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    Home > Medical News > Latest Medical News > 4 manufacturers and 3 countries talk about generic drugs to determine the price limit of centralized procurement

    4 manufacturers and 3 countries talk about generic drugs to determine the price limit of centralized procurement

    • Last Update: 2022-11-25
    • Source: Internet
    • Author: User
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    On November 15, Anhui Pharmaceutical Centralized Procurement Center issued an announcement to adjust
    the centralized procurement properties and prices of three drugs.
     
    These three drugs are dapagliflozin tablets, levalbutamol hydrochloride nebulized inhalation solution, and entecavir oral solution, involving Shandong Lukang, Jiangsu Dahongying Hengshun Pharmaceutical, Anhui New Century Pharmaceutical and Shenzhen Taitai Pharmaceutical
    .
     
    The above three drugs have all entered the medical insurance catalogue B after national negotiations, and then generic drugs have been approved for marketing
    .
    Nowadays, these generic drugs have entered the network everywhere, so the varieties that have been listed on the network are converted into national medical insurance negotiation drugs according to relevant national policies, and the price limit of the network is determined, and medical institutions can purchase
    within the limit price.
     
    Its policy basis is mainly as follows: The Notice of the Ministry of Human Resources and Social Security of the National Health Insurance Administration on Printing and Distributing the Catalogue of Drugs for National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2021) (Medical Insurance Fa [2021] No.
    50) requires:
     
    During the agreement period, if a drug with the same generic name as the negotiated drug is listed, the direct listing price of the same generic drug shall not be higher than the medical insurance payment standard
    of the same specification determined by the negotiation.
     
    Accordingly, in order to standardize the online centralized procurement of medical insurance negotiated drugs, Anhui now adjusts the relevant drugs from "online procurement drugs" to "national medical insurance negotiated drugs" (as shown in the table below) according to the application of drug production/agency enterprises, and takes "national medical insurance negotiation price" or "provincial medical insurance payment standard" as the centralized procurement limit
    .
    If an individual enterprise reduces the price at the lowest centralized procurement price in the country on the basis of the "national medical insurance negotiated price", the enterprise shall reduce the price independently and limit the price, and the medical institution is requested to adjust the catalog and price
    in a timely manner.
     
     
    Dapagliflozin
     
    The original manufacturer of dapagliflozin tablets is AstraZeneca, and the trade name is Andatang
    .
    In 2019, the national talk entered the medical insurance catalog, when the national talk scene "4.
    4 yuan is too ugly, and then lower the point" and other dialogues, the so-called "soul bargaining" has become a hot discussion
    on the Internet.
     
    At present, Shandong Lukang and Beijing Fuyuan Pharmaceutical have been approved for marketing in China, and there are also companies such as Beite, Shuanglu, Haosen and other companies that have submitted generic drug registration applications, in addition to Indian generic drug companies such as Sipra and Arabindu
    .
     
     
    Levobutamol hydrochloride nebulized solution for inhalation
     
    Inhalation preparations are the preferred drugs for the treatment of asthma and chronic obstructive pulmonary disease (COPD), because their drug-device integration has built extremely high technical barriers, and the current domestic substitution rate is only 10%.

    With the issuance of the Guidelines for Bioequivalence Research of Generic Drugs for Oral Inhalation Preparations in December 2020, the inhalation preparation industry may usher in an explosive period and an
    era of accelerated domestic substitution.
     
    Affected by the national centralized procurement, the market share of budesonide suspension for inhalation, which was originally in the king position in the field of COPD, declined, while levalbutamol hydrochloride nebulized inhalation solution, acetylcysteine solution for inhalation, and beclomethasone propionate suspension for inhalation increased
    steadily.
    Among them, Health Yuan (Mrs.
    Pharmaceutical) was the fastest growing product in drug sales in the first quarter of 2022, with a year-on-year growth of an astonishing 41 times
    .
     
    On September 27, 2019, HealthYuan launched the first new Class 3 registered and approved levosbutamol hydrochloride nebulized inhalation solution (Lisutong)
    in China.
    On April 21, 2022, the product was added by 3ml:1.
    25mg and was approved for marketing
    .
     
    At present, in the field of this variety, in addition to Health Yuan, there are also Dahongying Hengshun Pharmaceutical, Nanjing Hengdao, Yangzhou Zhongbao, Yangtze River, Beite (Priant), Jiangsu Changtai and other enterprises have this variety approval
    .
     
      
    Source: Minai.
    com
     
    Entecavir oral liquid
     
    This variety is a 2021 national drug, developed by BMS and approved in China in 2005, and is the first-line drug
    for anti-hepatitis B virus treatment.
    However, the main dosage forms of entecavir are tablets and capsules, with the highest market share of Chia Tai Tianqing, reaching 48.
    93%, and BMS accounting for 26.
    44%.

     
    Tablets, capsules, and dispersible tablets have been included in the 4+7 centralized procurement pilot, and the price has plummeted by more than 95%.

    At present, there are three companies approved for listing, Yangzijiang is the first imitation, Anhui New Century Pharmaceutical is closely following, and Guangzhou Daguang Pharmaceutical has just been approved for listing
    a few days ago.
     
    With the reform of the drug review and approval system, more and more generic drugs are on the market, and the following requirements are required for the listing and payment standards of generic drugs of national drugs according to the National Medical Insurance Administration (Medical Insurance Fa [2021] No.
    50):
     
    During the agreement period, the negotiation of drugs shall implement a unified national medical insurance payment standard, and each coordinating region shall determine its out-of-pocket payment ratio and reimbursement ratio according to the fund's affordability, and no secondary negotiation
    shall be conducted during the agreement period.
     
    During the agreement period, if a drug with the same generic name as the negotiated drug is listed, the direct listing price of the same generic drug shall not be higher than the medical insurance payment standard
    of the same specification determined by the negotiation.
     
    If the negotiated drug is listed with the same generic name drug or included in the centralized procurement of drugs (centralized procurement by the state organization and centralized procurement by provincial alliances) during the agreement period, the provincial medical insurance department may adjust the medical insurance payment standard
    of the drug according to market competition, the price of the same generic drug or the results of the centralized procurement of drugs.
     
    Therefore, if there are generic drugs on the market, we should pay close attention to the listing of online and medical insurance payment standards in various places, which is an important part
    of market access.
     
    Judging from the price information of the three varieties released by Anhui, they are basically slightly reduced on the basis of the price negotiated in the original country, and the difference is very small
    .
    Therefore, generic drugs use the original manufacturer to negotiate the price based on a good price to enter everywhere
    .
    The original manufacturer has also encountered challenges
    from generic drugs.
     
    The state stipulates that the price of its hanging network shall not be higher than the payment standard determined by negotiation, and the price and payment standard determination of the network are slightly different in different provinces, and enterprises should pay close attention to the relevant policies of each province and city, so as to "hang up everything" and enter the hospital as soon as possible to benefit patients
    .
     
    In addition, the "dual-channel" competition in the out-of-hospital market will also be launched at the same time, and the pricing strategy, prescription circulation method, and partner sought will be different
    .
    The competition between the two markets inside and outside the hospital is similar to the centralized procurement varieties, especially the oral dosage form of chronic disease
    .
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