Paclitaxel Medicine 09 January 2018 Extended indication Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Therapeutic value No judgement Total cost € 3,470,000.00 Registration phase Registered Product Active substance Paclitaxel Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Ovarian cancer Extended indication Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Current proprietary name Already available biosimilars / generics Proprietary name Apealea Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Mogelijk alleen cremophor-intolerante patienten, kleine impact. Ook andere alternatieven bij intolerantie. Nieuwe formulering (Paclical/Apealea is a Cremophor- and albumin-free formulation of the well-known cytostatic paclitaxel combined with Oasmia’s excipient technology XR17.) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date February 2016 Expected Registration November 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie september 2018. Geregistreerd in november 2018. 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 < 347 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Ovarium carcinoom NKR stadium 4: 347 Expected cost per patient per year Cost € 5,000.00 - 15,000.00 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 Medicijnkosten.nl Additional remarks Paclitaxel oplossing voor infusie 6mg/ml €1.384,46 per flacon van 100 ml. Voor mammacarcinoom kost normale formulering paclitaxel €8.400,00 gemiddeld p.p.p.j.. Potential total cost per year Total cost € 3,470,000.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions NSCLC, pancreas, ovarium (1L), borst. References Additional remarks Other information Additional remarks