Axalimogene filolisbac Medicine 13 December 2018 Extended indication Second-Line Treatment of Metastatic Cervical Cancer Therapeutic value No judgement Total cost € 13,750,000.00 Registration phase Withdrawn Product Active substance Axalimogene filolisbac Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Cervical cancer Extended indication Second-Line Treatment of Metastatic Cervical Cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Advaxis Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Gemodificeerd Listeria monocytogenes die een fusie-eiwit uitscheidt van HPV-16 E7 en getrunceerde (hoog antigeen) listeriolysine O. Dit fusie-eiwit stimuleert een immuunrespons tegen tumorcellen die het HPV E7 antigen presenteren. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2018 Expected Registration Orphan drug Unknown Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Advanced therapy medicinal product (ATMP). Aanvraag gebaseerd op een ongecontroleerde studie waarvan nog onduidelijk is hoe de EMA dit gaat beoordelen. Nadat de CAT zorgen had uitgesproken over de haalbaarheid van een succesvolle registratieaanvraag met de huidgie data heeft de fabrikant de aanvraag teruggetrokken in juli 2018. 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 NCT02853604 Additional remarks Subjects will receive 1 infusion of study treatment administered every 3 weeks for 3 doses for the first 3 months. Thereafter, subjects will receive study treatment every 8 weeks for a total of 5 doses or until disease recurrence. Expected patient volume per year Patient volume < 250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 809 diagnoses cervixcarcinoom in 2016 (NKR). Nagenoeg alle cervixcarcinomen worden veroorzaakt door HPV. Gezien het een tweedelijns behandeling betreft komt maar een deel van deze personen in aanmerking voor dit geneesmiddel. Schatting: max 250 personen. Expected cost per patient per year Cost € 50,000.00 - 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 Additional remarks Mogelijk in lijn met huidige immuuntherapiën (€50.000-€60.000). Potential total cost per year Total cost € 13,750,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks