Incobotulinumtoxina Medicine 04 December 2025 Extended indication Incobotulinumtoxina monotherapy for treatment of lower limb Muscle spasticity in adults and elderly with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury. Therapeutic value No estimate possible yet Total cost € 7,011,000.00 Registration phase Clinical trials Product Active substance Incobotulinumtoxina Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Muscular diseases other Extended indication Incobotulinumtoxina monotherapy for treatment of lower limb Muscle spasticity in adults and elderly with or without upper limb spasticity of the same body side caused by stroke or traumatic brain injury. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Merz Portfolio holder Merz Mechanism of action Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date March 2026 Expected Registration April 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Orale medicijnen zoals baclofen, tolperison, dantroleen of tizanidine kunnen helpen bij het ontspannen van de spieren en het verminderen van spierspanning. 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 NCT03992404 (PATTERN) Additional remarks Expected patient volume per year Patient volume < 15,580 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References 1: Hartstichting; Additional remarks In Nederland zijn er jaarlijks ongeveer 41.000 nieuwe gevallen van beroertes (CVA's), waarvan 80% een herseninfarct is en 20% een hersenbloeding (1). Na een hersenbloeding (cerebrovasculair accident of CVA) ontwikkelt ongeveer 38% van de mensen spasticiteit. Spasticiteit is een verhoogde spierspanning die kan leiden tot stijfheid en spasmen, en wordt veroorzaakt door hersenbeschadiging, in dit geval door een beroerte. Dit zou betekenen dat er maximaal 15.580 patiënten in aanmerking kunnen komen. Expected cost per patient per year Cost € 400.00 - 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 GIPdatabank Additional remarks Er wordt jaarlijks €400 tot €500 vergoed per gebruiker botuline toxine. Potential total cost per year Total cost € 7,011,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks