Is tucatinib/tucatinib now included in medical insurance?

Tucatinib is a new type of HER2-targeted oral small molecule drug that has attracted worldwide attention in recent years. It is mainly used to treat HER2-positive metastatic breast cancer and has shown obvious clinical advantages especially in patients with brain metastases. The drug was developed by the American company Seagen and was approved for marketing by the FDA in 2020. It was subsequently approved in many European and American countries for the treatment of HER2-positive breast cancer patients who have undergone multiple lines of treatment in combination with trastuzumab and capecitabine. However, for Chinese patients, the acquisition and use of tucatinib still faces practical obstacles. The most concerning issue is whether it has been included in the national medical insurance directory.

As of now, tucatinib has not yet achieved commercial sales of the original drug in mainland China, nor has it been officially included in the national medical insurance reimbursement catalog. Since China's medical insurance policy mainly relies on drugs that have been approved for marketing in China and are in the clinical use stage for drug list negotiations, new drugs that have not completed the local marketing process are usually unable to directly enter the medical insurance system. Although tucatinib has relatively sufficient clinical research support and registration foundation overseas, its registration path in China is lagging behind, which also directly affects its medical insurance access process.

Nonetheless, as China’s efficiency in new drug review and approval continues to improve and the concept of precision cancer treatment becomes increasingly mature, innovative drugs with clear targets and international treatment consensus, such as tucatinib, have become the focus of the National Medical Products Administration. In the future, once tucatinib completes its domestic marketing review and is put on the market, its possibility of entering medical insurance will be greatly increased, especially considering that it has a gap in the treatment of HER2-positive brain metastases in breast cancer and has outstanding unmet clinical needs.

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