Regenerative Skin Tissue Medicine 08 June 2021 Extended indication Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements. Therapeutic value No estimate possible yet Total cost € 4,000,000.00 Registration phase Clinical trials Product Active substance Regenerative Skin Tissue Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Skin diseases Extended indication Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements. Current proprietary name Already available biosimilars / generics Proprietary name StrataGraft Manufacturer Mallinckrodt Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks StrataGraft skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Yes Submission date 2023 Expected Registration 2024 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion datum van fase 3 studie in juli 2019. Therapeutic value Current treatment options De huidige behandeling bestaat uit het verwijderen van de dode huid en het beleggen met een huidtransplantaat afkomstig van een plek op de huid die onaangetast is. 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 NCT03005106 Additional remarks Expected patient volume per year Patient volume < 1,000 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Brandwondenstichting.nl Additional remarks De studie includeert patiënten waarvan 3%-49% van het totale lichaamsoppervlakte aangetast is door brandwonden waarvoor excisie en autograft geïndiceerd is. Elk jaar worden rond de 1.000 patiënten opgenomen in één van de drie brandwondencentra vanwege brandwonden of ander ernstig huidletsel. Expected cost per patient per year Cost € > 4,000.00 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 Drugs.com Additional remarks In de VS kost 1 film StrataGraft ongeveer $4,222 (~€4.000). De totale kosten zullen afhangen van de hoeveelheid films er gebruikt zullen worden. Potential total cost per year Total cost € 4,000,000.00 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