Pembrolizumab / vibostolimab Medicine 03 December 2024 Extended indication in combination with etoposide and platinum chemotherapy, is indicated for the first line treatment of adults with extensive stage small cell lung cancer (ES SCLC) Therapeutic value No estimate possible yet Total cost Registration phase No registration expected Product Active substance Pembrolizumab / vibostolimab Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication in combination with etoposide and platinum chemotherapy, is indicated for the first line treatment of adults with extensive stage small cell lung cancer (ES SCLC) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder MSD Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP No Submission date January 2025 Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Deze indicatie wordt niet meer verwacht. De studie is gestopt. Zie persbericht: https://www.merck.com/news/merck-provides-update-on-phase-3-keyvibe-008-trial-evaluating-an-investigational-fixed-dose-combination-of-vibostolimab-and-pembrolizumab-in-patients-with-extensive-stage-small-cell-lung-cancer/ Therapeutic value Current treatment options none, atezolizumab is not reimbursed in NL Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De studie is gestopt vanwege bijwerkingen en resultaten. Duration of treatment Maximal 2 year / years Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg / 200mg References NCT05224141 Additional remarks Expected patient volume per year Patient volume < 1,160 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: NKR2021. Additional remarks In 2021 waren er in totaal 1.646 patiënten met kleincellig longcarcinoom. Hiervan betrof het in 1.160 patiënten met een stadium 4 carcinoom. Expected cost per patient per year Cost References Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement tot 1 januari 2027. Potential total cost per year Total cost 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