Opportunities and challenges coexist in the insurance of innovative drugs

Source: China Economic Weekly 2017-04-18 in February this year, the new version of "national basic medical insurance, industrial injury insurance and maternity insurance drug catalog" was released, with 339 more than the 2009 version of the medical insurance catalog With the introduction of the new version of the medical insurance catalog, the adjustment of the provincial medical insurance drug catalog is about to start The reporter of China Economic Weekly noted that during the catalog adjustment, Beida Pharmaceutical Co., Ltd independently researched and developed the product "small molecule targeting anticancer drug exetinib hydrochloride", which finally entered the national medical insurance catalog five years after its listing "Behind the happiness, there have been many twists and turns." Ding liming, chairman of China pharmaceutical innovation promotion association and chairman of Beida Pharmaceutical Co., Ltd., expressed infinite emotion when reviewing the way of "entering the insurance" of ektinib 339 new drugs were added to the new medical insurance catalogue, and 45 life-saving drugs were still under negotiation In February 2017, the Ministry of human resources and social security issued the notice on printing and distributing the catalogue of drugs for national basic medical insurance, industrial injury insurance and maternity insurance (2017 Edition), officially announcing the catalogue of drugs for national basic medical insurance, industrial injury insurance and maternity insurance According to the Ministry of human resources and social security, the adjustment of the medical insurance catalog clearly takes innovative drugs as one of the key varieties of the adjustment, takes new drugs listed after 2009 as the key evaluation object, and further inclines the innovative drugs among them From 2008 to the first half of 2015, most of the new chemical drugs and biological products approved by China were included in the 2017 version of the drug catalog or the scope of negotiated drugs He Xiaowen, vice president and technical director of protocell Technology Group Co., Ltd., thinks that for companies focusing on the frontier technology innovation and R & D of biomedicine, the access of innovative drugs to medical insurance is both an opportunity and a challenge "The main sales channel of many innovative drugs is the hospital system, and access to the medical insurance catalog is very beneficial to expand the market and quickly recover the R & D cost, and can also improve the enterprise R & D and innovation are driven and motivated, so it is a good opportunity However, it must be acknowledged that the entry of innovative drugs into medical insurance is also a challenge The long cycle of drug research and development in the early stage and the large investment are great tests for enterprises or investors; the long cycle of cost recovery of innovative drugs also makes many small and medium-sized enterprises dare not enter the field " The reporter of China Economic Weekly noted that 2535 kinds of Western medicine and Chinese patent medicine were included in the medical insurance catalogue, an increase of 339 kinds compared with that in 2009 However, it is not satisfactory that there are still 45 patented life-saving drugs (some targeted cancer drugs) which are still under negotiation due to the high price Dr Yang Dajun, co-founder, chairman and chief executive officer of Yasheng pharmaceutical, told China Economic Weekly: "the medical insurance catalogue should focus on serious, serious and rare diseases, rather than general medicine In my opinion, those low-cost generic drugs that most people can afford are not included in the medical insurance catalog Those anticancer drugs and cardiovascular drugs, which often cost 10000 yuan a month, can't be afforded by the common people, so they should be included in the medical insurance as much as possible, which is the significance of medical insurance The research on medical economics in China is still weak, and there are not many medical insurance expenditures, but money should be used on the edge " According to Sang Guowei, academician of Chinese Academy of engineering and clinical pharmacology expert, China's drug innovation policy is divided into four stages: from the embryonic stage to the exploration stage, the basic formation stage, and then to the development and improvement stage of the policy environment Sangguowei said that the road to marketization of domestic innovative drugs is "long and bumpy", and there are many bottlenecks in drug review, financial policies, drug bidding, and access to medical insurance catalogue Take the exetinib of Beida pharmaceutical as an example, it is the first small molecule targeted drug with completely independent intellectual property rights in China, and has been awarded the first prize of national science and technology progress award Although its efficacy and safety have been recognized by experts at home and abroad, it is still very difficult to enter the local medical insurance catalog At that time, because the national medical insurance catalog was not adjusted, Beida medicine could only start from the local level In 2012, Qingdao, Shandong Province identified ektinib as the first batch of 11 kinds of special drugs that can receive major disease relief; in 2013, Zhejiang Province listed ektinib in the provincial medical insurance catalog As of January this year, ektini has entered the health insurance catalog of more than 20 provinces In 2015, the national health and Family Planning Commission and other departments jointly carried out the first batch of national drug price negotiations Beida pharmaceutical was specially invited to participate in the negotiations Exetinib became the only domestic drug among the first three negotiated drugs In the negotiation process, Beida pharmaceutical took the lead in reducing the price by 54%, forcing similar imported drugs to reduce the price significantly In the new national health insurance catalog released on February 21 this year, "ektini" was successfully included in the national health insurance catalog In the eyes of economist song Qinghui, the entry of innovative drugs (focusing on new anti-cancer drugs) into the medical insurance catalog represents a shift in the state's support for drugs A number of innovative drugs included in the medical insurance are expected to obtain medical insurance payment qualification through negotiation According to the report issued by Guolian securities, the medical insurance catalogue will focus on new drugs and other categories, which is consistent with the recent focus of the state on encouraging innovative drugs and attaching importance to clinical efficacy The effect of the new medical insurance catalog has yet to be tested, said Ding liming, chairman of Beida Pharmaceutical Co., Ltd that the adjustment of the medical insurance catalog is very difficult In recent years, China has paid more and more attention to the people's livelihood, and the scope of medical insurance has become wider and wider With this, the pressure on medical insurance payment is also growing, "how to ensure the balance of income and expenditure? How to use the limited funds? This is a big problem that needs to be solved urgently " However, there are also senior medical executives who are worried about the effect of the new health insurance catalog "The new national health insurance is really a long-awaited opportunity for us to do terminals However, in light of the current changing situation of the pharmaceutical industry, we can not be blindly optimistic First of all, the implementation of zero drug mark up makes hospitals no longer profit from the sale of drugs, and some hospitals are lack of motivation when introducing new products Secondly, the implementation of the two vote system has squeezed out the price of drugs, and the profit space of some terminal developers has been further compressed In addition, the implementation of GPO (drug purchase organization) in Shanghai market and the implementation of the national drug payment system may also reduce the space of medical insurance products to some extent " "Successful commercial health insurance is one of the important reasons why the United States can continue to support the development and payment of innovative drugs." Dr Yang Dajun told China Economic Weekly that in China, commercial medical insurance is still very weak, and the average annual medical insurance fee for a family in the United States can reach 10000-15000 dollars In his opinion, there is also a relatively simple way to change the situation of commercial medical insurance in China "In fact, there is no need for the government to pay a penny For example, if enterprises are required to buy commercial medical insurance for employees, or employees can buy a matching proportion of premium tax-free, then each person may have 10000-20000 yuan of commercial medical insurance expenses every year In terms of 100 million people, there are 10 to 2 trillion yuan of commercial medical insurance premiums You know, some of the best selling anti-tumor drugs in China have a turnover of 1 billion yuan every year " At present, the detailed rules for the implementation of the national policy have not come out, Ding said: "we very much look forward to the innovation of the policy in terms of the payment standard, so as to better encourage the drugs with appropriate price and good curative effect In the past, the general practice was simply to reimburse according to the proportion, which is easy to mislead patients and even experts to choose expensive drugs I think the state can make a reasonable reimbursement price for the same kind of drugs, and the excess part will be paid by the patients themselves, so as to better guide everyone to use drugs with higher cost performance " Although the medical insurance catalogue is published, there is still a process of implementation in each province, and there are some differences in the interpretation and implementation of policies in different regions, even causing disputes For example, a few regions did not include the domestic innovative drugs with lower prices in the medical insurance catalog, while the expensive imported drugs were included, which attracted the attention of the industry "I hope that the state can solve similar problems in the implementation of the new catalogue, not only bring benefits to patients, but also encourage domestic enterprises to innovate." Said Ding.