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 € 36,090,000.00 Registration phase Registered 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 ATMP No Submission date March 2023 Expected Registration February 2025 Orphan drug Yes Registration phase Registered Reimbursement Excluded from the basic package Medicine sluice Included in the sluice Additional remarks EMA-indiening in maart 2023. Zorginstituut Nederland heeft de minister van Volksgezondheid, Welzijn en Sport (VWS) in april 2026 geadviseerd om serplulimab (Hetronifly®) in combinatie met carboplatine en etoposide niet te vergoeden uit het basispakket van de zorgverzekering. Op dit moment is de prijs van het medicijn namelijk te hoog. Alleen als de prijs van het medicijn met minstens 39% daalt, kan het vergoed worden. Therapeutic value Current treatment options Chemotherapie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De PASKWIL criteria worden gehaald. Mediane overall survival 15,4 maanden [95% BI, 13,3 maanden - niet evalueerbaar] versus placebogroep 10,9 maanden [95% CI, 10,0-14,3 maanden] (hazard ratio, 0,63 [95% CI, 0,49-0,82]; p < 0,001). ASCO-jaarvergadering 2024: Mediane overall survival (15,8 versus 11,1 maanden; gestratificeerde HR 0,61, 95% CI 0,50-0,74). Het betreft voor 70% een Aziatische populatie. Duration of treatment Frequency of administration Dosage per administration References NCT04063163 (ASTRUM-005); NCT05468489 (ASTRIDE) Additional remarks Expected patient volume per year Patient volume < 802 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL, expert opinie Additional remarks In 2021 waren er 1.637 SCLC diagnoses. Waarvan 70% stadium 4 (1.146 patiënten). 70% wordt behandeld in de eerstelijn (802 patiënten). 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 € 36,090,000.00 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