The national health insurance bureau starts a new round of negotiations! 50% PD-1 price reduction for the existing products, xiumeile, etc

On November 11, according to the associated press, the National Health Insurance Bureau launched a new round of negotiations on the access of Medicare drugs this week Before that, the health insurance bureau has determined 128 drugs to be negotiated, including 109 Western medicines and 19 Chinese patent medicines In the catalogue to be negotiated issued with the new version of the regular access catalogue, the medical insurance bureau publicized 48 drugs within the agreement period, including 43 Western medicines and 5 Chinese patent medicines The drugs to be negotiated this time are exclusive products with high clinical value but relatively expensive price The treatment fields of these drugs mainly involve major diseases such as cancer, rare diseases, hepatitis C, hepatitis B, hypertension, diabetes, etc Many products are new drugs approved by the State Food and Drug Administration in recent years, including major innovative drugs in China Just now, Sina medicine learned that the first negotiated drug had been born: the price negotiation between Jiehua biology and the state health insurance bureau was successful, and Jiehua biology "lefuneng" will officially enter the national medical insurance reimbursement catalogue and be included in the payment scope of medical insurance fund from January 1, 2020 It is also reported that the price of a respiratory product has been reduced by 50%, which is equivalent to the price of surrounding countries and regions Obviously, compared with the previous disclosure of the final negotiation Access Catalogue to be published from September to October, the time has been delayed, and it can be vaguely seen that the negotiation work is cautious and tedious However, before the final negotiation access catalogue was released, a batch of drugs had become the focus of the industry At present, there are five kinds of PD-1 monoclonal antibodies on the market in China, namely, opdivo of Bristol Myers Squibb and keytruda of mosadong The other three are from domestic pharmaceutical companies, namely, treprimab of Junshi Biology (trade name: tuoyi), xindili of Cinda Biology (trade name: dabushu) And carrelizumab (trade name: Erica) of Hengrui medicine, which was approved for marketing at the end of May this year According to relevant regulations, the western medicine and Chinese patent medicine transferred into the medical insurance drug Catalog shall be the drugs registered and listed by the State Food and drug administration before December 31, 2018 (inclusive) According to this time, Hengrui PD-1 may not be included in the adjustment queue of this medical insurance catalog According to Sina pharmaceutical, after comprehensive drug donation assistance for PD-1 mAb that has been listed in China, the cost for patients in a year is as low as 93600 Some people in the industry and Internet users have different voices about the high anticancer drugs entering the medical insurance catalogue, and some doctors' representatives do not agree with it, believing that the limited medical insurance resources are wasted Will health care be considered in the face of such high costs? We will continue to pay attention Sumerial, developed by Aberdeen, has been at the top of the world's best-selling drugs list for seven consecutive years since it was launched in 2002, with global sales reaching US $20.485 billion in 2018 Although it is called "drug king", its market penetration in China is not high, which may be related to its high price and less approved indications Since this year, many regions in the country have announced the price reduction of adalimumab injection (trade name: xiumeile) solution Adalimumab injection dropped from 7600 yuan to 3160 yuan, a drop of nearly 60% While the 2019 new version of the medical insurance catalog has not yet been made public, many people in the industry believe that xiumeile's price cut is to enter the national medical insurance catalog But if xiumeile wants to enter the national health insurance, first of all, it needs to reduce the price to the same level as similar products Taking yisaipu as an example, the treatment cost of one month is about 5120 yuan, while xiumeile is about 6320 yuan, which is still higher than yisaipu It is worth noting that sumerial is also facing the challenge of biological similar drugs At present, the biological similar drugs of adamumumab of baiaotai in China have been officially approved for listing In addition, the biological similar drugs of adamumumab of many enterprises such as Haizheng pharmaceutical, Xinda biology and Fuhong Hanlin are also queuing up, which are expected to be approved for listing in this year and next year With more and more similar biological drugs coming to market in China in the future, xiumeile's profit margin is bound to be further squeezed in the domestic market Access to the national health insurance catalog, expand market share, or one of the opportunities for xiumeile to reverse the situation However, the good news is that on November 4, Alberto announced that Sumeria's fourth indication in China, the treatment of polyarticular juvenile idiopathic arthritis (pjia), has been approved by China drug administration With the optimization of drug approval policy of SFDA, sumil's market share in China is still considerable In 2019, the new version of the medical insurance catalog realized "free space" A total of 150 drugs were transferred out, mainly drugs with low clinical value, obvious abuse and better substitution 71 of the drugs transferred out have been revoked by the State Drug Administration In addition, 20 of the drugs listed in the national health and Health Commission's list of drugs for rational use, which was released in July this year, have also been transferred out For many years before that, auxiliary drugs have occupied the resources of medical insurance in China According to a survey conducted by relevant organizations in 2016, the annual waste amount of auxiliary drugs is up to 960 billion yuan According to the idea of "replacing birds with cages" in medical insurance, the space saved will be left for drugs with high clinical value and urgent need, which is enough to support the shuffling In addition to PD-1 and Sumeria, some anticancer drugs will be on the negotiation list, involving multinational pharmaceutical companies such as Roche and Pfizer, according to media reports Roche has two kinds of drugs, one is ansanza (aletinib), the target drug for ALK positive non-small cell lung cancer, and the other is Paget (patozumab), the innovative target drug for breast cancer Pfizer has three kinds of drugs, one is iboxin, the other is Shangjie, the rheumatoid drug, and enli, the biological DMARD drug for rheumatoid arthritis and ankylosing spondylitis According to the minutes of the "September 2 national health insurance catalog drug negotiation enterprise communication meeting" released in the industry, the health insurance bureau said that 70 new drugs have entered the round of negotiations, 30 of which are not possible to enter, and the specific reason is unclear (or because the manufacturer refuses to negotiate) The varieties to enter the negotiation include new drugs approved in recent two years, including many anticancer drugs with clinical value recognized by most experts and high price (including the first PD-1 inhibitors approved for market in China), as well as drugs for rare and chronic diseases.