Consistent generic drugs replace the original research supported by the top three! Will the country follow suit? The crisis of foreign enterprises is coming

The hospital, the direct user of the drug, unambiguously pointed out that "the drug should be tilted within the national policy framework through consistency evaluation", indicating that the follow-up supporting policies of consistency evaluation have penetrated to the front line This practice will also be followed by more hospitals, because the trend of using generic drugs to replace patent expired original research drugs with reference to the mature market practices in Europe and the United States is certain Yesterday, a picture of "Wuhan University People's Hospital (also known as Hubei Provincial People's Hospital) announcement on promoting the priority use of drugs through consistency evaluation" flowed out of the circle of friends Different from the previous policies on promoting consistency evaluation at the government level, this time it was the direct user of the drug - the hospital unequivocally pointed out that "drugs through consistency evaluation should be inclined within the framework of national policies", and stated that "clinicians are recommended to give priority to the issuance of drugs through consistency evaluation" Since the general office of the State Council issued document No 20 on April 23, 2018, the pace of consistency evaluation has been significantly accelerated, and supporting policies have been issued in succession However, due to the different efforts, some uncertainties have been added to the future of consistency evaluation, and the real response at the hospital level is also the focus of attention At this time, the people's Hospital of Hubei Province fired its first shot Hubei is not the first batch of provinces to release the follow-up supporting landing policies for consistency evaluation, but at present, it is the fastest growing province The clear voice at the hospital level makes all parties see the signal that the policy gradually infiltrates into the front line As one of the pilot cities of medical reform, the practice of Wuhan Hubei people's hospital will be followed by more medical institutions From a larger perspective, 2018 will be the key year for China's drug policy reform to be in line with the international standards The conformity evaluation of generic drugs is an important action in the linkage of three medical sectors The trend of imitating the mature market practices of Europe and the United States and replacing the expired original research drugs with generic drugs has become a certainty Recently, the film "drug God" triggered a national discussion on life-saving drugs, and then rose to the height of accelerating the application of high-quality generic drugs in China It not only carried out a wide range of popular science on generic drugs at the public level, but also stimulated pharmaceutical companies, bidding, and medical insurance parties to act, accelerate the process of generic drugs replacing the original research, and accelerate the adjustment and transformation of the current drug structure in China The top three hospitals are moving! So far, four batches of 41 products have passed the consistency evaluation According to the current be test progress and the pace of CDE review and approval, the second half of 2018 will be the half year when the consistency evaluation will be concentrated At this time, local supporting policies and the actual implementation of medical institutions have become the focus of attention By the end of May 2018, at least 11 provinces have issued supporting policies, including bidding procurement, medical insurance reimbursement, use and other links Guotai Junan said "the strength and progress are better than expected Most provinces have adopted unconventional measures to ensure that varieties, especially those that have not won the bid before, can enter the "conclusion through consistency evaluation   At the level of promoting the alternative use of generic drugs in medical institutions, the overall policy of the state is to include the generic drugs that have passed the evaluation into the list of interchangeable drugs with the original drugs: the health department should strengthen the supervision of clinical drug use, strictly implement the prescription according to the generic name of drugs, especially when providing drugs to AIDS and tuberculosis patients according to the regulations, priority should be given to the use of generic drugs It can be said that the national level has given a large framework From the analysis of local policies, there are many signals that "strength and progress are better than expected" trend For example, on July 16, the health and Family Planning Commission of Liaoning Province issued "policy support for increasing the procurement and use of generic drugs in Liaoning Province", in which it was proposed that "the proportion of national essential drugs and tumor targeted treatment drugs will not be included in the calculation of public hospital drugs" In addition, "by the end of 2018, medical institutions at all levels can temporarily increase the purchase and use of drugs passing the generic drug conformity assessment." The proportion of drugs is a sharp sword hanging on the head of the hospital, which has an overall regulatory effect on the use of drugs by doctors Before that, the liberalization of drug proportion in some provinces was aimed at national drug price negotiation varieties For the first time, Liaoning proposed "not included drug proportion" for base drugs and tumor targeted drugs under the framework of generic drugs, which will increase the use of generic drugs by medical institutions through consistency evaluation Zhejiang also made a breakthrough On April 28, Zhejiang medical equipment purchasing center proposed that medical institutions could temporarily break through the "one product, two regulations" in the prescription management measures before the end of 2018, and increase the purchase and use of products passing the consistency evaluation However, despite the call of the state and local governments for priority use, "priority use" is still a vague concept On April 26, the implementation plan for drug procurement of public medical institutions in Foshan City (Draft for comments) clearly stated that it would not adopt the opinion of "priority procurement and priority selection of consistency evaluation varieties in clinical practice" put forward by the enterprise, and that it would "respect clinical selection of medical institutions", which added uncertainty to the future trend In addition, some scholars hold that there are some differences between the current generic drugs through consistency evaluation and the original drugs in terms of "clinical consistency" How to persuade doctors in an all-round way and implement policies to the real decision-maker of drug use - medical institutions has always been a challenge To some extent, the price reduction trend of the original drugs will also impact the generic drugs Under the combination of national drug price negotiation, not included in the hospital drug proportion assessment, medical insurance reimbursement, tax reduction and price reduction, the price of the original research drug will no longer be "out of reach", and the market education level has not fully accepted the generic drug, so both patients and doctors tend to choose the original research drug Generic drugs face greater challenges From this point of view, at this time, the position of the top three hospitals clearly stated that "they should give preference to generic drugs in terms of purchasing policies and clinical applications", which undoubtedly has a reassuring effect, which means that their attitude towards the original research drugs and generic drugs has become loose If this practice is imitated by more medical institutions, it means that the policy of replacing the original research drugs with generic drugs has penetrated into the front line, and will encourage procurement, medical insurance and other parties to believe that generic drugs can be accepted by doctors and patients, so as to more actively mobilize the enthusiasm of policy-making 2 what is the most urgent task for an enterprise? The announcement of the people's Hospital of Hubei Province also released a signal that medical institutions have positioned generic drugs as "high quality and low price" This also means that the hospital level may not accept the view that the price of generic drugs has been increased through evaluation In fact, the national level also holds a "no price increase" attitude towards the generic drugs passing the evaluation GBF [2018] No 20 document puts forward "a scientific and reasonable purchase price with rise and fall" for generic drugs, and the expression for generic drugs is "more cost-effective" From the current landing policies of each province, each province has adopted the expression of "taking the lowest price of multiple provinces", and also set a clear direction for the price: steady downward The enterprise level has repeatedly released the signal that "through consistency evaluation, varieties should rise in price" On March 12, 2018, Chen Baohua, chairman of Zhejiang Huahai Pharmaceutical Co., Ltd., visited Xinhuanet and put forward policy demands for generic drugs in various dimensions, one of which includes "products should be consistent with or similar to the price of imported drugs through consistency evaluation" For the pricing problem of consistency evaluation varieties, Guotai Junan has given the conclusion that if there is a historical bid winning record, considering that most varieties have lower prices than the original research drugs, it is more difficult to raise prices in a big way, and the pressure of public opinion may be greater However, if there is no historical bid winning record, there is no clear price determination rule at present In terms of price strategy, Guotai Junan believes that with the increase of varieties with the same generic name, barriers in the shortlisted link are more difficult, and may face fierce competition The better strategy is to fully consider the situation of competitors and choose to quickly realize the network, rather than too much entanglement in price After that, we should realize the admission as soon as possible and seize the resources of hospitals and doctors and patients This is also the primary task of enterprises holding consistency evaluation varieties at this stage From the perspective of the path of substitution of generic drugs for original research in mature markets such as Japan, it is an important milestone to break through medical institutions through policies to promote the substitution of generic drugs for original research In 2005, pharmacies were allowed to change into generic drugs with the permission of doctors, and in 2011, private clinics were required to use generic names for prescriptions to give additional rewards In terms of market share, the overall substitution rate of generic drugs in Japan rose from 32% a decade ago to 56% in 2015 The box office of "I'm not the God of medicine" has exceeded 2.5 billion In such a way, the concepts of original research drugs and generic drugs have made a strong popularization at the level of doctors and patients Previously, the concept of consistency evaluation only circulated within the pharmaceutical industry has been understood by a wider range of people At such a time of high public opinion, it is an excellent opportunity for enterprises to popularize their products, carry out market education and publicize the concept of consistency evaluation, build trust in doctors and patients, so that more medical institutions have the motivation to follow the current practice of Hubei people's Hospital, and lay the foundation for the implementation of more policies 3 the fifth batch of varieties passed the consistency evaluation was announced two months ago, and the State Food and Drug Administration released the list of 12 varieties that passed the consistency evaluation in the fourth batch So far, 41 varieties have passed the consistency evaluation The insight database shows that 53 varieties have passed the acceptance number This also means that the fifth batch of varieties passing the consistency evaluation will be released soon According to the market progress, there are many heavyweight anti-tumor drugs in this batch of products, some of which have a sales volume of more than 1 billion The enterprises include Hengrui, Zhengda Tianqing, Kelun pharmaceutical, Yangzi River, Qilu pharmaceutical and other famous enterprises Source: the screenshot of insight database according to the public information, some enterprises have actually received the message that the consistency evaluation of SFDA has passed For example, on July 16, Jiangsu Haosen imatinib generic "Xinwei" passed the consistency evaluation This is the prototype of life-saving medicine in the film "drug God" In 2017, the total market of terminals of public medical institutions and retail pharmacies in China was 3.046 billion yuan, accounting for 17.37% of the total market of hausen pharmaceutical industry, second only to the original manufacturer Novartis Imatinib mesylate is also in the review sequence, and minenet predicts it will be approved by the end of this year or early next year Within one day on July 17, cefuroxime axetil tablets (0.125g) of Zhijun pharmaceutical and atorvastatin calcium tablets of xindonggang pharmaceutical passed the consistency evaluation The former 0.25g varieties have passed the consistency evaluation in the first batch In 2017, the sales volume of this product in China's public hospital terminal market was 1.728 billion yuan, with the proportion of Guoyao Zhijun accounting for 28.67%; the latter's domestic market was close to 16 billion yuan, and it will jointly seize the market with Lipitor and aloe, the heavyweight varieties in the cardiovascular field According to the data of minenet, as of July 13, the varieties that have passed or are deemed to have passed the consistency evaluation but have not been published by the State Food and Drug Administration