Imipenem / cilastatin / relebactam Medicine 12 June 2018 Extended indication Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Therapeutic value No estimate possible yet Total cost € 700,000.00 Registration phase Registered Product Active substance Imipenem / cilastatin / relebactam Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. Current proprietary name Already available biosimilars / generics Proprietary name Recarbrio 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 November 2018 Expected Registration February 2020 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in december 2019. Geregistreerd in februari 2020. Therapeutic value Current treatment options Ceftolozaan/tazobactam, Ceftazidim/avibactam Therapeutic value No estimate possible yet 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; fabrikant 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