Check and approve the highest guiding price and define the payment standard, Tianjin Medical Insurance Bureau will take action

On June 10, Tianjin Medical Insurance Bureau and health care Commission announced the price of the non-invasive gene test project of fetal chromosome aneuploidy At the same time, Tianjin Medical Insurance Bureau included the gene test project into the medical insurance and defined the payment standard of medical insurance It is worth noting that this may be the first time that the health insurance bureau has purchased NIPT services after the institutional reform It is undoubtedly of great significance for the industry to include gene testing programs in medical insurance, a person from the gene testing industry told e drug managers 1080 yuan is the highest government guided price set by Tianjin Medical Insurance Bureau and health care Commission for NIPT technology this time This is the role of the medical insurance bureau in price management after merging the drug and medical service price management responsibilities of the development and Reform Commission in the institutional reform For the payment standard of medical insurance, Tianjin Medical Insurance Bureau set at 260 yuan, which is another case of NIPT technology paid by the government after Shenzhen NIPT technology is included in the medical insurance this time, which comes from the promise of 20 livelihood projects in Tianjin in 2019, including free fetal chromosome aneuploid non-invasive gene detection for pregnant women registered in Tianjin, free cardiovascular and cerebrovascular disease screening for the target population, and increasing the reimbursement limit and proportion of outpatient and inpatient, etc NIPT technology is appraised as "a revolutionary technology in the field of prenatal diagnosis" In 1997, Lu Yuming, the current Vice President of the Chinese University of Hong Kong Medical School and academician of the Hong Kong Academy of Sciences, found free fetal DNA in the maternal peripheral blood Later, he used free fetal DNA to detect fetal sex, blood type, etc in 2008, Lu Yuming's team published NIPT technology, which was launched in the United States three years later The new technology has been on the market for less than 8 years Zhao Ruilin, China's general manager of Illumina, the main supplier of global gene sequencer, once said that at present, the most mature application of gene detection is non-invasive prenatal screening Compared with the traditional scheme, NIPT has the advantages of no trauma, high detection rate of Down's syndrome, low price and low technical access threshold 1 "NIPT's price reduction and volume increase are inevitable." we have lowered the price of non-invasive prenatal testing to more than 800 yuan in Shenzhen " Yin ye, CEO of BGI, said in an interview with e drug managers In terms of NIPT price, Zhao Ruilin said that in China, the cost of this inspection is about 1000 to 2000 yuan In some places, it will be higher because of the addition of other content; in others, it will be lower because of the local government subsidies In July 2016, the former Fujian health and Family Planning Commission issued the notice on modifying part of "medical service price database coding", which clearly stipulated that the service price of NIPT in Fujian Province was 1400 yuan In December of the same year, Zhejiang Provincial Price Bureau defined the NIPT price of the province as 1300 yuan / time Before the two provinces, there were four provinces that priced 1460 yuan / time in Hubei Province, 1705 yuan / time in Guangdong Province, 2210 yuan / time in Jiangsu Province and 2400 yuan / time in Sichuan Province It can be seen that with the technology maturity, market expansion, government subsidies and other factors, NIPT's price is also constantly under explored This time, Tianjin has reached the critical point of 1000 yuan As the main competitor in NIPT market, BGI hopes to promote such technology through government public projects strategically Yin ye once told e drug managers that BGI is now actively contacting provinces and cities to seek to promote NIPT technology through government payment In Shenzhen, where Huada is located, its price has dropped to more than 800 yuan According to the data, BGI's livelihood projects (including NIPT and other tests) have covered more than 20 provinces and autonomous regions in China, and the number of screening people has reached more than 6 million times In 2018, more than 20 regions including Linyi, Changsha and Zhuhai were added, and the number of new screening samples reached more than 2 million Yin Ye describes this technology promotion method with the most popular "volume procurement" at present: local governments package and purchase projects to exchange volume for price, reduce the cost of testing, and consider the financial capacity at the same time "The combination of these factors can actually promote price reduction while expanding market share and benefiting more people." For the drop-down of NIPT price, Gao Yang, CEO of berry gene, another major provider of NIPT technology in China, also told the e-drug manager, "we do not avoid the fact that price competition With the growing maturity of gene detection technology, the price reduction and increase of NIPT in the future is inevitable." 2 Behind the price reduction or hidden risks, "innovation driven is not only technology driven, we should not ignore policy driven, so gene testing should be included in the medical insurance as soon as possible." As early as 2016, Cheng Jing, academician of the Chinese Academy of engineering, called for the inclusion of gene detection technology in medical insurance In recent years, more and more such calls have been made In foreign countries, Switzerland will provide compulsory medical insurance for high-risk pregnant women who meet the requirements in 2015, and reimburse the costs related to non-invasive prenatal chromosomal aneuploidy (chromosomal trisomy) screening Switzerland has become the first country in the world to include NIPT in medical insurance In China, Shenzhen incorporated the prenatal non-invasive gene test into the birth insurance in 2013 Subsequently, Chongqing also included the non-invasive prenatal gene test for pregnant women, thalassemia gene test for pregnant women and genetic deafness gene test for newborns into the medical insurance in the whole province for screening On June 10, Tianjin Medical Insurance Bureau included NIPT in the medical insurance, and moved the original "Down syndrome screening" project out of the basic medical insurance catalog, realizing a "cage free bird replacement" for new medical technology According to the public information, Shenzhen, the first city to include NIPT in social security, increased the total detection rate of Down syndrome from 4700 / 10000 in 2011-2017 to 1164 / 10000 in 2017, but after intervention, the live rate of Down's in 2011-2017 decreased from 236 / 10000 in 2011 to 84 / 10000 in 2017 But in recent years, the industry has also been questioned by the public due to some events, and the industry's trust crisis still exists Many gene companies occupy the market through price reduction, and the price of NIPT technology is getting lower and lower According to Zhao Ruilin, NIPT's price is thousands of dollars in the United States According to media reports, NIPT's international price is also basically thousands of RMB Zhao Ruilin admitted that at the initial stage of NIPT technology listing, the industry grew savagely in China, lacking industry standards and norms until the government issued relevant policies But there are still many profit seekers in the industry "It's conceivable that there will be some companies, just because they want to be cheap, so they won't do this step," said Lu The "step" mentioned by Lu Yuming is to measure the fetal DNA concentration in the blood of pregnant women In some laboratories in foreign countries or Hong Kong, before doing NIPT, the detection personnel will first detect the fetal DNA concentration in the blood of pregnant women to confirm whether they can do NIPT Generally, when the concentration reaches more than 4%, the more accurate detection conclusion can be obtained In this regard, Zeng Xianghua gene, berry gene, Da'an gene and Jinyu medicine were asked about relevant matters by China Securities News Hua Da and berry all responded that they would normally test the fetal DNA concentration However, it is worth noting that the original documents of the health and family planning commission do not have relevant provisions on the concentration of fetal DNA, and whether the detection is the independent decision of the enterprise In addition, Lu also pointed out another way to reduce costs NIPT technology sorts DNA by looking for DNA in plasma, but the amount of DNA searching will affect the test results He believes that if we want to get very accurate results, we need to find more DNA, while the laboratory generally needs 30 million "But if some companies want to reduce the price very low, they will make a small amount of DNA, so the accuracy will be lower." Lu Yuming said in an exclusive interview with surging To this end, Lu Yuming believes that medical organizations need to formulate relevant guiding principles, such as specifying how many pieces of DNA testing companies should do at least when doing, testing fetal DNA concentration, etc When NIPT was incorporated into local medical insurance and livelihood projects, the industry's relevant guidelines and guidelines still failed to keep pace.