Serplulimab Medicine 03 December 2024 Extended indication Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly. Therapeutic value No estimate possible yet Total cost € 27,000,000.00 Registration phase Positive CHMP opinion Product Active substance Serplulimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Serplulimab in combination with carboplatin-etoposide for first line treatment of small cell lung cancer extensive stage in adults and elderly. 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 January 2025 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks EMA-indiening in maart 2023. Positieve CHMP-opinie in september 2024. Therapeutic value Current treatment options Chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog enkel data van uit een interim analyse bij 12 maanden beschikbaar. De HR van de algehele overleving was 0,63. Verdere resultaten moeten nog afgewacht worden. Duration of treatment Frequency of administration Dosage per administration References NCT04063163 (ASTRUM-005); NCT05468489 (ASTRIDE) 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 patiëntvolume is sterk afhankelijk van precieze indicatie. De inschatting is dat er uiteindelijk 500 tot 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 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 € 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 Unknown Indication extensions References Additional remarks Other information Additional remarks