Imipenem / cilastatin / relebactam

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	364,500.00
Registration phase	Registered and reimbursed

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 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
Submission date	November 2018
Expected Registration	February 2020
Orphan drug	No
Registration phase	Registered and reimbursed
Additional remarks	Positieve CHMP-opinie in december 2019. Geregistreerd in februari 2020. Recarbrio is momenteel via de DOT bekostigd.

Therapeutic value

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

Expected patient volume per year

Patient volume	< 50 Market share is generally not included unless otherwise stated.
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.

Patient volume

< 50

Market share is generally not included unless otherwise stated.

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	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	364,500.00 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.

Total cost

364,500.00

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.