Drug control ended with a one-size-fits-all life-saving drug into the market bottleneck

The Lu Yong case, which caused heated debate two years ago, sounded the alarm of China's new drug approval and payment reform: How should Chinese people get the life-saving drugs they need in a safe and accessible way?

On June 28th, a medical insurance policy that was the most important in 2017 was issued by the State Council: “Guiding Opinions of the General Office of the State Council on Further Deepening the Reform of Basic Medical Insurance Payment Methods” (hereinafter referred to as “Opinions”) It is pointed out that in the future, a multi-composite medical insurance payment method will be implemented, with a focus on promoting payment by disease type, conducting a pilot group for paying for disease diagnosis, etc., a new medical insurance catalogue and payment method, and a series of combination of drug review and approval reform. Launched, can you give the antidote to the Chinese people how to use good medicine for everyone?

Purchasing a new market

Lu Yong, who was hit by the Gleevec purchasing case in India, recently stood on the cusp.

He was once regarded as a "drug man" by a Chinese leukemia friend because he was able to use the Indian Gleevec-Imacy at a price of 1/30. A film about him, "Indian Medicine" will also be released. But now, a media report widely circulated in the Internet has re-drawn the image of Lu Yong: In this report, the Indian Imacy that he purchased is considered by many Chinese drug dealers to be "safe but ineffective." "The drug, and Lu Yong and Imacy's manufacturer Cyno's plan to build a new factory in China has also changed his identity in the eyes of his patients from "pharmaceutical man" to a "profit-making businessman"...

Under the impetus of Lu Yong, Indian generic drugs have become the gospel of many Chinese cancer families. They have opened up the Chinese market in a “purchasing” way. Now, the Indian pharmaceutical companies that plan to open new factories in China are increasing rapidly. It will become another squid in the Chinese pharmaceutical market in addition to the past multinational pharmaceutical companies.

Although safety and legitimacy are not guaranteed, access to medicines at a cheaper price is the main reason why these patients are willing to take the plunge. According to the First Financial Reporter, the sellers of the drug purchasing business between China and India can now reach millions of jobs every month.

Because India and China have adopted different "drug patents" attitudes, before the limited period of expensive imported drugs in China, China's generic drug companies cannot legally introduce cheap generic drugs, so Chinese patients can only buy expensive imports. Drugs, and quite a few are not covered by health care.

However, not only this, but the speed of approval of new drugs in China has also been criticized. Some domestic patients who have developed and listed new drugs in recent years are also unable to obtain them in the short term. This is another reason why Chinese patients seek overseas purchasing.

In the past year, Miss Liu was one of the thousands of Indian generic drug seekers. At that time, her father was experiencing a difficult treatment for liver cancer, and the doctor told her that if he wanted to achieve better treatment, he must first cure his father's hepatitis C.

At present, the best treatment for hepatitis C is the star drug Sofibuvir tablets produced by the United States Gilead and the "Jijidai" Ledifos, which has a cure rate of more than 90% for hepatitis C, but is expensive in the United States. The drug is priced at $1,000 per capsule, and the 12-week standard course of treatment costs $84,000. It is the most expensive drug in the world, and the drug is not yet available in China.

"The attending doctor recommended this drug to us, because China has not yet introduced it, so many people go to the United States to buy the original research, the price may be more than 100,000 a course of treatment. China's generic drug is still in the research and development stage, then A domestic top three hospital is recruiting patients for experiments, and has not yet entered the clinic. Considering that we finally chose to go to India to purchase," Miss Liu said.

After three months of taking the drug, Miss Liu’s father’s hepatitis C has been identified as cured, and the price they paid was RMB 7,000.

In the eyes of Miss Liu, the emergence of Indian generic drug purchases has turned their father's disease into a turn, they have become available, and the cost is not as burdensome as imported drugs. In fact, in the eyes of most patients who purchase Indian medicine, Indian generics have become the savior of their families.

A senior Indian pharmaceutical company in China told the First Financial News reporter that in recent years, Indian pharmaceutical companies that are expected to open factories in China are increasing substantially, and First Financial reporters have noticed that at some large drug fairs, Indian pharmaceutical companies have also begun to appear frequently.

Domestic generic drug enterprise

However, for the large Chinese patient population, it is still a "small probability" incident to hope that the generic drug in India will be safe. The safety of the drug in the purchasing channel is difficult to guarantee, and it is difficult to be held accountable in the event of an accident, and can find a reliable purchase. It's just a small group of people.

Domestic generic drugs have long been considered a good solution to this problem, but why can't they be expected?

An important reason is that the quality of treatment of domestically produced drugs often does not meet the requirements, which is the "safe but ineffective" cheap generic drug that is often criticized.

"For my father's disease, domestic medicine should go to the hospital for review once a week. You can't eat more or eat less, but the imported medicine is completely okay, but the imported medicine is too expensive, 200 yuan per day, each The monthly cost is more than 6,000 yuan, and can not enter medical insurance." A family member of a severely ill patient told the First Financial Reporter.

Such a situation is not uncommon in China, and as a result, on March 5, 2016, the General Office of the State Council issued the “Opinions on the Evaluation of the Quality and Efficacy of Generic Drugs”, requiring the approval of the new registration of chemical drugs before implementation. The generic drug, if it is not approved in accordance with the principle of the quality and efficacy of the original drug, requires a consistency evaluation before 2018. I hope to improve the quality of domestically produced drugs.

However, for enterprises, they believe that the crux of the introduction of good medicine is not limited to this. It is another situation that makes it difficult for enterprises to get approval.

"In fact, for overseas new drugs, we often start research and development ten years ago, so that once the patent expires, we can guarantee that it can be listed in time, but in the end, it is stuck in the approval time. The approval of generic drugs is as short as five years, and slower than ten. Year." Two years ago, the head of a domestic generic drug company disclosed to the First Financial Reporter.

The policy is regarded by these managers as a “barometer” for the healthy development of the enterprise. The greatest significance of the emergence of the Lu Yong case is to promote the drug approval reform that has been criticized before.

Since the second half of 2015, the State Council has been making heavy punches and pushing the drug approval reform on the string: On July 22, the State Food and Drug Administration issued the State Food and Drug Administration to conduct drug clinical trials. Announcement on Data Self-checking and Verification Work, which is called “the most stringent data verification requirement in history”; on August 18, the “Opinions of the State Council on Reforming the Approval System for Drug Medical Device Evaluation and Approval” was issued, strictly controlling the market for oversupply The approval and other information was officially disclosed, and promised that the current 2/3 breeds including sleep and other backlog stocks will be completed by the end of 2016.

In the year of May 20, and the two days from the 11th to the 12th, the CFDA issued four consecutive articles for public comment, and the sword pointed to medical innovation and approval speed.

According to the latest data disclosed by Bi Jingquan, the director of the State Food and Drug Administration on June 22 this year, China has basically eliminated the backlog of drug registration applications, and the number of applications for drug registration awaiting review has dropped from 22,000 at the peak of 2015 to 6,000.

Take Hengrui Medicine as an example of clinically approved paclitaxel for injection on June 27. The drug was first approved for marketing in the United States in January 2005. It is mainly used for the second-stage treatment of breast cancer and local late or metastatic non-small. First-line treatment of cell lung cancer and metastatic pancreatic cancer. According to the company's announcement, the company has been approved for clinical approval since August 30, 2016. The total cost of the drug is currently less than one year, and the drug's current sales in the Chinese market is about 34.48 million US dollars. One billion dollars.

According to CIC's knowledge of consultation, in 2016, 240 applications for chemical innovations were received, an increase of 18% compared with 2015. The application for new drug clinical trials and new drug listings increased by 37% and 81% respectively compared with 2015. The number continues to increase.

“For companies that treat major diseases and significantly improve public health, original research drugs and generic drugs are the most profitable companies. For example, biological blood products are biological drugs with high technical content for treating major diseases. Some business people said that a product review time was less than a month to get a production license, and the previous slowest review for 5 years can not get clinical approval." CIC Cao Consulting executive director Wang Wenhua told the first financial reporter.

How can good medicine be used?

The domestic Gleevec generic imatinib has been included in the medical insurance or the new rural cooperative medical system in more than 20 provinces and cities. After the patient's treatment expenses are reimbursed for one year, the individual only needs to bear about 30% of the expenses. Take the urban employee medical insurance in Jiangsu Province as an example. The patients use domestic imatinib. After reimbursement, the monthly medical expenses for personal expenses are only 400 yuan. In the new medical insurance catalogue announced earlier this year, imatinib is also on the list, which means that in the future, more provinces and cities will be able to take the drug at a lower price.

For Chinese patients, in addition to expecting the introduction of domestic generic drugs to use lower-priced drugs, whether high-priced drugs can enter medical insurance and enter the scope of reimbursement is another important concern.

In fact, the reimbursement of reimbursement of medical insurance medical insurance catalogues, the pricing bottom line of high-price drug medical insurance negotiations has become an increasingly troublesome issue. Under this status quo, the theory of pharmacoeconomics has been raised again.

This theory is considered by the industry to be a reference in the introduction of the new medical insurance payment method, the new medical insurance catalogue, and the selection of the second batch of drug negotiations recently completed – to bring out invalid drugs and spend money on Effective place, and no longer cheap but ineffective drugs.

“In the 1960s, drugs were marketed as long as they had three conditions: safe, effective, and high quality. At that time, the US FDA was established according to this. But by the 1980s and 1990s, the concept had changed. The listing of innovative drugs not only requires safety, effectiveness, and high quality, but also asks whether our society can afford it. Where are the values ​​of our society?” Xuan Jianwei, director of the Institute of Pharmaceutical Economics, School of Medicine, Sun Yat-sen University, accepted the first An interview with a financial reporter said, "We know that in our country's drug price negotiations, we have tried to use the theory of pharmacoeconomic evaluation of three drugs to provide a basis for decision-making on drug price negotiations in the country. By the beginning of this year, we have revised the national medical insurance catalogue. In this revision process, pharmacoeconomics has also played a role. This year, the country initiated negotiations on medical insurance drugs."

Xuan Jianwei’s call for a clear system standard to measure the economic benefits of drugs is because in recent years there have been some headaches in the country that have been “medical withdrawals”: ​​due to the control of medical expenses by local medical insurance centers, It is often the case that after the total reimbursement limit is exceeded, the medical insurance center will not reimburse the status quo. For some hospital directors, in order to ensure that they can get the cost of medical insurance reimbursement, they have to check the prescription ranking every month. If the consumption is in the front of the drug, and the medical insurance center indicators are used similarly, it will be taken. It is recommended to stop the drug to prevent the cost of reimbursement.

"But for some targeted drugs, although expensive, but for some patients, its five-year survival rate can be greatly improved, then this is meaningful to society, not only can make great progress in treatment, Patients can continue to provide social value," said Xuan Jianwei.

In his view, whether to include high-priced drugs represented by tumor-targeted drugs in the medical insurance system, and how to determine the scope of reimbursement, the most important thing is to consider the following clinical indicators: the patient's survival time from drug use intervention to death, taking Comprehensive judgment is made on the survival of the disease after the drug, and the index of objective tumor remission.

In this context, medical insurance negotiations have become another way for countries to apply the principles of pharmacoeconomics to medical insurance coverage in a relatively flexible manner.

In the just-concluded second batch of national medical insurance drug negotiations, 44 high-priced drugs were selected, including Novartis, Bayer, Roche, AstraZeneca and other multinational giants. Many of the finalists were clinically large varieties, and annual sales worldwide. The amount can reach several billion dollars.

For enterprises, the reason why they are willing to participate actively is an important reference. The sales volume of the first batch of negotiating talents last year has increased sharply since the price cut into medical insurance. The strategy of “price-for-value” has been recognized by the market. For the National Health Insurance Fund, new research shows that traditional chemotherapeutic drugs and targeted drugs are not very different in terms of cost. On some tumor types, the long-term use of targeted drugs has a control effect on patients. The overall economic benefits of the drug have also improved.

“For policy makers, some analysis of the budget is needed. Many experts and scholars believe that if all the existing targeted drugs are included in your medical insurance, or if you are fully reimbursed, is it not? Exceeding your fund's ability to withstand, this is why many countries, including some places, are starting to negotiate some serious diseases. One is to benefit these patients as soon as possible; the other is to consider whether the national fund can afford it." Pfizer China's drug economy Dong Peng, director of the study and results research, told the First Financial Reporter.

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