After the third batch of national pharmaceutical collection, the profits of the relevant pharmaceutical enterprises plummeted, "the entire pharmaceutical industry is shaken", to the chemical generic drugs as the main varieties of a company's executives Guo Jia that the chemical drugs have completed the third batch of the national collection, pCms into the national collection has been under discussion, the future (included) is inevitable, the earliest, in the fourth batch. In the future, it is inevitable that they will be included in the fourth batch at the earliest possible time.
Price cuts, price cuts, price cuts!
How hard is the "soul chopping" that makes pharmaceutical companies anxious about the national collection?
On November 5, the national collection of coronary stents in Tianjin bidding. 11 enterprises 26 stent products without group bidding. The final results show that the price of a single coronary stent fell from 13,000 yuan to an average price of 700 yuan, and the lowest offer was only 469 yuan/branch. Compared with 2019, the same products from the same companies have an average price reduction of 93%, domestic products have an average price reduction of 92%, and imported products have an average price reduction of 95%.
This is certainly not the case, the price of every product that enters the national collection has fallen to the floor, the price drop of more than 50% is the norm, and a drop of up to 90% abounds.
For example, the price of levofloxacin hydrochloride (2ml: 0.2g) was as high as $15.82 for a single unit, and now the national bid price is around $0.8, and in the collection of Shanxi, Jiangsu Wuzhong Pharmaceutical Group quoted a price of $0.43 for a single unit of this product.
Since November 16, the third batch of national centralized procurement of drugs in Shandong Rizhao each relevant medical institutions to fully start with the use of *** involves 55 kinds of drugs, the average price reduction of 53%.
The full name of centralized purchasing is centralized banded purchasing of medicines.On November 14, 2018, the fifth meeting of the Central Committee for Comprehensively Deepening Reform considered and adopted the "Pilot Program for Centralized Purchasing of Medicines by State Organizations", and the first batch of centralized purchasing pilots are 11 cities such as Beijing, Tianjin, Shanghai, Chongqing, etc., which is known in the industry as the "4+7 ".
Price reduction is the most direct goal of centralized procurement.
On December 10, 2019, the National Health Insurance Bureau issued the "Opinions on Doing a Good Job in the Current Management of Drug Prices", which makes it clear that the reform of the centralized banded purchasing system of drugs is deepening, and adheres to the direction of "banded purchasing, quantity and price linking, and recruitment and purchasing," and promotes a return to reasonable levels of drug prices. The first step is to make sure that the price of medicines returns to a reasonable level.
Yang Liu said, for pharmaceutical companies, this round of centralized purchasing and the biggest difference between the previous pharmaceutical procurement is the procurement volume and price directly linked, the amount of purchasing volume is there, the enterprise can either reduce the price of the bid, or only out.
The first batch of pilots showed the power of price killing in collective purchasing. on December 7, 2018, the state organization "4+7" city drug centralized purchasing pilot to be selected results announced, 25 pilot generic drug centralized purchasing to be selected, compared with the pilot city in 2017 the lowest purchase price of the same kind of medicine, the average reduction rate of 52%, the highest rate of reduction reached 96%.
By 2020, centralized procurement will become the norm in the country, and the scope of centralized procurement will be further expanded.
In May of this year, the State Drug Administration issued a notice stating that it would carry out a consistent evaluation of the quality and efficacy of generic chemical injections. This is regarded as a signal to carry out collective procurement. In the third batch of collection, *** there are seven injection varieties are included.
The National Essential Drugs Catalog (2018 Edition) *** has three parts: chemical drugs and biological products, proprietary Chinese medicines, and Chinese medicinal tablets, of which 417 types of chemical drugs and biological products, and 268 types of proprietary Chinese medicines, *** counting 685 types.
From the number of varieties, pCms account for quite a large proportion, and it is only a matter of time before pCms are included in the collection in the future.
No "consistency evaluation" of pCms, how to do the collection?
In Guo Jia's view, pCms to enter the collection, there are still a lot of obstacles to cross, the first problem to be solved is similar to the chemical "consistency evaluation".
Drug consistency evaluation refers to the "national drug safety" Twelfth Five-Year Plan "requirements, generic drugs should be consistent with the quality and efficacy of the original drug. According to the "Opinions on Carrying Out Consistent Evaluation of the Quality and Efficacy of Generic Drugs (Guo Ban Fa [2016] No. 8)" issued by the General Office of the State Council on March 5, 2016, the same variety of drugs through the consistency of the evaluation of the production enterprises to reach more than three, the centralized purchasing of medicines, etc., no longer choose to use the varieties of drugs that have not passed the consistency of the evaluation.
Guo Jia believes that the efficacy of pCms is often difficult to quantify, even if the same product produced in accordance with the National Pharmacopoeia, such as the six flavors of the pill of different companies, it is difficult to use a variety of indicators to measure the consistency of evaluation similar to chemical drugs. In addition, there are a lot of proprietary Chinese medicines, the national exclusive varieties, protected varieties, and even the varieties of the confidential party.
Ning Heli, deputy chief physician of Hunan Provincial Hospital of Chinese Medicine Research Institute, believes that the quality of Chinese medicine can be said to be the core, Chinese medicine is not divided, if the quality of Chinese medicine is poor, the therapeutic effect will not be good, in this regard, the need for strict supervision, good daoji medicinal materials.
In Hunan Lianqiao, which ranks as China's fourth largest market for Chinese herbal medicines, China Economic Weekly learned that at present, many Chinese herbal medicines are actually sold in accordance with the standards of agricultural products, and the production of daoji medicinal materials is the goal of local efforts. Obviously, if the quality of the herbs cannot be guaranteed at the source, the ultimate efficacy of pCms is water without a source.
Nonetheless, the centralized collection of pCms is still a major trend.
On July 15-16, 2020, the State Medical Insurance Bureau said it was listening to expert opinions and suggestions on the centralized procurement of biological products (including insulin) and proprietary Chinese medicines, studying and improving the procurement policy in related areas, and promoting the reform of the procurement method.
On September 15, the NHPA said in response to Recommendation No. 5936 of the Third Session of the Thirteenth National People's Congress that, up to now, the State has organized three batches of centralized banded purchasing,*** involving 112 varieties of medicines, all of which have passed the consistency evaluation of quality and efficacy. The next step will be to study and explore the centralized banded purchasing of drugs that have not been evaluated and drugs for which there is currently no consistency evaluation standard, such as biological products and proprietary Chinese medicines.
It has been rumored that the NHPA has drawn up a banded purchasing catalog of 500 pharmaceutical varieties, not only chemical drugs but also proprietary Chinese medicines, including 79 exclusive varieties. At present, this news has not been confirmed by authoritative channels.
On November 21, Ding Jinxi, executive vice president of the Graduate School of China Pharmaceutical University, said at the third "South Drugs Summit Forum", the fourth batch of collective purchasing program has been doing, is screening varieties, varieties of the scope will be expanded to expand to the injectable, will consider biologics (insulin) and proprietary Chinese medicines, to explore the various types of medicines suitable for the collective purchasing standards. The fourth batch of collection program has already been done, and is screening the varieties.
At present, although the national collection of proprietary Chinese medicines has not yet been implemented, but there have been local early action. For example, Qinghai has included six Chinese medicine injections, including thrombus, phlegm heat, hemosiderin, danshen polyphenolates, nephropathy, and xiyanping, in the scope of volume purchasing.
Zhejiang Jinhua, the second batch of banded purchasing catalog of 180 pCms, with the same generic name and the same specifications of pCms containing low-priced drugs to set a maximum price, on the basis of the maximum price, the offer shall not be reduced by less than (inclusive of) 10%, which is the exclusive enterprise production of pCms is a low-priced drug, on the basis of the maximum price, the offer shall not be reduced by less than (inclusive of) 20%.
In the end, in the 180 pCms only 39 products were selected, the selection rate of only 21.7%, including Yunnan Baiyao, pediatric black bean and warthog clearing heat particles, Pudilan anti-inflammatory oral solution and other best-selling products.
Where is the future of pCms?
"The state must find a way, the future of Chinese medicine companies will be more and more difficult." Talking about pCms into the collection, Yang Liu looks quite pessimistic.
Many pCms companies are really having a hard time. The first three quarters of this year's financial data show that Hansen Pharmaceuticals, Jichuan Pharmaceuticals, Panlong Pharmaceuticals, Guangyuguan, Taiji Group, Tianmu Pharmaceuticals and other proprietary Chinese medicine companies have declined, the market to the valuation of proprietary Chinese medicine companies are generally less than 30 times the price-earnings ratio. "Funds, institutions are not looking, pCms companies have very little research." A company securities affairs representative said.
Companies have sought to transform, in different directions. CITIC Securities research report released in November will be Yunnan Baiyao and Pientzehuang for large health consumer leaders. Yunnan Baiyao has been doing toothpaste, shampoo and other health products for many years, and in 2019, the company's health products net profit of 1.620 billion yuan, net profit accounted for 70.77% of the company's non-deductible net profit that year.
The eye of the sky APP shows that Pientzehuang (600436) business scope of new tea products production, animal breeding, medical research and experimental development, sales of household electrical appliances, stationery wholesale, sales of the second class of medical equipment, sales of sanitary products and disposable medical supplies, sales of household goods.
Cross-border consumption is more like a "side door". Yang Liu said that after the collection, including pCms, pharmaceutical companies want to survive, can only desperately to do innovation, the direction is mainly chemical and biological drugs.
And in this year's collection in Qinghai, Xiyanping injection is one of the winning varieties.
(In the article, "Guo Jia" and "Yang Liu" are pseudonyms)
Editor-in-chief | Yang Baihui
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