Extended indication Recarbrio is indicated for the treatment of infections due to aerobic Gram-negative organisms in adu
Therapeutic value No judgement
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.
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
Particularity New therapeutical formulation
Submission date November 2018
Expected Registration February 2020
Orphan drug No
Registration phase Registered
Additional comments Positieve CHMP-opinie in december 2019. Geregistreerd in februari 2020.

Therapeutic value

Current treatment options Ceftolozaan/tazobactam, Ceftazidim/avibactam
Therapeutic value No judgement
Frequency of administration 4 times a day
Additional comments Intraveneus infuus elke 6 uur.

Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.

Additional comments 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
References Blinkhealth.com; fabrikant
Additional comments 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

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 No
References SPS

Other information

There is currently no futher information available.