| Author of Huxiu Medical Group
| Chen Guangjing
title picture | Visual China
The mid-year profit-sharing "big giveaway" in the medical industry has come to an end.
The new "best-selling" Nifedipine Sustained Release Tablets (II) for the treatment of hypertension and angina pectoris , won the bid with the lowest price at 2.1 yuan/bottle, and the single row price was 4.2 points, compared with the highest effective declaration The price was 0.476 yuan, a decrease of more than 91%.
Influenza "miracle drug" The price of a single tablet of Oseltamivir has dropped to less than 1 yuan - Dongguangguang Pharmaceutical's product is 0.99 yuan/tablet. Compared with the maximum price, the decrease is 84.65%. If according to the original The purchase price also dropped by nearly 93%.
Even small molecule targeted drugs that were once unattainable are now significantly cheaper. The average price of a single tablet/tablet of the 4 targeted drugs involved in this centralized purchase is 18 yuan, and the price of some products has even dropped to less than 5 yuan - Simcere Pharmaceuticals 's lenvatinib mesylate capsules, 3.2 yuan / capsule, which is 97% lower than the 108 yuan limit price preset by the centralized procurement rule makers!
and the price is very tight. According to industry sources, the price of paricalcitol has been reduced by 92%, from 177 yuan/piece to 15 yuan/piece. Products priced at 18 yuan were not selected.
In the seventh batch of national drug centralized bulk procurement (referred to as "centralized procurement" or "national procurement"), which opened bids on July 12-13, 60 best-selling drugs saw significant price cuts. The average price reduction is 48%. Based on the agreed purchase volume, it is estimated that 18.5 billion yuan can be saved every year.
Official data shows that since 2018, under the organization of the National Medical Insurance Administration, 294 types of medicines have been significantly reduced in price through price-for-volume exchanges. The average decline rate of the 218 drugs in the first five batches of centralized purchases was more than 52%. According to statistics from the National Medical Insurance Administration, these drugs alone have reduced the burden on medical insurance funds and patients by at least 260 billion yuan.
Amid the overwhelming price cuts and "good news" of being selected, the rapidly advancing process of replacing imported original drugs with generic drugs has also caused some patients to worry about the quality of the drugs. What is the reason for the price reduction? Are low-priced generic drugs really inferior to high-priced original drugs?
"Sky-priced drugs" have reached "floor prices"
"The price reduction effect of medical insurance negotiations and centralized procurement is obvious."
Lawyer at Beijing Yuntong Law Firm and general counsel of Dancing with Cancer Forum Han Xiaochen told Huxiu that in order to Take the first-generation targeted drug for lung cancer , gefitinib , for example. It cost 550 yuan per tablet before being covered by medical insurance, which is 16,500 yuan a month. Generally, if you get a charity drug, you have already spent more than 100,000 yuan. After several rounds of price reductions through medical insurance negotiations and centralized purchasing in the past few years, patients’ out-of-pocket expenses are now only two to three hundred yuan per month. The financial burden is greatly reduced.
Judging from the official results of the seventh batch of centralized purchasing, a large number of relatively high-priced drugs were offered at staggeringly low prices.
For example: Omeprazole sodium injection, a blockbuster drug for the digestive system, originally had a minimum price of 2.46 yuan per unit. After centralized purchasing, the original bottom price became a "ceiling". The new bottom price is the price per unit of Harbin Sanlian Pharmaceutical's products. 0.694 yuan, which is lower than mineral water.
Tenofovir alafenamide fumarate, the "most powerful hepatitis B drug in history", is called "TAF" by patients. It is a recommended first-line antiviral drug for chronic hepatitis B. Its original drug is Gilead 's Vailide, which has just been launched. The price is 1,180 yuan/bottle, but after enrolling in medical insurance, it dropped to 540 yuan/bottle, which is still relatively high.
There are nearly 30 million hepatitis B patients in China, and the treatment rate is only 11%. Many of them are unable to take medication due to economic reasons.
In this round of centralized procurement, the first winner of this drug is also the company with the lowest price. Qilu Pharmaceutical has lowered its price to a new low of 9.6 yuan/30 tablets, which works out to only 3 cents per tablet. 2 cents. Compared with the price of the original drug, it is really less than a fraction. This can also reduce the situation of being unable to use the drug due to financial reasons. Not to mention
targeted drugs. The initial price of imported lenvatinib is 20,000 yuan per box, and sunitinib has just entered China for 46,000 yuan per box. Roche’s first-generation targeted drug , erlotinib , once sold for more than 640 yuan per piece, and it will also cost more after being covered by medical insurance. Nearly 200 yuan a piece...
These were once "extremely expensive drugs" that suffocated Chinese patients. After being included in medical insurance, it was difficult to enter hospitals and benefit patients because of high prices and a squeeze on the proportion of drugs.The new winning results of
show that the maximum price of a single pill of domestically produced lenvatinib does not exceed 30 yuan, erlotinib only costs a few yuan per pill, and the price of a single pill of sunitinib only costs 20 or 30 yuan. Under the pressure of competition, imported pharmaceutical companies will inevitably lower their prices. In this way, the pressure on hospitals and patients will be greatly reduced.
Behind these achievements, the competition in centralized purchasing is becoming increasingly fierce.
Although in the past few years, domestic companies have been wailing under the centralized purchasing, but in actual actions, they have laid out the consistency evaluation of generic drugs and eliminated competitors without mercy.
According to Insight statistics, in the seventh batch of centralized procurement, 54 companies have more than five competing companies. Among these products, 14 varieties have more than 10 competitors, and 7 of them have as many as 13 companies competing.
The price reduction models mentioned above are all battlegrounds for military strategists.
Among them, omeprazole sodium injection is the most competitive, with 28 products participating in the competition; tenofovir alafenamide fumarate, known as "the most powerful hepatitis B drug in history", has 19 companies bidding on the same stage; imported original research The original research drugs of lenvatinib, afatinib , erlotinib, and sunitinib are also surrounded by 10, 7, 7, and 5 local companies respectively.
Oseltamivir, a highly effective influenza drug that has attracted much attention, has also been shortlisted by 14 companies.
Data released by the National Medical Insurance Administration shows that an average of 5.4 companies have been selected for each drug. This data reflects both the stability of supply and the brutal competition.
Local giants such as Qilu Pharmaceutical , Yangtze River Pharmaceutical and CSPC Pharmaceutical Group, which have always been decisive in centralized procurement, have at least 10 varieties in centralized procurement - Qilu Pharmaceutical has the largest number of 17 Heavy variety.
Even Hengrui Medicine, which has always been on the sidelines on centralized procurement and was not positive about consistency evaluations , has 16 drugs that have passed the consistency evaluation in 2021, including many in this round of centralized procurement. drug.
As of the seventh batch, 294 kinds of drugs have been included in the centralized procurement. You must know that there are only four to five hundred kinds of drugs commonly used in public hospitals. In this sense, the seventh batch of centralized procurement is simply a decisive battle.
"The centralized procurement of mainstream generic drugs with large existing markets and easy to be reviewed will basically end by the end of this year, and the rest are hard to chew. The peak of 'reviewed' dividends in a specific era has passed." Nanjing Evidence-Based Biotechnology Guo Xinfeng, general manager of the company, told Huxiu.
Those who have experienced it summed up the essence of centralized purchasing as "Prisoner's Dilemma" and "Nash Equilibrium". To put it simply, if you don’t lower the price, many people will. In an interview with the media, a company representative said that he did not dare to think about profits, as long as he could win the bid.
Imported original research drug was sold out of the hospital
"Now public hospitals can no longer prescribe original research venlafaxine ." Since the beginning of the year, Mihua has been buying this drug on e-commerce platforms.
In the process of going to the hospital again and again to prescribe original medicine without success, she also gradually understood what "centralized procurement" is.
"The doctor said that this drug centralized procurement did not win the bid. At first, he said that he could try it again, but then he directly said that it was no longer available. It should have been removed from the purchase catalog." Mi Hua introduced to Huxiu.
The venlafaxine mentioned by Mi Hua is an antidepressant drug. It is the fifth batch of drugs in the national centralized procurement. Four products were finally selected. The imported original drugs Pfizer Effexor were not among them. .
Mi Hua is not an isolated case. In the past four years, under the guidance of consistency evaluation and centralized procurement, local generic drugs are on the rise. At the same time, imported original drugs that once dominated the mainstream Chinese pharmaceutical market are withdrawing in batches.
According to incomplete statistics from Huxiu, since 2018, nearly a hundred imported original research drugs have not won bids for centralized procurement. This includes well-known products such as Lipitor, Norvox, , Gleevec, and Cordine, which were once popular in China, as well as Effexor, which Mihua wants to buy.
In the seventh batch of centralized procurement, among the 60 drugs to be selected, there are only 6 imported products, and only 4 of them are original drugs - Tigecycline from Pfizer of the United States and Mica from Astellas of Japan. Fenjing, Ebastine from Spain's Amero Company, and Dimparol from Italy's Bracco Xinyi Company.
According to incomplete statistics from Huxiu, at least 36 original research drugs failed to be selected.
The data comes from the Shanghai Sunshine Procurement Platform and public information, compiled and charted by Huxiu.
According to market rules, companies selected for centralized procurement can get 50% to 80%, which means that there is limited space left for unselected drugs.
In actual operation, in order to solve the problem of using medicine to support medicine, public hospitals have greater assessment pressure in terms of the proportion of medicines and other aspects, and have strict restrictions on higher-priced medicines. Moreover, the medical insurance policy implemented by hospitals prioritizes drug selection and prescription from centralized procurement. “If the dosage of centralized drugs does not meet the standard, the clinic will be held accountable.” A clinician told Huxiu.
Therefore, there is indeed a situation where public hospitals directly stop using imported original drugs "one size fits all".
In China, drug sales in public hospitals still account for more than 60%. After failing to be selected for centralized procurement, these drugs have actually withdrawn from the mainstream market.
For a long time before, local pharmaceutical companies had weak R&D capabilities, backward technology, and severe homogeneous competition. They had no power to fight back in the competition with multinational pharmaceutical companies. Imported drugs are in a state of "making money while lying down" in the Chinese pharmaceutical market. Not only do they enjoy "super-national treatment" in terms of pricing, they are also the best choice in the minds of many doctors and patients.
Song Jin'an and Chen Dong from the Eighty-first Hospital of the People's Liberation Army stated in the article "Research on Reasons and Countermeasures of Domestic Drugs Difficulty Competing Joint Ventures and Imported Drugs" that in 1996, of the 120 million yuan in drug revenue of a major hospital in Beijing, imported drugs accounted for 50%. %, joint venture drugs account for more than 30%, and domestic drugs only account for about 17%. Nationwide, imported drugs and foreign-funded enterprises also account for 40% of drug sales.
Until centralized procurement, the domestic substitution rate was still limited. According to Chinese Pharmaceutical Association statistics, 7 of the top 10 pharmaceutical companies in the eastern region in terms of sales volume in 2018 were multinational pharmaceutical companies, accounting for more than 10% of the total purchase amount.
In the same year, experts from the Pharmacy Department of the First Affiliated Hospital of the Fourth Military Medical University conducted a "cost-effectiveness" analysis on octreotide and also found that although the cost-effectiveness analysis showed that the scores of imported drugs and domestic drugs were 48.66 and 14.38 respectively. , although domestic drugs are obviously more economical, clinically, the number of patients using imported drugs is 2.47 times that of patients with domestic drugs.
After the centralized procurement, a large number of original research drugs withdrew from the public hospital market, and generic drugs quickly counterattacked - the latest data from minet shows that Changchun Haiyue's Tadalafil tablets had a market share of only 0.43% in 2019 and has already reached 2021. Recently reached 35%; Sichuan Guowei Pharmaceutical’s solifenacin succinate tablets’ market share also surged from 0.44% to more than 50%.
However, the original drug still has a broad mass base and has also achieved rapid growth outside the hospital. Minai.com conducted statistics on drug sales in online pharmacies and physical pharmacies in 2021. The results show that many of the large varieties that ranked high on the drug list of public hospitals in the past have become new stars in the out-of-hospital market.
For example, AstraZeneca 's budenad suspension for inhalation, which was unsuccessful in the fifth batch of centralized procurement, its online sales increased by 214.82% in 2021; Huizhi (formerly: Pfizer), which was unsuccessful in the first batch Lipitor, with sales of 1.802 billion in physical pharmacies in 2021, ranks among the top 3 best-selling chemical drugs; Huizhi’s Viagra (sildenafil citrate tablets) growth rate exceeded that of its “old rival” Guangzhou Pharmaceutical Group for the first time.
Are cheap medicines worse than high-priced medicines?
Relying on centralized purchasing to accelerate the rise of generic drugs, it has not conquered the hearts of patients and their families.
"If I knew there was an original drug, I would definitely take it." On a winter day in 2021, Mi Hua felt that she had fallen into that state of "lack of energy and just wanted to lie down" again. "I had been taking generic drugs for two or three years at that time, and suddenly I felt that the effect was not as good as before."
Then she went to a private hospital and learned for the first time that there are generic and original drugs. "Are you taking generic medicines?" This was the first question the doctor asked after listening to Mi Hua's description of the symptoms. "I can't say whether it's because of the medicine or psychological effects, but the problem did improve after changing the medicine." Mi Hua told Huxiu, and the price was only 100 yuan more expensive.
In practice, there are many similar situations.
"A typical example is Gleevec. After the centralized procurement of domestic generic drugs, the average monthly cost of this drug is only a few hundred yuan, but the vast majority of patients will still choose imported drugs." Moderator of the Dancing with Cancer Forum, Shen Longhai, deputy director of the Cancer Center of Liaoyou Baoshihua Hospital, told Huxiu: "Because patients think that although domestic drugs are cheap, there is a huge price gap and they are worried about the quality gap. As long as economic conditions permit, they will still choose higher-priced imported drugs."
Gleevec , also known as imatinib tablets, is a drug used to treat chronic myelogenous leukemia. This medicine is also the prototype of Glenin in the movie "I am not the God of Medicine ". When I first entered China, a bottle cost 25,000 yuan. If I use 2 bottles a month, the cost is about 50,000 yuan. After enrolling in medical insurance, the out-of-pocket amount per bottle will be about 5,000 yuan.
After centralized purchasing, a box of generic drugs only costs a few hundred yuan, and the price of imported drugs has become more affordable. "As long as targeted drugs are effective, patients must take them for life." Shen Longhai analyzed to Huxiu that for a better medication experience, imported drugs will be chosen as long as the economic conditions are not too bad.
In fact, after centralized procurement has reduced the price of drugs to a few cents a piece, whether the selected generic drugs can be used for important tasks has also become a key point of concern for people from all walks of life.
Shi Luwen, director and professor of the International Research Center for Pharmaceutical Management at Peking University, wrote an article discussing this matter after the fifth batch of centralized purchasing. He believes that the large price gap between selected drugs in various regions has aggravated this doubt, and even the problem of "drug immigration" has arisen.
wrote in the article: "Patients' perception of 'good medicine' is usually linked to price. The higher the price, the better the quality... Although we as professionals know that their quality is consistent, this is not necessarily the case for patients." "It is believed that it may affect their trust and choice of the winning varieties."
Professionals and the public have historical reasons for their distrust of generic drugs.
In an era when doctors and medicines are scarce, in order to solve medication problems as soon as possible, the threshold for generic drugs in China is very low, and there is no such thing as "consistency evaluation." During this period, many generic drugs were not generic versions of original drugs, but generic versions of generic drugs. Coupled with problems such as excipients and backward technology, although many generic drugs have the same ingredients as the original drugs, their efficacy and safety are no longer guaranteed. Some antibacterial drugs are more susceptible to allergies due to more impurities, and some tablets do not even disintegrate in the body. discharge.
Therefore, for a long time in the past, clinical pharmacy experts have directly equated generic drugs with "fake drugs".
Since 2016, the State Food and Drug Administration has promoted new policies such as the consistency evaluation of generic drugs , which are also aimed at solving the problem of uneven quality of generic drugs. In the centralized drug procurement organized by the state, only original drugs and generic drugs that have passed consistency evaluation and are officially recognized as equivalent to the original drugs are eligible to participate.
In order to prove that the selected generic drugs are indeed equivalent to the original drugs, the relevant person in charge of the National Medical Insurance Administration has repeatedly stated that what is squeezed out is the water in the intermediate links and has no impact on the production companies. At the same time, 22 specialty hospitals in Beijing have been specifically linked to the centralized procurement of the selected drugs. The efficacy and safety of the drugs were evaluated, and the consistency of 14 generic drugs with the original drugs was initially proved.
Due to the limited number and short time, the above results are still unconvincing, and it is difficult to reach a consensus even in the professional field.
"Trust in the brand is slowly built up." Pan Yong, deputy chief physician of the Breast Cancer Center of Beijing US-China Airui Cancer Hospital, pointed out to Huxiu that in recent years, the quality of Chinese products, including mobile phones, cars and drugs, has improved. , but patients and their families don’t understand that it takes time to psychologically accept this change.
"The treatment options for cancer patients are irreversible, so it is not difficult to understand that as long as the financial conditions are sufficient, they would prefer to use imported drugs even if they pay for themselves." Pan Yong said.
According to the quotations leaked from the industry, almost all the imported drugs that failed to be selected have a "no intention of fighting" attitude. They are either quoted at the limit price or directly exceed the limit price.
For example: AstraZeneca's Omeprazole Sodium Injection is quoted at 54.77 yuan/tube, which is nearly 300% higher than the maximum price of 14 yuan/tube; Gilead's Vailide is quoted at 539.4 yuan, with an average price of 17.98 yuan per tablet, which is a top-line quote. .Neither was selected.
Behind this, there are not only considerations by multinational pharmaceutical companies to maintain the global price system, but also contempt for generic drugs and confidence in brand appeal.
This also means that whether it is through consistency evaluation or being selected through centralized procurement, it is only the first step in the rise of China's generic drugs.
"China's consumption will inevitably promote China's manufacturing." Many industry experts have pointed out to Huxiu that after centralized procurement and medical insurance negotiations have prompted a large number of domestic generic drugs to be used in clinical trials, and after being clinically reviewed in China, they are bound to become a Chinese pharmaceutical overseas in the short term. the main force.
However, if there is really no profit, will the company still have the motivation to do further research?
What exactly do patients want?
It is patients who demand price reductions, and it is patients who turn around and buy high-priced original drugs. What do they want?
"More people should know that drugs can be divided into generic drugs and original drugs." Mi Hua told Huxiu.
Objectively speaking, even if it is a generic drug that has passed the consistency evaluation, there is still a gap between it and the original drug. This has been confirmed by people close to the National Medical Insurance Bureau, but the gap is not as big as many people imagine. From a professional point of view, there is "no statistical difference". Taking into account economic and other factors, the advantages of domestic substitution still outweigh the disadvantages. This is also the basis for the establishment of centralized purchasing logic.
But for specific patients, the risks also exist objectively.
"My father-in-law developed severe gastrointestinal ulcers after taking capecitabine prescribed by a public hospital. He originally had a digestive tract tumor, and his weight has dropped sharply since then." A family member of the patient told Hu Sniff, the patient had no such reaction after taking imported medicines before.
Other drugs have also received "complaints" from patients.
"I still feel that it is better to take imported medicine." Many patients, including Mi Hua, have similar experiences. Some clinicians agree with Mi Hua's feelings and believe that generic drugs have greater side effects, while imported drugs are relatively more effective.
Beijing Anzhen Hospital A study by Ma Changsheng and others also found that when using statin drugs , the compliance rate of original drugs is 36.2%, while the compliance rate of domestic generic drugs is only 28.2%.
Are these "phenomena" and "feelings" accidental or inevitable? These require more research to clarify. A clinical pharmacy expert told Huxiu that although it is not necessary, it is better to conduct "head-to-head" research on domestic generic drugs. Because "it can reduce confounding factors and better demonstrate clinical equivalence."
Many clinical experts also pointed out to Huxiu that it is normal for drugs to have adverse reactions, and individual cases cannot prove that generic drugs do not necessarily have more adverse reactions than original drugs.
"Patients should be given the right to choose." Pan Yong expressed his views to Huxiu. It is true that there are patients in public hospitals who want to use imported drugs but cannot.
He believes that the medication process of is very complicated. Each drug has a different "adverse reaction spectrum" and will produce different curative effects according to the patient's own situation. It cannot simply be labeled as domestic, imported, or imitation. Original label. "I think patients should be informed of the side effects and efficacy and let them make their own choices."
Kang Zhen, deputy director of the National Licensed Pharmacist Development Research Center of China Pharmaceutical University, also pointed out to Huxiu, "The evaluation of whether medication is reasonable needs to start from the context of the use of the medication. "During the medication process, doctors, pharmacists, and patients should perform their respective duties and bear corresponding responsibilities.
As the decision-maker for medication, doctors usually prescribe medication based on the chief complaint. Drug treatment management can be carried out by pharmaceutical experts, who can tell patients what is the most reasonable, effective, safe and economical plan. Ultimately, it is up to the patient to choose what medication to use. Come and "make a final decision".
In China, the role of the latter two is often ignored in the management of the medication process.
As the saying goes, "it's three parts of medicine and poison". Adverse drug reactions are reactions that occur during normal use of drugs and have nothing to do with the purpose of medication. They are inherent properties of drugs and are not necessarily a scourge.
But sometimes, improper handling of adverse drug reactions can also cause serious consequences.More research and effective supervision can make doctors more aware and avoid unnecessary risks.
"For example, amlodipine , if the quality of many generic drugs is not up to standard, the edema rate will be higher than that of the brand-name drugs. If the patient develops edema after taking the medicine, the doctor may prescribe diuretics to the patient. , diuretics should be taken Too much and you need to supplement potassium... This will lead to a vicious cycle," Kang Zhen, deputy director of the National Licensed Pharmacist Development Research Center of China Pharmaceutical University, pointed out to Huxiu.
After the centralized purchasing, the profits of many drugs have dropped to the "freezing point". In order to make profits, drugstore companies will recommend "gross-profit" drugs to consumers. There may even be some unreasonable combinations of medications that can aggravate this chain reaction.
"The more medicines you take, the more diseases you will get." Kang Zhen told Huxiu that this is the current situation of medication use among Chinese elderly. There are too many patients taking multiple medications, which will inevitably lead to a prescription cascade effect, which is the vicious circle mentioned above.
The United States also faced the same problem in the 1970s. They proposed the concept of "pharmacy care" in the 1990s. In 2003, federal health insurance officially issued the "Medicare Modernization Act to Improve Prescription Drug Usage," which requires the provision of drug benefit plans while adding drug therapy management services and providing cost compensation to pharmacists. this service.
In the United States, when a prescription is delivered to a pharmacy, the pharmacist must clearly inform the patient what drugs are available and what the payment structure is for different drugs. For example, some drugs are paid in full by medical insurance, while some drugs require medical insurance, patients, and companies to pay a certain percentage. , patients can decide which medicine to use based on the information provided by the pharmacist and their actual situation.
Historical records have also mentioned the importance of payment for pharmaceutical services in conjunction with new policies such as medical insurance negotiations and centralized procurement. When
was interviewed by China Health , he clearly stated his ideal pharmaceutical service, that is: "Whether it is in a hospital pharmacy or a social pharmacy, as long as the pharmacist receives a prescription, he should conduct detailed inquiries with the patient in a timely manner. and explain, understand the patients’ daily life, tell them how to use these drugs, and how to deal with problems if they encounter them. After the patients take the drugs, they will continue to follow up on their medication.”
Pharmacists’ participation in drug treatment management is not only It can benefit patients and save hospitals a lot of money.
In China, this system has not been established, drug treatment management services are lacking, and patients and even doctors do not have much choice.
Of course, the situation is also developing in a good direction. Not long ago, the country established a rational drug use committee. As drug choices increase and patients' scientific literacy improves, clinical experts have begun to discuss the need to shift from "informed consent" to "informed choice."
"We can't say it. We can only sign and agree when we get to the patient." Some experts said bluntly at a recent industry conference.
Perhaps as He Bin, a special researcher at the Public Policy Research Center of the Chinese Academy of Social Sciences, once said to Huxiu, "What patients need is not only cheap prices, but controllable expenditures with the same quality of medical services."
From an industrial perspective, , China's pharmaceutical industry must upgrade. Guo Xinfeng said: "If we don't transform and improve new and innovative drugs, the company will be gone."
(Mihuahua's pseudonym in the article)
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