Five categories of products "no chance" 2019 medical insurance catalog? Multinational pharmaceutical companies "seize" China's 100 billion market and face four challenges

Four categories of products are expected to be transferred in, and five categories of products will be transferred out "soon" On April 17, the State Health Insurance Bureau officially released the work plan of national health insurance drug catalog adjustment in 2019 (hereinafter referred to as the "plan") This indicates that the adjustment of 2019 medical insurance catalog has officially started At present, the industry is under the impact of policies such as volume purchase, drug proportion, medical insurance payment standard, etc., and the product sales environment has changed dramatically If the enterprise wants to survive, it must seek a new way out The adjustment of national medical insurance drug catalogue in 2019 is a new opportunity and challenge for enterprises Entering the new version of the medical insurance catalog is the weight to increase the survival of their own products, and if they are transferred out of the catalog, it will aggravate the survival crisis So in terms of product transfer in, there have been industry figures who thought that these types of products are more likely to enter the new medical insurance catalog For example: products newly introduced into the basic drug catalogue but not listed in the medical insurance catalogue in 2018; products listed before December 31, 2018; products listed in the medical insurance negotiation catalogue, which are expected to be mainly high priced products for tumors and rare diseases; products approved in 2018 for consistency evaluation In terms of product transfer out, the insiders suspect that most of the products are kicked out of the new version of the base drug catalog, shut down, no procurement plan for three consecutive years, or facing elimination Specifically, there are several situations as follows: the oral drugs with the base drug list out That is to say, methyltestosterone tablets, dirithromycin enteric coated tablets, mycomycin tablets, tegafur tablets, ergotamine caffeine tablets, phenolphthalein tablets, compound diphenoxylate tablets, compound reserpine tablets, compound reserpine aminophenetidine tablets, dipyridamole tablets and buguizine hydrochloride tablets, which originally belong to 289 catalogue but have not been started by the factory for consistency evaluation, may be transferred out of the medical insurance catalogue The 2018 version of the list of basic drugs was transferred out of the traditional Chinese medicine products It includes two products: Xiaoer Huadu powder (capsule) for internal medicine and Mingmu tribulus pill for ophthalmology Products that have been discontinued but are still in the medical insurance catalog For example, minoxidil oral regular release dosage form and xaquinavir oral regular release dosage form, which have been listed in China but have no valid approval, are expected to be removed from the medical insurance catalog Products that have not entered the provincial bidding catalogue for three consecutive years are also expected to be transferred out of the medical insurance catalogue It is also possible that the products entering the national auxiliary drug catalogue can be transferred out of the catalogue "Shock wave" caused by the new version of medical insurance catalogue, high priced drugs are facing "price cutting", expired patent drugs or "bear the brunt" According to the plan, the state health insurance bureau stated that the transfer in can be divided into two ways: regular access and negotiation access Under the premise of meeting the effectiveness and safety, if the price (expense) is equal to or lower than the existing varieties in the drug catalog, it can be included in the catalog through the regular way; patent exclusive drugs with higher price or greater impact on the health insurance fund should be admitted through negotiation（ The identification time of exclusive drugs shall be the day before the voting date) In short, if the price is high, negotiation access will be initiated, and "price reduction" is an inevitable link When it comes to the high priced drugs mentioned above, they are anti-cancer drugs, exclusive products, innovative drugs, expired patent drugs, etc Among them, the expired patent drugs can keep a high price attitude in China for a long time, and the sales volume is also high Taking Pfizer as an example, Lipitor, which was listed in China in 2000, has already passed the patent period, but its sales in China in 2018 is still as high as 10 billion, more than a third of Pfizer's sales in China Therefore, for some patent expired drugs, the price access negotiation is exactly the right solution And in the first two rounds of national drug negotiations, the effect of "price cutting" is very obvious In 2017, the medical insurance Department launched the first national drug negotiation, and finally 36 kinds of high price clinical essential drugs entered the medical insurance catalog through negotiation, including 15 kinds of anti-cancer drugs, with an overall average decline of up to 50% In the second negotiation launched in 2018, 17 kinds of drugs were finally negotiated successfully However, compared with the average retail price, the payment standard of negotiated drugs decreased by 56.7% on average The payment standard of most imported drugs was lower than the market price of surrounding countries and regions, with an average of 36% lower After two rounds of national drug negotiations and 4 + 7 volume procurement, multinational pharmaceutical companies have a new understanding of China's medical reform policy Innovative drugs are their advantages, but the original research drugs after the patent period no longer enjoy "super national treatment" To grasp the Chinese market, we need to adjust the "high price posture" in time Multinational pharmaceutical companies grasp the 100 billion market in China and face four challenges The new medical insurance catalog brings challenges and opportunities to multinational pharmaceutical companies Especially after the 4 + 7 collection, multinational pharmaceutical companies understand that in addition to accelerating the pace of introducing their own innovative drugs into China, they also need to improve the accessibility of their innovative drugs to accelerate medical insurance access negotiations A few days ago, Ernst & Young officially released the first pharmaceutical industry research report "strategic response of multinational pharmaceutical enterprises in the context of China's pharmaceutical reform" in 2019 The report pointed out that the global pharmaceutical market size in 2018 is about $1.25 trillion, and it is expected that by 2023, the global pharmaceutical market size will exceed $1.50 trillion China has become the second largest drug market in the world in 2015 In 2018, the market size will reach about 137 billion US dollars, accounting for 11.37% of the global market It is estimated that by 2023, the market size will reach 140-170 billion US dollars At the same time, the report shows that multinational pharmaceutical companies in China are facing four challenges at present: • the original research drug will enter the cost competition field faster after the patent period At present, 60 generic drugs have passed the consistency evaluation, and 80% or more of the sales volume of multinational drug enterprises in China (more than 90% of the multinational drug enterprises mainly engaged in generic drugs) are facing the trend of substitution or price reduction • the innovative drug pipeline of multinational pharmaceutical companies can not keep up with the policy cycle As the R & D of multinational pharmaceutical companies are all in their headquarters, the R & D cycle is long, and the time plan cannot match the time when the relevant policies of the Chinese government are issued, so the dividend of innovative drug policies may be missed • professional promotion ability needs to be improved With the introduction of a series of government policies that are conducive to the listing of innovative drugs, the domestic pharmaceutical market will usher in the situation of multinational pharmaceutical companies' cluster listing of innovative drugs Therefore, multinational pharmaceutical companies need to quickly improve the relevant promotion ability or take external recruitment • marketing efficiency needs to be improved In the context of government control of fees, the bargaining space of pharmaceutical enterprises will also be compressed, and eventually "price for market" will be adopted At this time, it is necessary to improve the marketing efficiency of the company and reduce the internal operating costs According to the four challenges mentioned in the above report, multinational pharmaceutical enterprises should grasp the main battlefield of innovative drugs, make strategic adjustment based on the policy background, and actively formulate and implement a series of transformation measures when adjusting the new medical insurance catalog In response to China's medical reform policy, multinational pharmaceutical companies have taken actions to achieve clinical progress in line with Europe and the United States, and even put a class of new drugs on the market in China The Chinese government gives preferential policies to the first-class new drugs, and the application for registration of innovative drugs that are not listed and sold in or transferred to China will be reviewed and approved preferentially; at the same time, for the first-class new drugs that are listed in China, there is no reference for pricing, so it is conducive to the pricing of multinational pharmaceutical enterprises in China For example, aridrol (Rosa Sita capsule), which was jointly developed by AstraZeneca and fabergin, announced its approval for listing in December 2018, becoming the first class of new drugs developed globally and launched in China, and is expected to take the lead in listing in China in the second half of 2019 Multinational pharmaceutical companies evaluate the company's assets, and peel off the original research drugs that have passed the patent period and have generic drugs, the high-quality original research drugs that have passed the patent period but have high imitation threshold and innovative drugs There are two main ways: classifying the assets and restructuring the global structure This kind of multinational pharmaceutical companies are not eager to transfer high-quality mature drugs, but hope to expand the sales scope by changing the marketing mode, and improve the internal operation efficiency, so that the overall sales can remain at the original level For example, in October 2018, AstraZeneca transferred the Chinese commercial license of four diabetes products, including baibida and baidayang, to LVYE pharmaceutical Commercial risk is removed through commercial transfer of assets Some multinational pharmaceutical enterprises are able to transfer business risks and concentrate resources in key areas through external divestiture of assets of original research drugs that have passed the patent period For example, in November 2016, Lilly pharmaceutical transferred the exclusive distribution rights of hickoru and reliable China to Yiteng pharmaceutical Multinational pharmaceutical enterprises carry out the transformation of marketing mode, such as accelerating the promotion of medicine covering the original three, four and five lines and the blank market of township and county, opening up the channels of retail drugstores, digital marketing, cooperation with Internet companies, and cooperation with commercial insurance companies to innovate the payment mode Among them, in digital marketing, Pfizer has already taken action In 2018, the company launched a map platform (marketing automation and personalization) in China Platform); in terms of cooperation with Internet companies, Lilly pharmaceutical, AstraZeneca, Novartis pharmaceutical, GlaxoSmithKline and Ali health, Tencent, dingxiangyuan, meinian health and other Internet companies have established cooperation In addition, multinational pharmaceutical companies actively explore the transformation from "product centered" to "patient-centered" For example, in 2016, AstraZeneca established a China business innovation center in Wuxi, where it launched a whole course management solution integrating diagnosis, treatment and rehabilitation of eight major diseases The innovation of the adjustment mechanism of the new medical insurance catalogue is only a miniature of China's medical reform policy, but its influence is far-reaching For multinational pharmaceutical enterprises and domestic enterprises, the trend of the industry has become increasingly clear Innovative drugs and generic drugs give full play to the United Front advantages to gain market competitiveness Information source: yaozhiwang, cypress blue, biological exploration, medical Valley, etc