Brepocitinib Medicine 04 June 2026 Extended indication Brepocitinib monotherapy for treatment of active dermatomyositis in adults and elderly. Therapeutic value No estimate possible yet Total cost € 1,012,500.00 Registration phase Clinical trials Product Active substance Brepocitinib Domain Chronic immune diseases Reason of inclusion New medicine (specialité) Main indication Rheumatism Extended indication Brepocitinib monotherapy for treatment of active dermatomyositis in adults and elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Priovant Portfolio holder Priovant Mechanism of action Route of administration Oral Therapeutical formulation Tablet Budgetting framework Centre of expertise Additional remarks TYK2/JAK1-remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date June 2026 Expected Registration July 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options IVIg, Corticosteroiden, mycofenolaat mofetil, methotrexaat en azathioprine als steroid spaarders, rituximab (off label) (trials met JAK remmers lopen). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er zijn nog geen klinische trial resultaten. Duration of treatment Frequency of administration Dosage per administration References NCT05437263 (VALOR) Additional remarks Expected patient volume per year Patient volume 100 - 150 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Spierziekten.nl Additional remarks Jaarlijks krijgen ongeveer 100 tot 150 mensen in Nederland een vorm van myositis, waaronder dermatomyositis. Expected cost per patient per year Cost € 8,100.00 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 Additional remarks Kosten op basis van IHSI-inschatting, gebaseerd op de prijs van dezelfde ATC-klasse (L04AF - JAK remmers)) geneesmiddelen van €8.100 per patiënt per jaar. Potential total cost per year Total cost € 1,012,500.00 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