Leukocyte interleukin Medicine 06 June 2023 Extended indication Cancer of the oral cavity, neoadjuvant Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Leukocyte interleukin Domain Oncology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Cancer of the oral cavity, neoadjuvant Current proprietary name Already available biosimilars / generics Proprietary name Multikine Manufacturer CEL-SCI Portfolio holder Mechanism of action Unknown Route of administration Local Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Multikine is a mixture of naturally occurring cytokines that regulate the immune system. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chirurgie gevolgd door radiotherapie en mogelijk chemotherapie. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De behandeling lijkt wel een positief effect te kunnen hebben. Op dit moment is het product nog lastig te duiden. Het is namelijk niet vergelijkbaar met andere immunotherapie. Uit de klinische studie blijkt dat LI immunotherapie niet leidt tot extra veiligheidsrisico's. Een vroege LI respons verlaagde de mortaliteit. Er werd een winst in overall survival gevonden wanneer LI + SOC gegeven werd in plaats van enkel SOC 0.68 HR. Duration of treatment Average 3 week / weeks Frequency of administration 1 times a day Dosage per administration References NCT01265849 Additional remarks Expected patient volume per year Patient volume < 235 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL 2021 Additional remarks Het aantal diagnoses van patiënten in 2021 in Nederland die aan de selectiecriteria voldoen van de klinische studie (oral cavity (anterior tongue, floor of mouth, cheek)/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0) bedraagt 235. 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