• Before the impact of "4-7 volume procurement" has been digested, the pharmaceutical industry has been brushed by a policy. On December 12, the National Health Commission issued the Circular on the Management of Clinical Application of Auxiliary drugs, which clearly proposed the establishment of a national catalogue of adjuvant drugs. The trend that has been brewing for many years has come true.

Previously, due to the unclear definition of adjuvant drugs, non-uniform standards and lack of policy basis, the country has not issued a relevant catalogue. Now that the National Health Commission is really taking action, is this policy issued hastily or prepared? What is the layout of adjuvant drug use at the national level recently? What will be the criteria for defining adjuvant use?

As far as E drug managers know, under a series of arrangements and arrangements, the Health Commission has long been prepared for the introduction of the national version of the auxiliary drug catalogue.

1

A prepared national catalogue of adjuvant drugs

The state hopes to "start" the use of adjuvant drugs, not one or two days.

As early as November 2015, five departments, including the former National Health and Family Planning Commission, the National Development and Reform Commission, the Ministry of Finance, the former Ministry of Human Resources and Social Affairs, and the State Administration of traditional Chinese Medicine, jointly issued a circular entitled "opinions on controlling the unreasonable growth of Medical expenses in Public Hospitals." it is proposed to implement the product management system and tracking and monitoring system such as auxiliary drug use.

Under the voice of "limited auxiliary" throughout the country, local medical institutions have issued the "key Monitoring Catalog" one after another. Yunnan is the first province to formulate a "catalogue of adjuvant drugs" at the provincial level, including 122 adjuvant drugs for injection. in addition to many commonly used clinical vitamin injections and other adjuvant drugs, 48 varieties belong to traditional Chinese medicine injections, accounting for nearly 40%. Among them, there are many varieties of traditional Chinese medicine, especially those for the treatment of tumors, cardio-cerebrovascular diseases.

However, looking at the entire pharmaceutical industry, there has been no clear definition of "adjuvant use". For example, adjuvant drugs in some areas may be therapeutic drugs in other areas, and for example, some adjuvant drugs do have some effects in improving patient experience and promoting rehabilitation. Shi Lichen, a medical observer, once said: it is too difficult and unreasonable to use a catalogue to regulate the use of auxiliary drugs, and it should be dynamically managed by various localities according to their own characteristics of drug use.

It seems to be a feasible solution for all localities to formulate their own key monitoring catalogs according to their own situation. However, several recent actions at the national level indicate that the country has already made relevant arrangements at the top design level and is determined to be clinical value-oriented and thoroughly crack down on some of the so-called "safe, ineffective and expensive" so-called magic drugs.

On October 15, 2018, the National Conference on Pharmaceutical Administration was held in Beijing. The meeting made it clear that in the near future, China's drug administration work will focus on seven aspects, including "comprehensive clinical evaluation of drugs."

At that time, Zeng Yixin, vice minister of the National Health Commission, pointed out at the meeting: "it is necessary to reduce the cost of unreasonable drug use." "

In October, the Pharmaceutical Department of the National Health Commission simultaneously issued the overall work Plan of National Drug Clinical Comprehensive Evaluation (2018-2020, draft for soliciting opinions), which is the top-level design for the construction of drug clinical comprehensive evaluation system at the national level.

The program mentioned that: based on the nature of drug treatment of diseases, guided by the actual clinical value of drugs, classify and collect clinical evidence, and promote and improve the mechanism of clinical comprehensive evaluation of drugs.

In the definition of standards, the program said: collect the standard processes and technical methods fully recognized by domestic and foreign drug evaluation, and organize the formulation of scientific and standardized comprehensive evaluation guidelines, indicators and processes. The programme announced the establishment of a national coordination committee for clinical evaluation of drugs, with a secretariat under which the Department of Pharmacy of the National Health Commission is responsible for the management of matters. Every year, the committee needs to select 10 clinical evaluation topics, and the categories with high cost and great influence on the diagnosis and treatment service system are the priority evaluation objects.

The establishment of the mechanism system is the basis for the evaluation of auxiliary drug use. It shows that the national level is developing standards on the one hand and information collection on the other. According to the E Drug Manager, the Department of Pharmacy of the Health Commission has recently held many discussions with local health committees.

On November 5 and November 29, the Medical Administration of the National Health Commission held meetings in Nanjing and Changsha respectively, inviting provincial health committees, hospital presidents, directors of pharmacy, and industry associations to participate in the investigation and discussion on the rational use of drugs in medical institutions. The purpose of the meeting is to strengthen the rational management of clinical drug use in medical institutions, to build a rational drug use assessment system, and to conduct extensive research on promoting the standardized and rational use of drugs.

The National Health Commission has repeatedly conveyed such a message: the rational use and management of drugs in medical institutions is one of the important contents of daily work management, and it is also a clear work requirement for provincial and municipal health committees, which are implemented as a key work in all provinces. From the perspective of the research site, although the participating experts have different understandings and attitudes towards the definition of adjuvant use, they all highly agree that "it is necessary to strictly supervise the rational use of clinical drugs".

From October 15 to 17, 2018, Sun Chunlan, Vice Premier of the State Council and head of the State Council Medical Reform leading Group, conducted a survey in Fujian, during which he visited the first Hospital and Medical Security Management Center of Sanming City. This is also seen as a national signal to follow the example of "stop reimbursement for adjuvant medication".

As we all know, Sanming City, Fujian Province, "took the lead in monitoring high rebate drugs". In May 2017, it directly stopped using 200 adjuvant drugs recommended by clinical experts in the province, thus saving 8 billion yuan in health insurance funds.

It is the substantial savings in medical insurance costs that Sanming City has the strength to include anti-cancer drugs in health insurance on the one hand and raise the price of medical services on the other. In the six months since the withdrawal of adjuvant medication, not only the cost of medical insurance has been greatly saved, but also Fujian has not led to medical related problems. For a long time, there has been a continuous signal at the national level that it is necessary to promote Sanming experience, and now it seems that starting with the use of auxiliary drugs is the first step.

In fact, starting from the "4-7" volume procurement policy, we can gradually see the rhythm that appears in the national policy: the first result, and then the supporting policy. Not long ago, the National Health and Health Commission issued the National catalogue of essential drugs, proposing that the catalogue of basic drugs will be dynamically adjusted, and the so-called divine drugs and auxiliary drugs, which are costly and have no clear curative effect, are the key points. This shows that at that time, the Health Commission had decided to raise the concept of "adjuvant medication" to the national level.

This can also show that the state has done a lot of considerations on a series of measures related to medical reform, understand the core of the problem in place, first implement, and then gradually improve supporting measures, and the reform is speeding up.

2

Auxiliary drugs step down from the altar

In fact, from the point of view of people in the industry, although the state's action on "auxiliary drug use" makes some enterprises feel that "cold winter" is coming, it is a "serious disease and needs fierce medicine" for the pharmaceutical industry. it is an essential action to promote the pharmaceutical industry to get to the root of the disease and truly return to the essence of curing diseases and saving lives, and it is an action that should have been completed a long time ago.

In the past, if an enterprise has a large variety with good safety, a wide spectrum of diseases and many clinical applicable departments, it will have a competitive advantage in this field, with high product profits and wide market applications, and its small life should not be too good.

Adjuvant medication also consumes a large amount of medical insurance funds in our country for a long time. According to the sales amount, Mine.com counted the best-selling brands TOP20 in the country's three major terminals and six markets in 2017, of which 8 varieties are drugs for cardio-cerebrovascular diseases. Xueshuantong injection with annual sales of 7.3 billion yuan, Danhong injection of 6.1 billion yuan, salvia miltiorrhiza polyphenolates of 4.9 billion yuan, Xiyanping injection of 3.9 billion yuan and Shuxuetong injection of 3.7 billion yuan have been repeatedly listed in the catalogue of auxiliary drugs and key monitoring.

By contrast, in the 2017 global drug sales list, the top 10 products are Sumitol, Lenalidomide, rituximab, Herceptin, Sortan, Abexipe, Peer 13-valent vaccines and other innovative drugs that have obvious advantages in the treatment of tumors, autoimmune diseases and other critical areas.

According to the analysis of the existing provincial-level open catalogue of auxiliary drugs, there are basically the following characteristics: the word "adjuvant therapy" is included in the indication of manual examination and approval; the products are widely used, covering cardio-cerebrovascular diseases, oncology, orthopaedics, respiration and other multi-department drugs; traditional Chinese medicine products whose functions are "promoting blood circulation and removing blood stasis", "clearing heat and detoxification" and "Fuzheng Guben"; the top 30 products in each province "over-prescriptive medication" is more common and is usually a product of both health insurance and the national catalogue of essential drugs. Compared with the local monitoring catalogue, it is not difficult to find that "star products" such as calf blood deproteinized extract, ganglioside sodium, thymopentin, Edaravone, Xueshuantong and Shuxuening are key monitoring varieties.

From the list of auxiliary drugs in each province, there are many kinds of chemical drugs, such as immunomodulatory drugs, nutritional supplements, traditional Chinese medicine tonics, traditional Chinese medicine promoting blood circulation and removing blood stasis and some traditional Chinese medicine injections.

Liu Peng, an associate professor at the School of Public Administration at Renmin University of China, said in an interview with the media that the use of adjuvant drugs is a product left over from the background of lack of medicine and medicine in China. later, due to the characteristics of safety, multiple indications and large price space, it was in line with the interests of medical institutions to "use medicine to support doctors".

In order to control the growth of unreasonable drug use in medical institutions and prevent drug abuse, the state has successively introduced policy measures such as zero difference rate, drug proportion, drug cost growth of no more than 30%, and so on. Although major public hospitals have a certain motivation to focus on monitoring auxiliary drug use, it is still unable to fundamentally solve the problem of auxiliary drug abuse. Many products of adjuvant drugs are in the catalogue of basic medical insurance, coupled with years of medication habits, creating a "shrine" of adjuvant drugs.

At the moment when the medical reform enters the deep water area, the future direction is to really use health insurance on the cutting edge, return to the essence of drug treatment, and promote drug R & D and innovation by "three-medicine linkage". At this time, the national auxiliary drug is a kick in front of the door, raising the monitoring of auxiliary drug use to the national level, and then pulling it down from the altar.

3

The definition standard needs to be defined.

Industry insiders believe that the work of the National Health Commission on the management of clinical application of adjuvant drugs is not clear and the definition of adjuvant drug standards is not clear.

According to the statement of the Health Commission: the Committee of Pharmaceutical Administration and Pharmacology, according to drug instructions and drug use guidelines, fully evaluate and demonstrate the clinical value of auxiliary drugs, in accordance with the principle of not only meeting the basic clinical needs but also moderately tight, carry out strict selection.

The move is to hand over the right to define the standard of adjuvant use to medical institutions. In the past experience, medical institutions are more defined with reference to the experience of other similar hospitals, and have their own selection criteria. The Rubik's Cube counted the 100 auxiliary drugs and key monitoring varieties that were most named by the provincial and municipal health committees, 2 products were named more than 50 times, 19 products were named more than 30 times, and the remaining nearly 80 products were named more than 10 times. if 20 products are submitted according to the order of the amount of money by the provincial and municipal health committees, these are the products selected in the National catalogue of Auxiliary drugs.

From a series of previous deployments made by the Health Commission, we can also see that relevant standards for "auxiliary drugs" are being formulated at the national level. According to the logic of "setting the policy before landing," the national version of the auxiliary drug catalogue is released at the same time. The catalogue standards may be published at the same time.

A person in the industry commented that, in fact, the National Health Commission has already had its own standards for what "auxiliary drugs" are, and the Health Commission already has a "national catalogue of auxiliary drugs" in its mind. because if you follow the guidelines for the treatment of diseases in the United States, the European guidelines, and the guidelines of the Chinese Medical Association, and then compare the ranking of provincial health insurance claims, it is not difficult to list the catalogue. There is no doubt that the drugs in the gold standard and the drugs with real clinical efficacy will become the mainstream of clinical drug use in China. It is only a matter of time before and in what way.