01
Recently, many consumers reported that the price of hydrocortisone acetate tablets, a hormone drug on the market for the treatment of adrenal insufficiency and congenital adrenal hyperplasia, has skyrocketed. Since most of them need to be taken stably for a long time, the skyrocketing price has caused the cost of medication for many patients to rise sharply.
It is worth noting that at present, hydrocortisone acetate tablets are only produced by a pharmaceutical factory in Tianjin Xinyi Jinjin Pharmaceutical Co., Ltd. (hereinafter referred to as "Tianjin Xinyi Jinjin Pharmaceutical"). On April 20, when the e-commerce platform was investigated, the price of the drug rose from 749 yuan to 858 yuan in half a day. And now that I search again, the whole network is out of stock.
Pharmaceutical manufacturer Tianjin Xinyi Jinjin Pharmaceutical staff said that there is indeed a premium for hydrocortisone acetate tablets on the market, but this is not a company behavior. The 30 tablets and 100 tablets per bottle previously sold on the market are old versions of drugs, which have been discontinued because they cannot be included in medical insurance. Although the new version of hydrocortisone acetate tablets has been on the market, it needs to be uniformly purchased by local governments, and only a few provinces and cities have been purchased, and it will take a while to enter hospitals across the country.
Public information shows that the new version of hydrocortisone acetate tablets is 7 tablets / plate, the current purchase price is 69 yuan, and the price of a single tablet has also reached about 10 yuan / tablet, which is actually the same price as 1000 yuan per bottle (100 capsules) after the price increase.
02
There are two weirdness about this thing:
1) Although hydrocortisone acetate tablets are not a large-selling drug, they are also life-saving drugs, mainly used for alternative treatment of adrenal insufficiency and congenital adrenal hyperplasia. Like some patients, it is because the pituitary tumor affects hormone secretion and requires lifelong medication. As a result, only one company has approved the preparation of such a life-saving drug [1].
2) Before being included in medical insurance, the price of this drug was 86 yuan/100 tablets; After being included in medical insurance, 69 yuan/7 tablets, one piece is close to 10 yuan. Now 100 tablets have risen to 1,000 yuan, which is the same as the price of medical insurance. The question is why has the price increased after being included in Medicare?
The explanation given by the head of the company is that the cost of raw materials has risen and the API production process cannot be replaced. The production process of hydrocortisone acetate API has synthetic type and fermentation type, and the cost of hydrocortisone acetate produced by fermentation process is higher, and the cost difference is about 20 times.
But hydrocortisone acetate raw materials have many manufacturers, there are six that can be found on the Internet, it is impossible for each of them to use the fermentation process. Synthetic type and fermentation type are nothing more than different processes, but the product is the same, and being able to get the API production approval at least proves that the consistency evaluation can be passed, so what is the difference between replacing the process of the API with the synthetic type?
Source: PharmacoIntelligence Data
Source: PharmacoIntelligence Data
03
Since the collection, the price of many domestic generic drugs has been cut at the ankle, like high blood pressure drugs, which now only need a few dollars a box, and the price has dropped by more than 10 times. On the one hand, patients do get benefits, especially many low-income groups have solved the problem of taking drugs; But on the other hand, because centralized procurement erases the profits of pharmaceutical companies, pharmaceutical companies must rely more on API companies to control costs.
In addition, the consistency evaluation of generic drugs puts forward higher requirements for the production process, quality control, ingredient purity and other aspects of API factories, and the cost begins to soar. Coupled with the pressure of EIA, many companies in the API industry have also been eliminated.
The consequence of these factors is that API companies have monopolies, and API prices have skyrocketed. For example[2]:
As the main ingredient of cold medicine, chlorpheniramine once rose from 400 yuan per kilogram to 23,300 yuan in 2018, an increase of 58 times. The price surge stemmed from monopoly - before 2017, there were as many as forty or fifty production enterprises in the country, and by 2018, these companies withdrew due to strict rectification, high costs and low profits, and finally only 6 enterprises with approvals remained, and only one Henan Jiushi Pharmaceutical actually produced. The company was eventually fined 1,157,300 yuan for selling chlorpheniramine to downstream operators at an unfairly high price.
However, no matter how the price of APIs rises, the listing price of the centralized procurement terminal cannot be moved. Therefore, many pharmaceutical companies that win bids at low prices cannot bear the losses caused by the increase in the price of APIs, and can only cut off supply in the end, and the consequence is that patients cannot buy drugs.
According to incomplete statistics from the previous Beijing News, since the national drug centralized procurement was launched, about 20 enterprises have cut off supply. Among them, the most serious punishment was that in 2021, North China Pharmaceutical was included in the list of violations and disqualified from the national procurement declaration for the next ten months because it failed to complete the supply of ibuprofen sustained-release capsules as agreed.
Back to hydrocortisone acetate tablets, it is currently produced by only one enterprise, so there is no possibility of centralized procurement, and there is no price increase and then price reduction for centralized procurement. The current price increase factor can only come from the price increase caused by the monopoly of APIs/excipients, and not only the price increases, but even the shortage of stocks, which is enough to prove that there is no competitive pressure on the APIs/excipients manufacturers behind them.
To solve the problem that the price of APIs is rising too fast, the core method is that the terminal price of drugs should not be so limited, drug companies should leave a part of the profits, and at the same time encourage market competition (do not produce one drug in one enterprise). If pharmaceutical companies can compete freely and rely on product quality pricing instead of one-size-fits-all, the voice of API companies in the entire pharmaceutical industry chain will naturally decline, and monopoly will not easily appear.
reference
[1] https://mp.weixin.qq.com/s/akGckh9IawJy3I0qe5aTFA
[2] https://mp.weixin.qq.com/s/TAsD_o9H3cP7ETJ_zN7b4w