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Is the quality of centralized procurement of metformin for 6 cents per tablet good? The clinical real-world research results are here

2024-02-28   

According to the WeChat official account of the National Health Insurance Administration, the real world research results of metformin quality were released recently. Metformin is a first-line drug for the treatment of diabetes. It was included in the third batch of national organized drug collection in August 2020. Eight domestic generic drug enterprises were selected from each of the two dosage forms of oral regular release and sustained release. 1、 In the centralized procurement, the annual consumption of metformin reached 11.4 billion tablets. After the mainstream selection of patients for centralized procurement, how much does the price drop to one tablet of metformin? Does anyone dare to use it? In 2023, medical institutions across the country will use 11.4 billion selected tablets of metformin for centralized procurement, including 4.6 billion tablets for 0.25g specifications and 6.8 billion tablets for 0.5g specifications. The use of selected metformin accounts for 84% of the total drug use, and the vast majority of patients who use metformin will benefit from the use of selected products. According to the recommended daily dose calculation in the manual, it can be used by over 8 million patients for long-term standardized use, and the selected metformin has become the mainstream choice for doctors and patients. 2、 The price of selected drugs has decreased, significantly reducing the medication burden on patients. The price of metformin oral regular release dosage form (0.5g specification) has decreased from 0.4 yuan per tablet before centralized procurement to about 6 cents, and the daily cost has decreased from 1.6 yuan to 0.24 yuan; The price of the sustained-release dosage form dropped from 0.7 yuan to about 0.1 yuan per tablet, and the average daily cost dropped from 2.8 yuan to 0.4 yuan. For diabetes patients who take metformin for a long time, the cost burden is significantly reduced. 3、 How much does the efficacy and safety of the selected drug match that of the original drug in clinical settings? What is the quality of one tablet? Two well-known tertiary hospitals in China have conducted clinical real-world studies on selected metformin from centralized procurement, using the original drug as a control to evaluate its efficacy and safety. This study included 435 patients who used the original drug and 336 patients who used the selected generic drug. The two groups of patients were evaluated after 3 months of standardized medication. The four key evaluation indicators reflecting the effectiveness of blood glucose control are as follows: glycated hemoglobin level, both the original and imitation groups decreased from around 7.0% to 6.4%; The fasting blood glucose concentration decreased from 8.6mmol/L to 7.2mmol/L in the original study group, and from 8.8mmol/L to 7.2mmol/L in the imitation group. The hypoglycemic effect of generic drugs is equivalent to that of original research drugs. The compliance rate of glycated hemoglobin (lt; 7%) was 78.9% in the original research group and 83.4% in the imitation group; The compliance rate of fasting blood glucose (lt; 8mmol/L) was 87.6% in the original study group and 83.8% in the imitation group. The above two blood glucose compliance rate indicators have high and low values, but according to standardized statistical methods, there is no difference in blood glucose compliance rate between the generic drug group and the original research drug group. The statistical analysis results of the above four indicators show that the efficacy of the selected generic metformin is equivalent to that of the original research drug. The blood glucose compliance rate of patients using both original and generic drugs is around 80%, which in turn indicates that both original and generic drugs have a probability of poor efficacy in individual treatment, and patients need to use other treatment methods or drugs. Simply selecting "empirical" examples from a 20% probability of generic drugs to "prove" that generic drugs have poor efficacy

Edit:GuoGuo Responsible editor:FangZhiYou

Source:people.cnle

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