These five varieties are likely to enter into drug price negotiation

[market analysis of chinapharma.com] recently, a new version of the medical insurance catalog was released However, people were surprised to find that many innovative drugs that had been widely regarded were absent from the new version of the medical insurance catalog At the same time, 45 drugs with high clinical value but relatively expensive price have been reviewed and determined by experts, and they intend to participate in a new round of drug price negotiation led by the Ministry of human resources and social security (big picture source: Baidu picture) on February 23, a new version of the national health insurance catalog was officially released in the hope of a great deal of enthusiasm Before that, a much anticipated topic about the adjustment of the medical insurance catalog was the transfer of domestic innovative drugs and heavy-duty products Once these drugs are included in the medical insurance catalog, they will have a significant impact on the change of the domestic medical market pattern However, after the introduction of the catalogue, people found that many innovative drugs that had been widely regarded were absent from the new medical insurance catalogue At the same time, another important message is that 45 drugs with high clinical value but relatively expensive price have been reviewed and determined by experts, and they intend to participate in a new round of drug price negotiations led by the Ministry of human resources and social security In this case, being included in the next national drug price negotiation has become the way for these drugs to enter the medical insurance catalogue, especially the negotiation access of high price drugs and drugs for treatment of major diseases will become the key Recently, it was learned from people close to the Ministry of human resources and social security that 45 varieties in the round of drug price negotiation catalogue of the Ministry of human resources and social security have been basically determined and are currently in the confirmation stage, of which about 35 varieties are imported A small number of domestic varieties are mainly from domestic 1.1 new drugs approved since 2008 It is found that the five varieties are more likely to enter the negotiation People close to the Ministry of human resources and social security of the people's Republic of China said that this year's national drug price negotiation and the adjustment of the new version of the medical insurance catalogue fully showed the strong support for innovative drugs at the national level According to the data from the insight database of dingxiangyuan, since 2008, there have been 13 varieties of national class 1.1 new drugs approved for production in China (only chemical drugs and biological drugs are not included), of which ektinib belongs to the national drug price negotiation varieties led by the national health and Family Planning Commission, and achieved a 54% drop in that year In addition, seven varieties, including adefovir dipivoxil, elamud, palamivir sodium chloride, leflunomide, arexib, sirodoxin and pioglitazone, have also been included in the 2017 national health insurance catalog According to people familiar with the matter, since 2008, China has approved the listing of 23 class 1.1 new drugs, including chemical drugs and biopharmaceuticals (the statistical caliber is different, and the actual data may be slightly different), of which 8 have clearly entered the medical insurance, and 9 have been officially included in the national drug price negotiation, excluding 6 vaccines and other types of products Therefore, the remaining varieties, such as apatinib of Hengrui and siddabenzamine of microchip, are likely to be included in the 45 varieties of the national drug price negotiation, which is also the general expectation of the industry before Product: apatinib company: Jiangsu Hengrui apatinib is a global small molecule targeting drug that has been proved effective in advanced gastric cancer It was independently developed by Jiangsu Hengrui medicine and approved by CFDA in October 2014 and applied in clinical treatment of advanced gastric cancer At the same time, it is also expanding lung cancer, liver cancer and other indications According to relevant data, there are 1 million new cases of gastric cancer every year in the world, more than 70% of which are in Southeast Asia, and China is the highest According to the data of Nanfang Institute, the sales volume of apatini, a public hospital in key cities, was 58.42 million yuan in 2015, and whether it can be included in the medical insurance will undoubtedly have a huge impact on its market volume At present, many mainstream gastric cancer drugs have been included in the medical insurance, and the sales volume of tegio, the first-line drug for advanced gastric cancer, has exceeded 3 billion yuan Therefore, if it can enter the medical insurance through drug price negotiation successfully, it will usher in greater market space Product: xidabamide company: Shenzhen microchip in December 2014, the original Chinese chemical used in the treatment of lymphoid cancer developed by microchip biology, xidabamide, was approved by CFDA and officially launched in March 2015 This is a subtype selective histone deacetylase oral inhibitor approved for marketing in the world, and also an original new drug authorized by China to be used in the United States and other developed countries As an anti-tumor drug with a new chemical structure, xidaban is much cheaper than the imported drugs of the same kind, and its curative effect is also significantly improved However, because it has not yet entered the national medical insurance, its cost is still very high for ordinary people Xidaban is a product that has been in the medical insurance and national drug price negotiation At present, xidaban is expected to enter the negotiation list Product: morpholinidazole company: Haosen, Jiangsu Province Morpholinidazole is a nitroimidazole anti infective drug developed by Jiangsu Haosen Pharmaceutical Co., Ltd with independent intellectual property rights It took 13 years to complete the research and development of the drug in 2001 Its trade name is mylinda, which is also one of the major national science and technology projects undertaken by Haosen Pharmaceutical Co., Ltd As the third generation of nitroimidazoles, morpholinidazole is mainly used in the surgical and gynecological infections caused by anaerobic bacteria In 2016, morpholinidazole was included in the medical insurance in Jiangsu Province as an innovative drug Product: Antofloxacin company: Anhui universal Antofloxacin hydrochloride is a kind of national first-class fluoroquinolones antibacterial new drug with independent intellectual property rights independently developed by scientists of Shanghai Institute of medicine, Chinese Academy of Sciences It is also the result of the implementation of knowledge innovation project by Chinese Academy of Sciences and the national implementation of major science and technology projects of "major new drug creation" It obtained the new drug certificate issued by CFDA as early as April 2009 At present, it is produced by Anhui global pharmaceutical industry , the trade name is Youpeng Product: nanofloxacin company: the nanofloxacin malate capsule produced by Zhejiang Pharmaceutical was a kind of new drug successfully launched in China in October 2016 In June 2012, Zhejiang Pharmaceutical obtained the right to use and sell the product in China from Taijing Biotechnology Co., Ltd and Taijing pharmaceutical R & D (Beijing) Co., Ltd According to the data, the global sales of quinolones in 2015 was US $2023 million Price reduction is unchangeable Another information revealed is that in the early stage of the drug price negotiation, a total of 10 varieties were determined, and in the later stage, another 35 varieties were determined Among the 35 varieties, almost all of them are imported drugs This is closely related to the high price of imported original research drugs in the domestic pharmaceutical market Due to the lack of market competition, the international practice is to adopt a unified negotiation method to reduce the high price to a reasonable range In the last round of negotiations, tenofovir dipivoxil, used to treat chronic hepatitis B, was cut 67% As for the new biological drugs approved in recent years, it will also be an important direction for negotiation However, due to the lack of a unified understanding and clear definition of biopharmaceuticals in China, it is not possible to make effective statistics on them However, some biopharmaceuticals of concern, such as conbercept, are generally considered to be listed in a new round of drug price negotiations In addition, some experts revealed that among the 45 countries negotiating varieties, the varieties of Chinese patent medicine will not be an exception What's more, this negotiation will further reflect the basic logic of price reduction, taking "the state can pay, the patient can pay" as the standard, to ensure that the drug price is really reduced to the range that the patient can afford From the perspective of the current payment method, China's medical insurance positioning is still the basic insurance A real problem is that it is still difficult for medical insurance to support the development of innovative drugs at this stage Therefore, a new model to ensure the drug accessibility of patients should be introduced On the other hand, the support for innovative drugs is not only about the lack of money According to the survey, it is not the first-line rich provinces that have included high-priced tumor targeted drugs into the medical insurance Compared with abundant funds, it is also important to implement and implement supporting rules and standards, as well as hospital level coordination In this respect, Shanghai's experience in measuring the payment amount of medical insurance by price reduction may be worth learning.