Is Mirdametinib included in the scope of medical insurance reimbursement?

Up to now, Mirdametinib (Mildametinib, trade name Gomekli™) has not been approved for marketing by the National Medical Products Administration (NMPA) in China, and therefore is not included in China’s medical insurance reimbursement list. This means that Chinese patients who want to use midametinib cannot be reimbursed through medical insurance and must bear the full cost of the drug themselves. At the same time, they cannot enjoy the convenience of purchasing drugs from medical insurance pharmacies.

In the international market, midametinib received approval from the U.S. FDA in February 2025. It is approved for the treatment of symptomatic plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1) in adults and children 2 years of age and older. Following this, the European Medicines Agency (EMA) also gave a conditional marketing opinion in May 2025. However, these advances have yet to translate into medical registration and health insurance coverage in China.

Since China has not approved midametinib for marketing, even if it obtains international registration, it must go through the local application process of NMPA, including clinical trial data submission and approval. Once passed, it is expected to be included in China's medical insurance system. There is currently no public information showing relevant progress, so for patients in urgent need of this drug, there is currently no legal medical insurance support or reimbursement policy in China.

If midametinib is approved in China in the future, its final route to medical insurance will be based on whether it will be included in the national medical insurance catalog after launch. "Category C" negotiated drugs or "Category B" conventional drugs will be classified, and will be affected by provincial medical insurance policies. This will significantly change its accessibility and affordability. At present, it is recommended that patients and doctors keep an eye on the latest approvals and medical insurance directory developments of NMPA, and weigh whether to participate in international clinical trials or obtain drug support treatment through formal overseas channels.

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