Concentrate of proteolytic enzymes enriched in bromelain Medicine 07 December 2022 Extended indication NexoBrid is indicated in all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. Therapeutic value No estimate possible yet Total cost € 150,000.00 Registration phase Positive CHMP opinion Product Active substance Concentrate of proteolytic enzymes enriched in bromelain Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Skin diseases Extended indication NexoBrid is indicated in all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. Current proprietary name Already available biosimilars / generics Proprietary name NexoBrid Manufacturer MediWound Portfolio holder Mechanism of action Enzyme Route of administration Cutaneous Therapeutical formulation Gel Budgetting framework Intermural (MSZ) Centre of expertise Brandwondencentra in Rotterdam, Beverwijk en Groningen Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2022 Expected Registration January 2024 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie november 2023 Therapeutic value Current treatment options Chirurgie: verwijderen van dood weefsel (debridement) gevolgd door huidtransplantatie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is nog geen informatie over de resultaten van de klinische studie. Duration of treatment Average 0 one-off Frequency of administration 1 times a day Dosage per administration afhankelijk van de grootte van de wond References Additional remarks De gel wordt 4 uur op de wond gelaten en er dan afgeschraapt. Expected patient volume per year Patient volume < 750 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References https://www.venvn.nl/media/fvfpfnz3/harold-goei.pdf Additional remarks Er zijn per jaar ongeveer 750 kinderen met brandwonden die opname in een brandwondencentrum behoeven. Voor deze patiënten lijkt NexoBrid bedoeld. Expected cost per patient per year Cost € 200.00 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 De kosten van een behandeling liggen rond de €200. Potential total cost per year Total cost € 150,000.00 Total cost for sluice Additional remarks Kosten analyse: Nexobrid 6 dagen ICU en 25 medium care, versus 8 dagen ICU en 29 dagen medium care in de Standard of care groep, verschil €5.000 per behandeld kind. (Cost Analysis of a Novel Enzymatic Debriding Agent for Management of Burn Wounds Giuseppe Giudice et al. Biomed Res Int 2017;2017:9567498. doi: 10.1155/2017/9567498. Epub 2017 Feb 15.) Besparing in Nederland zou dan uitkomen op €3.750.000 per jaar. 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