Traditional Chinese Medicine Formula Granules Enter Medical Insurance Channel, Open Up Intensive Layout Of Enterprises And Undertake Market Volume

More and more attention has been paid to traditional Chinese medicine (TCM) in the national medical insurance system.

On October 19, Shandong Medical Insurance Bureau issued the notice on doing a good job in the payment of medical insurance for traditional Chinese medicine formula granules (Trial Implementation) > public consultation announcement, which said that it decided to prepare traditional Chinese medicine produced by pilot research enterprises with the approval of the provincial drug administration, corresponding to the traditional Chinese medicine Pieces approved by the national medical insurance fund, and approved by Shandong Provincial Department of industry and information technology Fang granule, included in the scope of medical insurance fund payment, trial period of 2 years. The scope of application is extended to medical institutions above grade one (including grade one).

Prior to this, the four departments of Hubei Province jointly issued a notice that, starting from July 1, this year, the Chinese medicine formula granules produced by the identified pilot enterprises in the province were allowed to be included in the provincial medical insurance, and used in the designated medical institutions at or above the second level in the Province, with a trial period of two years.

"Hubei and Shandong provinces have also implemented the supporting policies of TCM formula granules, which is the result of the vigorous development of traditional Chinese medicine in the past two years." On October 27, Shi lichen, founder and general manager of Beijing Dingchen Management Consulting Co., Ltd., said in an interview with 21st century economic reporter that the effect of traditional Chinese medicine formula granules is better than that of traditional Chinese medicine decoction pieces, which is also one of the reasons for its promotion.

Policy differentiation

Traditional Chinese medicine formula granule, also known as non Decoction Chinese medicine, is a kind of granule made by extracting and concentrating single Chinese medicine decoction pieces and used for clinical formula of traditional Chinese medicine. That is, traditional Chinese medicine pieces as raw materials, through extraction, separation, concentration, drying, granulation, packaging and other production processes, processing into a unified specification, unified dose, unified quality standards of new formula medicine.

According to the above announcement, the Shandong plan will manage the traditional Chinese medicine formula granules according to the "class B drugs" of the medical insurance catalogue, and the relevant medical insurance payment provisions shall refer to the provisions of the corresponding Chinese Herbal Pieces in the national drug catalog.

Up to now, Zhejiang, Yunnan, Beijing, Guizhou, Tianjin, Guangxi, Hubei, Shandong and other places have included TCM formula granules in medical insurance, but in Heilongjiang and Fujian, they are not allowed to be included. In January 2018, the Department of human resources and social security of Heilongjiang Province issued the drug list of basic medical insurance, industrial injury medical insurance and maternity insurance in Heilongjiang Province (2017 Edition), which clearly pointed out that the traditional Chinese medicine Pieces paid by the basic medical insurance fund were ordinary Chinese herbal pieces, and did not include Decoction free pieces, formula granules, broken wall pieces, etc. Fujian also mentioned that the medical insurance fund will no longer pay for traditional Chinese medicine formula granules.

In this regard, Shi lichen pointed out that it is normal for different medical insurance policies in different regions, and there is no divergence of views. "After all, there is always a debate about the ownership of TCM formula granules. According to the western medicine herbal medicine, plant medicine or traditional Chinese medicine, there is no conclusion. Not to mention the inconsistency of policy orientation. "

In fact, the core problem that has hindered the promotion of TCM formula granules is standardization. Before the State Pharmacopoeia Committee issued the "announcement on the unified standard for the pilot of Chinese medicine formula granules" in 2019, the unified standard for the varieties of traditional Chinese medicine formula granules was not clear. Before that, in accordance with the "Interim Provisions on the administration of traditional Chinese medicine formula granules" promulgated by the former State Drug Administration in April 2001, referring to the management of Chinese herbal pieces, the hospital president could decide on his own bidding, which also led to a large amount of power rent-seeking space.

"Because it is impossible to require manufacturers to use traditional Chinese medicine formula granules and decoction pieces for clinical use, it is more about cost analysis and comparison, verification and standardization of production technology. That is to say, the pilot project of Pharmacopoeia Commission. The first 160 products are experimental products. Therefore, the change from the existence of formula granules to the last two years and now restart can reflect the idea of supervision. First of all, stop everything with risks, and then formulate standards, and then push forward the good and compliance parts. " A long-term concern about the traditional Chinese medicine formula granule industry investors to the 21st century economic report reporter analysis.

As the market of traditional Chinese medicine formula granules is still in the development stage, the market is not fully opened, which makes the implementation of the policy is top-down. "Take Fujian as an example. By the end of 2017, all enterprises will be directly cut off and will not be allowed to sell. Enterprises with pilot production will be allowed to enter the market when the industry standards are promoted." The investors further explained.

Capacity expansion and speed up

However, it is an indisputable fact that the outstanding performance of traditional Chinese medicine in the prevention and control of Xinguan epidemic has accelerated the expansion of the market of traditional Chinese medicine formula granules.

Since February this year, a number of listed companies have successively laid out production bases for traditional Chinese medicine formula granules. In February, Yibai pharmaceutical, the leader of Guizhou traditional Chinese medicine, was confirmed as a pilot enterprise for the study of traditional Chinese medicine formula granules in Guizhou Province. At that time, Yibai pharmaceutical said that this will further improve the product structure and improve the whole industry chain of traditional Chinese medicine. Within two years from the date of confirmation of the pilot enterprise of traditional Chinese medicine formula granules, it should complete at least 400 kinds of research work on production process procedures and quality standards of traditional Chinese medicine formula granules.

In March, Tian Shili said that the drug regulatory department agreed to research and produce TCM formula granules and use them in medical institutions with TCM diagnosis and treatment subjects in Tianjin; in September, China Resources Sanjiu publicly said that in the future, the company would carry out the whole industry chain layout in TCM formula granules and decoction pieces business, so as to enable self diagnosis and prescription medicine business; in September, LiuYao announced that it would be in Liuzhou city Five projects, including the construction of the production and research base of traditional Chinese medicine formula granules, are expected to achieve an annual output value of 1.8 billion yuan.

According to incomplete statistics of Xinhua news agency, more than 60 pharmaceutical enterprises nationwide have obtained the production qualification of traditional Chinese medicine formula granules, including six pilot production enterprises initially approved by the State Food and drug administration. Among A-share listed companies, more than 30 pharmaceutical enterprises, including Jilin Aodong and Jingjing pharmaceutical, have laid out or will soon lay out TCM formula granules.

In Shi lichen's opinion, at present, the threshold of traditional Chinese medicine formula granule industry is low, and it can be put into production only by solving capital, talents and production line. Therefore, under the stimulation of policy, it is reasonable for more enterprises to participate. On the other hand, compared with the traditional Chinese medicine decoction pieces, the superposition of Chinese medicine formula granules is more convenient to carry and has equivalent efficacy. With the deepening of patient education, its market scale will continue to expand.

From 2015 to 2019, the market scale of traditional Chinese medicine formula granules industry (according to terminal sales) increased from 14.36 billion yuan to 25.56 billion yuan, with an annual compound growth rate of 15.5%. In the future, although the industry regulatory policies will be stricter and the annual compound growth rate will be slightly reduced, the market scale of the traditional Chinese medicine formula granule industry will maintain a rapid growth in the next five years. The annual compound growth rate is expected to be about 14.0%, and the industry scale will reach 49.21 billion yuan by 2023.

Shi lichen pointed out that the current market-oriented and large-scale layout will also be conducive to the gradual refinement of industry standards. "The impact of the standards issued by the end of 2019 on the industry is limited. The state can only lead a framework, while the specification is a continuous refinement process. Enterprises should take the lead to systematically sort out the production links, data accumulation and key technical points, and take 2-3 years to formulate the detailed rules and regulations."

"Traditional Chinese medicine formula granules are not a new market. The future competition needs participation in compliance, competition in technology and endorsement of strength. The first thing pharmaceutical enterprises need to do is to closely follow the regulation and get the approval of relevant supervision as soon as possible, which is the basis for entering the market. Other patient education and sales channel construction are actually very mature things. As long as they can enter the market again, they are all familiar things for these pharmaceutical enterprises. " The investors added.