“Patients’ concerns about price-cutting drugs stem from lower levels of trust. Although these drugs have passed the consistency assessment, there are still concerns about the specifications and processes for subsequent drug production.”
Recently, the 21st Century Business Herald reporter learned from an industry forum that the second batch of “4+7” cities have basically selected the varieties they have purchased.Soochow SecuritiesIt is also predicted that the second batch of varieties is expected to be released in the second half of the year, given the better procurement of the first batch of purchased varieties. In addition, there are also places to start to follow the “4+7” city to purchase new policies.
At this time, the first round of procurement was all over the country for nearly two months. Some insiders believe that there are still many problems to be solved in the first batch of implementation. The reporters of the 21st Century Business Herald visited for nearly half a month and learned that doctors and patients are currently worried about the quality and efficacy of the “4+7” procurement of selected drugs, and some people have started pilot and non-pilot areas. The idea of price difference, etc.
It is understood that the first batch of "4+7" purchases of 25 selected varieties have an average price reduction of more than 50% or even more than 90%, which also caused patients to worry about the quality of drugs and other issues. On May 7, Shi Lichen, head of the Dingchen Medical Consultation Center, analyzed the 21st Century Business Herald reporter that the patient's questioning about price-cutting drugs came from a lower degree of trust in domestic generic drugs.
For the question of the price questioned by the patient, on May 15th, “4+7” took the lead in purchasing the first batch of successful bidders. Wang Shanchun, president of Zhengda Tianqing Pharmaceutical Group explained that the company has taken a number of production measures to ensure that the price reduction does not degrade. For example, entecavir raw materials are self-made for Zhengda Tianqing, and there are great advantages in quality, price and supply control in the future. On May 14th, the same batch of “4+7” procurement procurement bidding enterprisesColumbine PharmaceuticalsThe marketing director told the 21st Century Business Herald that the reason why the winning bidders dared to cut prices sharply was because the state gave 60%-70% of the promise, while the company omitted the intermediate circulation link, and the winning bidders could also integrate from raw materials to preparations. Chemicals can strictly control costs and so on.
Another industry veteran pointed out that the international common practice is that after the expiration of the patented drug, it will be replaced by a high-quality and low-cost generic drug. A patent cliff will appear, and 90% of the original drug will be replaced, which will help reduce the economic burden of patients and save the country. Medical insurance funds. "In the past, there was a certain gap between Chinese generic drugs and the original drug, but the bioequivalence of generic drugs after consistency evaluation was consistent with the original drug. The drugs that our company won't receive any feedback on adverse reactions at present; In response to the problem of the price of goods between the land and the land, in fact, the country has already played a severe combination of cracking the 'fraud insurance'.
Doubts and concerns
"Entecavir has been reduced in price, will it have no effect?"
Recently, a netizen isBaiduPost it "Entecawe" and post the above question. The netizen mentioned "Entecavir" is a common drug in the treatment of hepatitis B. Affected by the “4+7” procurement of the New Deal, the original price of Runzhong Entecavir, which was produced in Zhengda Tianqing, which was won in the collection, was 310.8 yuan, and the price was only 17.36 yuan.
In addition, the results of the first batch of “4+7” quantity purchases announced at the end of 2018 showed that 25 varieties of drugs including irbesartan tablets and entecavir dispersible tablets were among them, and the average drug price dropped by 52%. The highest drop was 96%.
The 90% price cut has shocked the industry. The inherent concept of “a penny and a share of goods” also makes doctors and patients full of doubts and concerns.
On May 6, the 21st Century Business Herald reporter visited a top three hospital. A physician in the hospital said that some of the drugs in the collection list are considered “new drugs” for the hospital. The shelf-up time is not long. There are still a large number of patients who are reluctant to change the medicine. It is feared that the effect of dressing change is unpredictable. However, Some patients who have been replaced with the "4+7" winning drug have no adverse reactions or other feedback, mainly blood pressure lowering and blood fat lowering drugs. The blood lipid lowering drugs should be eaten at least one month to review the specific curative effect. .
Then the 21st Century Business Herald reporter visited a community health service station. A person in charge of the pharmacy said: "The '4+7' medicine has been put on the shelves, but the previous medicine still has some stocks. The future is definitely '4+7 'The drug that won the bid is the main one, but if the patient has the demand for imported medicine, it will be discussed again. There is no mandatory patient to use the '4+7' medicine, just recommend these medicines as much as possible."
The doctor said that the patient is now also trying "4 + 7" drugs, and will open for one month at a time, and no patients have reported any adverse conditions.
On May 7, another physician at the top three hospital admitted to the reporter that he had an attitude toward the "4+7" drug. "We also try to open it as '4+7'. As for whether it is really the same effect, I don't know. If the patient expressly does not want to, we will still open the original medicine."
In addition, there are other industry reports that in the process of “4+7” procurement, the medical institutions in some places have excessive implementation, and doctors and patients have only one drug to choose from. According to the report, since last year, a number of public hospitals with medical insurance patients have stopped using a large number of imported “big drugs”. A few months later, after the “4+7” quantity purchase was carried out in the area, the implementation of public hospitals was extremely strict, and there was no room for any modification. During the implementation process, most hospitals in the area directly purchased the quantity. The medicine is discontinued.
In this regard, the above report said that doctors have their own experience in clinical medication, and the patient's body also has a cycle to adapt to a drug, requiring a smooth transition. Some experts suggest that the amount of drugs to be purchased should be limited to 30% to 40%. The remaining shares are for the hospital to choose independently. The drugs are not limited to one of the winning varieties, but the “1+n” variety.
The 21st Century Business Herald reporters also interviewed some patients with hypertension and hepatitis B who have already used the "4+7" winning drug. They said that there is no significant difference between the current medication and the previous drug in controlling the disease, and doctors continue to observe. On May 14, a hepatitis B patient who used entecavir said that there is no problem with the use of drugs, but hopes to promote the pilot in more cities.
The reporters of the 21st Century Business Herald also learned that in the face of the “4+7” quantity purchases, the prices in the 11 pilot cities have formed, and some patients in the surrounding cities have begun to purchase drugs in the pilot cities. Many patients are looking forward to collecting products from Linkage between the province and the country.
However, it is understood that there are also some people who have started the edge ball of the price difference in the pilot cities, such as the mobile application of the “Smart Hospital” developed by the First Affiliated Hospital of Xi'an Jiaotong University. Patients in non-pilot cities only have to visit the hospital. If the card pays a certain amount of shipping, you can buy the "4+7" winning drug.
Pharmaceutical companies claim that low prices are not equal to low quality
For the difference in drug prices between pilot areas and non-pilot areas, Ji Renjun, senior vice president of Haixi Pharmaceutical Trading Center, told the 21st Century Business Herald that this is a transitional period in the process of medical reform. The ultimate goal of the country is to solve the problem of expensive patients. It is also hoped to promote price linkages in various regions.
In Shi Lichen’s view, there are indeed some uncertainties in the process of “4+7” cities’ procurement policies. For example, the above doctors and patients have a wait-and-see attitude on the efficacy of the Chinese medicines, and doctors and patients also have their own Medication habits, do not want to change the medication at will. “Patients’ concerns about price-cutting drugs stem from lower levels of trust. Although these drugs have passed the consistency assessment, there are still concerns about the specifications and processes for subsequent drug production.”
For patients who are concerned about the efficacy of generic drugs, the aboveColumbine PharmaceuticalsThe director believes that the public is not fully aware of national policies and generic drugs. The generic drugs that have won the bid are all evaluated by consistency. The quality is close to the original drug, and the state has always strictly monitored the winning generic drugs. There are many flight inspections every year. Once the problem is discovered, the qualification for winning the bid will be cancelled.
AboveColumbine PharmaceuticalsThe director pointed out that the low price of the winning bidder is because the intermediate circulation link is omitted, and the winning bidder can strictly control the cost from the raw material to the preparation. Therefore, low prices are not equal to low quality, such as the first batch of winning bids.Huahai PharmaceuticalSome of the winning varieties were originally exported to the United States. According to the clinician's recommendations and the FDA's past experience, for most drugs, if the circulatory system drug exposure difference is less than 20%, it will not have a significant impact on the clinical treatment effect.
Tang Ronghui, the quality director of Zhengda Tianqing, also said that the consistency evaluation is not a “one-off” evaluation. Zhengda Tianqing has been committed to creating a quality system that meets international standards. The oral solid preparation production line has passed the EU GMP certification. The production line and production equipment of entecavir dispersible film have been running stably for more than 8 years. The production process parameters are all within the controllable range. The quality review is carried out every year to ensure that the product quality is consistent with the design.
"In terms of product inspection, on the basis of the consistency evaluation, Zhengda Tianqing conducted in-depth research on the dissolution and related substances of entecavir dispersible tablets, and added a number of known impurities based on the latest version of the US Pharmacopoeia "USP41". Control, better ensure the quality of raw materials, greatly reduce the potential of process impurities and degradation of impurities, greatly improve product quality, ensure that entecavir dispersible tablets in the industry and international standards to implement the highest quality standards." Tang Ronghui pointed out.
Columbine PharmaceuticalsThe director analyzed the 21st Century Business Reporter’s report that although the “4+7” city’s procurement policy still needs to be perfected, the general direction is correct.Chinese medicineThe quality of the industry has improved, and it has also been able to save a lot of China's health insurance funds. According to the industry's calculation of 25 varieties, through this centralized procurement method, the country directly saved 5.8 billion yuan of funds, from the purchase price of 7.7 billion yuan to 1.9 billion yuan.
In fact, the “4+7” volume purchase effect is also obvious. On March 4, the Zhejiang Pharmaceutical Machinery Purchasing Center issued an announcement,LillyActively applied to lower the price of pemetrexed disodium injecting in Zhejiang Province. On March 5, Shanghai Sunshine Pharmaceutical Purchasing Network issued a notice on the adjustment of drug prices. Among them, pharmaceutical giant Novartis also chose to reduce its price independently. Its original anticancer drug imatinib mesylate (Gleevec) decreased by 30%. .
It is also worth noting that recently, there is news thatPfizerMoved its headquarters of Puqiang, which includes a number of patented expired products, such as Lipitor, Luohuxi, and Xile, to Shanghai, China; not long ago, rosuvastatin calcium from LEK, a subsidiary of Novartis generics company Sandoz The film passed the consistency evaluation; it is also known that another generic drug giant, Mei Lan, is also planning a generic drug in China.
According to the above-mentioned industry veterans, this phenomenon has almost never existed before. Multinational pharmaceutical companies are lying down to make money. The sales of expired original research drugs in the United States have hardly increased, but there are still billions of sales in China. The “4+7” quantity procurement policy will also force multinational pharmaceutical companies to cut prices and introduce generic drugs with more price advantages.
“The '4+7' urban quantity variety and the expansion of future pilot cities are all future development trends. In this process, Chinese companies cannot simply fight prices, but also have to do a good doctor-patient education like multinational pharmaceutical companies. Subject construction, let more doctors and patients understand the '4+7' winning varieties and the development status of China's generic drugs, etc., to do market standardization operations." The above-mentioned industry veterans pointed out.
(Article source: 21st Century Business Herald)