Posaconazol Medicine 08 December 2020 Extended indication Extension of indication to include treatment of invasive aspergillosis in adults Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Posaconazol Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Infectious diseases other Extended indication Extension of indication to include treatment of invasive aspergillosis in adults Current proprietary name Already available biosimilars / generics Proprietary name Noxafil Manufacturer MSD Portfolio holder Mechanism of action Antifungals Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Deze indicatie-uitbreiding is voor voorzowel de orale als intravenueze variant. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2020 Expected Registration October 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 300 mg References NCT01782131 Additional remarks POS IV: Day 1: 300 mg BID Day 2-84: 300 mg QD POS oral: Day 1: 300 mg BID Day 2-84: 300 mg QD 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 Rafael Cámara. Cost-Effectiveness of Posaconazole Tablets for Invasive Fungal Infections Prevention in Acute Myelogenous Leukemia or Myelodysplastic Syndrome Patients in Spain. Adv Ther. 2017. Additional remarks In de kosteneffectiviteitsstudie werd een gemiddelde kostenbeslag per patiënt van € 5.906,06 per 100 dagen gevonden. 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