Meropenem / vaborbactam

Active substance
Meropenem / vaborbactam
Domain
Infectious diseases
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Bacterial infections
Extended indication
Vabomere is indicated for the treatment of the following infections in adults: Complicated urinary tract infection (cUTI), including pyelonephritis; Complicated intra-abdominal infection (cIAI); Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Vabomere is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.

1. Product

Proprietary name
Vabomere
Manufacturer
TMC
Mechanism of action
Antibiotic
Route of administration
Intravenous
Therapeutical formulation
Intravenous drip
Budgetting framework
Intermural (MSZ)
Additional comments
Vabomere is een vaste combinatie van een carbapenem (meropenem) met een nieuwe beta lactamase remmer (vaborbactam).

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
August 2017
Expected Registration
November 2018
Orphan drug
No
Registration phase
Registered
Additional comments
Geregistreerd door de FDA in augustus 2017. Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
Beperkte impact verwacht
Duration of treatment
Average 14 day / days
Frequency of administration
3 times a day
Dosage per administration
4 g

4. Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.

References
NHG-Standaard Urineweginfecties, expert opinie
Additional comments
Gemiddelde incidentie van pyelonefritis: bij vrouwen ruim 2 en bij mannen minder dan 1 per 1.000 patiënten per jaar. Totaal aantal patiënten komt dan neer op 25.500 patiënten per jaar. Slechts een deel hiervan zal in aanmerking komen voor meropenem / vaborbactam. Inschatting: maximaal 50 patiënten per jaar.

5. Expected cost per patient per year

Cost
< 14,000
References
Blinkhealth.com
Additional comments
$5,175.44 voor 30x2g oplossing, 3x $5,175.44=$15,526.32 per kuur van 14 dagen. Dat komt neer op 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.