concern! 1.2 million yuan a shot of "life-saving miracle drug" into the medical insurance negotiation directory! How much can the price be cut?

Source: Guangzhou Daily

Yesterday (November 9)

The national "soul bargain" is here again

3-day 2021 National Health Care Negotiations

The curtain has officially begun

It is also the sixth round of health care negotiations since 2015

The medical insurance negotiation will involve Hengrui Pharmaceutical, BeiGene, Rongchang Biological, Roche, Pfizer and many other well-known enterprises of a number of important varieties, such as PD-1 monoclonal antibody, BTK inhibitors, PARP inhibitors, etc., dual antibodies, ADC, CAR-T and other new therapies are also expected to participate, the market attention is extremely hot.

It is worth mentioning that the CAR-T product Agironse injection, which was just approved in early June this year, is also on the list of formalities examination. As China's first CAR-T product, it was previously exposed to a high price of 1.2 million yuan, which is also the first time that CAR-T products have entered the national medical insurance negotiations, and the outside world has attracted much attention to whether it can negotiate successfully, and if the negotiation is successful, how much price reduction is concerned.

The 1.2 million yuan one-shot anti-cancer drug entered the medical insurance negotiations for the first time

This year's health insurance negotiations are expected to involve about 19 innovative drugs that are not in the medical insurance list, including dual antibodies, ADC drugs (antibody conjugate drugs), CAR-T therapy, etc. The targets that are recommended to be paid attention to are domestic listed pharmaceutical companies such as Cinda Biologics, Rongchang Biologics, BeiGene, Beida Pharmaceutical, and Hengrui Pharmaceutical.

The CAR-T product Agilense injection, which was just approved in early June this year, is also on the list of formalities vetting. As China's first CAR-T product, it was previously exposed to a high price of 1.2 million yuan, and the outside world has attracted much attention to whether it can negotiate successfully, and if the negotiation is successful, how much price reduction is concerned.

In fact, there are currently two CAR-T products approved in China, one is Fosun Kate's Agilense Injection (trade name: Yi Kaida), and the other is WuXi Junuo's Ricky Olense Injection (trade name: Benoda) officially approved. However, according to the medical insurance negotiation rules, the participating products need to be approved for listing before June 30, so the products approved by WuXi Junuo in September did not qualify for this negotiation.

This means that CAR-T products are "one-piece" negotiation. It is generally believed that without competition, the possibility of successful negotiations is unlikely.

Does the sky-high price of "anti-cancer miracle drug" really work?

"Spending 1.2 million yuan on an injection can clear zero cancer cells!"

Is CAR-T treatment really so divine?

Why is "value" so expensive?

What cancers can be cured? Are there any toxic side effects?

……

Guangzhou Daily And Xinhuacheng reporters visited relevant oncologists

Explore the truth behind the "anti-cancer miracle drug"

01 What is this medicine?

The first in China to use human immune cells to treat tumors

CAR-T cell therapy is an emerging treatment method, which is the first method in China to use immune cells in the human body to treat tumors. In the eyes of hematological oncologists, CAR-T is not a drug in the usual sense, it is a "personalized drug", more accurately called "chimeric antigen receptor T cell therapy".

Weng Jianyu, administrative director of the Department of Internal Medicine of Guangdong Provincial People's Hospital, made a popular analogy of this therapy: CAR-T cells, like a powerful "armored vehicle" with navigation and positioning devices, this CAR-T "armored vehicle" is like a "Qitian Dasheng" with "golden eyes and fire eyes", and when it meets with "monsters" (tumor cells), it immediately changes into a hundred, or even thousands, and the amplification of the logarithmic level rises sharply, and the effect of killing tumor cells rises sharply, exerting the effect of accurate, directional, and powerful destruction of tumor cells.

Since the beginning of this year, good news related to autologous CAR-T cell therapy has followed:

A 57-year-old patient with refractory diffuse large B-cell lymphoma whose condition was nearly "completely relieved" after receiving acynxa injection targeting the CD19 antigen in Jiangsu;

Patients with recurrent leukemia after bone marrow transplant failure were "stabilized" after using another CAR-T treatment product targeting CD19 in Guangdong;

Patients with advanced gastric cancer with specific targets adopted a domestic CAR-T treatment product CT041, and the total objective response rate reached 57.1%......

02 Why is this medicine so expensive?

One-on-one customization

"Too expensive, huh?" The exclamation stemmed from the price shown in a preliminary drug list: CAR-T agillonxa injection "1.2 million yuan / bag (68 ml)".

According to experts, all the CAR-T drugs approved in the world are currently priced very high, with foreign products priced between $373,000 and $475,000, equivalent to between 2,411,100 yuan and 3,070,500 yuan; Japan's price is 2 million yuan.

Many experts interviewed pointed out that the cost of CAR-T cell therapy, in addition to the huge cost of research and development with other new drugs, is also due to the extreme complexity of its production process. Moreover, the CAR-T cells of each patient are "individualized" customized "one-to-one", which is the main factor leading to high production costs.

03 Which tumors is CAR-T effective?

Du Xin, the leader of the Department of Hematology of Guangdong Provincial People's Hospital, pointed out that CAR-T cell therapy, which is relatively mature at present, mainly focuses on the successful treatment of recurrent refractory B lymphocyte tumors and multiple myeloma, but for acute myeloid leukemia, T lymphocyte tumors and other hematologic malignancies, it needs further research and overcome.

Duxin:

The CURRENTLY MARKETED CAR-T products have clear indications for adult patients with relapsed or refractory large B-cell lymphoma after previous systemic treatment of second-line or above.

In other words, this is to bring new treatment options to lymphoma patients who have poor efficacy in traditional treatment methods such as surgery, radiotherapy, chemotherapy and bone marrow transplantation.

Professor Tu Sanfang, an expert in the Department of Hematology of Zhujiang Hospital of Southern Medical University, said that in principle, CAR-T treatment can be used for immunotherapy for all tumors with clear targets, but in fact, the targets applicable to the products that have been approved for marketing are still relatively limited.

Tu Sanfang:

At present, the best treatment effect is internationally recognized as two targets, one is the CD19 target for the treatment of B-cell diseases, including B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin lymphoma, of which leukemia can achieve more than 90% complete remission, and non-Hodgkin lymphoma can also achieve more than 50% efficacy.

Another target, CAR-T therapy for BCMA, can achieve an effective response rate of 50%-80% or more for multiple myeloma. As for other types of leukemia and even car-T treatment for solid tumors, it is still in the early stage of research and development.

In addition, not all patients are suitable for this therapy, in addition to the need to find a qualified cell preparation mechanism, but also depends on the patient's own physical conditions, such as whether the body can provide enough and sufficient quality of T cells.

"At present, it has also achieved certain efficacy in digestive system tumors such as liver cancer, stomach cancer, and pancreatic cancer, but it has not met people's expectations." A stomach cancer expert in a top three hospital in Guangzhou said that this is mainly due to the difficulty of target selection, and CAR-T cells are relatively difficult to enter the solid tumor tissue, even if they enter the tumor tissue, they are easily blocked by other immunosuppressive molecules or cells, and cannot play a role.

Source: Guangzhou Daily Comprehensive Zhongxin Jingwei, Health Times, Daily Economic News, Guangzhou Daily Health Appointment

Part of the article / Guangzhou Daily , Xinhua City reporters: Ren Shanshan, He Xuehua, Zhou Jieying