Important research results are released!
Fourteen generic drugs selected in centralized procurement have the same clinical efficacy as the original drugs
On June 9, a press conference held by the National Medical Insurance Administration released the clinical efficacy and safety research results of generic drugs selected in centralized procurement.
Zhang Lan, head of the research team and director of the Department of Pharmacy of Xuanwu Hospital of Capital Medical University, said that the results of the study showed that the 14 generic drugs selected in the centralized procurement that were evaluated are equivalent in clinical effects and use.
There was no statistical difference in adverse reactions between generic drugs and original drugs.
Choose from five categories and 14 kinds of generic drugs from centralized procurement
Beginning in 2018, the National Medical Insurance Administration and relevant departments have successively carried out four batches of nationally organized centralized drug procurement, involving a total of 157 varieties, and the average drop of selected drugs was 53%.
The generic drugs selected in centralized procurement are all products that have passed the consistency evaluation of quality and efficacy. It is generally believed that generic drugs and original research drugs through the consistency evaluation are clinically equivalent.
However, in my country, due to the short start of the consistency evaluation of generic drugs, are the generic drugs and the original drugs that passed the consistency evaluation really clinically equivalent?
Many medical staff and patients have doubts.
In order to further verify the efficacy and safety of generic drugs selected in centralized procurement, 20 medical institutions in Beijing including Xuanwu Hospital jointly carried out the clinical efficacy of generic drugs selected in centralized procurement for 14 representative varieties in the "4+7" pilot. And safety research.
At the press conference, Zhang Lan said that the generic drugs selected for this study included treatment drugs for cardiovascular and cerebrovascular diseases, drugs for neuropsychiatric diseases, drugs for chronic hepatitis B, antitumor drugs, and injections.
Based on the advantages and characteristics of each medical institution's diagnosis and treatment, the research team determined the lead responsible unit for each category evaluation.
Xuanwu Hospital is responsible for the anti-epileptic drug Levetiracetam, Peking University First Hospital is responsible for the antihypertensive drug Amlodipine, Peking University People’s Hospital and Fuwai Hospital are responsible for the lipid-lowering drugs Atorvastatin and Rosuvastatin, Beijing An Zhen Hospital is responsible for the antiplatelet drug clopidogrel, PLA General Hospital Fifth Medical Center and Ditan Hospital are responsible for the chronic hepatitis B treatment drugs Entecavir and tenofovir dipivoxil, and Anding Hospital is responsible for the depression treatment drugs escitalopram and paroxetine. Huilongguan Hospital is responsible for the schizophrenia treatment drugs olanzapine and risperidone, Beijing Obstetrics and Gynecology Hospital is responsible for the injection of dexmedetomidine, the Cancer Hospital of the Medical Academy is responsible for the antitumor drug Pemetrexed, Peking University Cancer Hospital and Peking University People’s Hospital respectively Responsible for two different indications of the anti-tumor drug imatinib (gastric stromal tumor and chronic myeloid leukemia).
Collected over 110,000 clinical diagnosis and treatment data
The reporter learned from the press conference that the research team collected clinical diagnosis and treatment data from more than 20 medical institutions in Beijing, with a total of more than 110,000 cases, covering large-scale tertiary hospitals, specialty hospitals and community medical institutions. The content of the data includes patient diagnosis information and prescription information. , Check the inspection results, etc.
The sample size of each selected species is relatively large, such as 35,450 cases of chronic hepatitis B treatment drug entecavir, 13,613 cases of tenofovir dipivoxil, and 38510 cases of lipid-lowering drug atorvastatin.
The sample size of antineoplastic drugs with a small number of patients reached hundreds, such as 182 cases of pemetrexed.
According to reports, in selecting clinical indicators, the research team selected targeted clinical efficacy and safety evaluation indicators based on the indications and pharmacological characteristics of each drug. The indicators were multi-dimensional and comprehensive.
For example, when evaluating chronic hepatitis B treatment drugs entecavir and tenofovir dipivoxil, important indicators such as virological response rate, hepatitis B virus E antigen conversion rate and alanine aminotransferase return rate are used.
At the same time, indicators such as thrombocytopenia and increased blood creatinine were selected as adverse reaction indicators.
For example, when evaluating lipid-lowering drugs atorvastatin and rosuvastatin, the effective indicators are the blood lipid compliance rate and the percentage of blood lipid reduction, and the adverse reaction indicators are liver damage, increased creatine kinase and other indicators.
It is worth mentioning that the research team also adopted parallel comparisons between generic drugs and original research drugs, as well as before and after the implementation of the centralized procurement policy.
This approach not only evaluates the efficacy and safety of generic drugs compared with the original research drugs, but also evaluates whether the quality of selected products will be affected after the sharp price cuts in centralized procurement. At the same time, it also indirectly evaluates the effect of policy implementation.
Equivalent in clinical effect and use
At the press conference, Zhang Lan announced the results of the study: 14 generic drugs selected in the centralized procurement for evaluation are equivalent to the original drugs in clinical effects and use.
Such as entecavir and tenofovir dipivoxil in the treatment of viral hepatitis B, there is no statistical difference in the virological response rate.
The lipid-lowering drugs, atorvastatin and rosuvastatin, had no statistically significant differences in the blood lipid compliance rate and the percentage of blood lipid lowering compared with the original drug.
Compared with the original drug, the anti-tumor drug Pemetrexed generic drug had no statistical difference in objective remission rate, and the imatinib generic drug had no statistical difference in recurrence-free survival and progression-free survival indicators compared with the original drug.
There is no statistical difference in adverse reactions between the above generic drugs and the original drugs.
It is preliminarily confirmed that the 14 generic drugs that passed the consistency evaluation in this study are clinically equivalent to the original drugs.
After the meeting, Zhang Lan told the Chengdu Commercial Daily-Red Star News that the 14 selected drugs selected for this study are drugs that are widely used clinically.
The reason for choosing Beijing medical institutions to participate in the research is that the drugs selected in centralized procurement and the medical insurance policy itself have certain regional characteristics. The centralized procurement drugs used by Beijing medical institutions are consistent with the medical insurance policies implemented, ensuring the rigor of the research Sex and consistency.
This study has initially established an evaluation model for the clinical efficacy and safety of centralized procurement drugs, which can be extended to other regions in the future.
Chengdu Commercial Daily-Red Star News reporter Yan Yucheng