Fulvestrant Medicine 09 January 2018 Extended indication Treatment in combination with palbociclib of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. Therapeutic value No judgement Total cost € 2,626,444.00 Registration phase Unknown Product Active substance Fulvestrant Domain Oncology and Hematology Reason of inclusion Main indication Breast cancer Extended indication Treatment in combination with palbociclib of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. Current proprietary name Already available biosimilars / generics Proprietary name Faslodex Manufacturer AstraZeneca Portfolio holder Mechanism of action Unknown Route of administration Intramuscular Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration December 2017 Orphan drug No Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Positieve CHMP-opinie in oktober 2017. Therapeutic value Current treatment options Aromataseremmers Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Average 17 month / months Frequency of administration 1 times a month Dosage per administration 500 mg References Additional remarks Fabrikant: Gebaseerd op: Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial Expected patient volume per year Patient volume 117 - 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant Additional remarks Fabrikant: Max. patiëntvolume gebaseerd op: Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Van max. naar realistisch patiëntvolume gebaseerd op: Reacties van veld op data. Voordeel boven aromataseremmers wordt alleen in subgroep als relevant gezien. Expected cost per patient per year Cost € < 7,316.00 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 Kosten per 50 mg wegwerpspuit 5 ml: €304,82. 2x250 mg = 2 wegwerpsuiten = 2x€304,82=€609,64 per maand. Voor een heel jaar is dat 12x€609,64 = €7.315,68 pppj. Potential total cost per year Total cost € 2,626,444.00 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