According to the usual practice, China's "Medical Insurance Catalogue" is adjusted once every five years, focusing on the evaluation of new drugs, drugs added by local adjustments and drugs recommended by evaluation experts. From 65438 to 0999, China established the medical insurance system for urban workers, and the first edition of the medical insurance catalogue was formulated the following year, which was revised in 2004. From June, 5438 to February, 2009, Ministry of Human Resources and Social Security released the 2009 version of the medical insurance catalogue, which included all the therapeutic drugs in the essential drugs catalogue into the A part of the medical insurance catalogue, and added 260 drugs.
Five years have passed from 2009 to today. Therefore, some insiders believe that the 2009 version of the medical insurance catalogue can no longer meet the requirements of expanding medical insurance coverage and increasing medical consumption demand. At the same time, the deepening of medical reform also puts forward inherent requirements for revising the medical insurance catalogue.
As a matter of fact, as early as the first half of 20 14, officials from the Medicine Department of the Consumer Goods Department of the Ministry of Industry and Information Technology revealed at the China Pharmaceutical Industry Development Summit Forum that "the medical insurance catalogue will be revised and expanded this year and next".
Moreover, although the central government only expressed its position and did not really take any action, local governments have long been eager to move in this regard. Even as early as March of 20 13, Xinjiang could not help but include 9 varieties in Class B of medical insurance reimbursement in this region, and in June of 20 14, 13 varieties were added. In 20 14, Beijing also announced that 224 kinds of drugs used to treat common chronic diseases and senile diseases were included in the Beijing community drug medical insurance catalogue, and the proportion of individual reimbursement for community medical treatment was correspondingly increased to 90%. At this point, the scope of drug reimbursement in Beijing community has increased from the original 12 1 1 to 1435. In addition, the relevant departments in Chongqing, Hubei, Tianjin, Hebei and other places are also very enthusiastic about the adjustment of the medical insurance catalogue.
Xu Yucai, deputy director of the Health Bureau of Shanyang County, Shaanxi Province, said that the new medical reform has been going on for five years, during which many things have happened, which is "understandable". It can be called a medical reform drama, and its plot can be summarized in three words: "Tightness (strengthening control)-chaos-release". At present, the price of drugs has been liberalized, and there are different opinions on whether to continue to implement "centralized bidding" for drug procurement. The non-essential drugs in primary medical institutions have been liberalized, and the "second bargaining" that was originally prohibited has also been quietly cancelled. These policy changes are also based on "blood" as a lesson. In this situation, adjusting the medical insurance catalogue is really worthy of attention.
For pharmaceutical companies, under the current reimbursement system in China, medical insurance drugs naturally become the main driving force for their product growth. With the deepening of medical reform and the implementation of universal health insurance, the medical insurance status of products is becoming more and more important, and even becomes a protective trump card to determine the gold content and development potential of products. Especially the new specific drugs, this feeling is even stronger.
That's why any trouble with the medical insurance catalogue can always earn enough attention. Covering more than 2,000 varieties of medical insurance catalogues determines the overall clinical use of pharmaceutical products and whether the product sales are smooth. Under the situation that the retail guide price of essential drugs is in line with the bidding of various provinces, the pricing of the varieties declared in the medical insurance catalogue is directly related to the profit space of enterprises.
Therefore, from the past, we can see that many products that have no chance to enter the national medical insurance catalogue, or products that have not chosen to enter the national medical insurance catalogue because of the need of product price strategy, and products that cannot leave in time because of restrictions when entering the national medical insurance catalogue will "settle for the second best" and aim at local medical insurance catalogues.
Nowadays, the adjustment of medical insurance catalogue will be the highlight news in 20 15 years, which also makes pharmaceutical companies relive the feeling of "both expecting and fearing injury" after five years. How the market structure of medical insurance drugs will change naturally becomes the focus of enterprise speculation.
Combined with the current situation, Xu Yucai's attitude is that the new round of medical insurance catalogue adjustment should generally present the following two characteristics: first, expand capacity and increase varieties and specifications; The second is the integration and connection with the list of essential drugs.
"Considering that the national medical insurance catalogue has been adjusted four times, the 2 196 drugs in the 2009 edition of the medical insurance catalogue have basically met the clinical drug demand to some extent. Therefore, there will be four major trends in the adjustment of the national medical insurance catalogue in the future: First, under the pressure of medical insurance fee control, drugs are more stringent in medical insurance access standards and medical insurance funds are more stringent; Secondly, the number of adjustments may be limited, and more attention will be paid to the adjustment of the rationality of the drug list structure; Thirdly, pay full attention to the comparison between pharmacoeconomics and evidence-based medicine; Finally, pay attention to the clinical evidence supporting basis for the choice of medical insurance drugs in China. " Hua Shaoshao, the government affairs manager of a foreign-funded enterprise.
Guess the catalogue, innovate pharmaceutical companies or benefit.
The adjustment of medical insurance catalogue will rearrange the interests of drug market layout and marketing means. Hua Shao's point of view is that enterprises with innovative drugs, enterprises that attach importance to product health insurance strategic planning and conduct research in advance, and enterprises with strong government resources are expected to benefit from it.
Benefiting from innovative pharmaceutical companies should be the most exciting point among many speculations. Since the establishment of the medical insurance catalogue, how to select new drugs fairly and reasonably into the medical insurance evaluation has always been the focus of attention of industry experts and professionals. Among them, how to establish a fair selection mechanism is the most important thing for drugs with high price but large clinical demand.
Especially in recent years, with the change of disease spectrum, some diseases with low incidence have gradually become more frequent, such as hypertension, cardiovascular and cerebrovascular diseases and breast cancer. The call for more high-priced and effective drugs to enter medical insurance is also rising. Hua Shao also said that more innovative drugs should be included in the medical insurance reimbursement system, especially drugs for serious diseases, so as to reduce the burden on patients and benefit more people.
But the reality is that there are long obstacles for innovative drugs to enter the medical insurance catalogue. One thing that has been criticized for the choice of medical insurance catalogue in China is that it tends to choose low-priced drugs from the system design. This is because medical insurance payment needs to consider both the financial payment ability and the universality of diseases, so the scope of reimbursement is mostly economical and practical domestic drugs. In this context, although imported drugs from foreign pharmaceutical companies and innovative drugs from domestic pharmaceutical companies are more advanced and efficient, they will not become the main choice for medical insurance because of their higher prices.
In the United States and the European Union, the treatment of innovative drugs is completely different from that of China, because new drugs have been tested on animals and humans for as little as five years and as long as 65,438+00 years before they are put on the market. Once the regulatory authorities approve its listing and consider it safe and reliable, it will automatically enter the national medical insurance catalogue.
At the same time, in Germany, Britain, Singapore and other countries, the catalogue is updated by rolling, and other countries such as Spain, Italy and South Korea are also updated at least once a year. The renewal period of China's medical insurance catalogue is 4-5 years. In this process, even the best new drugs have no chance to enter the catalogue. Moreover, the existing policy does not clearly stipulate what kind of drugs can enter the medical insurance catalogue. For example, although it is called "a major breakthrough in the field of people's livelihood", it has encountered many difficulties in bidding and entering medical insurance. This is extremely unfavorable to people's interests, industrial development and enterprise innovation.
Nowadays, inspired by the trend of improving medical insurance level revealed by policies such as medical assistance and serious illness medical insurance, many viewpoints believe that new drugs in recent years, especially those that have entered the local medical insurance catalogue, are more likely to enter the national medical insurance catalogue. This also means that advantageous pharmaceutical companies that have continuously introduced new products in recent years will benefit from it.
However, Xu Yucai believes that the current policy trend can't actually be called clear, so which pharmaceutical companies will ultimately benefit remains to be discussed. If the competent department is open-minded and guided by market determinism, then the price is not a problem, and the original patented drugs will naturally usher in a great opportunity; However, according to Sanming's "medical insurance benchmark price" policy, these drugs are a dead end.
Innovative pharmaceutical companies are expected to benefit, and the benefit of exclusive proprietary Chinese medicines is also regarded as one of the trends of the new round of medical insurance catalogue adjustment. This is also traceable in the previous adjustment of the medical insurance catalogue. For example, in the medical insurance catalogue in 2009, the category of western medicine products expanded from 103 1 to164, with an increase of12.9%; The variety of traditional Chinese medicine products has been expanded from 823 to 987, with an increase of 19.9%.
Under this guidance, the industry is generally optimistic about Chinese patent medicines entering medical insurance. In fact, according to the local medical insurance catalogue, the so-called "exclusive variety with the greatest potential to enter the new medical insurance" has flowed out for several versions. Among them, the predicted number of traditional Chinese medicine far exceeds that of western medicine.
Hua Shao pointed out that the national medical insurance catalogue has always attached great importance to "paying equal attention to both Chinese and western medicines" in previous adjustments, and is constantly increasing the proportion of Chinese patent medicines entering the medical insurance catalogue. The expansion of the catalogue of Chinese patent medicines can play a positive role in promoting the coordinated development of Chinese medicine and traditional Chinese medicine and promoting the development of modern Chinese medicine industry. In the new round of medical insurance catalogue adjustment, we will pay more attention to the adjustment of the rationality of drug use structure, so we should also pay attention to the realistic national conditions of "paying equal attention to Chinese and Western medicine".
In this regard, Xu Yucai said frankly that although "everything is possible", the abuse of traditional Chinese medicine injections has become a major "public hazard" from the current problems in grass-roots drug use, and it is self-evident whether there is "unjust enrichment". If we only look at clinical use, there are two main problems: first, whether the user is qualified to use it, and second, whether it strictly follows the Principles of Clinical Use of Traditional Chinese Medicine Injection. Therefore, in the absence of "evidence-based medicine", it is a blessing or a curse for future generations to open the cage and let a large number of Chinese patent medicines enter medical insurance.
It is essential to enter the directory.
Although pharmaceutical companies have all kinds of beautiful expectations for the medical insurance catalogue, it is definitely not something that enterprises can enter if they want to. At present, the selection mechanism of new drugs in China's medical insurance catalogue is mainly a comprehensive evaluation method based on expert review. It is the classification of drugs by an expert group composed of seven departments, including the Ministry of Labor and Social Security and the State Planning Commission, and it is produced through strict procedures such as the selection of more than 0/000 experts nationwide. To put it bluntly, the drugs are comprehensively scored by experts according to their efficacy, safety, possible costs, expenses, economic burdens or other factors.
In this regard, some voices pointed out that under the expert-led review process, if non-medical insurance drugs want to enter the medical insurance catalogue, they will mainly be affected by factors such as expert resources and whether they enter local medical insurance.
"The medical insurance catalogue review adheres to the principle of expert review, and experts will put forward professional review opinions from the actual clinical and medication aspects." Hua Shao further stressed that entering the local medical insurance catalogue only shows that the product meets the clinical drug demand in a specific region. Of course, a large number of local medical insurance catalogues will have certain advantages in entering the national medical insurance catalogue in the future. Generally speaking, the varieties that have entered the Class B catalogue of medical insurance in provinces and cities above 10 are generally urgently needed in clinic, so it is more likely that such varieties will be transferred. Relevant statistics show that there are nearly 100 kinds of products that have entered the catalogue of provinces above 10, and these products will have the first-Mover advantage in entering the new national medical insurance catalogue in the future.
In fact, since the national medical insurance adjustment was completed in 2009, the provincial medical insurance catalogue has become a battleground for pharmaceutical companies. Compared with essential drugs, provinces have greater authority in adjusting the medical insurance catalogue. Although the provincial medical insurance catalogue will follow the adjustment of the national medical insurance catalogue in terms of adjustment principles and schemes, the key lies in the final drug prices and market use in each province. Moreover, there are some differences in specific processes in different places.
Hua Shao, for example, said that all provinces have the characteristics of local enterprises in the scope of transfer, the focus of transfer, the adjustment of database sources and the formation of alternative databases. For example, in the adjustment of provincial medical insurance catalogue in 2009, Fujian and Hubei focused on selecting and supplementing national new drugs, local drugs and drugs recommended by evaluation experts; Some provinces focus on varieties that are widely used in primary medical institutions with good curative effect and low price, as well as varieties that meet the medical security and clinical medication habits of the province.
Therefore, enterprises with less newly listed drugs or local medical insurance should actively look for opportunities to break through: looking for provincial and municipal reimbursement and supplementary access opportunities; Actively participate in the negotiation and admission of serious illness in various provinces; Pay attention to the PAP model, and take the way of sending medicine to charity like Herceptin and Gleevec. Try to participate in the innovative model and make full use of the opportunity of commercial insurance to participate in various provinces.
In addition, Hua Shao reminded that the importance of products, strategic planning of medical insurance and risk assessment of medical insurance should not be ignored. More importantly, enterprises should first make clear what are the core elements of product medical insurance catalogue selection. In the current supplementary realistic environment, it is the product that determines whether it can enter the medical insurance catalogue, including its clinical necessity, whether it can be replaced compared with similar products in the medical insurance catalogue, whether it has a better price, whether it has a higher cure rate and whether it is an innovative drug. Generally speaking, clinical necessity, safety and effectiveness, reasonable price and convenient use are the basic conditions considered by national government departments when choosing medical insurance catalogue.
Refined to new drug products, Hua Shao believes that government departments should focus on the following contents when selecting new drugs in the medical insurance catalogue: product innovation; Whether it is an urgent clinical need, aiming at extremely serious diseases and there is no effective therapeutic drug in clinic; The pressure of medical insurance fund; Social and public welfare.
In Xu Yucai's view, there are three key factors that determine whether products can be squeezed into medical insurance: First, the quality of drugs. No serious adverse drug reactions, especially hot events concerned by the media, such as raw materials and process fraud, suspected drug kickbacks, etc. ; The second is the price of drugs. The higher the price, the less likely it is to enter the medical insurance catalogue; The third is clinical efficacy. We should try our best to ensure the safety and reliability of clinical efficacy.
Of course, the criticism of the subjective evaluation method of expert scoring has never stopped. In contrast, in countries with more developed research in health economics and pharmacoeconomics, drug selection will largely refer to research evidence based on "cost-benefit" analysis. At present, Europe, the United States, Japan, South Korea, Australia and Canada all adopt this method for pricing and payment, forming a set of health technology assessment system (HTA). Therefore, many experts and scholars believe that the development of this selection technology should be promoted as much as possible.
However, although Xu Yucai and Hua Shao both agree that evidence-based economics of new drug selection is scientific, they both say that China still lacks an independent and authoritative evaluation institution and evaluation index system of pharmacoeconomics, and has not improved the specific health technology evaluation methods, standards and processes of evidence-based medicine and research evidence of pharmacoeconomics. Therefore, there is still a long way to go to keep up with the above countries.
Expert observation
Better give up than adjust.
Judging from the current situation, it is of little significance to adjust the medical insurance catalogue. Like many things we have been trying to do, we just try our best to do it, but forget why we did it in the first place, that is, why we started. So, this time, let's go back and see why we made the medical insurance catalogue in the first place.
This originated from WHO. 1979, who proposed to establish a national list of essential drugs, aiming at protecting people's basic health rights, mainly targeting developing countries. WHO has developed a guidance catalogue, which countries can adjust accordingly. Accordingly, China issued the Catalogue of Medications for Public Labor Insurance in 1980s, 1999 issued the Interim Measures for the Administration of Medication Scope for Urban Workers, and in 2000 issued the National Catalogue of Medications for Basic Medical Insurance, Work Injury Insurance and Maternity Insurance. From this, we can clearly see how the current medical insurance catalogue in China came from.
However, there are many drug catalogues in China, which have caused inconvenience to medical institutions, medical insurance supervision and patients, and also hindered the promotion of online reimbursement of medical insurance nationwide. Moreover, these catalogues have both national and provincial supplementary versions. I can only say that it is a dispute of rights and interests. Here, what I want to say is, since there are several versions of the list of essential drugs, can we not need the medical insurance list anymore?
The answer is "hard to give up". On the one hand, it may be because the bread here contains the interests of too many people; On the other hand, many of our current policies are also mixed medical insurance catalogues. For example, basic medical insurance is managed by "three catalogues" (disease catalogue, diagnosis and treatment catalogue and medication catalogue). At this point, what if there is no medication list? People will be "at a loss"
So, what should I do if I really want to give up the medical insurance catalogue? My suggestion is, don't choose to make the so-called medical insurance catalogue, and all drugs in the essential drugs list will be included in the compliance fee and reimbursed in proportion; The reimbursement of non-essential drugs, as long as it is "rational drug use", will be included in the compliance fee after paying a certain percentage.
Of course, after the implementation of this policy, we still need to pay attention to the following points: First, restrict the use of special drugs for certain special diseases; Second, after the reimbursement of basic medical insurance, the patient's out-of-pocket expenses exceed a certain percentage and directly enter the reimbursement of major illness insurance, and no project expenses may be excluded; Third, cancel the centralized procurement of drugs, and medical institutions can choose what drugs to use and what prices; Fourth, increase the control of average expenses and severely punish medical institutions that fail to control expenses according to the Agreement; Fifth, punish commercial bribery according to law; Sixth, actively explore the reform of "medical insurance payment price", raise the price of medical services, and mobilize the enthusiasm and initiative of medical institutions to control fees.
Further reading: How to buy insurance, which is good, and teach you how to avoid these "pits" of insurance.