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    Home > Active Ingredient News > Drugs Articles > Wind vane of national negotiation Catalogue: Interpretation and market expectation of the first round of price reduction

    Wind vane of national negotiation Catalogue: Interpretation and market expectation of the first round of price reduction

    • Last Update: 2016-06-24
    • Source: Internet
    • Author: User
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    Source: 2016-06-24 A, policy sorting and interpretation of high drug prices has become one of the important issues affecting social stability However, the author believes that the high drug price is not a comprehensive problem: the price of most commonly used clinical drugs and basic drugs has been reduced to a very low level; however, the price of patent drugs and special drugs involved in some serious diseases has remained high for a long time Due to the lack of alternative varieties, these varieties have a strong price in bidding How to reduce the price of these patent specific drugs for the treatment of serious diseases has become an urgent problem for the country Referring to the advanced experience of the west, taking the country as the negotiation subject, linking the price reduction with the policy factors such as sales volume and medical insurance is undoubtedly a solution In February 2015, the general office of the State Council issued the guiding opinions on improving the centralized drug procurement in public hospitals for the first time, which clearly stated that an open, transparent and multi-party price negotiation mechanism should be established for some patented drugs Subsequently, the national health and Family Planning Commission led the release of the "pilot work plan for establishing a drug price negotiation mechanism", which further improved the way and method of national drug negotiation from the implementation level The varieties of national drug negotiations will mainly include those high price special effect patent drugs and exclusive drugs of social concern, and the fields involved include cancer drugs, children drugs, public health drugs and exclusive Chinese patent drugs Since then, in November 2015, the first national drug negotiation was officially launched, including five varieties of liver disease drug Werder and cancer drug Iressa, troika, Kemena and rifeme, which were included in the first negotiation catalogue Different from the previous administrative price reduction adopted by the competent authorities of the state, although the price negotiation also represents the national interest, it is more hoped to achieve "price for quantity" through factors such as medical insurance Why did the negotiation result exceed the expectation? In view of the small amount of concession on the price of the original research drug in the regional price negotiation for some foreign high-priced special effect patent drugs that have been carried out in many places before, the national negotiation directly set a price reduction standard of no less than 50%, which has been looked down upon by many people in the industry However, the results of this national negotiation exceeded most people's expectations Among them, the price reductions promised by Werder, eresa and Kemena reached 67%, 55% and 54%, respectively The advantages of negotiation at the national level are self-evident The biggest benefit of regional price negotiation is to enter the regional medical insurance, but at present, the regional bidding is very concerned about the lowest bid price, which will lead to the increase of single regional sales volume but the risk of losing the bid if the price is not matched in other regions The national level of price reduction emphasizes that one-time price reduction is in place, and regional price reduction is no longer second time Once entering the national health insurance catalogue, the benefits will undoubtedly be huge Second, we have to say that the enterprises selected in this negotiation are very suitable As a representative of national innovative drug enterprises, Beida will undoubtedly support national policies and gain important chips for its products to enter the national health insurance; and after the GSK crisis, Beida hopes very much to rebuild its image in the Chinese government, and price reduction is also a good opportunity; In the context of three NSCLC (non-small cell lung cancer) varieties included in the negotiation catalogue and Kemena's price reduction, AstraZeneca and Roche will also face great pressure Therefore, in addition to Xinji, the other four enterprises are willing to reduce the price of drugs The final result of giving up the varieties of negotiation is that Xinji unexpectedly gave up this round of negotiation However, in the context of the imminent listing of Shuanglu's generic drugs, as well as the expectation of Xinji to expand the potential huge market in China, Rimage is likely to participate in price negotiations later As for Roche, because the price of Troika itself is significantly higher than that of Iressa and Kemena, its price reduction pressure is greater, and the state requires higher price reduction range In view of the advantage of trokai in clinical evidence, it is understandable that Roche finally gave up However, once both Iressa and Kemena enter the national health insurance, Troika will face the consequences of marginalization However, there are still many questions to be confirmed and resolved in the current drug country negotiations First of all, at present, there are certain conditions for price reduction According to some statements of manufacturers, there is a certain correlation between the implementation of the new price and the policy factors such as entering the medical insurance, but at present, the cooperation group led by the health and Family Planning Commission has no clear answer on whether the products can enter the medical insurance or not Second, it is not clear when it will be implemented It is not clear whether to execute it immediately, or whether it can be executed after entering the directory or after reimbursement Third, it is said that the drug price of the varieties that have been successfully negotiated for price reduction will not be included in the proportion of drugs in the future, which undoubtedly has a great advantage for the relevant enterprises However, there are still many problems in the implementation of this decision In addition, it is not clear whether the second negotiation in full swing will have an impact on the price reduction varieties The hospital or the regional bidding department may still link the second negotiation with the bid winning B Market expectation of price reduced varieties: the leading varieties take the lead in price reduction Werder (tenofovir) is a star variety of Gilead, which is currently a special drug for AIDS and hepatitis B, and was approved by FDA in 2001 The drug was approved for HIV use in China in 2008, while it was approved in 2014 for the hepatitis B treatment market, which is more concerned in China China is a big country of hepatitis B, and nucleoside drugs have long been in the ranks of first-line treatment drugs, so the latest approved nucleoside drug Werder is undoubtedly more expected for patients According to some research results and meta-analysis, tenofovir has some advantages over the main competing drugs, such as adefovir dipivoxil, telbivudine and entecavir, in terms of the negative conversion rate and drug resistance of hepatitis B, but mild renal toxicity still needs to be paid attention to From a clinical point of view, tenofovir is currently the best drug for hepatitis B, but given the risk of renal toxicity, the drug and entecavir have their own advantages However, in terms of sales volume, due to the late approval of Werder's hepatitis B indications and the high price, the market share of tenofovir in clinical practice is far lower than that of entecavir and other competing products In 2015, the sales volume of Werder sample hospital was only 25 million yuan, and the sales volume of entecavir sample hospital exceeded 1.4 billion yuan in the same period Due to its late listing, tenofovir has a very limited scale in the nucleoside Antihepatitis drug market Its main competitors include entecavir, adefovir Dipivoxil and telbivudine, which have been in the medical insurance market for many years and the price is lower All these hinder the growth of tenofovir market, and tenofovir urgently needs to solve the problem of weak growth Trend reviews the most sincere price reduction can be said to be Werder Although the core patent of the drug still has two years to expire, as the leading product of anti hepatitis B, the drug directly reduces the monthly treatment cost from 1470 yuan to 490 yuan without the pressure of generic drugs, a decrease of 67% Compared with the national pricing of the main competing product entecavir, the monthly treatment cost of the generic drug is about 600 yuan, while that of the original research drug bolutine is about 900 yuan The price of Werder is not only far lower than that of brooding, but also lower than that of entecavir Once the product enters the medical insurance, the market of Werder is expected to expand rapidly Yiruisha: in the face of the impact of generic drugs, yiruisha (gefitinib) is a targeted small molecule anti-tumor drug developed by AstraZeneca for non-small cell lung cancer The drug was approved for market in 2002 and approved by China in 2005 As a targeted anticancer drug, Iressa's road to success is very tortuous In the early days, it was thought that the drug could not improve the efficacy compared with placebo, until later studies found that IRESSA was specifically suitable for EGFR positive non-small cell lung cancer, and Iressa recovered "magic" According to IPASS and other research results, Iressa has been listed as the first-line drug of NSCLC with EGFR mutation by ASCO and NCCN As the first EGFR-TKI approved in China, Iresa has gained a huge market scale through years of promotion in China According to the database of PDB sample hospitals, the sales volume of Iressa sample hospitals in 2015 was 308 million yuan, ranking the first in the sales volume of this kind of drugs However, with the listing of exinib, Iresa was affected to some extent, and its sales volume shrank in 2015 At the same time, Eliza, as a star variety, will face the challenge of generic drug price with the expiration of patent in 2016 For example, the generic price of Gleevec, which is the same as TKI, is only 10% of that of Gleevec in China From the data of CDE, nearly 20 manufacturers, including Zhengda Tianqing, Huahai and Qilu, including gefitinib, have entered the declaration and production stage at least In terms of the impact of generic drugs, Iressa obviously faces greater challenges Trend comments on the price reduction of Iresa are not only a good gesture of AstraZeneca to relevant national departments More importantly, in view of the large number of EGFR positive NSCLC patients who do not use Iressa in China, with the help of price reduction and possible access to the medical insurance catalog, Iressa can rapidly expand the market size and increase the competitiveness with Kemena and Troika It is also necessary to point out that the existing EGFR-TKI has obvious drug resistance problems, which is considered to be related to the T790M mutation of EGFR, while the tagrisso (osimeritinib) of the first EGFR-TKI for T790M mutation successfully launched by AstraZeneca in 2015 is positioned as the new generation of EGFR-TKI With tagrisso entering clinical practice in China, it is expected to replace the status of existing drugs in the future The price reduction of eresa also makes room for the listing of this new product Kemena: price reduction provides a heavy chip for entering the medical insurance industry Kemena (exetane) undoubtedly plays an important role in the new drug industry in China It was once known as one of the most important innovations in biomedicine comparable to "two bombs and one star" Kemena's R & D and clinical research are all localized Beida pharmaceutical brings China's first TKI drug, and at the same time, China's top cancer experts directly participate in the global drug research and listing Similar to Iressa, Kemena belongs to EGFR-TKI in terms of mechanism Previous studies have shown that Kemena has the same efficacy and safety as Iressa, and the price of Kemena is lower than both Iressa and trocaine in terms of pricing The brand of national innovative medicine and the advantage of low price undoubtedly provide support for Kemena's rapid increase in volume According to the latest prospectus of Beida pharmaceutical, Kemena's sales volume in 2015 has reached 900 million yuan, which is very close to its goal of 1 billion yuan From the database of sample hospitals, the sales volume of Kemena in 2015 increased by 36% year on year, and the sales volume of Iressa and Troika decreased in the same period Obviously, Kemena occupied part of the market share of the two competing products Trend review from the prospectus, Kemena's rapid growth is closely related to its access to Zhejiang and a few other provinces and cities, so access to national health insurance will provide greater assistance to the product The 54% price reduction will reduce the monthly treatment cost of Kemena to about 6000 yuan, which is relatively low as a targeted anticancer drug With the support of a large number of Kemena clinical research experts, Kemena
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