A few days ago, the National Health Insurance Administration announced the results of a real-world study on the quality of metformin drugs collected in centralized procurement: the efficacy and safety of the selected drugs in the centralized procurement of metformin at 6 cents a piece are consistent with the efficacy and safety of the original drug in clinical real scenarios. Strict quality assurance systems, clinical real-world evaluation results, and widespread use by large-scale patient populations all show that generic drugs selected in centralized procurement are by no means inferior drugs, but good drugs that more patients can afford.
Over the past 40 years of reform and opening up, the medical and health conditions in the mainland have been continuously improved, and the pharmaceutical industry has developed rapidly, but the price of drugs has always remained high, the order of the pharmaceutical market is chaotic, and there is a problem of information asymmetry in the circulation and use of drugs. In addition, the existence of the phenomenon of secondary bargaining with medicine, medical institutions have a certain profit-seeking nature for drugs to enter the hospital, and patients in a disadvantaged position can often only passively accept some drugs with unreasonable prices, and the burden of medical treatment is heavier. In order to effectively solve the problem of expensive and difficult medical treatment, the state has vigorously promoted pharmaceutical reform with the centralized procurement and use of drugs as a breakthrough, eliminated the accumulated disadvantages such as sales with gold and rebate competition, squeezed out the inflated price of drugs, standardized the market order, and purified the industry ecology.
In January 2019, the General Office of the State Council issued the "Pilot Program for the Centralized Procurement and Use of Drugs Organized by the State". The plan clarifies the overall reform idea of "national organization, alliance procurement, and platform operation", and at the same time clarifies a number of specific measures such as volume procurement, volume for price, integration of bidding and procurement, guarantee of use, ensure quality, and guarantee supply.
From a principle point of view, centralized procurement is based on the basic principle of "integration of recruitment and procurement, linking quantity and price", gathering the demand for drugs in medical institutions, forming procurement targets, giving enterprises certain procurement expectations, and then producing the results of selection through a fair and reasonable market competition mechanism.
In the past, in order to successfully enter the hospital, the sales staff of the enterprise did not hesitate to give rebates or buy doctors to make them prescribe more, and they had to use money to make money. Eventually, the huge sales expenses of enterprises will be reflected in the price of drugs, bringing a heavy burden to patients and medical insurance funds.
Nowadays, centralized procurement has given enterprises clear procurement expectations and market commitments in advance, so that enterprises can calculate costs and formulate production plans, and save the high marketing expenditure required to open up sales channels in the past, and liberate themselves from the disorderly competition of "sales with gold". Studies have shown that the sales expenses of enterprises after centralized procurement have been reduced from the original 60% and 40% to less than 10%, and the sales expenses have dropped significantly, guiding enterprises to change their marketing models and shift from sales to research and development.
Once it is clear that the selected varieties can directly enter the hospital, the focus of competition of enterprises will also shift to improving drug quality and promoting drug innovation and research and development. Therefore, the price reduction effect brought about by centralized procurement will not only not reduce the quality of drugs, but also promote the healthy and sustainable development of the pharmaceutical industry in the mainland, and improve the quality level of drugs while ensuring the accessibility of drugs to the masses.
Guaranteed use and guaranteed payment collection are the two major supporting links of centralized procurement to promote the closed-loop of industrial transformation and upgrading.
Guarantee of use means that the hospital should unblock the policy channel of priority allocation and use to ensure the implementation of centralized procurement results. At the same time, the health administrative departments and medical units are required not to affect the rational use and supply guarantee of the selected drugs on the grounds of cost control, drug proportion, requirements for the specifications and quantity of drug varieties in medical institutions and the approval of the Pharmaceutical Affairs Committee. Only by ensuring the use of the selected products and completing the agreed purchase volume can we be regarded as taking the "last mile" of purchasing drugs with volume, so that high-quality and low-cost drugs can really be used by patients.
Guarantee payment refers to the provincial health administrative departments to urge medical institutions to collect money in a timely manner, and shall not be in arrears. In the past, there were many bad behaviors such as arrears and pressure of medical institutions, and the financial pressure of enterprises was high, and small and medium-sized enterprises often faced survival difficulties. The "Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of Centralized Drug Procurement" clarifies the establishment of a prepayment mechanism for centralized drug procurement, and the medical insurance fund will be prepaid to medical institutions according to no less than 30% of the annual agreed procurement amount, and the medical insurance fund will be promoted to directly settle the payment for pharmaceutical goods. In this way, on the one hand, it can improve the efficiency of the use of medical insurance funds, guide the market to form long-term stable expectations, and promote the standardized development of centralized procurement; on the other hand, it can shorten the settlement cycle of pharmaceutical payments and accelerate the return of enterprise funds, so as to ensure the stable production and supply of selected drugs, promote enterprise innovation and research and development, and promote the high-quality innovative development of the industry.
Ensuring the quality of the selected drugs is a consistent policy requirement of the reform of centralized drug procurement. In order to achieve this goal and reduce the public's concerns about the quality of the selected drugs, the relevant government departments have made a series of efforts to ensure the "high quality and reasonable price" of generic drugs in centralized procurement. First of all, the state has set a quality threshold for centralized drug procurement, requiring generic drugs participating in centralized procurement to pass the consistency evaluation of quality and efficacy, so as to avoid the phenomenon of "bad money driving out good money" in the competition. In addition, the medical insurance department and the drug regulatory department encourage enterprises to improve the quality of the selected generic drugs on the basis of ensuring supply through various means, and enhance the determination and confidence of the pharmaceutical industry for consistency evaluation.
It is worth emphasizing that the consistency evaluation is not a one-time evaluation, and passing the consistency evaluation is not a "talisman" or "pass" for drug quality. After the drug passes the consistency evaluation, the drug regulatory department will conduct full-chain quality supervision on the production, circulation and use of the drug with stricter standards to ensure the stable and reliable quality of the drug. For the selected drugs in centralized procurement, the drug regulatory department will carry out the "three full coverage" of enterprise supervision and inspection, product sampling, and adverse drug reaction monitoring in accordance with the "four strictest" requirements - the most rigorous standards, the most stringent supervision, the most severe punishment, and the most serious accountability. For the behavior of enterprises that endanger public health by producing low-quality or even inferior drugs after being selected at a low price, the medical insurance department will work with the drug regulatory department to deal with it, adhere to the attitude of "zero tolerance", resolutely crack down on it mercilessly, and punish it by canceling the qualification for the selection, being included in the "violation list", and restricting the enterprises involved from participating in the centralized procurement organized by the state for a certain period of time.
Regarding the quality evaluation of generic drugs and original drugs selected in centralized procurement, the National Health Insurance Administration organized the first batch of real-world studies on the efficacy and safety evaluation of selected drugs in centralized procurement as early as 2019, and evaluated 14 drugs for the treatment of chronic diseases and major specialized diseases.
Since 2021, the National Health Insurance Administration has commissioned a number of hospitals to carry out a new round of larger-scale and wider-scale real-world data research. In order to ensure the scientificity and rigor of the research, the research team collected 140,000 cases within two years and evaluated 23 generic drugs from 38 brands selected in the second and third batches of centralized procurement. The data of large samples of clinical cases include diagnosis, prescription, examination and test results, and the health status of patients in the generic drug group and the original drug group was observed before and after the implementation of the results of centralized procurement and one year after the implementation of the results of centralized procurement and beyond. This design can not only compare the difference between the generic drug group and the original drug group, but also compare the changes of the generic drug group before and after centralized procurement.
In order to ensure that the data is more convincing, the research project selects multi-dimensional clinical efficacy and safety evaluation indicators according to the indications and pharmacological characteristics of each drug to reflect the real situation of the drug. Taking six anti-tumor drugs of public concern as an example, the efficacy was evaluated by indicators such as disease-free survival, 5-year disease-free survival rate, recurrence rate and metastasis rate, treatment remission rate, tumor marker level, etc., and the incidence rate of adverse drug reactions was used to evaluate safety.
This research report from real-world data shows that the clinical efficacy and safety of 23 generic drugs in the fields of anti-infection and anti-tumor are "equivalent" and "equivalent in quality" to the original drugs, and the safety or treatment remission rate of individual generic drugs is "higher" than that of the original drugs, and the "generic products" are not inferior to or even exceed the "genuine drugs".
The regulatory report of the drug regulatory department also supports the conclusion that the quality of the selected drugs in centralized procurement is safe and reliable. The first eight batches of centralized procurement by the state involved a total of 1,387 selected products, and under the full coverage supervision and inspection, the annual pass rate of centralized procurement of drugs reached 99.8%, which was higher than the national average level of chemical drugs.
The market-oriented mechanism not only brings high-quality and affordable benefits to people's livelihood, but also prompts enterprises to devote more energy to innovation and R&D and quality improvement. Driven by the centralized procurement system, since 2018, the cumulative number of drugs that have passed the consistency evaluation of generic drug quality and efficacy in mainland China has risen rapidly from less than 200 at that time to more than 8,000 at present, and high-quality drugs are gradually occupying the mainstream of clinical drugs. （ZGYB-2024.03）
Original title: Price reduction does not reduce quality! Centralized procurement allows more patients to use high-quality and good medicines
Author | Lu Yun, Pharmaceutical Price Research Center, China Pharmaceutical University
Source | China Medical Insurance
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