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    Home > Medical News > Medical World News > The latest progress of medical insurance Negotiation: are the existing products going through the relay of Sinopharm and petrochemicals?

    The latest progress of medical insurance Negotiation: are the existing products going through the relay of Sinopharm and petrochemicals?

    • Last Update: 2019-11-12
    • Source: Internet
    • Author: User
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    Obviously, under the background of the establishment of the National Health Insurance Bureau, the promotion of volume procurement and the dynamic adjustment of the medical insurance catalog, the introduction of DRGs rules, and the shift of clinical medication to value-based medicine, the medical insurance negotiation has undoubtedly been given more significance The attitude of policy towards pharmaceutical innovation and the formation mechanism of innovative drug prices will be clearly revealed in this negotiation For enterprises, the next direction of efforts has been very clear A new round of national health care negotiations has been officially started after three months' delay! On November 11, a number of industry figures confirmed to e drug managers that a new round of national health care negotiations has officially begun At about 2:30 p.m that day, news came out of the circle of friends: as the first variety to enter the national medical insurance catalog through a new round of medical insurance negotiations, lefuneng, a product of JHB biotherapy, officially broke through The news also sparked a heated debate in the industry There is no doubt that price negotiation has become an important way for innovative drugs to enter the national health insurance catalog in the future, and also an access method to be considered for the first time after innovative drugs enter the market This has been confirmed by past healthcare catalog negotiations and market volume performance after entering the catalog According to the Research Report of Everbright Securities, the sales volume of Xinhuosu, the core product of Tibet pharmaceutical industry, increased by more than 60% in the first half of 2019 compared with the same period of last year, and the rapid and large-scale estimated contribution revenue of China's biologics in the first half of 2019 exceeded 1.3 billion yuan As a whole, the effect of helping high clinical value drugs to achieve rapid dosage through the medical insurance catalog is very obvious The new round of health insurance negotiation involves more products, manufacturers and treatment fields than the previous round, and the number of negotiations is large, which undoubtedly has a greater impact on the industry It is an unprecedented challenge for negotiation experts, governments and enterprises Under the background of the establishment of the National Health Insurance Bureau, the promotion of procurement with quantity and the dynamic adjustment of the medical insurance catalogue, the promulgation of DRGs rules, and the shift of clinical medication to value oriented medical care, the negotiation on medical insurance is undoubtedly endowed with more significance The attitude of policy towards pharmaceutical innovation and the formation mechanism of innovative drug prices will be clearly revealed in this negotiation For enterprises, the next direction of efforts has been very clear At around 2:30 p.m on November 11, news came out that the recombinant cytokine gene-derived protein injection (trade name: lefuneng), a new biological drug approved by JHB for the treatment of hepatitis B, had successfully passed a new round of national health insurance negotiations, becoming the first variety to enter the national health insurance catalog through negotiations this year In the afternoon of the same day, the official website of Jiehua biology also released a press release to announce the news Lefuneng became the first variety to enter the medical insurance industry, which soon triggered a discussion in the industry On the one hand, it is a "star product" with many halos on its head According to the press release, the drug belongs to the class of nce (new chemical) Entity), which has obtained the patent authorization of new macromolecular compounds in the United States, has been listed in the national "11th Five Year Plan" and "12th Five Year Plan" major new drug innovation science and technology major special projects, and is considered as "the world's new type of chronic hepatitis B treatment drugs (first in class) in addition to nucleoside antiviral drugs and human interferon drugs invented in the past 30 years." But at the same time, the drug once faced a lot of questions in the industry, especially in its mechanism of action and clinical data But leaving aside the dispute over the product itself, Lefu successfully passed the negotiation, which officially marks the start of a new round of national health insurance negotiation On August 20, 2019, the new version of the national health insurance regular catalogue was published The state health insurance bureau also said: according to the results of expert review and voting selection, 128 drugs were initially determined to be included in the scope of access to be negotiated, including 109 Western medicines and 19 Chinese patent medicines However, it is worth noting that due to the complex consideration factors and heavy workload, the negotiation of medical insurance has been postponed for three months compared with the original time (August to September 2019) The State Medical Insurance Bureau has organized tens of thousands of experts, spanning clinical experts, pharmaceutical experts, medical insurance management experts, pharmacoeconomics experts, etc., which also put forward high requirements for enterprises To a large extent, this is because the drugs covered in this negotiation are exclusive products with high clinical value but relatively expensive price in the treatment of cancer, diabetes, liver disease and other major diseases Many products are new drugs approved by the State Food and Drug Administration in recent years, including major innovative drugs in China Before that, the national health insurance bureau also said, "due to the variety of this negotiation and the general impact on the fund, there is no requirement for the success rate of this negotiation." On September 2, the minutes of a communication meeting of drug negotiation enterprises in the national medical insurance catalog flowed out According to relevant contents, 128 new drugs will be listed in 2017-2018 according to the common name, excluding 10 special anti-cancer drugs that have been negotiated and admitted in 2018, 18 new regular directories in 2019, 70 new drugs enter this round of negotiations, and 30 new drugs are not According to industry news, 70 varieties entered the negotiation, including 4 PD-1 products (two imported and two domestic), the new hepatitis C drug sophibuvirapatavir compound, the PARP inhibitor olapari, pulmonary hypertension drugs (multiple PAHs), abacept / conbercept, furaquinidine, aletinib, renvaltinib, ekuzumab, CKD related drugs and so on According to the prediction of Everbright Securities, there will be a number of heavy varieties to be added to the national health insurance negotiation, such as lidocaine and letetrexed of China biopharmaceutical, conbercept of Kanghong pharmaceutical, paclitaxel for injection of Shiyao group, doxorubicin hydrochloride, etc In terms of negotiation process, "value" is still the key factor of price formation According to the content of the minutes, the on-site negotiation process is for the medical insurance release to carry out on-site negotiation with the enterprise and sign on the spot to confirm the negotiation results; the negotiation varieties are randomly selected, in principle, the competitive products are negotiated in a group; each variety is 30 minutes, with two quotation opportunities "In the negotiation, enterprises should focus on the multi-dimensional value of products to obtain a satisfactory access price." In fact, "value" first includes the clinical value of drugs, which needs to be discussed through clinical research evidence Secondly, from the perspective of patients' actual needs, we should consider the patient value of drugs, and finally the economic value of drugs, which is still a new field in China Zhang Jinyang, chief analyst of Guosheng securities pharmaceutical industry, commented in the circle of friends that: in fact, the negotiation of innovative medicine medical insurance mainly focuses on the average decline, because it will reflect two attitudes: the first is the overall attitude towards innovative medicine, and the second is the special attitude towards domestic innovative medicine The impact on the stock price is short-term In the future, it will be large-scale It only depends on the price paid It reflects the policy of the representative of the medical insurance bureau to determine the group's overall attitude towards future innovation, and further affects the overall market's expectation on innovation In just a few years, the review and approval, medical insurance access and other links involved in the R & D chain of innovative drugs have made great progress The implementation of centralized procurement of drugs will further accelerate the structural change of the pharmaceutical industry, and support innovation by releasing cages and replacing birds We can clearly see the support of the state for innovative drugs On November 8, CDE issued seven announcements on its official website, including 16 attachments, with more than 100000 words Among them, the notice on Soliciting Opinions on the work procedures for breakthrough therapeutic drugs and the work procedures for priority review and approval, and the notice on Soliciting Opinions on the technical guidelines for conditional approval and listing of clinically urgently needed drugs once again will further improve the policy of priority review and approval, which will encourage and develop innovative drugs and accelerate the research and development of clinically valuable and clinically urgently needed drugs There are significant advantages in listing As a matter of fact, China's policies on priority review of drug registration have been carried out since 2005 According to the review of Everbright Securities Research Report, the special approval procedure for drugs issued on November 8, 2005 has begun to involve priority review, but the scope is more concentrated in the state of emergency, or in the event of major public health emergencies Until December 18, 2017, the opinions of the General Administration on encouraging drug innovation to implement priority review and approval came into being, at least seven documents involved in priority review However, on May 23, 2018, the health and Health Commission issued No The announcement on relevant matters formally proposed that "for the prevention and control of diseases that are seriously life-threatening and have no effective treatment means for overseas listing, and for the drugs with rare diseases, the clinical trial data obtained from overseas can be submitted to directly apply for drug listing registration Based on the need of product safety risk control, the drug inspection work shall be carried out and the re registration and filing procedures for imported drugs shall be cancelled." According to the 2018 annual drug review report, 313 registered drugs will be included in the priority review process in 2018, of which 63 are children's drugs and drugs for rare diseases However, this consultation draft on priority review and approval emphasizes more on the inclusion of breakthrough treatment drugs, drugs with conditional approval for listing and registration, drugs urgently needed in clinical, drugs for treatment of rare diseases, children's drugs, innovative vaccines with obvious clinical value, etc The system will further improve the priority review and approval system and form a formal working procedure.
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