On November 28, the results of the 2024 medical insurance catalog negotiation were announced: 91 new drugs were added to the national medical insurance drug catalog, of which 89 were included by negotiation/bidding, and another 2 were selected in the national centralized procurement. After checking the medical insurance drugs, Sina Medical Editor found that the 4 CAR-T products that had passed the preliminary review did not appear on the list.

Regarding "Why is it difficult for CAR-T to enter the medical insurance catalog", at the press conference held by the National Medical Insurance Administration on the morning of November 28, Wang Guodong, deputy director of the Medical Insurance Management Center of the National Medical Insurance Administration, introduced that some expensive cell and gene therapy drugs have been launched one after another, and it is difficult to fully support them by relying solely on basic medical insurance. At present, the National Medical Insurance Administration is also working hard to build a "1+3+N" multi-level medical insurance system to better support the development of innovative drugs.

CAR-T therapy has a very good therapeutic effect on many malignant tumors, especially lymphoma and myeloma, especially when other drugs are ineffective, it may still be effective for many patients.

As the largest payment source for domestic drugs, medical insurance has always been the tree that CAR-T therapy hopes to rely on. Even though the attempts in previous years have failed, companies are still moving forward. This year, a total of 4 CAR-T therapy drugs have entered the list of non-catalog drugs that have passed the preliminary formal review, including Fosun Kite's Akirensel Injection, Innovent Biologics' Ruiqiorensel Injection, Heyuan Bio's Nakiorensel Injection, and Coherus Pharmaceuticals' Zewokiorensel Injection, setting a record in history. It is widely rumored in the industry that there is a rule in medical insurance negotiations that "500,000 (yuan) will not be discussed, and 300,000 (yuan) will not be entered." The high price does not match the medical insurance payment, resulting in CAR-T products failing to rush for medical insurance many times.

According to Sina Medicine statistics, the prices of the six CAR-T therapies approved by the FDA range from US$370,000 to US$475,000 (approximately RMB 2 million to RMB 3 million); six CAR-T therapies have been approved in China, of which five are priced between RMB 1 million and RMB 1.3 million. Legend Biotech's newly approved Cidacioren is priced at $465,000 in the United States (about 3.1 million RMB at the current exchange rate), and its domestic price is estimated to be no less than 1.2 million RMB per injection.

Currently, all CAR-Ts approved for marketing are autologous CAR-Ts. Autologous CAR-Ts require the collection of T cells from each patient, so each patient requires a separate production line, and the finished product is limited to the patient's own use. In terms of production and preparation, after the collected patient T cells are delivered to the product preparation base, they will go through more than 600 processes and more than 20 professional preparation engineers to complete the production, and must pass strict quality control and quality inspection steps. This is the reason why all CAR-T products are expensive.

High pricing will undoubtedly affect the commercialization of CAR-T therapy. In 2021, the demand for CAR-T immune cell therapy in China is 60 injections, and the demand for domestic CAR-T immune cell therapy will increase to 568 injections in 2023. It is estimated that the demand for domestic CAR-T immune cell therapy in 2024 will be about 1,392 injections. A person in charge of a domestic CAR-T manufacturer said that only 2%-3% of large B-cell lymphoma patients in China have used CAR-T therapy, and the potential demand is huge. The inability to enter the medical insurance has obviously limited the market size of CAR-T products, and companies are also actively seeking change.

The industry believes that the annual cost of high-value drugs that have successfully negotiated medical insurance is mostly controlled within 300,000 yuan. Can CAR-T therapy reduce the annual cost to less than 300,000 yuan?

Localization is considered a way to reduce costs and ultimately reduce annual costs. For example, in March this year, an article in the journal Nature revealed that India took advantage of the low-cost production advantages of localization to greatly reduce the costs of CAR-T raw materials, equipment and labor, and ultimately achieved a single CAR-T treatment cost of 200,000-300,000 yuan. In its 2023 annual report, domestic CAR-T manufacturer Innovent Biologics mentioned that as of December 31, 2023, the company had begun to purchase key materials from domestic suppliers, and planned to purchase additional raw materials from domestic suppliers in the future. Due to the localization of raw materials and more patients receiving treatment, the sales cost per batch in 2023 will be reduced by 17.3% compared with the average sales cost in 2022.

Universal CAR-T therapy is also one of the directions for cost reduction in the future. In early November, CAR-T (2171.HK) announced a trial data of CT0590, an allogeneic dual-target CAR-T cell therapy. The preliminary results of the study showed that the safety of CT0590 is controllable and achieves deep and lasting clinical remission. Li Zonghai, chairman of the board of directors of CAR-T, told the media that compared with autologous CAR-T, the production cost of universal CAR-T is expected to be reduced by more than 95%, and the result of mass production is that patients do not have to wait and can use it at any time. After the above information was released, CAR-T's stock price rose for three consecutive days. However, universal CAR-T therapy still needs to solve the problems of fewer patients in phase 1 clinical trials, as well as treatment effects and cell rejection.

In addition, diversified payment mechanisms have become the current industry consensus, and diversified payment methods such as commercial insurance and Huiminbao have become possible solutions. So far, 40 provinces and cities in my country, including Beijing, Shanghai, Changsha, Suzhou, Shenzhen, and Zhongshan, have included CAR-T cell therapy in the reimbursement scope of Huiminbao; some insurance companies have also included CAR-T immune cell therapy in their high-end protection plans, and even set the upper limit of compensation to several million yuan. As of the end of last year, Akilencel has been included in more than 70 commercial insurances; Rekioluncel has been included in 56 commercial insurance products. Huge clinical needs exist objectively, but further improving accessibility has become an urgent need for CAR-T products.

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