Is Riflimab included in medical insurance? The latest reimbursement policy in 2025

Retifanlimab, commercially known as Zynyz, is a monoclonal antibody targeting the PD-1 immune checkpoint. It was first approved in the United States in March 2023 for the treatment of metastatic or recurrent Merkel cell carcinoma(Merkel cell carcinoma, MCC), and was extended approval by the FDA in May 2025. It is used in combination with carboplatin + paclitaxel for the first-line treatment of inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). It also supports single-agent use in patients with SCAC who have failed or are intolerant to platinum therapy. In May this year, the FDA went a step further and attracted much attention with Zynyz as the first FDA-approved PD‑1 inhibitor in the treatment of SCAC. The drug offers treatment options that emphasize its potential to extend survival and tumor response, especially for patients with progressive tumors.

However, in mainland China, Riflimab has not yet been approved by the national drug regulatory authorities, so it is neither on the market nor included in the medical insurance list. This means that domestic hospitals and pharmacies cannot provide the drug, and patients cannot obtain treatment opportunities or reimbursement through conventional medical insurance channels. At present, if Chinese people need treatment, they can only obtain the original Zynyz through cross-border medical treatment, prescription referral or overseas drug purchase platforms. Although these channels can fill the gap in domestic treatment, they involve challenges such as legal attributes, cost burden, cold chain transportation and medication safety.

Currently,China has not issued any formal reimbursement policy for Zynyz in 2025, and patients still need to be prepared for "self-pay + auxiliary support", such as through cross-border medical insurance, patient assistance projects, etc. to reduce financial pressure.

In short, althoughZynyz brings new options for cancer treatment, its accessibility in China is still in its early stages. Patients and medical staff need to pay attention to drug regulatory announcements and clinical trial progress so that they can exit overseas channels and enter the formal clinical and medical insurance systems as soon as possible.

Reference materials:https://www.drugs.com/mtm/retifanlimab.html