Is capicetinib/capacetinib included in the scope of medical insurance reimbursement?

Capivasertib is a drug that represents the targeted innovation direction of "AKT inhibition". Its trade name is TRUQAP. It was developed by AstraZeneca and was approved for marketing in Europe, the United States, Japan and other regions at the end of 2023. In 2024, the drug was officially approved in mainland China under the name Capisete Tablets for the treatment of hormone receptor-positive, HER2-negative, advanced breast cancer with PIK3CA/AKT1/PTEN mutations. This type of patients often faces drug resistance problems in previous treatments, so the emergence of carpisetin is considered a new breakthrough in treatment.

However, considering that the drug has been on the market for a short time in China, it has not yet been included in the national medical insurance directory, nor has it appeared in the local reimbursement directory. Medical insurance inclusion generally requires the drug negotiation process of the National Medical Insurance Administration. The evaluation criteria include multiple dimensions such as drug efficacy, cost-effectiveness ratio, patient group coverage, and international pricing. As carpiseti, as an imported innovative drug, has high research and development costs and a relatively specific target population, its pricing is usually relatively expensive. Therefore, medical insurance negotiations are expected to start within one to two years after its launch.

Judging from the international market situation, the price of carpisetin in the United States and Europe is relatively high, with a course of treatment costing approximately several thousand dollars. Domestically, some cross-border pharmacies or import channels may already provide supplies, but prices are still unstable. As AstraZeneca accelerates its deployment in the Chinese market, it may lower prices through localized production, medical insurance negotiations, etc. to improve patient accessibility.

On the whole, the industry is generally optimistic about the prospect of carpiseti being included in medical insurance. Its precise positioning of clear genetic mutations and its therapeutic advantages in combination with endocrine drugs such as fulvestrant are in line with the medical insurance priority consideration criteria of "innovative drugs of high clinical value". If included in medical insurance in the future, it will significantly reduce the burden on patients and promote the popularization and optimization of AKT targeted therapy in the field of breast cancer.

Reference materials:https://www.drugs.com/mtm/capivasertib.html