Sirolimus Medicine 07 June 2022 Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Sirolimus Domain Chronic immune diseases Reason of inclusion Generic G Main indication Skin diseases Extended indication Treatment of angiofibroma associated with tuberous sclerosis complex Current proprietary name Rapamune (Pfizer) Already available biosimilars / generics Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Cutaneous Therapeutical formulation Gel Budgetting framework Extramural (GVS) Centre of expertise Additional remarks mTOR remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date December 2021 Expected Registration March 2023 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Geen geldig SPC bekend. Therapeutic value Current treatment options Therapeutic value Possible equal value 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 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