From the medical insurance drug survival of the fittest to see the pharmaceutical industry metabolism.

Text . . . Fan Jiaxuan, Wu Yu
May 12, the State Administration of Health Insurance drafted the "Basic Medical Insurance Drug Administration Interim Measures (draft for comments) (the following body referred to as the "Measures") to the public to seek comments to the end. It is understood that the Measures were drafted in order to implement the "Social Insurance Law of the People's Republic of China" and "The Opinions of the State Council of the CPC Central Committee on Deepening the Reform of the Medical Security System" (Zhongfa (2020) No. 5) and other documents. The Measures put forward comprehensive and specific reform directions and implementation measures for medical insurance drug use in the aspects of the formulation and adjustment of the drug catalogue, the use of the drug catalogue, the payment of medical insurance drugs, and the management and supervision of medical insurance drugs.
the drafting of the Measures also means that the "basic medical insurance drug catalogue" (the following body is referred to as the "drug catalog") dynamic adjustment system, marking China's medical insurance drug survival of the survival of the survival of the long-term mechanism has been formed. In fact, every health care catalog adjustment will provide the industry and pharmaceutical companies, especially innovative pharmaceutical companies, with good development opportunities. With the opportunity of dynamic adjustment of health insurance, pharmaceutical companies can quickly expand the market and obtain research and development dividends, which will also play a positive role in promoting the metabolism of the entire pharmaceutical industry.. Pharmaceutical observers: "Measures clearly play a tonic role of drugs, including the country's precious and endangered wildlife medicine drugs, health drugs, Class B OTC drugs and other ten categories of drugs are not included in the "Drug List", what is the intention?
Valley Pioneer: Recently, the above-mentioned "Clear Ten" in the industry widely spread, some companies with such products also have a shock, especially those with such varieties mainly hit the product smaller impact. The starting point of the state's introduction of this policy includes:
first, fully reflect the medical insurance drug "basic" positioning, both to do their best, but also to do their best. Among them, the main tonic role of drugs, its role significantly exceeds the "basic protection."
second, protect precious and endangered wildlife. The policy could reduce the use of such drugs by not including them, or force companies to apply to regulators to replace them with similarly-administered drugs, such as buffalo horns, instead of antelope horns.
third, to have such drugs approved or is developing such products to play a guiding role, so that enterprises understand that the market positioning of such products, in the future can not be "treatment" as the goal of the "grade hospital" channels, it is not possible to enjoy the "health insurance" dividend.
Wang Zhenlin: The main intentions are: First, the need for rational drug use and standard ization of drug use;
Drug Watchers: Among the above-mentioned 10 drugs, Class B OTC drugs have received wideattention. Due to the development of the primary healthcare market and the changing bidding policies, many pharmaceutical companies will actively switch prescription drug products to over-the-counter drugs, which has also led to the expansion of the OTC market in recent years. How do you think this move will affect pharmaceutical companies and the retail industry? Will it develop into all OTCs not included in the future?
Valley Pioneer: the rise of pharmaceutical e-commerce and grass-roots markets, as well as the state's strict control of prescription drugs, leading pharmaceutical companies to product "de-prescription" trend, once the product has "OTC" label, it reduces a lot of sales constraints. But the introduction of this policy is clearly a blow to Class B OTC drugs. After all, the current drug sales are mainly driven by prescriptions, as well as advertising, manufacturers and so on. Once such drugs do not make the health-care catalog, they will lose the public hospital market, which accounts for nearly 70% of drug sales, which will not only reduce the viability of businesses, but also make sales of other channels more difficult due to the lack of prescriptions. It also has a big impact on retailers. After all, pharmacies are the main battleground for OTC products, and if Class B OTC health insurance is no longer reimbursed, it will have a big impact on the sales volume of retail businesses.
as to whether all OTCs will be removed from the topic of health insurance catalog in the future, the recent industry discussion is fierce, but also a lot of corporate concerns. Personally, however, I don't think it's a big deal to worry, because to analyze this problem, you must first understand the purpose of setting up the OTC logo. OTC, or over-the-counter drug, refers to the drug that patients can purchase and use at their own because they have been used for many years in clinical practice, are safe and effective, have few toxic side effects and do not require guidance from clinicians or professional pharmacists. The criteria for the national selection of health insurance catalogues are mainly based on "therapeutic" as the standard. From the definition of OTC products, only limited to the sale of drugstores or hospitals, because of many years of clinical use, verified its safety and effectiveness, coupled with "in a hospital or pharmacy with professional pharmacists can be sold" provisions, drug safety is also guaranteed. The logo "OTC" is entirely to enhance the convenience of the general public to buy, so the state should not not not put Class A OTC products into the health insurance catalog. In addition, at present, a number of domestic pharmaceutical giants in the existing key products, Class A OTC varieties are also many, the influence of these pharmaceutical giants, and decision-making experts, the strength of communication, will be an important basis for this conclusion. Wang Zhenlin,
: Class B OTC drugs moved out of the Drug Catalog, for some or individual pharmaceutical enterprises, especially for Class B OTC drugs more dependent enterprises will have a certain impact, but for the pharmaceutical retail industry will not have any impact. Because otC drug market number is very small, more than 1100 chemical drugs, more than 4700 Chinese traditional medicine, compared with China's more than 160,000 text numbers, not worth mentioning, and Class B OTC is even less. So it won't have much impact on the retail industry.
as to whether the future will develop into all OTC are not included in the "drug catalog", personally think it is not possible, although OTC accounted for a small number, but involving diseases, dosage forms, drug use is very wide, and the use of safety is better than prescription drugs, so the relevant departments will not be "one-size-fits-all".. Medical Observer: The Measures clarify the mechanism and method of expert selection, and implement the mechanismof expert responsibility system, conflict of interest management and accountability. The economics of drugs and the economic assessment of drugs are mentioned several times in the chapters on the conditions for the transfer of the Drug Catalog and the "Basic Conditions for Inclusion in the List". May I ask, what is the significance of the two-pronged approach of expert review and drug economics? Wang Zhenlin,
: Expert review and drug economics, the two-pronged approach, mainly to reflect the formation of a fair and just institutional mechanism, to put an end to the occurrence of human-induced unfair phenomenon, is of great significance, the clinical value of drugs, patient sbenefits, innovation value, enterprise cost effect and health insurance fund control have positive significance. Drug economics is an international practice of drug price control, a general means to control drug costs, and embodies the formation of value-oriented prices. In our country, the first thing is to change the idea of drug price management, and secondly, we should establish the evaluation mechanism of drug economics.
Valley Pioneer: In fact, the selection mechanism and evaluation system of the health insurance directory, has often been hotly debated by the industry before, including the voice of doubt. This two-pronged approach, no doubt from the institutional level to increase the fairness, regulate the responsibility mechanism. Specifically, there are several aspects of significance: First, it is determined that the subject of responsibility is an expert, at the same time the experts have been bound, clear the "right and the right to equal" basic principle. To some extent, the accountability system avoids power rent-seeking, but also a kind of protection for experts at the institutional level. Secondly, it is clear that the evaluation criterion of the medical insurance catalogue of drugs in and out of the drug economy should not only consider safety and effectiveness, but also evaluate its economy. Finally, it contributes to the efficiency of the use of health insurance funds. The same disease, the drug selected by the drug economics indicators into the health insurance catalog use, will greatly improve the efficiency of the use of health insurance funds, effectively reduce the "fund bottom" risk.
Medical Observer: The Measures make it clear that the state administration of medical security shall establish a perfect dynamic adjustment mechanism, which in principle is adjusted once a year. For a long time, China's "drug catalog" adjustment can not enter, there is no formation of the survival of the fittest benign mechanism. Now, the establishment of perfect dynamic adjustment mechanism does it mean that China's medical insurance drugs survival of the survival of the long-term mechanism will be established?
Valley Pioneer: Once the Measures form an official document, the selection system of China's medical insurance drugs will have a landmark impact. It completely subverted the previous selection system, selection criteria, responsibility subject, through the "direct transfer, direct transfer, recommended transfer, adjustment scope" four kinds of access to the provisions, so that the medical insurance catalog to achieve dynamic adjustment, for the survival of medical insurance drugs to provide institutional protection, but also for China's innovative drugs into the medical insurance catalog reserved space, conducive to the development of the entire pharmaceutical industry. Wang Zhenlin,
: "Measures" will be dynamic adjustment of the long-term mechanism into the document, marking in the policy level and theory, China's medical insurance drugs survival of the survival of the long-term mechanism has been formed. The key, however, depends on future implementation and landing.
Medical Observer: The Measures propose the establishment of an enterprise declaration system. In the 2019 national health insurance drug catalog adjustment work, is not accepted enterprise declaration or recommendation, do not charge evaluation fees and other fees. Excuse me, what is the intention of establishing the enterprise declaration system now? What is the impact?
Wang Zhenlin: The intention of establishing the enterprise declaration system is to better mobilize the enthusiasm of enterprises to participate in the declaration. By enterprise declaration, first, is conducive to enterprises new drugs faster into the medical insurance vision, enhance the enthusiasm of new drug research and development, change the past many years after the development of new drugs can not enter the hospital, benefit patients of the embarrassing situation;
Valley Pioneer: Before, if pharmaceutical companies want their products into the national health insurance catalog, basically can be described as "no door to report", so can only think of some other methods, this is the industry's open secret, some enterprises have paid a certain price for this, or even be deceived. The enterprise declaration system proposed by the Measures is a revision of the previous "double no" policy, giving the pharmaceutical companies a clear application channel, reflecting the most basic fairness. For enterprises, in the future, regardless of size, regardless of geography, regardless of whether there is a "relationship", as long as they believe that their products have the strength to enter the national health insurance, they can be declared through their own platform, fair participation in competition, which is obviously a system of progress.. Pharmaceutical Observers: The Measures propose to gradually establish the drug catalogue and the drug-equipped linkage mechanism of the designated medical institutions, and the fixed-point medical institutions shall adjust and optimize the drug catalogue of this medical institution in a timely manner according to the results of the adjustment of the Drug Catalog. And the "Drug Catalog" will be adjusted once a year, the designated medical institutions are required to prioritize the provision and use of drugs in the Drug Catalog, what do you think this will affect the doctor's medication habits and the use of drugs of patients with chronic diseases?
Valley Pioneer: This annual adjustment frequency, because of the standard, clear adjustment standards, so the doctor's medical habits and patients with chronic diseases have limited effects on the use of drugs. The first is that the adjustment will not be too large. Because there is a process of upgrading therapeutic drugs, especially doctors in some professional areas, one or two new varieties may appear once a year, it is not difficult to adapt to the use of new therapeutic drugs. Second, the transfer of new varieties does not mean that the original product transfer, sometimes may be due to lack of clinical application, will be used as a second-line drug, or because of the higher price, patients bear more costs, large-area use may have a process. Third, for patients, the annual adjustment frequency is a little higher than before, but the adjustment of drugs for patients with chronic diseases are mostly in accordance with medical advice, once fixed down, the impact is not great. In fact, even if the health care catalog is not adjusted, doctors will be based on the development of disease in patients with chronic diseases, timely deployment of drugs, such as for patients with diabetes and hypertension, the allocation of drugs and adjusted doses are very common.
Wang Zhenlin: For doctors, although there are drug habits, but, doctors are senior intellectuals, adaptability and the ability to keep pace with the times should be very strong, even in the drug transfer and transfer out of the initial may be a little uncomfortable, but will soon adapt. Therefore, I personally don't think it will have much effect on the doctor's medication habits.
may have an effect on medication for patients with chronic diseases. Because, chronically ill patients are long-term use of drugs suitable for their own physique, if the long-term use of drugs were transferred out of the "drug catalog", for a while there is no suitable for their own physique of the same kind of drugs, then had to use the original customary drug. But I believe there is less likely to happen, because for patients with chronic diseases, there can be no single drug for use by disease, there will be multiple alternatives.
Pharmaceutical Observers: The Measures point out that Western and traditional Chinese medicines in the Drug Catalog are classified as "Class A" and "Class B drugs", Class A is clinically necessary and low in price, Class B is clinically optional and slightly higher, and according to different payment standards. Do you think this classification payment method is reasonable? What is the impact?
Valley Pioneer: The medical insurance catalog adopts the classification of A and B, not only to the product attributes, but also to give the payment ratio classification, is a practical initiative, but also the health insurance catalog has been implemented for so many years to adopt the system. Class A products not only reflect the "treatment necessary, widely used, the efficacy is accurate, low price" characteristics, but also to the vast number of users of the first impression is "old medicine", "old friends", with a good hand, the efficacy and side effects are very clear, the dose is also accurate. B products give an innovative drug a stage, is the driving force of the development of the pharmaceutical industry, but also the performance of product replacement. New products tend to represent a clearer target, lower toxic side effects, safer use, faster efficiency and, of course, more expensive. The implementation of the classification system of A and B not only provides different levels of drug demand for the national drug users, but also fully reflects the market-oriented classification system, all over the country can according to the level of payment of medical insurance funds and individual affordability, in the actual use of medium-scale efforts. Therefore, it is reasonable to pay for the classification of A and B for medical insurance drugs.
Wang Zhenlin: The classification of the list price is very reasonable. This allows the doctor to propose a medication plan in advance and obtain the consent of the patient or family member, as conditions permit. This can not only treat patients well, but also harmonious doctor-patient relationship, so as to put an end to the patient's suspected drug use caused by unnecessary doctor-patient disputes.. Medical observation.