The adjustment of the catalog expansion is on the board
According to the customary practice, China's "Medical Insurance Catalog" is adjusted about once every five years, focusing on the evaluation of new medicines, local adjustments to increase the number of medicines and review of expert recommendations for additional medicines.In 1999, China set up a medical insurance system for urban workers and workers, and the following year, the first version of the Medical Insurance Catalog was formulated, and revised in 2004; in 2009, the Ministry of Human Resources and Social Security released the 2009 version of the Medical Insurance Catalog. In December 2009, the Ministry of Human Resources and Social Security released the 2009 version of the medical insurance catalog, which included all the therapeutic drugs in the basic drug list in the Class A portion of the medical insurance catalog, while adding 260 new drugs.
And from 2009 to today, five years have passed. Therefore, some industry insiders believe that the 2009 version of the health insurance catalog is now unable to adapt to the requirements of the increase in health insurance coverage and the increase in demand for medical consumption. At the same time, the deepening of health care reform has also put forward inherent requirements for the revision of the health insurance catalog.
In fact, as early as the first half of 2014, the Ministry of Industry and Information Technology Department of Consumer Goods Division of the Pharmaceutical Division officials will be in the China Pharmaceutical Industry Development Summit Forum revealed that "this year and next year to start the revision of the health insurance catalog, the catalog will be expanded."
And, although the central government is only a statement, has not yet really made a move, the local authorities in this regard has long been eager to move. Even as early as March 2013, Xinjiang has pressed the nine varieties into the region's medical insurance reimbursement category B catalog, and in January 2014 added 13 varieties. Beijing also announced in 2014 that 224 types of drugs used to treat common chronic and geriatric diseases would be included in Beijing's community drug health insurance catalog, and the corresponding percentage of individual reimbursement for medical treatment in the community was raised to 90%, thus increasing the scope of community drug reimbursement in Beijing from the original 1,211 to 1,435 types. In addition, Chongqing, Hubei, Tianjin, Hebei and other relevant departments, the health insurance catalog adjustment is also extremely "enthusiastic".
For the local fist-pumping and drug companies full of expectations, Shanyang County, Shaanxi Province, deputy director of the Health Bureau Xu Yucai said "understandable": the implementation of the new health care reform for five years, around the "drug" tossed a lot of fun during the period, a lot of things happened! Things, can be called a health care reform drama, the plot can be summarized in three words "tight (strengthened control) - chaotic - put". At present, drug prices have been liberalized, and there are divergent views on whether drug procurement should continue to be subject to "centralized bidding", but non-essential medicines for primary health care institutions have been liberalized, and "secondary bargaining", which used to be strictly prohibited, has also been quietly abolished. These policy changes are also "blood" for the lessons learned. In this situation, the adjustment of the medical insurance catalog is indeed of great concern.
For pharmaceutical companies, under China's current reimbursement system, health insurance drugs have rightly become the main driving force behind the growth of their products. With the deepening of healthcare reform and the implementation of universal healthcare insurance, the product's health insurance status is becoming more and more important, and has even become a protective trump card that determines the product's gold content and development potential. Especially for the new special drugs, such a feeling is even stronger.
That's why, any fluctuation in the medical insurance catalog always earns a lot of eyeballs. The health insurance catalog, which covers more than 2,000 varieties, determines the big picture of the clinical use of pharmaceutical companies' products, and determines whether or not the products will sell well. In the base drug retail guide price and the provinces bidding pressure, the medical insurance catalog to declare varieties of pricing directly related to the profitability of the enterprise space.
Thus, from the past situation can be seen, many do not have the opportunity to enter the national health insurance catalog, or due to the product price strategy needs not choose to enter the national health insurance catalog, as well as to enter the national health insurance catalog is subject to more restrictions so that not in time to the whole body of the product, will "retreat to the next best thing," the attention of the local health insurance catalog. The company's products have been in the national health insurance catalog for more than a decade.
Now, the news that health insurance catalog adjustments will be the main event in 2015 will also allow pharmaceutical companies to revisit the feeling of "anticipation and fear of injury" after a lapse of five years. On the medical insurance drug market pattern will be how to change, naturally became the focus of business speculation.
Combined with the current dynamics, Xu Yucai's attitude is that the new round of health insurance catalog adjustment in general should present the following two characteristics - one, expansion, increase varieties, specifications; and the second, integration, and the basic drug directory convergence.
"Considering that the national health insurance catalog has gone through four adjustments, the 2,196 medicines in the 2009 version of the health insurance catalog have also basically met the clinical demand for medicines to a certain extent, therefore, the future adjustment of the national health insurance catalog will show four major trends: firstly, under the pressure of the health insurance control, the medicines will be more stringent in the health insurance access standards. Health insurance funding restrictions are more stringent; second, the number of adjustments may be limited, focusing more on the rationality of the directory drug structure; again, full attention to pharmacoeconomics, evidence-based medicine and other data comparisons; and finally, focus on the basis of clinical evidence to support the selection of drugs for China's health insurance." A foreign enterprise government affairs manager Hua Shao said.
Guess the catalog of innovative drug companies or benefit
The adjustment of the health insurance catalog will rearrange the interests of the drug market layout and marketing methods. Huashao's view is that companies with innovative drugs, companies that focus on strategic planning for product health insurance and have carried out research in advance, and companies with strong government affairs resources will hopefully benefit from it.
Benefiting innovative drug companies should be the most exciting point of the many speculations. Since the development of the health insurance catalog, how to fairly and reasonably select new drugs into the health insurance review, has been the focus of industry experts and industry players. Among them, how to establish a fair selection mechanism for high-priced drugs with clinical needs is the most important.
Particularly in recent years, with the changes in the disease spectrum, some of the lower incidence of diseases gradually become more prevalent, such as hypertension, cardiovascular and cerebrovascular diseases and breast cancer, so that more high-priced but effective drugs into the medical insurance call is also rising. Huashao also said that more innovative drugs, especially for serious diseases, should be included in the health insurance reimbursement system to reduce the burden on patients and benefit more people.
But the reality is that it is a long way for innovative drugs to enter the health insurance catalog. One of the most criticized aspects of China's health insurance catalog selection is that the system is designed to favor low-priced drugs. This is due to the fact that health insurance payments need to take into account both the financial ability to pay and the prevalence of diseases, so the reimbursement scope is mostly for economical and practical domestic drugs. In this context, imported drugs from foreign pharmaceutical companies and innovative drugs from domestic pharmaceutical companies, although more advanced and efficient, will not be the main choice for health insurance because they are more expensive.
In the United States and the European Union, however, innovative drugs are treated very differently from those in China, as new drugs undergo animal and human trials for as little as five or as many as 10 years before they are put on the market. Once regulators approve them for marketing, they are considered safe and reliable and will automatically enter the country's health insurance catalog.
Meanwhile, in countries such as Germany, the United Kingdom and Singapore, which update their catalogs on a rolling basis, others such as Spain, Italy and South Korea do so at least once a year. But China's health insurance catalog is updated on a 4-5 year cycle, during which new drugs don't stand a chance of making it into the catalog, no matter how good they are. Moreover, the existing policy does not clarify what kind of drugs can enter the health insurance catalog. Taking Eketinib hydrochloride (Kemena), which was launched in 2011, for example, although it is called "a major breakthrough in the field of people's livelihood, comparable to the two bombs and one star", it has encountered difficulties in both bidding and entering the health insurance program. This is extremely unfavorable for the benefit of the public, the development of the industry, the innovation of enterprises.
And now, encouraged by the trend of medical aid, major medical insurance and other policies revealing a trend to raise the level of health insurance, many viewpoints believe that new medicines in recent years, especially those that have already entered the local health insurance catalog, have a higher possibility of entering the national health insurance catalog. This also means that advantageous pharmaceutical companies that have been launching new products in recent years will benefit from it.
However, according to Xu Yucai, the current policy winds can't actually be called clear, so it's debatable which pharmaceutical companies will ultimately benefit. If the authorities think openly to market determinism as the leading, then the price is not a problem, the original research patented drugs will naturally usher in a great opportunity; but if it is in accordance with Sanming's "health insurance benchmark price" policy, these drugs is a dead end.
Innovative drug companies are expected to benefit from the exclusive proprietary Chinese medicines are also seen as one of the trends of the new round of health insurance catalog adjustment. This is in the previous health insurance catalog adjustment, is also traceable. For example, in the 2009 version of the medical insurance catalog, the western medicine product category from 1031 to 1164, the number of 12.9%; Chinese medicine product category from 823 to 987, the number of 19.9%.
In this direction, the industry is generally optimistic about the pCms into the medical insurance. In fact, the so-called "exclusive varieties with the greatest potential to enter the new medical insurance" sorted out according to the local medical insurance catalog additions have been out of several versions. Among them, the number of predicted favorable traditional Chinese medicine far exceeds the number of Western medicine.
Huashao pointed out that the national health insurance catalog in the successive adjustments has been quite focusing on the "equal importance of Chinese and Western medicines", but also continue to improve the proportion of pCms into the health insurance catalog. The expansion of the pCm drug list can play a positive role in promoting the coordinated development of Chinese medicine and traditional Chinese medicine, as well as the modernization of the Chinese medicine industry. In the new round of medical insurance catalog adjustment process, will focus more on the rationality of the adjustment of the structure of the medication, and therefore should also focus on the "Chinese and Western medicines," the reality of the national situation.
In this regard, Xu Yucai frankly said that although "everything is possible", but from the current grass-roots drug problems, the abuse of traditional Chinese medicine injections has become a major "public health hazard", which is whether or not there is "undue advantage". Whether or not there is "undue profit" is self-evident. 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 is in strict accordance with the "Principles for the Clinical Use of Chinese Medicine Injections". Therefore, in the absence of "evidence-based medicine" background, open the cage to allow a large number of pCms to enter the health insurance, whether it is a blessing or a curse can only be left to future generations to comment.
Into the directory strong strong outside indispensable
Although the pharmaceutical companies have all kinds of good visions of the medical insurance catalog, but this is definitely not a business want to enter can enter. China's current health insurance directory of new drug selection mechanism, mainly based on expert evaluation of the comprehensive evaluation method, "is determined by the Ministry of Labor and Social Security, the State Planning Commission and other seven departments of the panel of experts on the classification of medicines and the preparation of alternative directories, more than 1,000 experts from across the country to vote on the selection of such strict procedures". To put it more bluntly, this is based on a comprehensive scoring by experts on the efficacy, safety, possible cost, cost, economic burden, or some other element of the drug.
In this regard, some voices have pointed out that under the expert-driven evaluation process, non-Medicare drugs will be mainly affected by factors such as expert resources and whether or not they are admitted to local medical insurance in order to enter the Medicare catalog.
"The review of the medical insurance catalog adheres to the principle of expert review, and experts will provide professional review opinions from the actual clinical and medication aspects." Hua Shao further emphasized that entering the local medical insurance directory only indicates that the product meets the clinical medication needs of a specific region. Of course, entering the local health insurance catalog in larger numbers will have a certain advantage when entering the national health insurance catalog in the future. Generally speaking, has entered the 10 provinces and cities more than the medical insurance category B catalog varieties are generally urgent clinical needs, so the possibility of transferring varieties is relatively large. And relevant statistics show that now into the 10 provinces more than directory of nearly a hundred products, these products in the future into the new version of the national health insurance catalog, is to have the advantage of first-mover.
In fact, since the completion of the adjustment of the national health insurance in 2009, the provincial health insurance catalog has become the place where drug companies must fight. Compared with the basic drugs, the provinces have greater authority in the adjustment of the health insurance catalog. Although the provincial health insurance catalog in the adjustment principle and program will follow the adjustment of the national health insurance catalog, but the key lies in the final decision of the provinces of the price of drugs and market use. And there are some differences in the specific process.
Huashao said, for example, the provinces in the scope of the transfer, the focus of the transfer, the adjustment of the database source, the formation of alternative databases are characterized by local enterprises. For example, in 2009, the provincial health insurance catalog adjustment, Fujian, Hubei focus on the national new drugs, local drugs and review experts recommend the addition of drugs to select additions; some provinces focus on the consideration of primary health care institutions are widely used, better efficacy, low price varieties, adapted to the province's health care needs and the province's clinical use of medication habits of the varieties.
As a result, newly-launched drugs or local health insurance access to not many companies, should actively seek opportunities to break out: looking for provincial and municipal reimbursement of supplemental access opportunities; actively participate in the provinces to negotiate access to the major diseases; focus on the PAP model, to take a similar approach to Herceptin, Gleevec and other charitable gift of drugs; try to participate in the innovative model, make full use of the opportunity to participate in the provinces of the commercial insurance.
In addition to this, Hua Shao reminded that pharmaceutical companies can not ignore the importance of the product, health insurance strategic planning, health insurance risk assessment and other internal basic skills. More importantly, companies must first be clear, what are the core elements of the product health insurance catalog selection. In the existing complementary realities, the decision to enter the health insurance catalog is the product, which includes the clinical necessity of the product, whether the product and the health insurance catalog of similar products compared with the substitutability of the product, whether the price is better, whether the efficacy ratio is higher, or whether it is an innovative class of drugs and so on. Generally speaking, clinical necessity, safety and efficacy, reasonable price and ease of use are the basic conditions considered by the national government departments in the selection of the medical insurance catalog.
Specializing to the new drug products, Huashao believes that the government departments in the selection of new drugs in the health insurance catalog, focusing on the following: product innovation; whether the clinical need, for major diseases and the current clinically ineffective treatment of drugs; the impact of the pressure on the health insurance fund; the public benefits.
And in Xu Yucai's view, the key elements that determine whether a product can be squeezed into the health insurance, there are three main elements: First, the quality of drugs. There can not be serious adverse drug reactions occur, especially can not be involved in the media attention of hot events, such as raw materials, process falsification, suspected of drug kickbacks, etc.; Second, the price of drugs. The higher the price, the less likely it is to enter the health insurance catalog; Third, clinical efficacy. Should try to ensure the safety and reliability of clinical efficacy.
Of course, there has been no end to the criticism of expert scoring, which is a highly subjective evaluation method. In contrast, in countries where health economics and pharmacoeconomics research are more developed, drug selection is based heavily on research evidence from "cost-benefit" analyses. At present, Europe and the United States, Japan and South Korea, Australia and Canada have adopted such an approach to pricing and payment, forming a set of health technology assessment system (HTA). Therefore, many experts and scholars believe that the development of this selection technique should be promoted as much as possible.
But while both Xu Yucai and Hua Shao recognize the scientific validity of the evidence-based economics of new drug selection, they both say that China still lacks an independent and authoritative pharmacoeconomic evaluation organization and evaluation index system, and has not improved the health technology assessment methods, standards and processes specific to evidence-based medicine and pharmacoeconomic research evidence. Therefore, there is still a long way to go to be on par with the above countries.
Expert observation
Instead of adjusting, it is better to discard
According to the current situation, it does not make much sense to implement the adjustment of the medical insurance catalog. As with many of the things we've been trying to do, we've just been digging in and forgetting why we're doing it in the first place, which means we've forgotten why we set out in the first place. So this time, let's go back together and look at why we developed the Medicare Catalog in the first place?
This is due to the fact that in 1979, WHO proposed the development of a National Essential Medicines List (NEML) with the aim of guaranteeing people's basic right to health, mainly for developing countries.
The WHO developed a guideline list on the basis of which each country could make adjustments. Accordingly, in the 1980s, China introduced the "Publicly-funded Labor Insurance Drug Catalog", in 1999, the "Interim Measures for the Administration of the Scope of Drugs Used by Urban Workers' Medical Insurance" was introduced, and in 2000, there was the "National Catalog of Drugs for Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance". From this, we will be able to see very clearly how our current medical insurance catalog actually came about.
But nowadays, there are quite a few drug catalogs in China, which have caused inconvenience to medical institutions, health insurance regulators, and patients, and also hindered the progress of national network reimbursement of health insurance. And, these catalogs have both national and provincial supplemental version, which whether there is power and profit entanglement, I can only say that the water is too deep. And here, I want to say, since the basic drug catalog has several versions, we can no longer need the medical insurance catalog?
The answer is "hard to give up". On the one hand, perhaps because it contains the interests of too many people; on the other hand, it is because many of our current policies are still mixed with the medical insurance catalog, such as the basic medical insurance to implement the "three catalogs" (disease catalog, diagnosis and treatment catalog, medication catalog) management. At this time, if there is no medication catalog, how to do? People will be "at a loss".
So, if we really want to abandon the medical insurance catalog, what should we do? My suggestion is to stop selecting the so-called medical insurance catalog, all drugs in the essential drugs catalog will be included in the proportion of reimbursement of eligible expenses; non-essential drugs reimbursement, as long as it is a "reasonable use of drugs", after a certain percentage of out-of-pocket payments, all included in the proportion of reimbursement of eligible expenses.
Of course, the implementation of this policy, but also need to pay attention to the following points: First, for some special drugs limited to the use of special diseases; Second, the basic medical insurance reimbursement, the patient's out-of-pocket expenses over a certain percentage of the direct reimbursement of the major medical insurance, shall not be excluded from the cost of any project; Third, the abolition of centralized drug purchasing by the medical institutions to independently choose to use what medicines, at what price? Purchase of drugs; four is to increase the average cost control efforts, for cost control is not effective medical institutions in accordance with the "agreement" strict penalties; five is to punish commercial bribery according to law; six is to actively explore the "medical insurance payment price" reform, improve the price of medical services, mobilize the medical institutions to take the initiative to control costs. Medical institutions to control the cost of positive initiative.
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