"4 7" volume procurement landing tracking survey: drug price reverse effect works

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"Patients' doubts about reduced-price drugs stem from low trust. Although these drugs have passed the consistency evaluation, people still have concerns about the specifications and processes of subsequent production of drugs."

Recently, a reporter from the 21st Century Business Herald learned from an industry forum that the second batch of "4 7" urban belt purchases have been basically selected. Soochow Securities also predicts that in view of the good hospital purchases of the first batch of belt purchases, It is expected that the second batch of varieties is expected to be released in the second half of the year. In addition, there are also places to follow up the "4 7" city belt procurement new policy.

At this time, it has been nearly two months since the first round of procurement has been implemented in various places. Some people in the industry believe that there are still many problems to be solved in the first batch of implementation. A reporter from the 21st Century Business Herald visited for nearly half a month and learned that doctors and patients currently have certain concerns about the quality and efficacy of the selected drugs in the "4 7" volume procurement. At the same time, some people have also started the pilot area and non-pilot area. The idea of price difference, etc.

It is understood that the average price reduction of the first batch of "4+7" purchased 25 selected varieties exceeded 50% or even more than 90%, which also caused patients to worry about drug quality and other issues. On May 7, Shi Lichen, head of the Dingchen Medical Consulting Center, analyzed to a reporter from 21st Century Business Herald that patients' doubts about reduced-price drugs stem from their low trust in domestic generic drugs.

Regarding the price question questioned by patients, on May 15, Wang Shanchun, president of Zhengda Tianqing Pharmaceutical Group, the first batch of "4+7" bid-winning enterprises, explained that the enterprises have taken a number of production measures to ensure that the price reduction does not degrade. For example, entecavir raw materials are made by Zhengda Tianqing, and will have great advantages in quality, price and supply control in the future. On May 14, the marketing director of Kelun Pharmaceutical, which is also the first batch of "4+7" volume procurement winning enterprises, told reporters in 21st century business herald that the reason why the winning enterprises dare to cut prices sharply is that the state has given 60%-70% of the amount of commitment. At the same time, the enterprises have omitted the intermediate circulation links, and the winning enterprises can also strictly control the cost from raw materials to preparations.

In addition, senior people in the industry pointed out that the international practice is that after the expiration of patented drugs, they should be replaced by high-quality and low-cost generic drugs, resulting in a patent cliff, and 90% of the original research drugs are replaced, which is conducive to reducing the economic burden of patients and saving national medical insurance funds. "In the past, there was indeed a certain gap between Chinese generic drugs and original research drugs, but after passing the consistency evaluation, the bioequivalence of generic drugs is consistent with the original research drugs. Our company has not received any adverse reactions and other feedback on the drugs that won the bid; and for the price depression between the goods and other issues, in fact, the country has played a combination of severe crackdown on 'fraudulent insurance."

doubts and worries

"Entecavir has been reduced in price. Will it have no effect?"

Recently, a netizen posted on Baidu Post Bar "entecavir Bar" and raised the above questions. The netizen mentioned "entecavir" is a common drug in the treatment of hepatitis B. Influenced by the "47" new policy of purchasing with quantity, the original price of Runzhong Entecavir produced by Zhengda Tianqing, which won the bid in the centralized purchasing, was 310.8 yuan, but only 17.36 yuan after the price was reduced.

In addition, the first batch of "4+7" belt procurement results released at the end of 2018 showed that 25 varieties of drugs, including irbesartan tablets and entecavir dispersible tablets, were among them, with an average drop of 52% in drug prices and a maximum drop of 96%.

The industry was shocked by the price reduction of more than 90%, and the inherent concept of "you get what you pay for" also filled doctors and patients with doubts and worries.

On May 6, the 21st century economic reporter visited a hospital. A physician in the hospital said that some of the drugs on the collection list are "new drugs" for the hospital. They have not been on the shelves for a long time. There are still a large number of patients who are unwilling to change the dressing, fearing that the effect of the dressing change is unpredictable. However, Some patients who have been replaced with the "47" bid-winning drugs have not yet had adverse reactions or other feedback, mainly drugs for lowering blood pressure and blood lipids, blood lipid-lowering drugs should be taken for at least one month to be reviewed before the specific curative effect can be known.

Then the 21st century economic report reporter visited a community health service station, a person in charge of the pharmacy said: "'4 7 'drugs have been on the shelves, but there are some stocks of the previous drugs. The future is certainly '4 7' won the standard drug mainly, but patients if there is a demand for imported drugs, will also be discussed again. There is no mandatory use of '4 7 'drugs, just as much as possible to recommend these drugs."

The doctor said that the patient is also trying the "4 7" drug now, and the amount will be prescribed for one month at a time. At present, no patient has reported any adverse situation.

On May 7, a physician at another tertiary hospital confessed to reporters about his attitude towards the "4 7" drug, "We also try to prescribe it as '4 7 ', and we don't know if it's the same as if it's true or not. If the patient makes it clear that he or she doesn't want to, we'll still prescribe the original drug."

And another industry report, in the "4 7" with the volume of procurement landing process, there is a phenomenon of excessive implementation of a medical institution, doctors and patients have only one drug can choose the situation. The report said that since last year, a number of public hospitals in the area, which mainly focus on medical insurance patients, have stopped using a variety of imported "big drugs" in large quantities. A few months later, after the "4 7" volume procurement was implemented in the area, the public hospitals were extremely strict in implementation, and there was no room for flexibility. During the implementation process, most hospitals in the area directly used the volume procurement. Stop using drugs.

In this regard, the above report stated that doctors have their own clinical medication experience, and the patient's body also has a cycle of adapting to a medicine and needs a smooth transition. Some experts suggest that the amount of drugs purchased with quantity should be limited to 30% ~ 40%, and the remaining share should be left to the hospital to choose independently. Drugs are not limited to the winning one variety, but "1 + n" varieties.

The 21st Century Business Herald reporter also successively interviewed some patients with hypertension and hepatitis B who have already used the "4 7" winning drugs. They said that there is no significant difference between the current medication and the previous drugs in controlling the disease, and doctors are continuing to observe. On May 14, a hepatitis B patient who used entecavir said that there was no problem in the current use of the drug, but he hoped to promote the pilot in more cities.

The 21st Century Business Herald reporter also learned that in the face of the "4 7" volume procurement landing in 11 pilot cities to form a price depression, patients in neighboring cities have begun to buy drugs in the pilot cities, many patients are looking forward to the collection from the province to the national linkage.

However, it is understood that at present, some people have played the edge of the price difference in the pilot cities, such as the mobile phone application of "smart good hospital" developed by the First Affiliated Hospital of Xi'an Jiaotong University. Patients in non pilot cities can buy "47" winning drugs as long as they have the medical card of the hospital and pay a certain amount of freight.

Drug companies say low price does not mean low quality

Regarding the difference in drug prices between pilot and non-pilot areas, Ji Renkai, senior vice president of Haixi Pharmaceutical Trading Center, told the 21st Century Business Herald reporter that this is a transitional period in the medical reform process. The ultimate goal of the country is to solve the problem of expensive medication for patients. It also hopes to promote price linkage in various regions.

In Shi Lichen's view, there are indeed some uncertainties in the process of the "4 7" urban procurement policy, such as the above-mentioned doctors and patients who wait and see or even distrust the efficacy of the bid-winning drugs, and doctors and patients also have their own medication habits. I don't want to change the medication at will. "Patients' doubts about reduced-price drugs stem from low trust. Although these drugs have passed the consistency evaluation, people still have concerns about the specifications and processes of subsequent production of drugs."

For patients who have doubts about the efficacy of generic drugs, the above-mentioned director of Kelun Pharmaceuticals believes that the public does not know enough about national policies and generic drugs themselves. At present, the winning generic drugs have passed the consistency evaluation, and the quality is close to that of the original research drugs. Moreover, the state has always strictly monitored the winning generic drugs, and there will be many flight inspections every year. Once problems are found, the bid winning qualification will be canceled.

The above-mentioned director of Kelun Pharmaceutical pointed out that the low price of the winning drug is due to the omission of intermediate circulation links, and the integration of the winning enterprise from raw materials to preparations can strictly control the cost. Therefore, low price does not mean low quality. For example, some of the winning varieties of Huahai Pharmaceutical Co., Ltd., which won the first batch of bids, were originally exported to the United States. Based on the recommendations of clinicians and the past experience of the FDA, for most drugs, if the difference in drug exposure of the circulatory system is within 20%, there will be no significant impact on the clinical treatment effect.

Tang Ronghui, quality director of Zhengda Tianqing, also said that the consistency evaluation is not a "one-off" evaluation. Zhengda Tianqing has been committed to building a quality system in line with international standards, and the oral solid preparation production line has passed the EU GMP certification. The production line and equipment of entecavir dispersible tablets have been in stable operation for more than 8 years, and the production process parameters are within the controllable range. The quality review is carried out every year to ensure that the product quality is consistent with the design.

"From the perspective of product inspection, on the basis of consistency evaluation, Zhengda Tianqing conducted in-depth research on the dissolution and related substances of entecavir dispersible tablets, and added a number of known impurity controls on the basis of the latest edition of USP41 to better ensure the quality of raw materials, greatly reduce the generation of potential process impurities and degradation impurities, greatly improve product quality, and ensure that entecavir dispersible tablets implement the highest quality standards in the same industry and international standards." Tang Ronghui pointed out.

The director of Kelun Pharmaceutical analyzed to the 21st Century Business Herald reporter that although the "4 7" urban belt procurement policy still needs to be improved, the general direction is correct, forcing the quality of China's pharmaceutical industry to improve, and it can also save a lot. China's medical insurance fund. According to the industry's calculation of 25 varieties, through this centralized procurement method, 5.8 billion yuan has been directly saved for the country, and the purchase price has been reduced from 7.7 billion yuan to 1.9 billion yuan.

In fact, the reverse effect of "4+7" volume procurement is also obvious. On March 4, the Zhejiang Medical Equipment Procurement Center issued an announcement showing that Lilly took the initiative to apply for a reduction in the price of pemetrexed disodium for injection in Zhejiang Province. On March 5, Shanghai Sunshine Pharmaceutical Purchasing Network issued a notice on the adjustment of relevant drug prices. Among them, pharmaceutical giant Novartis also chose to cut prices independently, and its original anti-cancer drug imatinib mesylate (Gleevec) dropped by 30%.

In addition, it is worth noting that recently, it was reported that Pfizer moved its headquarters of Puqiang Company, which includes Lipitor, Luohuoxi, Celebrex and other expired products of original research drugs, to Shanghai, China. Not long ago, rosuvastatin calcium tablets of LEK, a subsidiary of Novartis generic drug company Sandoz, passed the consistency evaluation. It is also understood that another generic drug giant, Mylan, is also carrying out generic drug layout in China.

According to the above-mentioned industry veterans, this phenomenon has hardly 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 tens of billions of sales in China. The "4 7" volume procurement policy will also force multinational pharmaceutical companies to reduce prices and introduce generic drugs with more price advantages.


"The variety of '4 7 'cities and the expansion of pilot cities in the future are the future development trends. In this process, Chinese companies cannot simply fight for prices. At the same time, they must do a good job in doctor-patient education and multi-discipline like multinational pharmaceutical companies. Construction, so that more doctors and patients can understand the winning varieties of '4 7' and the development of generic drugs in China, and do market standardization operations." The industry veteran pointed out.