-added negotiation catalog products, the perfluoropropane human albumin microspheres for injection and clotrimazole vaginal expansion suppositories were entered into the medical insurance list without entering the formal review
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Perfluoropropane human albumin microspheres for injection are expected to enter the medical insurance list following the perfluorobutane microspheres for injection
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The medical insurance limit of perfluoropropane human albumin microspheres for injection is “used for those whose conventional echocardiography is not clear enough to enhance the imaging effect, increase the identification rate of lesions and the accuracy of lesion qualitative, and enhance the boundary of the left ventricle.
Recognition"
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The medical insurance limit of perfluorobutane microspheres for injection is "This product is only for diagnostic use: perfluorobutane microspheres for injection is an ultrasound contrast agent used for ultrasound of focal liver lesions in the vascular phase and Kupffer phase.
Imaging"
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Clotrimazole suppositories (medical suppositories including suppositories, rectal suppositories, and vaginal suppositories) were originally listed in the medical insurance routine list.
According to a report from the Medical Insurance Bureau, clotrimazole vaginal swelling suppositories were included in the medical insurance negotiation list because they were exclusive products in the essential drug list
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In addition, Eltropolamine and Icotinib were transferred from the medical insurance routine list to the medical insurance negotiation list, both of which are exclusive products
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This means that it is increasingly difficult for exclusive products to remain in the medical insurance routine catalogue
.
07.
Thresholds for rare diseases to be included in the medical insurance catalogue: In terms of strict price requirements for rare disease drugs, a total of 7 rare disease drugs are included in the catalog, namely human coagulation factor Ⅸ, icatibant acetate injection, noxinazan sodium injection, and fampridine Sustained-release tablets, concentrated solution for agalsidase alpha injection, iloyuumab injection, and clofloxacin soft capsules
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The drop from 550,000 yuan/bottle to less than 33,000 yuan/bottle for Noxinagen Sodium Injection has made the industry think: If the threshold price requirements for entering the medical insurance catalogue are so strict, how can the development of rare disease drugs get a return? This is indeed a problem
.
08.
Compound preparations, new formulations, and innovative drugs that have entered the formal review but have not entered the medical insurance catalogue.
Innovative drug products have entered medical insurance faster and accounted for an increasing proportion, reflecting the benefits of medical insurance to domestic innovative drugs
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In contrast, in recent years, many new compound prescriptions and dosage forms that have not yet been marketed in China (including generic drugs and innovative drugs) have been on the market, but not many products have entered medical insurance.

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Aripiprazole oral solution, olanzapine oral membrane, granisetron transdermal patch, midazolam buccal mucosal solution, posaconazole enteric-coated tablets, posaconazole injection, ambroxol hydrochloride for inhalation Cefodizime Sodium/5% Glucose Injection for Injection, Cefodizime Sodium/Sodium Chloride Injection for Injection, Cefuroxime Sodium/Sodium Chloride Injection for Injection, Cefmetazole Sodium/Chloride for Injection Sodium Injection, Ceftazidime/Sodium Chloride Injection for Injection, Cefazolin Sodium/Sodium Chloride Injection for Injection, Cefepime Hydrochloride/Sodium Chloride Injection for Injection, Esmolol Hydrochloride and Sodium Chloride Injection Although new dosage forms such as dexmedetomidine hydrochloride and sodium chloride injection were approved to enter the medical insurance form review, they failed to enter the medical insurance
.
And omeprazole sodium bicarbonate dry suspension (Ⅰ), omeprazole sodium bicarbonate dry suspension (Ⅱ), bisoprolol amlodipine tablets, lamivudine tenofovir tablets, Misartan and amlodipine tablets (II), children's multivitamin injection (13) and other compound preparation products have neither entered the medical insurance form review nor entered the medical insurance
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In addition, Fosun Kate’s CAR-T treatment drug Akirensai injection also entered the medical insurance form review but did not enter the medical insurance
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The above-mentioned products failed to enter the medical insurance catalog, and the big barrier lies in economic restrictions
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This will force the industry to rethink: What kind of product is approved by the Medical Insurance Bureau for reimbursement?