Zopapogene Imadenovec Medicine 03 June 2025 Extended indication Zopapogene imadenovec monotherapy for adjuvant treatment of recurrent Respiratory papillomatosis in adults and elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Zopapogene Imadenovec Domain Oncology Reason of inclusion New medicine (specialité) Main indication Lung cancer Extended indication Zopapogene imadenovec monotherapy for adjuvant treatment of recurrent Respiratory papillomatosis in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Immunostimulation Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date June 2025 Expected Registration July 2026 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Er bestaat op dit moment helaas geen genezende behandeling voor larynxpapilloom. Het larynxpapilloom komt na operatieve verwijderen vaak terug. Op dit moment bestaat de behandeling uit symptoombestrijding en is gericht op het zoveel mogelijk beperken van schade aan de stembanden en luchtwegen. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04724980 Additional remarks Expected patient volume per year Patient volume 20 - 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Stichting RRP; Additional remarks RRP komt voor bij ongeveer 0,1 tot 2,8 per 100.000 personen per jaar. Er zijn drie leeftijdspieken waarop RRP ontstaat: rondom het 7de, 35ste en 64ste levensjaar. Dit betekent dat er mogelijk 20 tot 500 patiënten in Nederland in aanmerking zullen 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 Unknown Indication extensions References Additional remarks Other information Additional remarks