It is certain to adjust the catalogue and expand its capacity
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. In 1999, 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 24. In December 29, the Ministry of Human Resources and Social Security issued the 29 version of the medical insurance catalogue, which included all the therapeutic drugs in the basic drug catalogue into the A part of the medical insurance catalogue, and added 26 drugs.
from 29 to today, five years have passed. Therefore, some insiders believe that the 29 version of the medical insurance catalogue can no longer meet the requirements of increasing 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.
In fact, as early as the first half of 214, an official 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 this year and next, and the catalogue will be expanded".
moreover, although the central government only made a statement and has not really taken any action, the local authorities have already been eager to move in this regard. Even as early as March 213, Xinjiang could not help but include 9 varieties in the B category of medical insurance reimbursement in the region, and added 13 varieties in January 214. In 214, Beijing also announced that 224 kinds of drugs used to treat common chronic and senile diseases would be included in the Beijing community medical insurance catalogue, and the corresponding proportion of individual reimbursement for medical treatment in the community increased to 9%. So far, the scope of reimbursement for drugs in Beijing community has increased from 1211 to 1435. In addition, relevant departments in Chongqing, Hubei, Tianjin, Hebei and other places are also extremely enthusiastic about the adjustment of medical insurance catalogues.
Xu Yucai, deputy director of the Health Bureau of Shanyang County, Shaanxi Province, said that it was "understandable" that the new medical reform had been going around "drugs" for five years, during which many things happened, which can be called a medical reform drama, and its plot can be summarized by three words: "tightening (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. However, the non-essential drugs in primary medical institutions have been liberalized, and the "second bargaining" that was strictly prohibited has been quietly abolished. And these policy changes are also based on "blood" as a lesson. In this situation, it is really concerned to adjust the medical insurance catalogue.
for pharmaceutical enterprises, under the current reimbursement system in China, medical insurance drugs have 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 it has even become a protective trump card that determines the gold content and development potential of products. Especially for new special drugs, this feeling is even stronger.
That's why any trouble about the medical insurance catalogue can always earn enough attention. Covering more than 2 varieties of medical insurance catalogue, it determines the overall situation of clinical use of products of pharmaceutical enterprises and whether the sales of products are smooth. Under the situation that the retail guidance price of basic 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 did not have the opportunity to enter the national medical insurance catalogue, or did not choose to enter the national medical insurance catalogue because of the product price strategy, and were unable to leave in time because of the restrictions when entering the national medical insurance catalogue, will "settle for the second best" and set their sights on the local medical insurance catalogue.
Now, the news that the adjustment of medical insurance catalogue will be the highlight in 215 has also made pharmaceutical companies relive the feeling of "both expecting and fearing injury" after a lapse of five years. How the market structure of medical insurance drugs will change has naturally become the focus of enterprise speculation.
according to 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, expanding capacity and increasing varieties and specifications; Second, integration and connection with the list of basic drugs.
"Considering that the national medical insurance catalogue has undergone four adjustments, the 2196 drugs in the 29 edition of the medical insurance catalogue have basically met the clinical drug demand to a certain extent, therefore, the future adjustment of the national medical insurance catalogue will show four major trends: First, under the pressure of medical insurance fee control, drugs will be more stringent in medical insurance access standards and medical insurance funds will be more stringent; Secondly, the number of adjustments may be limited, and more emphasis will be placed on the adjustment of the rationality of the drug list structure; Thirdly, pay full attention to the comparison of data such as pharmacoeconomics and evidence-based medicine; Finally, pay attention to the clinical evidence supporting basis for the selection of medical insurance drugs in China. " Hua Shao, the government affairs manager of a foreign-funded enterprise, said.
Guess that innovating pharmaceutical companies in the catalogue or benefiting from the adjustment of the medical insurance catalogue will rearrange the interests of the pharmaceutical market layout and marketing means. Hua Shao's view is that enterprises with innovative drugs, enterprises that pay attention to the strategic planning of product medical insurance and carry out research in advance, and enterprises with strong government affairs resources will hopefully benefit from it.
it should be the most exciting point among many speculations to benefit innovative pharmaceutical companies. Since the establishment of the medical insurance catalogue, how to select new drugs fairly and reasonably to enter the medical insurance evaluation has always been the focus 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 clinical demand.
Especially in recent years, with the change of disease spectrum, some diseases with low incidence gradually become more frequent, such as hypertension, cardiovascular and cerebrovascular diseases and breast cancer, and 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 for serious diseases, so as to reduce the burden on patients and benefit more people.
However, the reality is that if innovative drugs want to enter the medical insurance catalogue, the obstacles are long. One thing that has been criticized in the selection 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 financial payment ability and disease universality, so most of the reimbursement scope is 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 quite different from that of China, because new drugs have been tested in animals and humans for as little as 5 years and as many as 1 years before going 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 catalogue.
At the same time, in Germany, Britain and Singapore, the catalogue is updated on a rolling basis, and other countries such as Spain, Italy and South Korea also update it at least once a year. However, the renewal period of China's medical insurance catalogue is 4-5 years. In this process, no matter how good the new drug is, there is no chance to enter the catalogue. Moreover, the existing policy does not specify what kind of drugs can enter the medical insurance catalogue. Take Ektinib Hydrochloride (Kemena) listed in 211 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 in bidding and entering medical insurance. This is extremely unfavorable to people's benefit, industrial development and enterprise innovation.
Now, encouraged by the trend of improving the medical insurance level revealed by policies such as medical assistance and medical insurance for serious illness, 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 will not be 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.
in addition to the expected benefits of innovative pharmaceutical companies, it 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 medical insurance catalogue. For example, in the 29 edition of the medical insurance catalogue, the types of western medicine products expanded from 131 to 1164, and the number increased by 12.9%; The variety of traditional Chinese medicine products expanded from 823 to 987, and the number increased by 19.9%.
under this guidance, the industry is generally optimistic about Chinese patent medicines entering medical insurance. In fact, several versions of the so-called "exclusive variety with the most potential to enter the new medical insurance" sorted out according to the supplement of the local medical insurance catalogue have flowed out. Among them, the number of Chinese medicines predicted to be better far exceeds that of western medicines.
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 the proportion of Chinese patent medicines entering the medical insurance catalogue is constantly increasing. The expansion of the catalogue 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 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", it is self-evident that the abuse of traditional Chinese medicine injections has become a major "public hazard" from the current problems in drug use at the grassroots level, and whether there is "unjust enrichment" among them. 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 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 the medical insurance.
It is indispensable to enter the medical insurance catalogue.
Although pharmaceutical enterprises all 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 evaluation. "It is produced by strict procedures such as the classification of drugs by expert groups determined by seven departments, including the Ministry of Labor and Social Security and the State Planning Commission, and the selection by more than 1, experts nationwide." In a more straightforward way, that is, based on the efficacy, safety, possible costs, costs, economic burdens, or other factors of drugs, experts will comprehensively score them.
In this regard, some voices pointed out that under the expert-led review procedure, non-medical insurance drugs will be mainly affected by factors such as expert resources and whether they enter local medical insurance.
"The evaluation of medical insurance catalogue adheres to the principle of expert evaluation, and experts will put forward professional evaluation opinions from the aspects of actual clinic and medication." Hua Shao further emphasized 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 when entering the national medical insurance catalogue in the future. Generally speaking, the varieties that have entered the Class B catalogue of medical insurance in more than 1 provinces and cities are generally urgently needed in clinic, and it is more likely that such varieties will be transferred. Relevant statistics show that there are nearly 1 products that have entered the catalogue of more than 1 provinces, and these products will have the first-Mover advantage when they enter the new national medical insurance catalogue in the future.
In fact, since the national medical insurance adjustment was completed in 29, the provincial medical insurance catalogue has become a battleground for pharmaceutical companies. Compared with basic 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 plans, the key lies in the final drug prices and market use in each province. And there are also 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 29, 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, and varieties that meet the needs of provincial medical security and clinical medication habits in this province.
Therefore, enterprises with few newly listed drugs or local medical insurance should actively look for opportunities to break through: looking for opportunities for reimbursement and supplementation in provinces and cities; Actively participate in the negotiation and admission of serious illness in various provinces; Pay attention to the PAP model, and adopt the methods of giving 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 inherent basic skills such as the importance of products, medical insurance strategic planning and medical insurance risk assessment should not be ignored. More importantly, enterprises must first make clear what are the core elements of product medical insurance catalogue selection. In the current supplementary reality environment, it is the product that determines whether it can enter the medical insurance catalogue, including the clinical necessity of the product, whether the product is replaceable compared with similar products in the medical insurance catalogue, whether it has a better price, whether it has a higher curative ratio or 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 selecting medical insurance catalogues.
When it comes to new drug products, Hua Shao thinks that the government departments should focus on the following contents when selecting new drugs in the medical insurance catalogue: product innovation; Whether it is urgently needed in clinic, aiming at extremely serious diseases and there is no effective therapeutic drug in clinic; The pressure on the medical insurance fund; Social and public benefits.
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. There must be 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 expert scoring, a subjective evaluation method, 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, America, Japan, South Korea, Australia and Canada all adopt this way 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 both Xu Yucai and Hua Shao agree that the evidence-based economics of new drug selection is scientific, they all say that China still lacks an independent and authoritative evaluation institution and evaluation index system for pharmacoeconomics, and has not improved the specific health technology evaluation methods, standards and processes for evidence-based medicine and research evidence of pharmacoeconomics. Therefore, there is still a long way to go before we can keep up with the above 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 catalogue. Just like many things we have been trying to do, we just try our best to do it, but we forget why we did it in the first place, that is, why we started. So this time,