Serplulimab immunotherapy now reimbursed for extensive-stage small cell lung cancer

The French Ministry of Health has granted reimbursement to the immunotherapy HETRONIFLY (serplulimab) for the first-line treatment of extensive-stage small cell lung cancer (CPPC-SE). Two orders signed on 19 and 20 August 2026, published in the Journal officiel de la République française n°0194 of 21 August 2026, add the drug to the lists of specialties covered by the national health insurance scheme.

The decision rests on two complementary texts: an order of 20 August 2026 amending the list of pharmaceutical specialties reimbursed in addition to hospitalisation charges under Article L. 162-22-7 of the Social Security Code (reference JORFTEXT000054729026), and an order of 19 August 2026 amending the list of specialties approved for use by public bodies and services (reference JORFTEXT000054728952). Both were issued by the Ministère de la santé, des familles, de l’autonomie et des personnes handicapées.

A new option against an aggressive cancer

Small cell lung cancer is one of the most aggressive forms of the disease, and the extensive-stage form (CPPC-SE) has historically carried a poor prognosis. The reimbursement decision opens a new therapeutic avenue for adult patients, for whom the immunotherapy is now covered in first-line treatment.

The single indication that opens the right to reimbursement is precisely defined in the official texts:

• In combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (CPPC-SE).

Product and marketing details

The drug is marketed by the laboratory ACCORD HEALTHCARE FRANCE SAS under the trade name HETRONIFLY, as a 10 mg/mL solution to be diluted for perfusion, supplied in 10 ml glass vials.

• Presentation: HETRONIFLY 10 mg/mL (serplulimab), solution to be diluted for perfusion, 10 ml glass vial (B/1).
• CIP code: 34009 551 045 7 5.
• UCD code: 3400890049740 (HETRONIFLY 10MG/ML FL10ML).

Two complementary reimbursement channels

The two orders operate in parallel. The first, signed on 20 August, inscribes the specialty on the list of drugs billed in addition to hospitalisation charges, meaning it can be financed separately from the hospital stay under Article L. 162-22-7 of the Social Security Code. The second, signed on 19 August, adds it to the list of medicines approved for use by public bodies and services, covering the hospital and collective-use channel.

Both texts specify that the only therapeutic indication giving rise to reimbursement is the combination with carboplatin and etoposide in first-line treatment of CPPC-SE, and both were published in the same issue of the Journal officiel on 21 August 2026.

Impact for patients

For patients with extensive-stage small cell lung cancer, this decision means that the immunotherapy serplulimab is now accessible within the framework of the national health insurance scheme, in combination with standard chemotherapy. By covering the drug both in the hospital “en sus” channel and in the collective-use list, the French authorities give clinicians a new, reimbursed treatment option for a disease where therapeutic choices remain limited.

Source: Journal officiel de la République française, n°0194 du 21 août 2026, section notices (official references: JORFTEXT000054729026 and JORFTEXT000054728952).