Medical insurance reimbursement policy for sotoraxibu in 2025

Sotorasib (AMG510, Sotorasib) has attracted attention from the global oncology community since it was approved overseas for the treatment of KRAS G12C mutation-positive non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. Unfortunately, as of now, the drug has not been officially launched in mainland China, so it is not yet eligible for medical insurance reimbursement through the National Drug Directory. According to China's current medical insurance policy, imported drugs that have not been approved by the NMPA do not meet the prerequisites for inclusion in the medical insurance catalog, and they cannot achieve special reimbursement through local single-disease catalogues. This means that if mainland patients need to use sotorasibu, they can only obtain it through overseas drug purchase or clinical trial channels.

Currently, Sotorasibu has been approved for sale in Hong Kong and is sold in specific pharmacies. According to Hong Kong market data, the price of the original drug120mg*240 tablets is approximately RMB 80,000. The specific price may fluctuate slightly due to exchange rate fluctuations, procurement channels and packaging batches. Since it has not yet been included in the general reimbursement catalog of Hong Kong’s public medical system, patients mostly need to pay for it at their own expense. In addition, some insurance companies may provide partial reimbursement of targeted drug expenses in critical illness benefits, but this depends on the terms of the contract. In mainland China, some patients purchase the drug through legal overseas purchasing channels, but they need to be wary of the risks of counterfeit drugs and legal compliance issues.

At present, many multinational pharmaceutical companies have submitted new drug marketing applications for sotorasibu to the State Food and Drug Administration. If approved for marketing in the future, it may be included in the medical insurance negotiation catalog, and the price is expected to drop significantly by then. For patients who urgently need this drug, it is recommended to pay close attention to domestic clinical trial recruitment information, or participate in overseas multi-center treatment projects under the guidance of doctors, so as to obtain effective treatment opportunities under dual legal and medical protection.

Reference materials:https://www.lumakras.com/