Adjustment and expansion of the catalog is a certainty
According to common practice, my country's "Medical Insurance Catalog" will be adjusted about once every five years, focusing on new drugs, drugs added by local adjustment and drugs recommended by review experts. Review. In 1999, my country established a medical insurance system for urban employees. The first version of the medical insurance catalog was formulated the following year and revised in 2004. In December 2009, the Ministry of Human Resources and Social Security released the 2009 version of the medical insurance catalog, which included All therapeutic drugs in the essential drug catalog have been included in the Class A part of the medical insurance catalog, and 260 new drugs have been added.
Five years have passed from 2009 to today. Therefore, some people in the industry believe that the 2009 version of the medical insurance catalog is no longer able to meet the requirements of increased medical insurance coverage and increased medical consumption demand. At the same time, the continuous deepening of medical reform has also put forward inherent requirements for revising the medical insurance catalog.
In fact, as early as the first half of 2014, officials from the Pharmaceutical Division of the Department of Consumer Goods of the Ministry of Industry and Information Technology revealed at the China Pharmaceutical Industry Development Summit Forum that "the revision of the medical insurance catalog will start this year and next, and the catalog will be expanded."
Moreover, although the central government has only expressed its stance and has not yet taken any real action, the local governments are already ready to take action in this regard. Even as early as March 2013, Xinjiang couldn't help but include 9 varieties in the region's Category B list of medical insurance reimbursements, and added 13 more varieties in January 2014. Beijing also announced in 2014 that 224 kinds of drugs used to treat common chronic and geriatric diseases will be included in the Beijing community drug and medical insurance catalog, and the corresponding proportion of personal medical reimbursement in the community will be increased to 90. At this point, the scope of community drug reimbursement in Beijing has been increased from the original 1211 The number of species increased to 1435. In addition, relevant departments in Chongqing, Hubei, Tianjin, Hebei and other places are also extremely "enthusiastic" about the adjustment of the medical insurance catalog.
As for the local eagerness and the high expectations of pharmaceutical companies, Xu Yucai, deputy director of the Health Bureau of Shanyang County, Shaanxi Province, said it is "understandable": In the five years since the implementation of the new medical reform, there has been a lot of excitement around "drugs". , many things happened, it can be called a drama of medical reform, and its plot can be summarized in three words: "tighten (strengthen control)-chaos-release". At present, drug prices have been liberalized, and there are different opinions on whether to continue to implement "centralized bidding" for drug procurement. However, non-essential drugs in primary medical institutions have been liberalized, and "secondary price negotiation" that was once strictly prohibited has been quietly abolished. And these policy changes were also obtained with "blood" as lessons. Under this situation, adjustments to the medical insurance catalog have indeed attracted much attention.
For pharmaceutical companies, under my country's current reimbursement system, medical insurance drugs have naturally become the main driving force for their product growth. With the continuous deepening of medical reform and the implementation of universal medical insurance, the medical insurance status of products is becoming more and more important, and has even become a protective trump card that determines the gold content and development potential of products. Especially for new specialty drugs, this feeling is even stronger.
This is why any news about the medical insurance catalog always attracts attention. The medical insurance catalog, which covers more than 2,000 varieties, determines the overall clinical use of pharmaceutical companies' products and determines whether the product sales are smooth. In a situation where the retail guide price of essential drugs and the bidding of various provinces are under pressure, the pricing of the varieties declared in the medical insurance catalog is directly related to the profit margin of the enterprise.
Therefore, it can be seen from the past that many people have no chance to enter the national medical insurance directory, or do not choose to enter the national medical insurance directory due to product price strategies, and there are many restrictions when entering the national medical insurance directory. Products that cannot be eliminated in time will "fall back to the next best thing" and set their sights on the local medical insurance catalogue.
Now, the news that the adjustment of the medical insurance catalog will become a major event in 2015 has also allowed pharmaceutical companies to relive the feeling of "both looking forward to but afraid of being hurt" after a lapse of five years. How the market structure of medical insurance drugs will change has naturally become the focus of corporate speculation.
Based on the current dynamics, Xu Yucai’s attitude is that the new round of adjustments to the medical insurance catalog should generally present the following two characteristics - first, expansion, increasing varieties and specifications; second, integration, Connected with essential medicine catalog.
“Considering that the National Medical Insurance Catalog has undergone four adjustments, the 2196 drugs in the 2009 version of the Medical Insurance Catalog have basically met clinical drug needs to a certain extent. Therefore, future adjustments to the National Medical Insurance Catalog will , there will be four major trends: First, under the pressure of medical insurance cost control, the medical insurance access standards for drugs will be more stringent, and the medical insurance fund restrictions will be more stringent; secondly, the number of adjustments may be limited, and more emphasis will be placed on the rational structure of catalog drugs. Secondly, pay full attention to the comparison of pharmacoeconomics, evidence-based medicine and other data; finally, pay attention to the clinical evidence supporting basis for the selection of my country’s medical insurance drugs,” said Hua Shao, the government affairs manager of a foreign-funded enterprise.
Innovative pharmaceutical companies may benefit from guessing the catalog
The adjustment of the medical insurance catalog will rearrange the interests of the drug market layout and marketing methods. Hua Shao’s view is that companies with innovative drugs, companies that focus on product medical insurance strategic planning and have conducted research in advance, and companies with strong government affairs resources will all hope to benefit from it.
Benefiting innovative pharmaceutical companies should be the most exciting point among the many speculations. Since the establishment of the medical insurance catalog, how to fairly and reasonably select new drugs for medical insurance review has been the focus of most concern among industry experts and industry insiders. Among them, how to establish a fair selection mechanism for drugs that are expensive but in clinical demand is a top priority.
Especially in recent years, with the changes in the disease spectrum, some diseases with low incidence have gradually become more frequent, such as hypertension, cardiovascular and cerebrovascular diseases, and breast cancer, making more high-priced There are also growing calls for drugs with good efficacy to be included in medical insurance. Hua Shao also said that more innovative drugs, especially drugs for serious diseases, should be included in the medical insurance reimbursement system to reduce the burden on patients and benefit more people.
But the reality is that there is a long road ahead for innovative drugs to enter the medical insurance catalog. One point that has been criticized in the selection of my country's medical insurance catalog is that the system design tends to select low-priced drugs. This is because medical insurance payment needs to consider both financial affordability and disease prevalence, so the reimbursement scope is mostly economical and practical domestic drugs. In this context, although imported drugs from foreign-funded pharmaceutical companies and innovative drugs from domestic pharmaceutical companies are more advanced and efficient, they will not become the main choice for medical insurance due to their higher prices.
In the United States and the European Union, the treatment of innovative drugs is very different from that in China, because new drugs have gone through animal and human testing for at least 5 years and as many as 10 years before being put on the market. Once the regulatory authorities approve its listing, it is considered safe and reliable and will automatically enter the country's medical insurance directory.
At the same time, countries such as Germany, the United Kingdom, and Singapore update their catalogs on a rolling basis, and other countries such as Spain, Italy, and South Korea also update their catalogs at least once a year. However, the update cycle of my country's medical insurance catalog is 4-5 years. During this process, no matter how good a new drug is, there is no chance of entering the catalog. Moreover, the existing policy does not clarify what kind of drugs can be included in the medical insurance catalog. Take icotinib hydrochloride (Kemena), which was launched in 2011 as an example. Although it is called "a major breakthrough in the field of people's livelihood comparable to two bombs and one satellite," it has encountered many difficulties whether it is bidding or entering medical insurance. difficulty. This is extremely detrimental to the benefit of the people, the development of industries, and the innovation of enterprises.
Now, encouraged by policies such as medical assistance and critical illness insurance that reveal the trend of improving the level of medical insurance, many people believe that new drugs in recent years, especially those that have entered the local medical insurance catalog, have entered the national The medical insurance catalog is more likely. This also means that advantageous pharmaceutical companies that have continuously launched new products in recent years will benefit from this.
However, Xu Yucai believes that the current policy direction cannot actually be called clear, so which pharmaceutical companies will ultimately benefit remains to be discussed.
If the competent authorities are open-minded and guided by market determinism, then price will not be an issue, and original patented drugs will naturally have great opportunities; but if Sanming's "medical insurance benchmark price" policy is followed, these drugs will be a dead end.
In addition to the expected benefits for innovative pharmaceutical companies, benefiting from exclusive Chinese patent medicines is also seen as one of the trends in the new round of adjustments to the medical insurance catalog. This is also traceable in previous adjustments to the medical insurance catalog. For example, in the 2009 version of the medical insurance catalog, the categories of Western medicine products were expanded from 1031 to 1164, with the number increasing by 12.9 points; the types of traditional Chinese medicine products were expanded from 823 to 987, with the number increasing by 19.9 points.
Under this guidance, the industry is generally optimistic about the inclusion of Chinese patent medicines in medical insurance. In fact, several versions of the so-called "exclusive varieties with the greatest potential to enter the new medical insurance" sorted out based on the additions to the local medical insurance catalog have been released. Among them, the number of traditional Chinese medicines that are predicted to be good far exceeds that of Western medicines.
Hua Shao pointed out that the national medical insurance catalog has always paid great attention to "equal emphasis on Chinese and Western medicines" in previous adjustments, and has also continued to increase the proportion of Chinese patent medicines entering the medical insurance catalog. The expansion of the list of Chinese patent medicines can play a positive role in promoting the coordinated development of traditional Chinese medicine and traditional Chinese medicine and promoting the development of the modern traditional Chinese medicine industry. In the new round of adjustment of the medical insurance catalog, more emphasis will be placed on the rational adjustment of the medication structure. Therefore, attention should also be paid to the realistic national conditions of "paying equal attention to both Chinese and Western medicines."
In this regard, Xu Yucai said frankly that although "everything is possible", judging from the current problems with drug use at the grassroots level, the abuse of traditional Chinese medicine injections has become a major "public hazard". Is there any "unjust enrichment" among them? ” is self-explanatory. If we only look at the clinical use, there are two main problems: first, whether the user is qualified to use it, and second, whether the "Clinical Use Principles of Traditional Chinese Medicine Injections" are strictly followed. Therefore, in the absence of "evidence-based medical basis", opening the cage and allowing a large number of Chinese patent medicines to enter medical insurance can only be left to future generations to comment on whether it is a blessing or a curse.
It is indispensable to enter the directory to strengthen the inside and outside.
Although pharmaceutical companies all have all kinds of beautiful visions for the medical insurance directory, it is definitely not something that companies can enter if they want to. my country's current selection mechanism for new drugs in the medical insurance catalog is mainly a comprehensive evaluation method based on expert review. "It is an expert group determined by seven departments including the Ministry of Labor and Social Security and the State Planning Commission to classify drugs and prepare a candidate catalog." It was selected through strict procedures such as voting and selection by more than 1,000 experts across the country." To put it more bluntly, experts provide a comprehensive score based on the drug’s efficacy, safety, possible charges, cost, economic burden, 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 catalog, they will mainly be affected by factors such as expert resources and whether they are included in local medical insurance.
“The review of the medical insurance catalog adheres to the principle of expert review. Experts will put forward professional review opinions from actual clinical and medication aspects.” Hua Shao further emphasized that entering the local medical insurance catalog only means that the product meets certain requirements. Regional clinical drug needs. Of course, if a large number of people enter the local medical insurance directory, they will have certain advantages when entering the national medical insurance directory in the future. Generally speaking, varieties that have been included in the Class B medical insurance catalogs of more than 10 provinces and cities are generally urgently needed for clinical needs, and the possibility of such varieties being transferred is relatively high. Relevant statistics show that there are nearly a hundred products that have entered the catalog of more than 10 provinces. These products will have first-mover advantages when they enter the new version of the national medical insurance catalog in the future.
In fact, since the completion of the national medical insurance adjustment in 2009, the provincial medical insurance catalog has become a battleground for pharmaceutical companies. Compared with essential drugs, each province has greater authority in adjusting the medical insurance catalog. Although the provincial medical insurance catalog will follow the adjustment of the national medical insurance catalog in terms of adjustment principles and plans, the key lies in the final decision of each province on drug prices and market usage. There are also certain differences in specific procedures across regions.
For example, Hua Shao said that each province has the characteristics of local enterprises in terms of transfer scope, transfer focus, adjustment of database sources, and formation of alternative databases.
For example, in the adjustment of the provincial medical insurance catalog in 2009, Fujian and Hubei focused on selecting and adding national new drugs, local drugs, and drugs recommended by review experts; some provinces focused on selecting and adding drugs that are widely used in primary medical institutions, have good curative effects, and have low prices. Varieties that meet the provincial medical security needs and clinical medication habits of the province.
Therefore, companies with few newly launched drugs or local medical insurance should actively look for opportunities to break through: look for opportunities for provincial and municipal reimbursement supplementary access; actively participate in serious disease access negotiations in each province; pay attention to the PAP model and adopt similar measures Charitable drug donation methods such as Herceptin and Gleevec; try to participate in innovative models and make full use of opportunities for commercial insurance to participate in various provinces.
In addition, Hua Shao reminded that the importance that pharmaceutical companies attach to their products, medical insurance strategic planning, medical insurance risk assessment and other inherent basic skills cannot be ignored. More importantly, companies must first clarify what are the core elements of product medical insurance catalog selection. In the current supplementary reality environment, what determines whether the product can be included in the medical insurance catalog is the product, which includes the clinical necessity of the product, whether the product is substitutable, and whether it has better price and efficacy compared with similar products in the medical insurance catalog. Whether the ratio is higher or whether it is an innovative drug, etc. Generally speaking, clinical necessity, safety and effectiveness, reasonable price, and ease of use are the basic conditions that national government departments consider when selecting medical insurance catalogs.
Refining new drug products, Hua Shao believes that when government departments select new drugs for the medical insurance catalog, they focus on the following: product innovation; whether it is urgently needed clinically, and whether it is targeted at extremely serious diseases that are not clinically effective. Therapeutic drugs; impact on the pressure on medical insurance funds; social and public benefits.
In Xu Yucai’s view, there are three key factors that determine whether a product can be included in medical insurance: First, drug quality. There must be no serious adverse drug reactions, especially hot events that are of media concern, such as fake raw materials and processes, suspected drug kickbacks, etc.; second, drug prices. The higher the price, the less likely it is to be included in the medical insurance catalog; the third is clinical efficacy. Safety and reliability of clinical efficacy should be ensured as much as possible.
Of course, criticism of the highly subjective evaluation method of expert scoring has never stopped. In contrast, in countries with relatively developed health economics and pharmacoeconomics research, 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 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 recognized the scientific nature of economic evidence-based selection of new drugs, they both said that my country still lacks an independent and authoritative pharmacoeconomics evaluation institution and evaluation index system. There are no specific health technology assessment methods, standards and processes for evidence-based medicine and pharmacoeconomics research evidence. Therefore, there is still a long way to go before we can catch up with the above-mentioned countries.
Expert Observation
It is better to abandon it than to adjust it
According to the current situation, it is of little significance to adjust the medical insurance catalog. Just like many things we have been working hard to do, we only spare no effort to do it, but we forget why we did it in the first place, that is, we forgot why we set out in the first place. Therefore, this time, let’s look back together and see why we formulated the medical insurance catalog in the first place?
This originated from the WHO. In 1979, WHO proposed the formulation of a "National Essential Medicines List" with the purpose of protecting people's basic right to health, mainly targeting developing countries. WHO has developed a guidance catalog based on which individual countries can make adjustments. Accordingly, in the 1980s, my country introduced the "Public Labor Insurance Drug Catalog". In 1999, the "Interim Measures for the Management of the Scope of Medical Insurance Drugs for Urban Employees" were promulgated. In 2000, the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog" was issued. . From this, we can clearly see how my country’s current medical insurance catalog came about.
But nowadays, there are really many drug catalogs in our country. This has caused inconvenience to medical institutions, medical insurance supervision, and patients. It has also caused certain difficulties in promoting the national network reimbursement of medical insurance. hinder. Moreover, these directories have both national and provincial supplementary editions. Whether there is a dispute between rights and interests, I can only say that the water is too deep. And here, what I want to say is, since there are several editions of the Essential Drugs List, can we no longer need the Medical Insurance List?
The answer is "hard to give up". On the one hand, it may be because it contains the interests of too many people; on the other hand, it is because many of our current policies also include the medical insurance catalog. For example, the basic medical insurance implements "three major catalogs" (disease catalog, diagnosis and treatment catalog, and medication catalog). directory) management. At this time, what should we do if there is no medication list? People will be "at a loss".
So, if you really want to abandon the medical insurance catalog, what should you do? My suggestion is to stop selecting and formulating the so-called medical insurance catalog and include all the drugs in the essential drug catalog into the compliance fee basis. Proportional reimbursement; reimbursement of non-essential drugs, as long as they are "reasonable drug use", after paying a certain proportion out of pocket, all will be included in the compliance expenses and reimbursed proportionally.
Of course, after implementing this policy, we also need to pay attention to the following points: first, the use of certain special drugs is limited to special diseases; second, after basic medical insurance reimbursement, patients’ out-of-pocket expenses exceed A certain proportion will be directly reimbursed by critical illness insurance, and no project expenses shall be excluded; the third is to abolish the centralized procurement of drugs, allowing medical institutions to independently choose what drugs to use and at what price to purchase the drugs; the fourth is to increase the average cost control, for Medical institutions that fail to control costs will be strictly punished in accordance with the "agreement"; the fifth is to punish commercial bribery in accordance with the law; the sixth is to actively explore the reform of "medical insurance payment prices", increase the price of medical services, and mobilize the enthusiasm and initiative of medical institutions to control costs.
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