pegfilgrastim Medicine 10 June 2020 Extended indication In combination with plinabulin in patients with chemotherapy-induced neutropenia. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance pegfilgrastim Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Other hematology Extended indication In combination with plinabulin in patients with chemotherapy-induced neutropenia. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Beyondspring Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Guanine nucleotide exchange factor stimulant Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration July 2021 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Pegfilgrastim Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 12 week / weeks Frequency of administration 1 times every 3 weeks Dosage per administration 40 mg References NCT03294577 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 Yes Indication extensions Non-small cell lung cancer References clincaltrials.gov Additional remarks Lopende fase 3 studie Other information Additional remarks