Concentrate of proteolytic enzymes enriched in bromelain

NexoBrid

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	Registered

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	NexoBrid is indicated in all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns.
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	December 2023
Orphan drug	Yes
Registration phase	Registered
Additional remarks	Registratie december 2023

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.

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, 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.

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, 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

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.

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