1.2-Million-Dollar-per-Dose Cancer Therapy Likely Excluded from China's National Reimbursement Drug List

　　【Pharmaceutical Network Market Analysis】The three-day national medical insurance negotiation concluded officially on November 11. Notably, from November 10 until the end of the medical insurance negotiation, representatives from Fosun Kite Biotechnology Co., Ltd., the producer of the much-anticipated 1.2 million RMB per dose "astronomically-priced cancer drug," were nowhere to be seen.
 

According to available data, the number of cancer patients in China is substantial. As these drugs are often expensive, anti-tumor PD-1 antibody drugs have become a focal point of attention in each round of medical insurance negotiations. In previous rounds of negotiations, Camrelizumab from Hengrui Medicine, Sintilimab from Innovent Biologics, Tislelizumab from BeiGene, and Toripalimab from Junshi Biosciences were included in the medical insurance catalog with price reductions of 85.21%, 63.73%, 79.60%, and 70.82% respectively, with an overall reduction range of 60-85%.
 

In this round of medical insurance negotiations, according to the preliminary list of drugs that passed the formal review, a total of 15 domestically produced innovative drugs in China are participating in national negotiations for the first time. These include Ensartinib from Betta Pharmaceuticals, Orelabrutinib from InnoCare Pharma, and Yimitawe from Dongyang Light, among others. All these drugs have been newly approved for market release within the past three years, with nine of them being launched this year. Notably, among these 15 domestically produced innovative drugs, there are also significant CAR-T products, such as the 1.2 million yuan anti-cancer drug—Axicabtagene Ciloleucel.
 

According to reports, Axicabtagene Ciloleucel is a cell therapy product localized in China by Fosun Kite based on the CAR-T cell therapy product Yescarta, which was introduced from Kite Pharma and underwent technology transfer. On June 10, 2021, this product received approval from the National Medical Products Administration for clinical trials to treat relapsed or refractory indolent non-Hodgkin lymphoma (r/r iNHL) after two or more lines of systemic therapy, including follicular lymphoma (FL) and marginal zone lymphoma (MZL).
 

On June 22, 2021, the product was approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after receiving two or more lines of systemic therapy. This includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma. As the first CD19 CAR-T cell therapy approved in China, the approval of Axicabtagene Ciloleucel marks a new chapter in the treatment of patients with relapsed or refractory large B-cell lymphoma after systemic therapy in China. However, although patients can achieve complete remission with just one infusion, the product is extremely expensive due to its personalized customization, currently priced at 1.2 million yuan per bag.
 

From the extent of inclusion and price reduction of tumor drugs in previous rounds of medical insurance negotiations, the industry has high expectations for a good outcome for Axicabtagene Ciloleucel in this negotiation. However, some analysts suggest that it is unlikely for Axicabtagene Ciloleucel to be included in the medical insurance catalog because it is unrealistic for high-cost drugs priced at millions to be covered by medical insurance. Moreover, considering that no representatives from Fosun Kite Biotechnology Co., Ltd. were seen at the negotiation site after its conclusion, this prediction may have already become a reality—Axicabtagene Ciloleucel Injection will ultimately miss out on medical insurance coverage, and the hope within the industry for its significant price reduction might also have been dashed.
 

In fact, a drug passing the preliminary formal review does not mean that it has entered the medical insurance directory. It only represents that the drug meets the corresponding application conditions after examination, and has initially obtained the qualification to participate in the next stage of the review. According to publicly available information, Fosun Kite Biotechnology Co., Ltd.'s Axicabtagene Ciloleucel Injection was just approved on June 23 this year. Although it made the deadline for the medical insurance negotiation drug application, the clinical efficacy and pharmacoeconomic data of the drug are still incomplete, and may not yet be sufficient to support its entry into the subsequent medical insurance negotiation stage.
 

In addition, the development of Axicabtagene Ciloleucel Injection from research to market launch requires the support of hundreds of studies, which has also led to high research and development costs. For instance, the R&D expenses for Axicabtagene Ciloleucel Injection, which only conducted a bridging trial, amounted to 675 million yuan. Therefore, considering the need to recoup costs and achieve economic benefits, it is impossible to significantly reduce the price just to be included in the medical insurance.
 

In summary, the 2021 medical insurance negotiation has come to an end. Based on past experience, the negotiation results may be announced this month or in December, at which time all speculation and evaluations will be revealed. Regardless of the outcome, pharmaceutical companies can only adapt flexibly and prepare actively.