Imipenem / cilastatin / relebactam Medicine 08 December 2020 Extended indication Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults. Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults. Therapeutic value No judgement Total cost € 167,670.00 Registration phase Positive CHMP opinion Product Active substance Imipenem / cilastatin / relebactam Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults. Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults. 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 Unknown ATMP Unknown Submission date April 2020 Expected Registration December 2020 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in oktober 2020. Therapeutic value Current treatment options ceftazidime-avobactam, meropenem-vaborbactam Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 3 studie (RESTORE-IMI) werden de eindpunten behaald. Hiermee werd statistisch non-inferioriteit aangetoond ten opzichte van piperacillin/tazobactam. Mogelijk zal meropenem-vaborbactam in de toekomst de voorkeur. Duration of treatment Average 1.5 week / weeks Frequency of administration 4 times a day Dosage per administration 500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam References NCT03583333 Additional remarks Imipenem/cilastatin/relebactam (IMI/REL) administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL/500 mg Cilastatin, once every 6 hours for a minimum 7 days, up to 14 days. Expected patient volume per year Patient volume 20 - 25 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Record Ceftolozaan / tazobactam Additional remarks Imipenem / cilastatin / relebactam zal vooral gegeven worden bij gecompliceerde abdominale infecties, aangezien hierbij vaak zeer langdurig antibiotisch behandeld wordt en daarmee een relatief groot risico is op selectie van resistentie. De toevoeging van HAP/VAP zal naar verwachting leiden tot een kleine toename van ongeveer 25 patiënten. Expected cost per patient per year Cost € 4,860.00 - 9,720.00 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 Additional remarks RECARBRIO INFUSIEPOEDER FLACON 500/500/250MG €190,75 exclusief afleverkosten. €173,58 exclusief btw tarief. 4 maal daags voor 7 tot 14 dagen. Potential total cost per year Total cost € 167,670.00 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 Gram-negative infections References Adisinsight. Additional remarks Lopende fase II/III studie Other information Additional remarks