Teprotumumab Medicine 13 December 2018 Extended indication Graves' Orbitopathy (Thyroid Eye Disease) Therapeutic value Possible added value Total cost Registration phase Clinical trials Product Active substance Teprotumumab Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Other chronic immune diseases Extended indication Graves' Orbitopathy (Thyroid Eye Disease) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Human IgG1k monoclonaal antilichaam gericht tegen insulin-like growth factor-1 receptor (IGF-1R) . Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion date fase III OPTIC study in juni 2019 Therapeutic value Current treatment options Thyreostatica, riodioactief jodium, chirurgie. Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation Resulaten van een fase 2 klinische studie zijn erg veelbelovend. Duration of treatment Frequency of administration 1 times every 3 weeks Dosage per administration 10-20 mg/kg References NCT03298867; Smith et al. N Engl J Med 2017; 376:1748-1761 Additional remarks Expected patient volume per year Patient volume < 3,750 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Schildklier.nl Additional remarks Ongeveer 75.000 mensen hebben de ziekte van Graves, 20% daarvan heeft de oogaandoening Graves ophthalmopathie. Ongeveer 5% loopt het risico de oogziekte in ernstige vorm te ontwikkelen (3.750). Gezien de inclusiecriteria van de klinische studie zal het vooral gaan om deze laatste groep patiënten. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks