Thalidomide Medicine 07 December 2021 Extended indication In combinatie met melfalan en prednison als eerste behandeloptie van onbehandeld multipel myeloom bij patiënten van ≥65 jaar of bij patiënten die niet in aanmerking komen voor chemotherapie in hoge doseringen. Therapeutic value Possible equal value Total cost Registration phase Registration application pending Product Active substance Thalidomide Domain Hematology Reason of inclusion Generic G Main indication Multiple Myeloma Extended indication In combinatie met melfalan en prednison als eerste behandeloptie van onbehandeld multipel myeloom bij patiënten van ≥65 jaar of bij patiënten die niet in aanmerking komen voor chemotherapie in hoge doseringen. Current proprietary name Thalidomide (Celgene) Already available biosimilars / generics geen Proprietary name Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Angiogenesis inhibitors; Immunosuppressants; Tumour necrosis factor inhibitors Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date May 2021 Expected Registration June 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks SPC patent verlopen. 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