Sirolimus Medicine 07 June 2022 Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sirolimus Domain Oncology Reason of inclusion Indication extension IND Main indication Unknown Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex Current proprietary name Already available biosimilars / generics Proprietary name Rapamune Manufacturer Merck Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks mTOR remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2021 Expected Registration September 2022 Orphan drug Yes Registration phase Registration application pending 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 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 Medicijnkosten Additional remarks Gemiddelde prijs per verpakking €433,34. Behandelduur en dosering nog niet bekend. 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