Brilacidin Medicine 12 June 2018 Extended indication Mucositis in head and neck cancer. Therapeutic value No judgement yet Total cost € 11,475,000.00 Registration phase No registration expected Product Active substance Brilacidin Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Head and neck cancer Extended indication Mucositis in head and neck cancer. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Innovation Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks First-in-class a synthetic, small-molecule defensin-mimetic, for treatment of bacterial infections. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks Scrip pipeline watch 8 jan 2018: Delayed onset of severe oral symptoms. Updated Phase III Results. Op dit moment zijn er geen duidelijke aanwijzingen dat er binnen afzienbare tijd een registratieaanvraag zal worden ingediend. Therapeutic value Current treatment options Momenteel geen behandeling. Therapeutic value No judgement yet This assessment does not indicate any potential inclusion in the package. Substantiation Beperkte informatie beschikbaar. Duration of treatment Frequency of administration 3 times a day Dosage per administration 3mg/ml References NCT02324335 Additional remarks De studie NCT02324335 heeft een behandelduur van 7 weken. Expected patient volume per year Patient volume 1,500 - 1,900 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Oncoline Additional remarks In 2015 werden 1.899 patiënten met hoofd- en hals tumoren behandeld met radiotherapie. Bij 80%-100% van deze patiënten treedt mucositis op als bijwerking van deze behandeling, dit bedraagt dus 1.519-1.899 patiënten. Expected cost per patient per year Cost € 4,500.00 - 9,000.00 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 http://www.ipharminc.com/new-blog/2019/4/9/brilacidin-competitive-positioning-market-opportunity-for-oral-mucositis. Additional remarks De fabrikant verwacht $5.000-$10.000 te kunnen vragen per behandeling. Omgerekend is dit ongeveer €4.500-€9.000 Potential total cost per year Total cost € 11,475,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Skin Infection (Bacterial Infection) References Clinicaltrials.gov Additional remarks Other information Additional remarks