A few days ago, the reporter learned from the conference site of the "Blue Book on the Progress and Effectiveness of China's Medical Insurance Drug Administration Reform" (hereinafter referred to as the "Blue Book") that my country has carried out the adjustment of the National Medical Insurance Drug Catalog for three consecutive years since 2018. Reimbursement has reduced the burden on patients by nearly 170 billion yuan. Since the centralized procurement reform in 2018, as of September 2021, the accumulated cost savings is about 250 billion yuan.
Behind the astonishing figures is a profound adjustment of the market structure. The "Blue Book" has tracked the clinical drug use in 804 hospitals in 31 provinces since 2015, and analyzed the changes of clinical drug use in hospitals combined with national data. "In the first quarter of 2021, compared with the first quarter of 2015, the consumption of the first batch of national centralized drugs increased by 3.5 times, but the amount decreased by 3.6%, and the market share increased from about 40% to 85.3%." " Liu Fiaoyang, an expert from the Science and Technology Development Center of the Chinese Pharmaceutical Association, the author of the Blue Book, said.
 
Medical insurance negotiated large volume of drugs
"If there is no medical insurance negotiation (drug) price reduction, I can't be able to cure this disease." 80-year-old Fang Guiqing said happily, because the price of viral hepatitis C treatment drugs entered the national medical insurance list, he only spent less than two 10,000 yuan will cure the disease, and "the original price will cost 100,000 yuan".
Medical insurance negotiation is known as "soul bargaining", and the object of negotiation is innovative drugs, which has gradually expanded in the past three years. In 2018, 17 anticancer drugs were included in the national medical insurance list through negotiation, with an average price reduction of 56.7%. In 2019, 97 medicines were negotiated, of which 70 new medicines had an average price drop of 60.7%, and 27 renewed medicines had an average price drop of 26.4%. In 2020, 119 drugs were successfully negotiated, with an average price reduction of 50.64%. Through negotiation, expensive imported drugs and newly marketed innovative drugs are offered at "common prices" or even the world's lowest prices, benefiting a large number of patients.
With such a big price drop, why should innovative drug companies “follow”? This is because of the importance of China's drug market and medical insurance market. For many pharmaceutical companies, China is one of the most important markets in the world, and the medical insurance fund is the largest payer in my country's pharmaceutical market. Through negotiation, drugs can enter the national medical insurance catalog more quickly, enter more hospitals, and obtain medical insurance funds to "pay".
In the medical insurance negotiation in 2019, the imported hypoglycemic drug Dapagliflozin was "cut" to the world's lowest price of 4.36 yuan per tablet. AstraZeneca China Vice President Huang Bin recently introduced that as of October this year, Dapagliflozin had entered 10,098 medical institutions at all levels in China, compared with only 2,160 hospitals before the inclusion of medical insurance. "10,098 companies are compared to 2,160 companies, which is a huge change and difference." He emphasized.
The amount of negotiated drugs has been greatly increased after entering the national medical insurance list. The "Blue Book" shows that the growth rate of negotiated drug consumption in 2018 showed rapid growth from the fourth quarter of 2018 to the fourth quarter of 2019. Under the circumstance that the total drug consumption (chemical drugs and biological products) has dropped significantly after the outbreak of the new crown pneumonia, the growth rate of the newly negotiated drug consumption in 2019 still showed a significant growth trend, and the year-on-year growth rate of the consumption in the third and fourth quarters of 2020 was 657.6%, 768.6%.
 
The trend of generic drugs to replace original drugs appears
In parallel with the two lines of medical insurance negotiation, the national centralized procurement exchanges price for original research drugs and generic drugs. The first five batches of centralized procurement covered 218 varieties, including mainstream drugs for chronic diseases and common diseases such as hypertension, diabetes, chronic hepatitis B, etc. The price of selected drugs dropped from 2 to 3 times the international price to a comparable level.
How big is the price reduction? The price of acarbogen research drug before centralized procurement is 1.3 yuan/tablet, and the price after centralized acquisition is reduced to 0.18 yuan/tablet. The price of tumor treatment drug gefitinib was reduced by 69% through centralized procurement, with an average of 41.8 yuan per tablet.
Due to the large price reduction and large purchase volume of medicines, the national centralized procurement has profoundly stirred the market in just a few years, which has promoted the increase of market concentration, and has also led to active price reductions for products with the same generic name that have not been selected. The "Blue Book" shows that the proportion of the selected products in each batch to the drugs with the same generic name (dosage form) increased rapidly after landing. As of the first quarter of 2021, the proportion of selected varieties in the first three batches of national centralized procurement has reached 80%. From the perspective of hospital level, the proportion of the selected products in the second-level and lower hospitals is slightly higher than that in the third-level hospitals. From a regional perspective, the consumption of selected products in the western region in the first quarter of 2021 accounted for more than 90%.
The quality assurance of post-collection medicines has received widespread attention. During the same period when the "4+7" centralized procurement pilot entered the result implementation stage, under the guidance of relevant state departments, medical institutions such as Xuanwu Hospital of Capital Medical University selected some of the selected varieties, and evaluated the efficacy and safety by analyzing the data in the real diagnosis and treatment environment. Zhang Lan, director of the Department of Pharmacy of Xuanwu Hospital, introduced that the study lasted for nearly two years from January 27, 2019, and included 22 medical institutions in Beijing. Different drugs have different research programs.
The research results show that there is no difference in clinical efficacy and safety between the 14 selected generic drugs and the original research drugs in 8 therapeutic areas including hepatitis B, hypertension and tumor, which provides an important evidence-based medicine for the generic drugs to replace the original research drugs. evidence.
In some varieties, the trend of generic drug substitution is very obvious. Liu Wenxin, director of the Technical Standards Department of the China Medical Insurance Research Association, said: "Before the implementation of the first batch of centralized procurement, the market share of original research drugs could reach more than 60%, but with the advancement of the first batch of centralized procurement, the market share of original research drugs was gradually compressed. By the first quarter of 2021, only about 20% will remain. It can be seen that the centralized procurement policy has effectively promoted the substitution of generic drugs for original drugs."
 
Major adjustment of hospital drug structure
Behind the medical insurance negotiation and the normalization of the national centralized procurement is the accelerated progress of the national medical insurance catalogue to "vacate the cage and replace the bird". The structure of clinical medication has been profoundly adjusted in this process, and the high-value drugs used by medical institutions have undergone tremendous changes. Only 4 of the top 20 (TOP20) varieties in 2015 will remain in the TOP20 in the first quarter of 2021.
The "First Batch of National Key Monitoring Rational Drugs List (Chemical Drugs and Biological Products)" released in July 2019 contains 20 varieties, of which 7 varieties including oxiracetam are among the 2015 TOP20 varieties. After the key monitoring list of rational drug use was announced and the relevant varieties were called out from the National Medical Insurance List, these varieties were completely withdrawn from the TOP20.
In fact, the market of these 20 varieties has generally shrunk, and their sales amount and consumption have begun to decline since the third quarter of 2019, and have been greatly reduced after the adjustment of the National Medical Insurance Catalogue. Compared with the first quarter of 2015, the use of these varieties in the first quarter of 2021 decreased by 83.7%, and the amount of use decreased by 87%.
Due to the decline in the total cost of medicines, some nationally-collected varieties have also withdrawn from the TOP20 in the first quarter of 2021, including the cardiovascular system drug atorvastatin and the digestive system drugs lansoprazole and pantoprazole.
At the same time, the number of anti-tumor drugs has increased from zero to six, the number of neurological drugs has increased from one to three, and the number of hematological drugs has increased from two to three. "We can clearly see that the current hospital drug structure uses more drugs and the burden of disease is more compatible." Liu Jiaoyang added.
 
It is worth mentioning that in several therapeutic areas with a heavy disease burden, my country's investment in drug costs is more consistent with the global trend. According to the "Blue Book", the TOP20 drugs by global sales in 2020 include 14 anti-tumor and immunomodulatory agents, 2 systemic anti-infective drugs, 2 blood and hematopoietic system drugs, 1 sensory system drug, and 1 digestive system and metabolism. drug. Among the top 20 drugs in the first quarter of 2021 in my country, there are 4 systemic anti-infective drugs, 3 blood and hematopoietic system drugs, and 6 anti-tumor drugs.
 
In addition, with the changes in the hospital's clinical drug use, the hospital's internal revenue structure has also been gradually optimized. According to Liu Wenxin, the medical service utilization survey data shows that the proportion of hospital drug expenses has dropped continuously, from 50.7% in 2015 to 38.5% in 2019.

(Source: Pharmaceutical Network)