Serplulimab Medicine 06 June 2023 Extended indication Treatment of extensive-stage small cell lung cancer (ES-SCLC) Therapeutic value No estimate possible yet Total cost € 27,000,000.00 Registration phase Registration application pending Product Active substance Serplulimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Treatment of extensive-stage small cell lung cancer (ES-SCLC) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Shanghai Henlius Biotech Portfolio holder Mechanism of action PD-1 / PD-L1 inhibitor 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 Unknown ATMP No Submission date March 2023 Expected Registration April 2024 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 300 mg References NCT05353257 Additional remarks Expected patient volume per year Patient volume 500 - 700 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL, expert opinie Additional remarks In 2020 werden er 1.157 diagnoses stadium 4 SCLC geregistreerd. Inschatting patientvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500-700 patiënten in aanmerking kunnen komen voor deze behandeling. 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 GIP-databank, Horizonscan Additional remarks Gegeven de andere PD1 remmers binnen dit indicatiegebied is de verwachting dat de kosten 30.000-60.000 euro pppj zullen bedragen. Potential total cost per year Total cost € 27,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Fase 3: Oesophageal cancer Gastric cancer Colorectal cancer Cervical cancer References Adis Insight, Clinicaltrials.gov Additional remarks Other information Additional remarks