Imipenem / cilastatin / relebactam

Active substance Imipenem / cilastatin / relebactam
Domain Infectious diseases
Reason of inclusion Indication extension
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.

Product

Proprietary name Recarbrio
Manufacturer MSD
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Een combinatie van een carbapenem (Imipenem) met een beta lactamase remmer (Relebactam).

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2020
Expected Registration December 2020
Orphan drug No
Registration phase Positive CHMP opinion
Additional comments Positieve CHMP-opinie in oktober 2020.

Therapeutic value

Current treatment options ceftazidime-avobactam, meropenem-vaborbactam
Therapeutic value No judgement
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 comments 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.

References Record Ceftolozaan / tazobactam
Additional comments 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
References Medicijnkosten
Additional comments 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

164,025

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.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Gram-negative infections
References Adisinsight.
Additional comments Lopende fase II/III studie

Other information

There is currently no futher information available.