177Lu-PSMA617 Medicine 10 June 2020 Extended indication Progressive Metastatic Castration Resistant Prostate Cancer Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance 177Lu-PSMA617 Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Progressive Metastatic Castration Resistant Prostate Cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Advanced Accelerator Applications Portfolio holder Mechanism of action Other Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Radioligand Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2021 Expected Registration 2022 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options 177Lu-PSMA617 Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation 177Lu-PSMA617 wordt momenteel zelf bereid door ziekenhuizen. Duration of treatment Frequency of administration 1 times every 6 weeks Dosage per administration 6-8.5GBq References The first dose will be administered at 8.5GBq, reducing by 0.5GBq with every cycle given (i.e. to 6.0GBq on the sixth cycle, if reached) Additional remarks NCT03392428 Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2015. 75% van deze patiënten ontwikkelt CRCP (n=1.727). Expected cost per patient per year Cost € 83,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Horizonscan Geneesmiddelen Lutathera Additional remarks De kosten zullen waarschijnlijk vergelijkbaar zijn met Lutetium (177Lu) oxodotreotide € 83.000. 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 No Indication extensions References clinicaltrials.gov Additional remarks Geen andere lopende fase 3 studies. Other information Additional remarks