Is gaffetuzumab already included in medical insurance?

Glofitumab (Glofitamab), also known as Glofitumab, with the trade name Columvi, is a CD20×CD3 bispecific antibody developed by Roche. It is specially used to treat relapsed or refractory large B-cell lymphoma (DLBCL; non-Hodgkin lymphoma ) and other malignant hematological tumors. The drug has been approved for marketing in many European and American countries since 2023, and has been officially approved for drug registration in mainland China in 2024, marking the official introduction of a new bispecific antibody treatment mechanism in the field of lymphoma treatment in my country.

Currently, grefituzumab has been officially marketed in China, but has not yet been included in the national medical insurance directory. According to public information on the domestic market, the price of a single preparation of 10mg/10ml is approximately RMB 30,000 per box. Considering that multiple injections are usually required during treatment, the overall treatment cost still poses a large burden to the average patient. Therefore, whether to be included in medical insurance has become a key issue that clinicians and patients are currently paying attention to.

From the perspective of medical insurance policy, my country’s attitude towards innovative cancer drugs in recent years has gradually shifted towards accelerated review and medical insurance support. A variety of immunotherapy drugs, such as PD-1 inhibitors, CAR-T therapy, BTK inhibitors, etc., have entered the medical insurance negotiation process after their clinical benefits are clear. As a representative of bispecific antibodies, gaffetuzumab has a clear target mechanism, good single-agent efficacy, and predictable toxicity control, and has strong potential for medical insurance application. It is expected that as its user population expands and cost data accumulates, it is expected to be included in the scope of reimbursement in the next one or two rounds of medical insurance negotiations.

However, in addition to efficacy and safety, medical insurance negotiations also need to consider factors such as cost-effectiveness ratio, suitability of the treatment population, and whether there are alternative drugs. At present, there are a variety of monoclonal antibody drugs targeting CD20 in China, such as rituximab, obinutuzumab, etc. Although their mechanisms of action are different, they may constitute reference factors in the evaluation of the medical insurance catalog. In addition, the price of geffetumab is also high in overseas markets. The total cost of a single course of treatment in the U.S. market can exceed US$200,000, which also puts certain pressure on price reduction negotiations.

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