Pembrolizumab Medicine 05 December 2023 Extended indication Pembrolizumab (MK-3475) Subcutaneous (SC) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC). Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Pembrolizumab (MK-3475) Subcutaneous (SC) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC). Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD Portfolio holder MSD Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks De aanvullende vergoedingsstatus per indicatie zal naar verwachting gelijk zijn aan die van intraveneuze formulering. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date January 2025 Expected Registration January 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Out of the sluice Additional remarks Voor alle indicaties van pembrolizumab geldt een financieel arrangement tot 1 januari 2027. 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 Dosage per administration References NCT04956692 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Voor pembrolizumab is een financieel arrangement van toepassing tot 1 januari 2027. Aankomende indicatie uitbreidingen vallen onder deze overeenkomst, mits zij voldoen aan stand der wetenschap en praktijk. Potential total cost per year Total cost 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