Leuprolide mesylate Medicine 07 June 2022 Extended indication Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. Therapeutic value Possible benefit in ease of use Total cost Registration phase Registered Product Active substance Leuprolide mesylate Domain Oncology Reason of inclusion New medicine (specialité) Main indication Prostate cancer Extended indication Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. Current proprietary name Already available biosimilars / generics Proprietary name Camcevi Manufacturer Foresee Portfolio holder Mechanism of action Receptor agonist Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks LHRH agonist, ook bekend als FP-001 Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date April 2020 Expected Registration May 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Ingediend bij de FDA in maart 2019. Positieve CHMP opinie ontvangen in maart 2022. Therapeutic value Current treatment options Leuprolide (kortwerkend) Therapeutic value Possible benefit in ease of use This assessment does not indicate any potential inclusion in the package. Substantiation Het betreft een 6-maands depot versie. Duration of treatment Average 1 year / years Frequency of administration 1 times every 6 months Dosage per administration 50 mg References NCT02234115; https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-submission-of-nda-for-fda-approval-of-lmis-50-mg-300821225.html 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 Dit zal met name substitutie betreffen van de huidige kortdurende vorm van leuproreline. Expected cost per patient per year Cost € < 8,250.00 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 drugs.ccom Additional remarks De kosten voor Camcevi subcutane emulsie (42mg/6 maanden) bedragen ongeveer $4.116 voor 1 emulsie. Het gaat dus maximaal om zo'n €8.250 per jaar. 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 Additional remarks Other information Additional remarks