PharmaSources/LaoxueJune 08, 2023
Tag: hydrocortisone , National Healthcare Security Administration , price reduction , API
On the evening of May 29, a fellow pharmaceutical company stated that the price of hydrocortisone acetate tablets was reduced.
As far as the source of the news is concerned, it is actually the Tianjin Healthcare Security Bureau, which issued a notice announcement on the 29th.
The announcement not only limits the price, for example, the price of the seven-tablet pack is reduced to RMB 13.3, or RMB 1.9 per tablet. The price of the 30-tablet package dropped to RMB 54.1, or RMB 1.81 per tablet, and a stable supply of the national market must be ensured.
For the price reduction of preparation, in addition to the coordination of the formulation enterprises, there are also factors of API companies involved. The monopoly of norepinephrine injection also reveals that the impact of APIs on the price of preparations should never be ignored.
In April, a self-media report indicated that hydrocortisone acetate tablets rose from RMB 0.45 in 2019 to RMB 9.86 per tablet. The medicine can still be available at this stage.
And by May 4th, the online store had become difficult to buy and direct searches were not available. And at the same time, some online pharmacies began to pre-sell Turkish products. It is worth noting that the drug's document number could not be checked in the NMPA's imported drugs.
There is also only one enterprise producing the drug in China, so there is not much competition in the market.
Notably, it is used for the replacement therapy of hyperalgesia and congenital adrenocortical hyperplasia, where patients require long-term or lifelong medication. Unlike cold medicine, you can stop taking it in stages. Therefore, the price increase has a very big impact on them. Of course, what's worse than the price increase is the out-of-stock. And other alternative drugs, such as hydrocortisone tablets, are likewise out of stock.
Since then, plenty of headline media have started to focus on the status of the drug. On May 19, according to a report by The Paper, the manufacturer of hydrocortisone acetate tablets responded that it is now a window period when the old and new versions are alternating and there is no intention to cut off the supply. Moreover, the registered manufacturing process for APIs is fermentation-based, while cheaper synthetic processes are now starting to be available abroad.
The coordination of the National Healthcare Security Administration only makes the price drop, and the status quo of the difficulty of exporting APIs is still unresolved. This price adjustment and supply guarantee are difficult at this time. The benefit is that Chinese patients who use drugs for a long time or even for a lifetime can accept the price, and the supply of drugs is guaranteed. If there is consumption, there is bound to be profit.
In fact, it is still the cost difference between fermented and synthetic types that plagues API and preparation enterprises. The price difference of API is actually for the export market. It is unrealistic to make up for the loss of one market from another.
Many drugs may face this problem. The original API production process was not competitive with the lower-cost process that followed. If the API is changed, the cost input is higher, which is a dilemma. This is a state of development in which pharmaceuticals are constantly updated and iterated. Any botanical raw material has seasonality and capacity fluctuation. Back then, oseltamivir phosphate had a raw material consisting of anise, a traditional Chinese medicine, which was later changed to a process of producing intermediates from recombinant E. coli, which greatly reduced the cost.
Therefore, other processes will also be developed for API, otherwise it will only be eliminated. The stable advantage of an API is also cyclical, and few drugs can remain stagnant. Even the penicillin antibiotic class is working to reduce allergens. In the case of hydrocortisone acetate tablets, at this stage, it is perfectly possible to have both fermented and synthetic forms. After all, in the Chinese market, with the exclusive advantage of variety, there is still an acceptable level of price. The profit concessions made by the enterprise for this time are very rare.
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