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Concentrate of proteolytic enzymes enriched in bromelain

NexoBrid

Extended indication Extension of current indication for removal of eschar in adults with deep partial- and full-thicknes
Therapeutic value No estimate possible yet
Total cost 150,000.00
Registration phase Registration application pending

Product

Active substance Concentrate of proteolytic enzymes enriched in bromelain
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Skin diseases
Extended indication Extension of current indication for removal of eschar in adults with deep partial- and full-thickness thermal burns to the paediatric population.
Proprietary name NexoBrid
Manufacturer MediWound
Mechanism of action Enzyme
Route of administration Cutaneous
Therapeutical formulation Gel
Budgetting framework Intermural (MSZ)
Centre of expertise Brandwondencentra in Rotterdam, Beverwijk en Groningen

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2022
Expected Registration October 2023
Orphan drug Yes
Registration phase Registration application pending

Therapeutic value

Current treatment options Chirurgie: verwijderen van dood weefsel (debridement) gevolgd door huidtransplantatie
Therapeutic value No estimate possible yet
Substantiation Er is nog geen informatie over de resultaten van de klinische studie.
Duration of treatment one-off
Frequency of administration 1 times a day
Dosage per administration afhankelijk van de grootte van de wond
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.
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
Additional remarks De kosten van een behandeling liggen rond de €200.

Potential total cost per year

Total cost

150,000.00

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.
Additional remarks Kosten analyse: Nexobrid 6 dagen ICU en 25 medium care, vs 8d ICU en 29 dagen medium care in de Standard of care groep, verschil 5000 euro 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

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.