The first hepatitis B new drug listed expert in 5 years: the price becomes a new drug
Oyster Sauce,Oyster Sauce Seasoning,Qualified Oyster Sauce,Premium Oyster Sauce Chinese Seasoning (Shandong) Trading Co.,Ltd , https://www.zt-trading.com
Medical Network December 10th, on December 8th, the news was informed that the second-generation product of tenofovir, fentanyl fumarate tablets (TAF), was officially launched, which is the only one approved in China for five years. A new hepatitis B drug. Ren Hong, dean of the Second Affiliated Hospital of Chongqing Medical University, analyzed the superiority of propofol fumarate tablets compared with the previous hepatitis B treatment plan at the press conference, but he also told the news that the price will be Become a key factor affecting the accessibility of the drug.
86 million people infected with hepatitis B, nearly 80% are not diagnosed
According to the data released in the 2018 "Lancet" sub-publishing, the positive rate of hepatitis B surface antigen in China is 6.1%. According to this ratio, there are currently 86 million people infected with hepatitis B virus in China.
"To know that there are 257 million people infected with chronic hepatitis B virus in the world, China's 86 million people account for one-third of the global infection." Academician of the Chinese Academy of Engineering, Professor Zhuang Hui of Peking University Medical Department, Zhuang Hui, introduced in hepatitis B Among the virus-infected patients, only 16.08 million infected people were diagnosed, accounting for only 18.7%, and the treatment rate was only 4.1%, which is 3.5 million.
“At the same time, in a cross-sectional study evaluating 8080 patients with cirrhosis in southern China from 2001 to 2010, it was found that 77.22% of cirrhosis in China was caused by hepatitis B virus infection. More than 84% of liver cancer and hepatitis B virus infection in China Relevant." Academician Zhuang Hui called for China to strengthen prevention, expand screening, and actively treat it to achieve the goal of eliminating hepatitis B by the World Health Organization in 2030.
The first approved hepatitis B drug in 5 years
Before the approval of propofol fumarate tablets in November this year, five chronic hepatitis B antiviral nucleosides were approved in China: lamivudine, adefovir dipivoxil, telbivudine, Entecavir, tenofovir fumarate (TDF). The first three drugs are defective in drug resistance, and many patients have to find more suitable drugs after drug resistance. TDF was also developed by Gilead and approved for listing in China in 2013.
The drugs that are more widely used clinically at home and abroad are entecavir and tenofovir fumarate (TDF), both of which are far superior in pharmacodynamics and drug resistance to the other three drugs, so In the United States or European guidelines for the development of liver disease research, entecavir and tenofovir fumarate (TDF) are the drugs of choice.
Also a hepatitis B antiviral drug developed by Gilead Science, where is the superiority of tenofovir fumarate (TAF) compared to the previously developed tenofovir fumarate (TDF)? Ren Hong, dean of the Second Affiliated Hospital of Chongqing Medical University, explained that in terms of drug resistance, the current observation data showed that the drug resistance rate of the two drugs was 0% as of the 96th week.
"Compared to TDF, the average exposure of TAF in human systemic plasma was reduced by 89% after administration, and the concentration of TAF-DP produced in human primary hepatocytes was 5 times that of TDF," Ren Hong analysis, TAF administration After the drug accumulates in the liver, TAF can also be called a new "targeted liver" hepatitis B treatment. Therefore, from the dose point of view, to achieve the same efficacy, the dose of TAF is only one tenth of TDF.
"The other point is that compared to TDF, TAF has less effect on kidney function, bone density on the hips and spine." Ren Hong said that this is for people over the age of 60, or with bone disease or "kidney" Especially for patients with functional changes.
Price factor, become a difficult problem for new drugs
“Price is a key factor.†Ren Hong said in response to the news that the new drug affects the accessibility of the new drug fumarate propofol tablet. The newly approved propofol fumarate tablet is effective. It will definitely replace the original tenofovir fumarate in the future, but it will take some time.
For many hepatitis B patients in China, tenofovir's first-generation product, tenofovir fumarate, is also a new drug. Although the drug was approved in 2013, the pricing at that time made many hepatitis B patients unable to afford it. Until 2016, the country initiated the first drug price negotiations, and tenofovir fumarate was one of the three drugs selected at the time, and it was the drug with the largest price cut among the three negotiating successful drugs. According to the results of the negotiations, the monthly average drug cost of tenofovir fumarate was reduced from 1,500 yuan to 490 yuan, and the price dropped by 67%.
Subsequently, tenofovir fumarate was successfully included in the medical insurance, which greatly improved the accessibility of tenofovir disoproxil.
"We will officially announce the price of medicines in January next year. The principle of pricing in China is to set a reasonable price according to the level of economic development and the status quo. After all, this medicine has just entered the Chinese market and will be a self-funded drug. We also I hope that in the future, I will have the opportunity to cooperate with the government and enter the national medical insurance through the use of price negotiation mode to improve the accessibility of medicines.†Luo Yongqing, the global vice president of Gilead and general manager of China, said in response to the reporter's drug pricing.
澎湃News found that a bottle of 30 tablets of propofol fenofuran tablets in the United States was sold for about $1,100 by inquiring about the US drug comparison website goodrx, which is calculated by taking the drug every month. Will exceed 7,000 yuan.
"China (price) will not be so high, but comparing the availability of domestic tenofovir or entecavir, (the new drug for hepatitis B) is a problem." Ren Hong told the news.