Romiplostim Medicine 08 December 2020 Extended indication Extension of indication to add the use of romiplostim in adult patients who have had idiopathic thrombocytopenic purpura (ITP) for ≤ 12 months and who have had an insufficient response to corticosteroids or immunoglobulins. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Romiplostim Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other non-oncological hematological medications Extended indication Extension of indication to add the use of romiplostim in adult patients who have had idiopathic thrombocytopenic purpura (ITP) for ≤ 12 months and who have had an insufficient response to corticosteroids or immunoglobulins. Current proprietary name Already available biosimilars / generics Proprietary name Nplate Manufacturer Amgen Portfolio holder Mechanism of action Unknown Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration April 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 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.nl Additional remarks Gemiddelde prijs per 1 injectieflacon NPLATE, 125 μg POEDER VOOR INJECTIEVLOEISTOF 125UG € 393,61 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