Has Enasidenib been included in the National Medical Insurance List?

Although Enasidenib has been approved and marketed in the United States and other countries for many years and is mainly used for patients with relapsed or refractory acute myeloid leukemia (AML) harboring IDH2 gene mutations, its registration and marketing progress in China is still lagging behind. At present, the drug has not been approved for marketing in mainland China, and therefore it has not been included in the national medical insurance list. For patients, this means that domestic medical institutions cannot obtain the drug through medical insurance channels. If they need to use it, they can only rely on overseas drug purchase or clinical trials.

Inclusion in the medical insurance directory requires a strict process, including drug registration and application in the country, marketing approval, clinical value assessment and price negotiation. As a new targeted drug, the price of ensidipine is relatively high in the international market, and the treatment population belongs to a relatively small number of AML patients with genetic mutation subtypes. These factors may affect their entry into medical insurance. At present, the treatment of AML in China is still dominated by chemotherapy, hematopoietic stem cell transplantation and some marketed targeted drugs. Although the clinical demand for IDH2 inhibitors is increasing, this type of drug is not yet covered by medical insurance.

However, judging from the overall trend, my country's introduction of targeted drugs for rare diseases and blood tumors has gradually accelerated in recent years. Many innovative drugs that were only available in Europe and the United States in the past have gradually entered the Chinese market, and their prices have been reduced through medical insurance negotiations, improving accessibility for patients. Therefore, ensidipine is expected to be introduced into the country when conditions are mature in the future, and further applications will be made to be included in the scope of medical insurance reimbursement. For patients, if they need to use the drug before this, they can only obtain it through formal overseas channels. Clinicians will also provide patients with reasonable medication recommendations based on individual genetic test results and overall treatment plans.

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