Leukocyte interleukin Medicine 12 June 2019 Extended indication Head and neck (or upper airways tract) cancers, squamous cell - first-line Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Leukocyte interleukin Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Head and neck (or upper airways tract) cancers, squamous cell - first-line Current proprietary name Already available biosimilars / generics Proprietary name Multikine Manufacturer Teva Portfolio holder Mechanism of action Immunostimulation Route of administration Peritumoral Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Immunotherapie die zowel actieve als passieve immuunactiviteit biedt en wordt toegediend voorafgaand aan andere therapie waaronder ook chirurgie of radiotherapie. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Orphan status bij de FDA Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 200 mL References NCT01265849 Additional remarks In the clinical trial IT-MATTERS: LI 400IU (2.0mL total daily, 1.0 mL peritumoral, 1.0 mL perilymphatic) is administered 5 times a week for 3 weeks. Expected patient volume per year Patient volume 160 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; IT-MATTERS trial Additional remarks Er zijn in totaal 2.855 met SCC van het hoofd-halsgebied. 375 hiervan hebben stadium III en 1.015 stadium IV. In totaal dus 1.390 met stadium III/IV. Schatting op basis van IT-MATTERS-inclusiecriteria (SCC oral cavity or soft palate with clinical stage III & IVA): 354 patiënten per jaar. Van deze groep worden er momenteel 160 patiënten per jaar behandeld met de huidige SOC (chirurgie met (C)RT). Expected cost per patient per year Cost References Additional remarks 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 No Indication extensions References Additional remarks Other information Additional remarks