Ruxolitinib Medicine 03 December 2024 Extended indication Extension of indication for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies and for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies. Therapeutic value No estimate possible yet Total cost Registration phase Registered and reimbursed Product Active substance Ruxolitinib Domain Hematology Reason of inclusion New medicine (specialité) Main indication Graft versus Host Extended indication Extension of indication for the treatment of adults and paediatric patients aged 28 days and older with acute graft versus host disease who have inadequate response to corticosteroids or other systemic therapies and for the treatment of adults and paediatric patients aged 6 months and older with chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies. Current proprietary name Already available biosimilars / generics Proprietary name Jakavi Manufacturer Novartis Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Solution Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date January 2024 Expected Registration January 2025 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 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 NCT03774082 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks