Asunercept Medicine 12 June 2019 Extended indication Treatment of recurrent glioblastoma Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Asunercept Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Brain cancer Extended indication Treatment of recurrent glioblastoma Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Apogenix Portfolio holder Mechanism of action Immunostimulation Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Asunercept works by attaching to a protein known as the CD95 ligand, which triggers a natural process that leads to cell death (apoptosis). Registration Registration route Centralised (EMA) Type of trajectory Accelerated assessment Particularity New medicine with Priority Medicines (PRIME) ATMP Unknown Submission date Expected Registration Orphan drug Yes 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 Duration of treatment Frequency of administration Dosage per administration References Additional remarks IV 800 mg weekelijks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; expertopinie Additional remarks In Nederland zijn er jaarlijks ongeveer 1.100 patiënten met de diagnose glioma waarbij er ongeveer 800 de diagnose glioblastoma krijgen. Hiervan worden er tussen de 60-70% primair behandeld met chemoradiatie. Meer dan 90% van de glioblastoma's zijn recurrent. Er zullen dus maximaal 500 patiënten mogelijk in aanmerking komen voor deze behandeling. 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