Pembrolizumab Medicine 10 December 2019 Extended indication Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the treatmen of extensive stage Small Cell Lung Cancer (SCLC) (1L) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Pembrolizumab Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) for the treatmen of extensive stage Small Cell Lung Cancer (SCLC) (1L) Current proprietary name Already available biosimilars / generics Proprietary name Keytruda Manufacturer MSD 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 Humanised monoclonal IgG4 antibody against the programmed death-1 (PD-1) protein. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Op basis van fase 2 data zijn de verwachtingen van experts niet hooggespannen, fase 3 data moet nog volgen. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 200 mg References SmPC, NCT03066778 Additional remarks Max 2 jaar behandeling. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Er waren in 2016 1.672 patiënten met SCLC. In 2016 werden er 1.118 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 (gelijk aan de inschatting voor atezolizumab). Echter, gegeven de resultaten van eerdere studies is de inschatting van experts dat niet veel patiënten dit middel zullen krijgen. Expected cost per patient per year Cost € 40,000.00 - 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 G-standaard Additional remarks Voor alle indicatie van pembrolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot eind 2019). AIP per nov 2017: €2.624,38 per injectieflacon 25MG/ML FL 4ML (oplossing). Inschatting: in lijn met andere indicaties. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Fabrikant Additional remarks Indication extension Indication extensions Yes Indication extensions Indicatie-uitbreidingen worden weergegeven in de Horizonscan (Maagkanker, Hoofd- en halskanker, huidkanker, Borstkanker, etc.) References Fabrikant en Horizonscan Additional remarks Other information Additional remarks