Recently, the news that China's first car-t product, akelunsai injection (yikaida), an anticancer drug with a dose of 1.2 million yuan, is expected to enter the national medical insurance negotiation has attracted much attention. Although it was finally confirmed that the drug was not involved in the negotiation of the medical insurance catalogue, the resulting hot debate continued to ferment.
On November 14, the second South China tumor immunotherapy forum of 2021 precision medicine conference hosted by Guangdong precision medicine application society was held in Guangzhou. At the meeting, experts answered the questions about the therapeutic effect and why the cost of car-t anticancer drug was so high, and discussed the new technology and Prospect of cancer immunotherapy.
One shot works?
Some patients will still relapse
According to the report of Xinhua News Agency on November 12, according to the latest news from the National Medical Insurance Bureau, the car-t product akilunsai injection worth 1.2 million yuan has passed the preliminary formal review, but it has not entered the negotiation link of medical insurance catalogue.
Car-t is a major breakthrough in cancer treatment in China this year. It can cure tumors for patients only by injection. According to the health times, on August 26 this year, Aunt Chen, a patient with diffuse large B-cell lymphoma, went through the discharge formalities from the Department of Hematology of Ruijin Hospital Affiliated to the Medical College of Shanghai Jiaotong University. Aunt Chen became the first patient with complete remission after receiving car-t treatment.
"It's a pity that car-t failed to enter the medical insurance catalog negotiation," said Li Yuhua, chief physician of the Department of Hematology of Zhujiang Hospital of Southern Medical University. "The drug can cure some lymphatic cancers in one shot, but the price is really too expensive."
Li Yuhua introduced that car-t treatment is an emerging anti-cancer method. Akilunsai injection (yikaida) is the first listed drug in China to use immune cells in the human body to treat tumors. It is effective in the treatment of B-cell hematological malignancies, so it is approved to treat adult patients with recurrent or refractory large B-cell lymphoma after previous second-line or more systematic treatment.
Since 2016, Zhujiang Hospital has conducted clinical trials of car-t cell therapy on more than 100 patients with hematological diseases. The data show that the effective rate for relapsed and refractory acute B-lymphocyte leukemia is more than 90%, and for relapsed and refractory B-cell non-Hodgkin lymphoma, the effective rate can reach 60% - 70%.
"Effectiveness does not mean cure. Some patients will still relapse after car-t treatment. The cure rates for different disease types and disease states are different, and some cure rates are 40%," Li Yuhua said.
The emergence of car-t cells has changed the concept of malignant tumor treatment. Li Yuhua said that, for example, the treatment of high-risk lymphoma often takes 2-3 years. The first six courses of chemotherapy, another six courses of chemotherapy after recurrence, and then transplantation. It may take another two years to maintain treatment after transplantation. However, car-t cell therapy may only take 2-3 months.
price oneself out of the market?
The treatment process is complex and the cost is high
How can ordinary people afford 1.2 million yuan of anticancer drugs for a needle? Many experts said at the meeting that the pricing of this new anticancer drug is determined according to its efficacy, cost, value and other factors. From the perspective of R & D cost, the price of 1.2 million yuan is not a wild price. At present, the pricing of all car-t drugs approved in the world is very expensive. The pricing of foreign products is between us $373000 and US $475000, equivalent to RMB 2.4 million to RMB 3.07 million.
Li Liangping, director of the Institute of Clinical Oncology of the First Affiliated Hospital of Jinan University, introduced that car-t is a cell therapy, not a single drug. Its high price is because it needs to be "tailored" for each cancer patient. Firstly, immune T cells were isolated from cancer patients; Then, use genetic engineering technology to strengthen the role of T cells, so that it can recognize cancer cells and activate the ability of T cells to kill cancer accurately; Then, the T cells with anticancer activity are cultured and expanded in vitro. A patient needs to culture at least tens of millions of car-t cells; Finally, after the culture is completed, these cells will be re imported into the patient's body to complete anti-cancer.
"The complexity of this process is unimaginable for ordinary people. Each process is customized individually, and requires very complex experimental and clinical operations. It requires huge human, material and financial resources, so it leads to high prices," Li Liangping said.
Why did you lose the election?
The current technology has a small scope of adaptation and the price has not been reduced to the affordable point of medical insurance
After the drugs pass the preliminary formal examination, whether they can enter the national medical insurance drug catalogue needs to be subject to strict evaluation in terms of economy, and exclusive drugs need to be subject to price negotiation. According to the explanation of the National Medical Insurance Bureau, at present, the financing level of basic medical insurance in China, especially the financing level of medical insurance for urban and rural residents, is relatively low. From the perspective of the overall development of the medical insurance system, the people's demand for disease treatment, the financing level and anti risk ability of the medical insurance fund at this stage, the current basic medical insurance system is mainly based on providing basic disease treatment guarantee for the people, We will strive to meet the people's basic medical needs.
Experts believe that pharmaceutical enterprises should consider costs and profits, and medical insurance should consider the affordability of the fund. The drug price has not dropped to the point that the medical insurance fund can bear, and the medical insurance fund will not consider including drugs in the medical insurance catalogue for the time being.
"Although akilunsai injection finally failed to enter the negotiation link of the medical insurance catalogue, it can be understood as the rationality of the national medical insurance in selecting drugs." Li Yuhua said that there are many other drugs for the lymphoma targeted by car-t cells. Especially for early lymphoma, after first-line standard chemotherapy or combined targeted therapy, theoretically 60% - 70% of patients can be cured, and most first-line treatment drugs have entered medical insurance.
"If car-t can reduce prices in the future, it will be more possible to cure patients with recurrent and refractory blood diseases." Li Yuhua mentioned that not all patients are suitable for car-t therapy. In addition to finding qualified cell preparation institutions, it also depends on the patient's own physical conditions, such as whether the body can provide enough quality T cells.
An oncology expert from Guangdong Provincial People's Hospital said that in addition to "one-to-one" individualized customization and complex treatment, car-t technology also has the problem of small adaptability. Most of the current indications of this drug are blood tumors. If there are solid tumors such as gastric cancer, lung cancer and liver cancer, this technology has not yet achieved the desired effect. This determines that its market is not large and it is difficult to become a universal anti-cancer drug. This also leads to the high price of a single piece at the time of purchase.
Pratt Whitney hopeless?
The pricing of anticancer and immune drugs is close to and beneficial to the people
The reporter learned at this forum that in addition to the multi-directional in-depth discussion on the clinical application and product R & D of tumor immunotherapy technologies such as PD-1 and car-t, the appearance of some new technologies still in the R & D stage has also attracted much attention, such as tcr-t cell therapy, new immune detection point therapy, etc. Among them, tcr-t cell therapy is a hot immune anticancer technology that scientists all over the world are racing to seize the track and invest in research and development, and its safety has been effectively verified in clinical trials.
Li Liangping said that car-t therapy has a good effect on blood tumors; TCR-T cell therapy focuses on solid tumors such as liver cancer, lung cancer, breast cancer and colon cancer. It has the advantages of multiple targets, directional, efficient and wide coverage of tumors. If this technology becomes more and more mature, it will benefit more cancer patients.
Li Liangping introduced that the development of modern anticancer drugs has experienced cytotoxic chemotherapeutic drugs and targeted therapy. The current immunotherapy is the third revolution. The goal is to activate and enhance the body's own anticancer immunity to treat cancer. Both tcr-t and car-t are cellular immune drugs. As customized personalized drugs, the production process is extremely complex and demanding. In addition, the research and development of new drugs requires huge cost, and the pricing is generally high at home and abroad. The domestic introduction of car-t therapy from the United States also includes expensive patent license fees.
However, Li Liangping believes that in the future, the pricing of anti-cancer immune drugs will be close to the people and benefit the people, "we local immunotherapy product developers are working in this direction".
Source: Yangcheng Evening News
https://finance.sina.com.cn/jjxw/2021-11-16/doc-iktzscyy5824465.shtml
