Hexaminolevulinate hydrochloride Medicine 03 June 2025 Extended indication Hexaminolevulinate hydrochloride monotherapy for first line treatment of histologic cervical high grade squamous intraepithelial lesion in adults and elderly in combination with Cevira device. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Hexaminolevulinate hydrochloride Domain Oncology Reason of inclusion New medicine (specialité) Main indication Cervical cancer Extended indication Hexaminolevulinate hydrochloride monotherapy for first line treatment of histologic cervical high grade squamous intraepithelial lesion in adults and elderly in combination with Cevira device. Current proprietary name Already available biosimilars / generics Proprietary name Cysview/Cevira Manufacturer Asieris Portfolio holder Mechanism of action Other, see general comments Route of administration Vaginal Therapeutical formulation Gel for vaginal use Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Fabrikant: Asieris Pharmaceutical. Cevira is een fotodynamisch drug-device combinatie product dat wordt ontwikkeld voor de niet-chirurgische behandeling van hooggradige premaligne laesies van de baarmoederhals. Een specifieke golflengte van licht activeert het apparaat om het geneesmiddel vrij te geven en de baarmoederhalslaesies te behandelen. Fotodynamische therapie (PDT) is gebaseerd op de accumulatie van een fotosensibilisator (hexaminolevulinaathydrochloride) of zijn precursor in de doelcellen, die bij belichting reactieve zuurstofradicalen genereert die de zieke cellen doden. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen resultaten bekend. Duration of treatment Frequency of administration Dosage per administration References NCT04484415 (APRICITY) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Gezondheidsraad Additional remarks In Nederland worden jaarlijks ongeveer 1.000 gevallen van cervicaal hooggradig plaveisel intra-epitheliaal neoplasma (HSIL) gediagnosticeerd. 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 Unknown Indication extensions References Additional remarks Other information Additional remarks