Serplulimab (5) – Hetronifly®

Name: Frühe Nutzenbewertungen nach § 35a SGB V
Creator: Gemeinsamer Bundesausschuss

Small-cell lung cancer, in combination with carboplatin and etoposide, first-line treatment

Start date	01.08.2026
Resolution	21.01.2027 – active procedure
INN	Serplulimab
Brand name	Hetronifly®
Pharm. company	Accord Healthcare GmbH
G-BA Procedure ID	D-1374
Therapeutic area	Oncological diseases
Reason for procedure	Reassessment: Loss of orphan status

active procedures repealed resolutions


01.08.2026	21.01.2027	Serplulimab (5)	Hetronifly®	Accord Healthcare GmbH	Oncological diseases	Small-cell lung cancer, in combination with carboplatin and etoposide, first-line treatment	n.d.	active procedure
01.08.2026	21.01.2027	Serplulimab (4)	Hetronifly®	Accord Healthcare GmbH	Oncological diseases	Non-small cell lung cancer, squamous cell, first-line treatment, combination with carboplatin and nab-paclitaxel	n.d.	active procedure
01.08.2026	21.01.2027	Serplulimab (3)	Hetronifly®	Accord Healthcare GmbH	Oncological diseases	Squamous cell carcinoma of the oesophagus, PD-L1 with CPS ≥ 5, first-line treatment, in combination with fluoropyrimidine- and platinum-based chemotherapy	n.d.	active procedure
01.08.2026	21.01.2027	Serplulimab (2)	Hetronifly®	Accord Healthcare GmbH	Oncological diseases	Non-small cell lung cancer, non-squamous, EGFR-, ALK- and ROS-negative, first-line treatment, combination with carboplatin and pemetrexed	n.d.	active procedure
01.05.2025	16.10.2025	Serplulimab (1)	Hetronifly®	Accord Healthcare GmbH	Oncological diseases	Small cell lung cancer, in combination with carboplatin and etoposide, first-line treatment	3,210–7,719	100% Hint for non-quantifiable additional benefit Orphan

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