On the way of negotiation of drugs in five countries

Source: Medical cloud information 2016-05-25 caption: in today's era, vuca is often used to describe our era, such as volatile, unpredictable, complex and ambiguous To put it plainly, the era of vuca is a dynamic one Well frogs can't speak to the sea, and they are limited to emptiness; summer insects can't speak to the ice, and they are loyal to the time In the era of vuca, pigs on the tuyere can go to heaven next minute, and turkeys before Thanksgiving can become Chinese dishes tomorrow Past experience may no longer have a key reference value for the future The national negotiation on patent and exclusive drugs is one of the biggest vuca in drug price this year According to the guidance on improving the centralized drug procurement in public hospitals (GBF [2015] No 7, hereinafter referred to as No 7 document), the national health and Family Planning Commission officially launched the national drug price negotiation pilot in November 2015, involving five drugs of three diseases were included in the negotiation scope: lenalidomide (new base medicine) for the treatment of multiple myeloma; Tenofovir dipivoxil (GSK) in the treatment of hepatitis B; gefitinib (AstraZeneca), erlotinib (Roche pharmaceutical) and exetane (Zhejiang Beida) in the treatment of advanced non-small cell lung cancer None of the above five generic names was listed in the 2009 national medical insurance drug catalog It took half a year On May 20, 2016, the national health and Family Planning Commission announced the national negotiation results of the first batch of drug prices to the society Negotiations between tenofovir dipivoxil (GSK), gefitinib (AstraZeneca) and ektinib (Beida, Zhejiang) were successful Why is the national negotiation the biggest vuca of drug price this year? Because this round of negotiation is not directly with payers or purchasers This means that the price reduction is certain, but whether the sales volume can be increased by using this as a bargaining chip needs to be broken down by the national and provincial health insurance policies Under the background of high uncertainty, different product characteristics, access conditions and long-term strategies of enterprises may make different participants take different response ideas, and the results further promote future market changes There are many countries that negotiate with manufacturers and payers when drugs are on the market: negotiate with medical insurance funds in social insurance countries or regions (such as Japan, Germany, South Korea, Taiwan); negotiate with insurance operators in government insurance countries (such as Hong Kong and the medical authority); negotiate with insurance companies in commercial insurance countries (such as the United States) However, in either mode, the subject matter of negotiation is the price reimbursed (price for quantity) If the negotiation is unsuccessful, it will not be included in the reimbursement scope, and the manufacturer will make free pricing The negotiation of vuca must be tangled, but the inner tangle should be put aside Let's take a look at the performance of each athlete in this round of vuca competition: 1 Diver's tenofovirate (GSK Werder, down 67%) Tenofovir dipivoxil, which was approved for hepatitis B indications in 2013 and went to the market in 2014, is the most sincere product in the negotiation (it is reported that the patent expired in 2017) The R & D manufacturer is Gilead, and GSK has obtained the exclusive right to sell the product in China It's no joke to say that for patented drugs, the long journey to hospital caused by the backlogs in China's review and approval process, the delay in listing, the lack of reimbursement access for many years and the long journey to hospital can be described as eternal pain From the perspective of business, the most intuitive performance is that drug patents just (or have not) been included in the medical insurance when they are about to expire After being included in the medical insurance, the sales volume of the Chinese mainland market can not even reach the so-called small market such as Hong Kong, Taiwan or South Korea for quite a long time After the high price of the widely criticized drugs, there is no choice for the bitter baby to say The price of tenofovir dipivoxil, a new hepatitis B drug, has been greatly reduced It's just like walking to the medical insurance fund as the payer and saying, "dear, nice, sweet, beautiful and rich girl, do you make it?" Tenofovir dipivoxil is positioned as the first-line treatment of hepatitis B, and the clinical data prove that the curative effect and tolerance are good After the price reduction, the daily average treatment cost is about 16 yuan, significantly lower than that of entecavir, which is the first-line treatment of hepatitis B (in 2009, class B drugs in the national medical insurance catalog, originally researched as Squibb, the daily average treatment cost is about 33 yuan; The average daily treatment cost is about 25 yuan How can entecavir be allowed to reduce the price of tenofovir? GSK's move is a new attempt after compliance reform and slimming After all kinds of shocks and adjustments since 2013, GSK is the first foreign pharmaceutical company to cancel the lecture fees for medical and health professionals, the first to launch the first line sales staff bonus and the completion of sales indicators, and the first to make an attempt to obtain market through price reduction for patented products This is a story that takes place in the exclusive and proprietary market It is worth thinking that the introduction of the two vote system in 2016 appears to be a streamlined circulation channel, but the impact on the original sin hidden behind the industrial chain is similar It remains to be seen how domestic manufacturers and other market participants will adjust their behaviors and choose their models 2 Lenalidomide (refume, new base medicine) from Yubo Pipa is a star product of new base company, which was listed in China in 2013 (it is reported that the patent expired in 2017), and used to treat myelodysplastic / dysplastic syndrome, mantle cell lymphoma and multiple myeloma As the only player to enter the national negotiations in the field of treatment, the result of the negotiations announced by the national health and family planning commission that rifeme has not appeared seems to be that the two sides have not yet reached a consensus on the price It is worth noting that CFDA announced in April 2016 that lenalidomide of Shuanglu pharmaceutical industry is "urgently needed clinically or has obvious clinical advantages compared with existing therapeutic drugs in China, which is to be included in the priority review procedure" Lenalidomide preparation (with composition patent) of Shuanglu pharmaceutical entered CDE for review in November 2014, which is the first application for production in China It is expected that the patent of new base compound will be listed in China soon after expiration Therefore, it is not difficult to see that price for volume is not the mainstream product strategy of NSMC In the face of the high-quality domestic drugs to be launched, rifeme still has its own value orientation 3 Group games with progress and retirement: gefitinib (AstraZeneca, 54% decrease), erlotini (Roche Pharma, troika, torrent, 55% decrease), ektini (Beida Kemena, Zhejiang) The three drugs for the treatment of advanced non-small cell lung cancer are included in the scope of negotiation, which reflects the admittance competition in the same treatment field (before provincial bidding, generic name + dosage form + specification are the competition units) This is also the embodiment of "optimizing the combination and combination of drugs with similar indications and functional effects, reducing the quantity of negotiated products and promoting fair competition" in the notice of the national health and Family Planning Commission on the implementation and improvement of the guiding opinions on the centralized purchase of drugs in public hospitals (gwyzf [2015] No 70, hereinafter referred to as No 70 document) In the group competition of three in two, how to measure the advance and retreat according to their own characteristics? Although the specific information is unknown, the factors that affect the decision-making of the competitors at least include: Although the treatment field is the same, but it is three different drugs after all, the market segmentation of the products and their clinical irreplaceable in their own target market determine the manufacturer's acceptance of price reduction; Corresponding patents: it is reported that gefitinib's patent expires in 2016, while erlotini's patent still has time to expire; the trade-off between reducing or canceling existing patient assistance projects and price reduction All three drugs have patient assistance programs in China It is one of the industry practices to implement patient assistance programs for high-value cancer drugs considering patients' ability to pay The manufacturer provides free use drugs in specific provinces for patients who meet certain conditions (including income level, disease status, and purchase and use records of the drug in a certain period of time) Generally speaking, the sum of the purchase period and the drug donation period is a complete treatment cycle (whether the patients can actually complete this cycle depends on their own disease status) The launch of the patient assistance program originated from foreign pharmaceutical companies, which helped patients with limited income to get high-priced drugs on the premise of maintaining product prices, and was later followed by domestic innovative pharmaceutical manufacturers If the price reduction of Iressa and Kemena is accompanied by the cancellation or reduction of the original patient assistance program, it can be regarded as the adjustment of the original product strategy by the manufacturer Previously, in some provinces or cities' negotiations on access to high-value drugs for serious illness insurance, some tumor products achieved a price reduction of about 50% by reducing or canceling patient assistance projects This means that drugs can go to more patients and larger markets, but the impact on the beneficiaries of the original patient assistance program is difficult to be generalized From the characteristics of the disease, NSCLC is usually dangerous, and patients are often diagnosed with little follow-up time In addition, although the targeted drug has the advantage of action site specificity without over worrying about side effects, it also has the characteristics of drug resistance caused by cancer cells for a period of time, so the drug may need to be changed The national negotiation price reduction benefits the patients as a whole, breaks through the income and other restrictions of the participants of the original patient assistance project, breaks through the characteristics that the manufacturers usually limit the operation of the patient assistance project to the big cities, improves the patient access of drugs and provides patients with a greater degree of options Two institutional features of this round of negotiation are also worthy of attention: first, the international reference pricing of patent drugs has played a reference role in the price formation for the first time after years of discussion Prior to the national negotiations, in June 2015, the national health and Family Planning Commission carried out a wide range of patent exclusive product information surveys, including the current price information of 15 countries and regions (country of origin, Hong Kong, Macao, Taiwan, the United States, Germany, Britain, France, Russia, Australia, Japan, South Korea, India, Brazil and South Africa) At the same time, in Document No 70, it is also proposed to "collect information on drug purchase prices in different stages and in neighboring countries and regions, so as to provide support for all kinds of drug purchase" In 2016, based on the requirements of the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), CFDA also launched a new drug listing price commitment announcement, which requires that the committed selling price of the drugs first listed in China shall not be higher than the post listing selling price of the comparable markets in the country of origin or around China (Japan, South Korea, India, Hong Kong, Macao Taiwan) So far, it is basically clear that the reference range of international reference pricing for Chinese drugs is the country of origin or comparable market around China, and the reference principle is no higher than The second is that the three drugs for the treatment of advanced non-small cell lung cancer are included in the scope of negotiation, reflecting the admittance competition in the same treatment field (before provincial bidding, the generic name + dosage form + specification are all competitive units) This is the consideration of the access strategy of the manufacturer, and also the consideration of the product positioning and differentiation strategy Conclusion: in the era of vuca, where do we go from the era of vuca, the most important thing is not what we know, what we already know, but what we have no experience to follow