The price is down and the effect remains the same! Centralized procurement of generic drugs on the market allows patients to use "reasonable drugs"
In order to alleviate the problems of difficult medical treatment, expensive medication, and heavy burden for patients, the National Medical Insurance Administration has successively carried out four batches of national drug centralized procurement since 2018, involving a total of 157 varieties and 533 selected products.
The average price of selected drugs fell by more than 53%, and generic drugs accounted for most of the drugs included in the national drug collection list.
Since the cost of generic drugs in terms of R&D time and economic investment is lower than that of original drugs, their prices are also lower than original drugs, which greatly reduces the cost of medication for patients and brings benefits to patients.
A large number of generic drugs are included in the centralized procurement of the country. Although the cost of medication has been reduced, many patients have doubts about the therapeutic effects of generic drugs.
On the 9th, the National Medical Insurance Bureau held a press conference to introduce the relevant situation.
In this program, we will focus on issues related to generic drugs in centralized procurement:
First, what is a generic drug?
Second, are the therapeutic effects of generic drugs "the same" as the original drugs?
Third, how to ensure that patients use high-quality generic drugs?
Generic drugs are not "counterfeit drugs" or "fake drugs"
Let's first look at the first question, what is a generic drug?
Many people may not understand generic drugs. Generic drugs are not "counterfeit drugs" or "counterfeit drugs". Generic drugs are alternative drugs that have the same active ingredients, dosage forms, routes of administration, and therapeutic effects as the original drugs.
According to international practice, once the protection of patented drugs expires, other countries and pharmaceutical factories can produce generic drugs. This has also become an important way for countries to control treatment costs and improve the level of drug protection for patients.
Generic drugs and original drugs are clinically equivalent
When the cost has come down, the price of medicine has naturally come down, but patients are also worried: If the price has come down, can the effect of the medicine be guaranteed?
The second question is also a concern of many patients. Are the therapeutic effects of generic drugs "the same" as the original drugs?
Prior to this, the relevant departments of medical insurance and health care jointly organized 20 medical institutions in Beijing to jointly carry out real-world research on the clinical efficacy and safety of the selected products in the centralized procurement of 14 representative generic drugs among the selected drugs.
After two years of tracking more than 110,000 cases, the research team conducted research on the effectiveness indicators and adverse reactions of the drugs.
At the press conference on the 9th, relevant experts introduced the research results.
Zhang Lan, director of the Department of Pharmacy, Xuanwu Hospital, Capital Medical University:
Compared with the original research drugs, the 14 selected generic drugs in the collection we evaluated have no significant differences (statistical differences) in clinical effects and use (statistical differences), such as in the treatment of virality. In the case of hepatitis B patients, there was no statistical difference in the virological response rate between the two groups, and there was no statistical difference in the lipid-lowering drug compliance rate and the percentage of lipid-lowering drugs compared with the original drug.
In terms of adverse reactions, that is, in terms of safety, we evaluated the safety of the 14 selected generic drugs and the original drugs, and there was no significant difference (statistical difference).
But overall, we were able to initially confirm that the 14 generic drugs that passed the consistency evaluation in this study are clinically equivalent to the original drugs.
In the field of drug research and development, there is a professional term called "real world research", that is, in real clinical situations, in a non-experimental environment, collect relevant data on the use of the drug by patients for analysis and research.
In this follow-up study, the 14 collectively-sourced generic drugs are clinically equivalent to the original drugs based on the data of "real world research".
This study focused on five major categories of drugs, including drugs for cardiovascular and cerebrovascular diseases, drugs for neuropsychiatric diseases, drugs for chronic hepatitis B, antitumor drugs, injections, etc.
According to the indications and pharmacological characteristics of each drug, the research team selects targeted clinical efficacy and safety evaluation indicators, and verifies the clinical effects of the drug through multiple dimensions.
Chang Feng, Professor of International Medicine Business School of China Pharmaceutical University:
"Real-world research" is a very important, new and very important evidence for the equivalence between generic drugs and expired patent drugs.
So for us in the future, we can return to international practice and be able to replace original research drugs with a large number of high-quality generic drugs, which can reduce our medical insurance and patient expenditures, and then enable our medical insurance to cover more diseases and expand our coverage. It is of great significance.
The state issued a document to ensure that patients use "relaxed medicine"
We see that generic drugs are not only cheap, but also clinically equivalent to the original research drugs.
Next, there is the third question, how can we ensure that patients use high-quality generic drugs?
In 2016, my country issued relevant documents requiring consistency evaluation of the quality and efficacy of all marketed generic drugs.
Pave the way for high-quality generic drugs to replace the original research drugs, and ensure that the masses can use "reassurance drugs."
On the basis of drug consistency evaluation, generic drugs can enter the state to organize centralized drug procurement.
Jiang Changsong, Associate Researcher of the National Institute of Medical Security, Capital Medical University:
Generic drugs that can pass the consistency evaluation can actually be called high-quality drugs. Medical staff and friends of patients are also welcome to use them.
Over-reviewed generic drugs and original research drugs are actually equivalent, not only bioequivalent, but also clinically equivalent.