Serplulimab Medicine 04 December 2025 Extended indication Extension of indication to include, in combination with fluoropyrimidine- and platinum-based chemotherapy, the first-line treatment of adult patients with unresectable, locally advanced/recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 1 Therapeutic value Possible added value Total cost € 22,500,000.00 Registration phase Registration application pending Product Active substance Serplulimab Domain Oncology Reason of inclusion Indication extension IND Main indication Oncology other Extended indication Extension of indication to include, in combination with fluoropyrimidine- and platinum-based chemotherapy, the first-line treatment of adult patients with unresectable, locally advanced/recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 1 Current proprietary name Already available biosimilars / generics Proprietary name Hetronifly Manufacturer Intas Portfolio holder Mechanism of action Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date July 2025 Expected Registration May 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Broadly excluded Additional remarks Verwachte registratie op basis van een gemiddelde doorlooptijd van tien maanden voor een indicatieuitbreiding. Therapeutic value Current treatment options Combinate van fluoropyrimidine- en platinum-gebaseerde chemotherapie. PD-(L)1-remmers. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In de ASTRUM-007 studie, waarin serplulimab plus chemotherapie werd vergeleken met placebo plus chemotherapie, waren de primaire eindpunten progressievrije overleving (PFS) en algehele overleving (OS). Serplulimab in combinatie met chemotherapie leidde tot een significante verlenging van de PFS (mediaan 5,8 versus 5,3 maanden; hazardratio 0,60; 95% BI 0,48–0,75; P < 0,0001) en ook tot een significante verbetering van de OS (mediaan 15,3 versus 11,8 maanden; hazardratio 0,68; 95% BI 0,53–0,87; P = 0,0020) vergeleken met de controlegroep. Deze resultaten zullen mogelijk voldoen aan de PASKWIL-criteria. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 4,5 mg/kg References NCT03958890 (HLX10-007-EC301, ASTRUM-007); Song et al. Nat Med. 2023; Expertopinie. Additional remarks Expected patient volume per year Patient volume 400 - 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR 2022 (1); Expertopinie (2). Additional remarks In 2022 waren er 1.753 gevallen van stadium III/IV slokdarmcarcinoom (1). Ongeveer 25-30% van de patiënten heeft plaveiselcelcarcinoom (2). Expected cost per patient per year Cost € 30,000.00 - 60,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References GIPdatabank, Horizonscan Additional remarks Gegeven de andere PD1-remmers binnen dit indicatiegebied is de verwachting dat de kosten €30.000 tot €60.000 per patiënt per jaar zullen bedragen. Potential total cost per year Total cost € 22,500,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks