Imipenem / Relebactam Medicine 12 June 2018 Extended indication Behandeling van ernstige bacteriele infecties veroorzaakt door carbapenem-resistente pathogenen Therapeutic value No judgement Total cost € 700,000.00 Registration phase Clinical trials Product Active substance Imipenem / Relebactam Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Behandeling van ernstige bacteriele infecties veroorzaakt door carbapenem-resistente pathogenen Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer MSD Portfolio holder Mechanism of action Antibiotic Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Een combinatie van een carbapenem (Imipenem) met een beta lactamase remmer (Relebactam). Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity New therapeutical formulation ATMP Unknown Submission date 2019 Expected Registration July 2020 Orphan drug Unknown Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Ceftolozaan/tazobactam, Ceftazidim/avibactam Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 4 times a day Dosage per administration References Additional remarks Intraveneus infuus elke 6 uur. Expected patient volume per year Patient volume < 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De inschatting is dat er in totaal voor de behandeling van matig tot ernstige gecompliceerde intra-abdominale infecties en voor de behandeling van matig tot ernstige gecompliceerde urineweginfecties maximaal 50 patiënten zijn. Expected cost per patient per year Cost € < 14,000.00 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 Blinkhealth.com Additional remarks Kosten waarschijnlijk vergelijkbaar met Meropenem / vaborbactam: $5,175.44 voor 30x2g oplossing, 3x $5,175.44=$15,526.32 per kuur van 14 dagen. Dit is ongeveer €14.000. Potential total cost per year Total cost € 700,000.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References SPS Additional remarks Other information Additional remarks