Will enasidenib be included in the medical insurance directory in 2025?

Enasidenib is a targeted drug targeting specific gene mutations (IDH2 mutations) in patients with acute myeloid leukemia (AML). It improves the metabolic disorder of tumor cells by selectively inhibiting the activity of IDH2 mutant protein, and helps abnormally differentiated leukemia cells return to a state closer to normal blood cells. The emergence of this drug provides a new treatment option for some patients who are not sensitive to conventional treatments, and is considered an important achievement in the development of precision medicine. Overseas, ensidipine has been approved by the US FDA and the European EMA for patients with relapsed or refractory AML, and is recommended as a second-line or subsequent treatment option in clinical guidelines in some countries.

Judging from the situation in China, ensidipine has not yet been officially launched in the country, so it has not been included in the national medical insurance directory. This means that patients are temporarily unable to obtain the drug through medical insurance reimbursement channels. In the process of domestic drug introduction, it usually needs to go through registration application, clinical trials, local approval and other links, so the time to market often lags behind that of European and American countries. The adjustment of the medical insurance catalog depends on the evaluation and negotiation between the State Food and Drug Administration and the Medical Insurance Bureau, including the clinical value of the drug, the number of patient groups, cost-effectiveness, and comparison of existing treatment options. Since ensidipine is an innovative targeted drug and covers a relatively limited population, it is unlikely to be included in the medical insurance catalog in the short term.

However, as China attaches greater importance to precision cancer treatment, many small molecule targeted drugs have achieved price reductions and been included in medical insurance negotiations in recent years. This trend shows that as long as the efficacy and safety of the drug are verified and the price is adjusted to a level affordable by medical insurance, the possibility of inclusion in medical insurance in the future still exists. For patients, the current way to obtain ensidipine mainly relies on overseas purchase or clinical research use of drugs.

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