"Before the implementation of drug collection, there was no patent cliff in China." On December 15, Jiang Changsong of the National Medical Insurance Research Institute pointed out at the "Press Conference on the Changes in the Use of The Original Research Drugs Selected in the Collection".
For a long time, expired patents and generic drugs accounted for 65% of the purchase amount of China's prescription drug market, while generic drugs in developed countries accounted for only 20% of the purchase amount. Those who have long been superstitious about "imported drugs" are not only patients, but also a large number of doctors.
Hu Xin, chief pharmacist of the Pharmacy Department of Beijing Hospital, said: Before the drug collection, many doctors did not even know how to prescribe generic names (drugs).
Around 2010, the world's major pharmaceutical companies have come to the edge of the "patent cliff", a large number of excellent small molecule drugs developed and listed in the 1990s are facing the expiration of patents, the rise of generic drugs competition, large pharmaceutical companies have to reduce prices to cope with competition.
However, in the Chinese market, because generic drugs cannot compete with expired patent drugs, the expected situation of "price reduction of imported drugs" has not arrived.
For example, aspirin that has been listed for more than 120 years, Bayer's original varieties were priced at about 0.5 yuan per piece in 2010, and domestic varieties were only about 0.1 yuan at that time. "The quality of imported varieties is reliable" is the main reason for supporting the continuous high price of original research drugs with expired patents.
If it were not for the National Medical Insurance Bureau to start the collection, China's version of the "patent cliff" does not know when it will come.
The substitution effect is obvious, and the purchase volume of unselected original research drugs has dropped sharply
Jiang Changsong believes that the United States, Germany, the United Kingdom and Japan and other countries have launched different forms of procurement models, while China's drug collection is in line with international standards.
The most direct result of drug collection is that the purchase amount of the original research drugs that have not been selected has dropped significantly, while the procurement volume of the selected generic drugs has increased significantly.
The China Medical Insurance Research Association selected 9 kinds of drugs such as atorvastatin oral regular-release dosage form and amlodipine oral regular-release dosage form and found that the procurement amount of unselected original research drugs was 4.681 billion yuan before the collection; in the first year after the implementation of the collection, the procurement amount of unselected original research drugs plummeted to 2.527 billion yuan, a drop of 46.03%.
From the perspective of specific varieties, Merck's "Shu Descending", Bayer's "Daxi" and Novartis' "Daiwen" decreased by 74.43%, 60.28% and 55.05% respectively, ranking the top three in the change in procurement amount before and after collection.
The decline in the purchase volume of unselected original research drugs is only one of the changes in the pharmaceutical market. Looking at the hospital market involved in the national collection, the advantages of multinational pharmaceutical companies have long gone, and Chinese pharmaceutical companies have ushered in major opportunities.
The data provided by the China Medical Insurance Research Association shows that the purchase volume of selected generic drugs has risen sharply, and the masses use the selected drugs with "high quality and good price". Purchases of 9 of these drugs continued to rise, with entecavir oral regular-release agents increasing the most, at 77%. At the same time, the structure of drug use is optimized: under the same generic name, the purchase volume of original research drugs has dropped from 28.9% before the collection to 12.7%.
The "struggle" between China's generic drugs and original research drugs originally had no full chance of winning, and it was the hand of policy that boosted the domestic substitution.
Of course, in order to compete with the original research drugs, quality must be put first. Zhao Xiang, manager of the central affairs department of the policy and regulation department of Qilu Pharmaceutical Sales Corporation, revealed that Qilu Pharmaceutical has won a total of 34 varieties in 5 collections, and its market share in the supply provinces is basically more than 80%, and its market share has increased significantly.
At present, 96 drugs in Qilu have passed the consistency evaluation, and some of the production line products for collecting drugs have also been exported overseas. "Over-evaluation" means that the state proves that its quality and efficacy are consistent with the expired patent drugs in order to be recognized by the market.
If a large number of expired patented drugs want to regain the market, they must win in the national drug collection.
The selected varieties continue to increase, and the rules of the generic drug industry are reshaped
Expired patented drugs that have been calling for rain in China have had to start price reduction strategies after the collection, and some have fallen to the "floor price".
The report "The Logic and Progress of National Organization of Drug Collection" shows that in the five national collections, the proportion of the original research drugs in the selection is the highest and only 32%, and the lowest is only 10%.
In addition to the insulin field, many original research drugs have not entered the collection. Foreign companies "vote with their feet", in fact, have their own difficulties, Because multinational pharmaceutical companies are a global pricing strategy, the pricing of a certain market is too low or too high, will affect the pricing of other countries or regions.
After the original research drugs that entered the collection were significantly reduced, the products were reduced by more than 43% after the report combed 22 expired patented drugs such as Bayer acarbose, Pfizer's linezolid, and Sanofi's oxaliplatin entered the collection.
Expired patented drugs that have not been collected have also reduced their prices, which is similar to the performance of the developed markets in Europe and the United States: after the patent period of the original research drugs, the price of the product will plummet, and even take the initiative to withdraw from the market and no longer produce.
Domestic generic drugs have developed rapidly. Taking Huiyu Pharmaceutical as an example, the company's domestic sales before the collection were almost zero. However, from the "4 + 7 collection", Huiyu Pharmaceutical actively participated, and 6 varieties were selected in the 5 rounds of collection. According to the data released by Huiyu Pharmaceutical, the company's business scale has exceeded 1.3 billion yuan in 2020.
Drug collection not only brings new opportunities to domestic pharmaceutical companies, but also reverses the medication habits of medical institutions. Hu Xin believes that the collection of drugs unifies the dosage form of the selected variety.
"It turns out that moxifloxacin hydrochloride tablets have multiple dosage forms such as 0.25g, 0.35g, 0.5g and 0.70g, resulting in unsafe factors in clinical use." Hu Xin believes that 0.25g and 0.5g are relatively safe dosage forms for patients to use.
Hu Xin frankly said that before pharmaceutical companies arbitrarily modified the specification dosage form, in order to obtain the identity of "new drugs" and pursue greater economic interests. After the collection and collection enter the normalization, this phenomenon will be curbed.
Some analysts pointed out that through the consistency evaluation work, generic drugs have proved the safety and effectiveness of clinical manifestations themselves, which is undoubtedly a win-win situation for medical insurance and patients.
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