Plitidepsin Medicine 09 January 2018 Extended indication Multiple myeloma (MM), relapsed/refractory, in patients who have received bortezomib and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available). Therapeutic value No judgement Total cost Registration phase Unknown Product Active substance Plitidepsin Domain Oncology and Hematology Reason of inclusion Main indication Multiple Myeloma Extended indication Multiple myeloma (MM), relapsed/refractory, in patients who have received bortezomib and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available). Current proprietary name Already available biosimilars / generics Proprietary name Aplidin Manufacturer Pharma Mar Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date November 2016 Expected Registration February 2018 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Negatieve opinie CHMP december 2017 Therapeutic value Current treatment options Therapeutic value No judgement 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 135 - 1,250 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Budget impact analyse van daratumumab (Darzalex) in combinatie met lenalidomide en dexamethason voor de indicatie volwassen patiënten met multipel myeloom die minstens één eerdere behandeling hebben gehad. Additional remarks NKR (2015): 1242 patienten met MM (max). Gezien relapsed / refractory en overige behandelingen zal het realistische volume echter een stuk lager liggen. Voor Daratumumab is het verwachte aantal patienten dat in 2018 in aanmerking komt voor behandeling 135. 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