China News Service, February 28 (Reporter Zhang Ni) Is the quality of the metformin purchased from a 6-cent tablet?

The answer is: OK!

　　On the 27th, the "National Medical Insurance Administration" WeChat public account released a real-world study on the quality of centralized procurement drugs.

The article mentioned that metformin is a first-line drug for the treatment of diabetes. In August 2020, it was included in the third batch of nationally organized drug procurement. Eight domestic generic drug companies each selected the oral regular-release and sustained-release dosage forms.

In addition, the article responds to many issues of concern to the outside world.

1. The annual dosage of metformin selected in the centralized procurement reached 11.4 billion tablets, making it the mainstream choice for patients.

　　After the centralized purchasing, the price dropped to a few cents per tablet. Does anyone dare to use metformin?

In 2023, medical institutions across the country will use 11.4 billion tablets of metformin in the centralized procurement of selected drugs, of which 4.6 billion tablets are used in the 0.25g specification and 6.8 billion tablets are used in the 0.5g specification

. The dosage of the selected metformin accounts for 84% of the total consumption of the drug. Metformin is used The vast majority of patients are using the selected products and benefiting from them

.

Calculated based on the recommended daily dosage in the instructions, it can be used by more than 8 million patients in a long-term standard. The selected metformin has become the mainstream choice of doctors and patients.

2. The price of the selected drugs has been reduced, and the patient’s medication burden has been significantly reduced.

　　The price of oral sustained-release dosage form of metformin (0.5g specification) has dropped from 0.4 yuan per tablet before the centralized procurement to about 6 cents, and the average daily cost has dropped from 1.6 yuan to 0.24 yuan; the price of sustained-release dosage form has dropped from 0.7 yuan per tablet. to about 0.1 yuan, and the average daily cost dropped from 2.8 yuan to 0.4 yuan. For diabetic patients taking metformin for a long time, the cost burden is significantly reduced.

3. The efficacy and safety of the selected drug and the original drug in real clinical scenarios are consistent

　　How much is the quality of the medicine for how many cents per tablet?

Two well-known tertiary hospitals in China have conducted real-world clinical studies on metformin selected from the centralized procurement, using the original drug as a control to evaluate its efficacy and safety.

The 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 sugar control are as follows:

　　The level of glycated hemoglobin dropped from about 7.0% to 6.4% in both the original research group and the imitation group; the fasting blood glucose concentration dropped from 8.6mmol/L to 7.2mmol/L in the original research 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 drugs.

　　The compliance rate of glycosylated hemoglobin (<7%) was 78.9% in the original research group and 83.4% in the generic group; the compliance rate of fasting blood glucose (<8mmol/L) was 87.6% in the original research group and 83.8% in the generic group.

The above two indicators of blood glucose attainment rate are different from each other, but analysis based on standardized statistical methods shows that there is no difference between the blood glucose attainment rate of the generic drug group and the original drug group.

　　The statistical analysis results of the above four indicators show that

the efficacy of the selected generic drug of metformin is equivalent to that of the original drug

.

The blood glucose compliance rate of patients using original drugs and generic drugs is about 80%. This in turn also shows that whether it is original drugs or generic drugs, there is about a 20% probability of poor efficacy in individual treatment, and patients need to take Other treatments or medications.

It is inaccurate to simply select "empirical" cases from the 20% probability of generic drugs to "prove" that generic drugs are not effective.

　　At the same time, the above-mentioned clinical real-world evaluation focused on liver function, renal function indicators and gastrointestinal adverse reactions. There was no difference in liver and renal function indicators between the two groups of patients before and after treatment, and no obvious adverse reactions occurred. No adverse reactions occurred. Medication status.

4. Strict quality requirements for the selected products to ensure that price reduction does not reduce quality

　　In order to ensure that patients have access to high-quality generic drugs, the medical insurance department has adopted consistency evaluation as the threshold for being shortlisted for centralized purchasing of generic drugs.

Varieties for consistency evaluation generally use the original drug as the reference preparation. Generic drugs should comply with the technical guidelines issued by the drug regulatory department, comply with the quality standards required by the Chinese Pharmacopoeia, and also need to meet the technical requirements for the registration of pharmaceuticals for human use (ICH). guiding principles.

　　For drugs that have passed the consistency evaluation, regulatory authorities will continue to conduct quality supervision throughout the entire chain of production, circulation and use.

Carry out full-coverage inspections of enterprises selected for centralized drug procurement organized by the state, conduct full-coverage sampling inspections of selected drugs, and continue to monitor adverse drug reactions.

Urge enterprises to continue to comply with regulations and consolidate their main responsibilities for drug quality and safety.

For those who find problems during inspections and inspections, the drug regulatory authorities will impose severe penalties in accordance with the law, and will implement joint punishments with the medical insurance department.

　　Strict quality assurance systems, clinical real-world evaluation results, and widespread use among large patient populations all indicate that

generic drugs selected through centralized procurement are not inferior drugs, but good drugs that more patients can afford

.

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