Bizalimogene ralaplasmid Medicine 07 December 2021 Extended indication Cervical dysplasia caused by human papillomavirus (HPV) types 16 and 18. Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Clinical trials Product Active substance Bizalimogene ralaplasmid Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Cervical dysplasia caused by human papillomavirus (HPV) types 16 and 18. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Inovio Portfolio holder Mechanism of action Immunostimulation Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: Gene transference; Immunostimulants. Fabrikant: Inovio. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2024 Expected Registration 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chirurgie Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3 data van REVEL 1 wijst uit dat in de actieve arm bij 24% regressie van high grade laesies plaatsvindt ten opzichte van 11% in placebo arm. Standard of care is op dit moment chirurgie met regressie in 75% van de patiënten. Chirurgie is effectiever gebleken, er zal dus naar verwachting geen plaats in de behandelrichtlijn zijn. Duration of treatment Frequency of administration 1 times a day Dosage per administration 1 ml References NCT03185013 Additional remarks 1 milliliter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12. Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References WHO, IKNL Additional remarks Cervicale dysplasie is een premaligne afwijking (dysplasie) van de cellen van de baarmoederhals. IKNL: 841 patiënten met cervixcarcinoom in 2018. WHO: HPV types (16 and 18) veroorzaken 70% van baarmoederhalskankers. De verwachting is dus dat maximaal 600 patiënten in aanmerking komen. 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 Yes Indication extensions Phase 2: Anal intraepithelial neoplasia; Human papillomavirus infections; Vulvar intraepithelial neoplasia References Adis Insight Additional remarks Mogelijk zal deze behandeling wel een meerwaarde hebben voor mannen met een HIV infectie. Op dit moment loopt er een fase 2 studie. Other information Additional remarks