Will zolbetuximab be included in medical insurance and reimbursement policies in 2025?

Zolbetuximab (trade name Vyloy) is a drug that targets Claudin 18.2 (CLDN18.2) monoclonal antibody has been released in 2025At the beginning of the year, it was approved by the China National Food and Drug Administration (NMPA) for the first-line treatment of CLDN18.2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma. However, as of now, the drug has not been included in China's national medical insurance directory, which means that patients still need to bear all costs when purchasing drugs domestically, and should consult medical institutions or pharmacies for the latest pricing information.

In terms of cost, the price of domestic original research zotuximab is not yet clear, but it is speculated that it is similar in scale to other imported antibody drugs and is in the high-end price range of more than 10,000 yuan. The economic reference for overseas markets is relatively clear: the European version or the Japanese version may sell for around 7,000 yuan per box (exchange rate fluctuations may cause the price to differ). Since no generics or domestic biosimilars have yet emerged, the originator version remains the only available product.

Patients can obtain zotuximab through regular hospitals, imported drug suppliers or international pharmacies, but they should pay attention to the authenticity and transportation conditions of the drug to ensure drug quality and safety. Patients who are still in the approval stage can pay attention to the updates of medical insurance policies in various provinces and cities, and actively participate in the gradually expanding clinical use projects or patient assistance programs to lay the foundation for possible future inclusion in medical insurance. At present, there is still no clear pricing system and affordability plan in China, so we need to pay attention to the progress.

In general, zotuximab, as a new first-line drug for CLDN18.2 targeted therapy, has received regulatory approval but has not yet been included in medical insurance. Its price is expected to be higher, with limited purchasing channels and at your own expense. With the update of the drug catalog and progress in medical insurance negotiations in 2025, the drug is expected to be open to a wider range of patients. Patients and their families should pay attention to policy developments, consult professional medical institutions in a timely manner, and plan treatment plans reasonably.

Reference:https://www.astellas.com/en/news/29401