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Imipenem / cilastatin / relebactam

Recarbrio

Extended indication Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in
Therapeutic value No estimate possible yet
Total cost 164,025.00
Registration phase Registered

Product

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.
Proprietary name Recarbrio
Manufacturer MSD
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks 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 November 2020
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP-opinie in oktober 2020. Registratie per december 2020 .

Therapeutic value

Current treatment options ceftazidime-avobactam, meropenem-vaborbactam
Therapeutic value No estimate possible yet
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 krijgen.
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 500mg IMI/250mg REL/500mg 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 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
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

164,025.00

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.

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 remarks Lopende fase 2-3 studie

Other information

There is currently no futher information available.