Interview with Song Yuqin, assistant president of Peking University Cancer Hospital: Cracking the mystery of basic drug supply

Text | Cai Jian Dao, author | Wu Ni, Editor | Yang Zhongxu

Entering 2022, the revision of the new essential medicines list is imminent.

At this time, it has been exactly 40 years since the first edition of China's basic drug catalogue in 1982. With the strengthening of national strength and the rise of residents' living standards, the meaning of essential medicines has also moved from basic (basic) to essential (essential). Once upon a time, the dozen or twenty basic drugs in the medicine box on the shoulders of barefoot doctors were the bottom line to ensure the drug demand of people in developing countries; by the time of the revision of the basic drug list in 2018, 12 new anti-tumor drugs urgently needed in clinical practice had been included, and the essential taste was gradually stronger.

It is rumored that compared with 685 in 2018, the new version of the basic drug list will be greatly expanded to 1,000. If the hour hand is turned back to the first year of the new medical reform in 2009, there are only 307 basic drug lists.

In order to better protect the people's basic drug needs, in October 2019, the General Office of the State Council issued the "986 Policy", that is, to gradually realize that the proportion of the number of varieties of essential drugs in government-run grass-roots medical and health institutions, second-level public hospitals, and tertiary public hospitals should not be less than 90%, 80%, and 60% respectively in principle; it is also proposed to promote the formation of "1 + X" ("1" is the national essential drug list, "X" is a non-essential drug, It is determined by each region according to the actual situation) drug use mode, optimize and standardize the drug use structure.

However, there is still a gap between the proportion of basic drug allocation in hospitals at all levels nationwide and the target. According to the 2019 national sampling survey, the proportion of basic drug varieties used in primary medical and health institutions and second- and third-level public hospitals was 59%, 45% and 39% respectively, which did not meet the proportion requirements.

The director of the pharmacy department of the top three hospitals has publicly questioned that there are 2,000 kinds of standing drugs in the hospital, and even if all 685 basic drugs are prepared, it only accounts for 34% of all drugs, and it is still 26 percentage points away from reaching the standard. By that, the base drug catalog has greatly expanded the arrow on the string.

Unlike the combination of the basic drug catalogue/health insurance catalogue in developed countries, in developing countries, the medical insurance catalogue covers low to high demand, while the basic drug catalogue is responsible for maintaining the bottom line. When the new version of the basic drug catalogue is revised, what standards to follow has become the focus of the industry. A leader of the former State Food and Drug Administration told Caijian Dao that there are two criteria for the choice of the basic drug catalog: first, clinically, the doctor has the final say; second, in terms of supply, follow the principles of pharmacoeconomics, especially to ensure the reasonable profits of enterprises and avoid low-cost supply cuts.

The interruption of basic drug supply means the panic of "having a meal but not a meal", and the risk of treatment interruption, surgical suspension, and family bankruptcy.

More unfortunately, the base drug is the "hardest hit area" of the supply cut. "Cai Jian Dao" combed and found that in the past 5 years, there have been hundreds of basic drug supply cuts or shortages across the country, which have received widespread media attention.

During the national "two sessions", Professor Song Yuqin, assistant to the president of Peking University Cancer Hospital and deputy director of the Department of Lymphogy and Internal Medicine, accepted an exclusive interview with Caijian Dao, explaining this people's livelihood problem in detail from the perspective of the clinical frontline industry. Song Yuqin, as a PI (academic leader) or co-PI, has led more than 70 clinical studies in the field of domestic lymphoma, and currently the clinical research on new drugs undertaken by her center accounts for 2/3 of the registered clinical research of lymphoma in China, of which 60% is the clinical research of phase I/II new drugs.

It all starts with the basic logic of the basic medicine.

01 How should we view basic drugs? Basic or essential

"Cai Jian Dao": How to understand the word "basic" of essential drugs?

Song Yuqin: I understand "basic" to refer to essential (required) rather than basic. Essential means that every drug in the basic drug list is indispensable, and even if there is a substitute, the efficacy and price-performance ratio are not as good as the original drug.

Take cytarabine, for example, a commonly used base drug for the treatment of a variety of adult and pediatric leukemia and other meningeal malignancies. It is able to penetrate the blood-brain barrier and is a central agent for induction chemotherapy in the treatment of these diseases. Even the most cutting-edge BTK inhibitors and CAR-T therapies in the field of hematological tumors cannot replace the role of cytarabine.

"Cai Jian Dao": With the improvement of medical level, will the scope of essentials be updated and changed with the times?

Song Yuqin: I look forward to more reasonable adjustments.

There are some traditional drugs that can be used when there is a shortage of doctors and drugs, and later when there are alternatives with better efficacy, they are not needed clinically. These drugs should be eliminated from the base drug list.

There are also innovative drugs that have become an irreplaceable choice for a certain stage of the disease, or can significantly improve the cure rate, while significantly reducing prices and reducing the financial burden on patients. I am not opposed to the transfer of such innovative drugs into the basic drug list.

Rituximab is an example. The common chemotherapy regimen for the treatment of invasive B-cell lymphoma is the CHOP regimen, which has a cure rate of 40%. The combined rituximab + CHOP regimen can increase the overall cure rate to 55%-60%. In 2017, rituximab entered the medical insurance directory, and the price dropped from 50ml / bottle of 16041 yuan to 50ml / bottle of 8298 yuan. The efficacy and accessibility of rituximab make me think it is reasonable for it to be transferred to the 2018 edition of the National Basic Drug List.

"Financial Key Road": In many developed economies, medical insurance basically covers the vast majority of clinical drugs, so there is no additional basic drug list. For developing countries with limited health insurance coverage, in addition to the health insurance catalogue, there is also a catalogue of basic drugs that emphasize safety and accessibility. How do you see the relationship between China's basic drug catalogue and the medicare catalogue?

Song Yuqin: There are overlapping parts between the basic drug catalogue and the medical insurance catalogue, but they are not exactly the same.

First, the requirements for inclusion in the medical insurance catalogue should be clarified, first, the drug must be verified by clinical trials for one or more indications; second, the price is reasonable and in line with the country's ability to pay.

In this case, some basic drugs may not be able to enter the medical insurance directory. For example, the treatment of gemcitabine for relapsed refractory lymphoma has high safety and good efficacy, but unfortunately there are no indications. But on the other hand, gemcitabine does not necessarily need to be included in the medical insurance directory, its price is low, and ordinary people can afford it themselves.

There are also some drugs that can be included in the medical insurance directory, but do not necessarily include in the basic drug directory. For example, several PD-1 monoclonal antibodies with indications for relapsed and refractory Hodgkin lymphoma. The number of new cases of Hodgkin lymphoma nationwide each year is about 7,000, and a minority of patients who need to use PD-1 monoclonal antibody to develop relapse refractory treatment are in the minority. There are fewer patients and a small burden on national medical insurance, so these PD-1 monoclonal antibodies can be considered to be included in the medical insurance list. However, PD-1 monoclonal antibody is not irreplaceable compared with similar drugs and does not conform to the positioning of basic drugs.

"Cai Jian Dao": Since the basic drugs (catalogue) are of great significance, should we not pay more attention to the supply guarantee of basic drugs?

Song Yuqin: We can regard basic medicine as a people's livelihood commodity like meat, eggs and milk of grain, rape and vegetables. Grain, rape, meat, eggs and milk need to be supplied in sufficient quantities and prices are generally stable to ensure the basic livelihood of the people. The same is needed for basic medicines to build a life support line for the people. And we can't rely solely on importing basic drugs from overseas, otherwise as long as overseas supply is interrupted, the instability of domestic society will rise sharply.

02 The core of ensuring the supply of basic drugs: price, price, or price

"Cai Jian Dao": We combed and found that in the past 5 years, there have been hundreds of basic drug supply cuts or shortages across the country. What do you think is the main reason for the frequent supply of basic drugs?

Song Yuqin: The main reason is the low price of basic drugs.

The price of basic drugs is low, the profit margins of pharmaceutical companies are compressed, the enthusiasm for production is greatly affected, and supply cuts are likely to occur. If we put the board on the pharmaceutical company, it is inevitable that the headache will be treated, and the foot will be painful.

The price of basic drugs is low, and after the implementation of "zero addition" of drugs, regardless of the level of drug pricing, public hospitals do not have the bonus profit of drugs. However, many basic drugs are used in small quantities and varieties, which will occupy hospital inventory and management costs, and even have losses, and the enthusiasm of hospitals in procurement may not be high.

In the long run, the demand for basic drugs in hospitals has decreased, and the sales of basic drugs have decreased. For example, a basic drug, pharmaceutical companies in the annual supply of 200,000, the profit is moderate; if the sales of sharply reduced to 50,000, pharmaceutical companies can not dilute the cost, profits doubled, will turn the production line into other high-profit products. As a result, the supply of basic drugs occurred one after another.

Cai Jian Dao: How to adjust the incentive mechanism for hospitals to make the price of basic drugs an advantage?

Song Yuqin: The DRG payment model can play a role in correcting deviations (in the DRG payment model, the medical insurance department does not pay for the costs exceeding the payment standard, and the balance below the payment standard is left to the hospital). For example, the ABVD program commonly used in the treatment of Hodgkin lymphoma costs about 5,000 yuan in a cycle and can cure 80% of patients. Under the DRG paid model, the payment standard for the treatment of Hodgkin lymphoma is slightly higher than 5,000 yuan, which is significantly lower than the price of other high-priced equivalent drugs. At this time, the low price of basic drugs becomes an advantage. If a hospital wants to be profitable, the best option is to adopt an ABVD solution. The demand for basic drugs in hospitals has increased, and the problems of pharmacy costs and sales of pharmaceutical companies have been solved.

It is worth noting that the rationality of medical insurance payment standards is very important, and it is necessary to leave a certain profit margin for the hospital according to the actual clinical situation in order to achieve the purpose of positive incentives.

Cai Jian Dao: If the price of basic drugs is too low, will it affect the quality of drugs?

Song Yuqin: Absolutely. A long time ago, in order to save costs and improve utilization, a pharmaceutical factory put two basic drugs on the same production line. Since the production equipment was not cleaned, the second base drug mixed with the ingredients of the first base drug, resulting in serious adverse events in patients using the second base drug.

In the face of this situation, punishment is certain, but I don't think anyone likes to be punished. The cure is to reduce the occurrence of similar tragedies by providing guaranteed profits for enterprises.

Cai Jian Dao: How to use this as a starting point to build a positive cycle?

Song Yuqin: In terms of price, it is necessary to allow the price of basic drugs to increase within a reasonable range. I remember that vincristine (for the treatment of acute leukemia and malignant lymphoma, small cell lung cancer and breast cancer) was only sold for 15 yuan / stick many years ago, leaving too little profit margin for the company, so there was the first supply cut. After causing widespread concern in the society, pharmaceutical companies decided to resume the supply of vincristine and raised the price to more than 50 yuan / piece. In 2018, the supply of vincristine was cut off for the second time, and the price was 195 yuan / piece when the supply was restored again. At present, the supply of vincristine has been stable, at least reflecting the current pricing has a certain rationality.

It is also necessary to ensure the sales of certain basic drugs. I am optimistic about the method of using basic drugs at all levels of medical institutions at different levels. Specifically, the diagnosis and treatment capacity of medical institutions at all levels is first evaluated, and then the scope and proportion of basic drugs that medical institutions at all levels should be equipped with are delineated, and they are required to purchase in accordance with their respective diagnosis and treatment scope and diagnosis and treatment norms.

For example, hospitals below the second level do not have the capacity to treat malignant tumors. In order to ensure that the drug use specifications are reasonable, hospitals below the second level should be equipped with basic drugs within the scope of diagnosis and treatment capacity, without purchasing anti-tumor basic drugs. Hospitals with higher tumor diagnosis and treatment capabilities should follow the diagnosis and treatment norms, must have anti-tumor base drugs, and other basic drugs within the scope of diagnosis and treatment capabilities cannot be absent.

After the pharmacy purchases the basic drug back, the doctor will naturally use it, so that it can continuously regulate the clinical rational use of drugs. When the national sales of a basic drug species have a certain guarantee, and the procurement volume is relatively stable, the manufacturer can have visible profits, which can ensure production safety and mobilize production enthusiasm.

Cai Jian Dao: This year, the national basic drug list entered a three-year adjustment period. People are looking forward to not only the adjustment of the basic drug list, but also the solution of the problem of basic drug supply interruption. What do you think the ideal state of the basic drug related party is?

Song Yuqin: The ideal state is that all parties can have room for survival and development, so as to form a model that can sustainably guarantee the supply of basic drugs. Simply suppressing either side is not sustainable.

In the face of basic drugs related to the national economy and people's livelihood, the industry also needs self-discipline to persistently maintain and realize the functional positioning of basic drugs, that is, "highlighting the basic, prevention and control, ensuring supply, prioritizing use, ensuring quality, and reducing burdens". If everyone wants to maximize profits, it is the patient who suffers last.

Who is the patient? All of us.

Resources:

[1] Xinna Children's Drugs, Banned From Five Types of Drugs 2021 Edition of the Basic Drug Catalogue for Comments, Qu Yixian, 2021

[2] Why life-saving drugs cheap drugs "flash" off supply, Shuai Cai Dong Xiaohong, 2019

[3] Medical insurance data tells you: zero drug bonus, to solve the problem of medicine to support medicine, Ma Reward Yueyang Xiamen University School of Economics and Wang Yanan Institute of Economics, 2019