Version 4

Botulinum A toxin

Medicine

Extended indication Lower limb spasticity (LLS), in adults post stroke or traumatic brain injury (TBI).
Therapeutic value Possible equal value
Registration phase Withdrawn

Product

Active substance Botulinum A toxin
Domain Neurological disorders
Reason of inclusion Indication extension IND
Main indication Muscular diseases other
Extended indication Lower limb spasticity (LLS), in adults post stroke or traumatic brain injury (TBI).
Proprietary name Dysport
Manufacturer Ipsen
Mechanism of action Neurotoxin
Route of administration Intramuscular
Therapeutical formulation Injection
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Unknown
Particularity Unknown
ATMP Unknown
Orphan drug No
Registration phase Withdrawn
Additional remarks Fabrikant (juni 2019): Er is geen nieuwe data om de registratie opnieuw aan te vragen.

Therapeutic value

Current treatment options Botox, Fenol, Baclofen intrathecaal, Dantroleen, tizanidine, diazepam, clonidine, cannabis.
Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.
Substantiation Mogelijke gelijke waarde verwacht aan Xeomin.
Dosage per administration Totaal 1000 tot 1500 units per cyclus
References https://www.ipsen.com/websites/IPSENCOM-PROD/wp-content/uploads/2017/06/16182401/16-06-2017-sNDA-DYSPORT-ALL-US-FINAL-1.pdf, clinicaltrials.gov: NCT01249404, NCT01251367,
Additional remarks Toedieningsfrequentie: indien nodig elke 12-16 week herhalen.

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.
References Martin A. et al. Neuropsychiatr Dis Treat. 2014 Jan 23;10:111-22.
Additional remarks LLS post stroke: 40-600 per 100.000 (68.000-1.020.000 in NL), LLS post TBI: 100-235 per 100.000 (17.000-399.500 in NL). In verband met de huidige behandelopties mogelijke gelijke waarde aan Xeomin zal een deel van deze patiënten in aanmerking komen voor dit geneesmiddel.

Expected cost per patient per year

Cost € 1,500.00

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 Fabrikant
Additional remarks Huidige VVP 500 eenheden dysport betreft 243,97 euro. Per behandeling 800 eenheden en 4 behandelingen per jaar = ruim 1500 euro.

Potential total cost per year

Off label use

Off label use Yes

Indication extension

Indication extensions No

Other information