Imipenem / cilastatin / relebactam

Active substance
Imipenem / cilastatin / relebactam
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
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.

1. 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).

2. 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.

3. Therapeutic value

Current treatment options
Ceftolozaan/tazobactam, Ceftazidim/avibactam
Therapeutic value
No judgement
Duration of treatment
Not found
Frequency of administration
4 times a day
Additional comments
Intraveneus infuus elke 6 uur.

4. 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.

5. Expected cost per patient per year

Cost
< 14,000
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.

6. Potential total cost per year

Total cost

700,000

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.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

Indication extension
No
References
SPS

9. Other information

There is currently no futher information available.