Extended indication Vabomere is indicated for the treatment of the following infections in adults: Complicated urinary t
Therapeutic value No judgement
Total cost 700,000.00
Registration phase Registered

Product

Active substance Meropenem / vaborbactam
Domain Infectious diseases
Reason of inclusion 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.
Proprietary name Vabomere
Manufacturer TMC
Mechanism of action Antibiotic
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Vabomere is een vaste combinatie van een carbapenem (meropenem) met een nieuwe beta lactamase remmer (vaborbactam).

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 remarks Geregistreerd door de FDA in augustus 2017. Positieve CHMP-opinie september 2018. Geregistreerd in november 2018.

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

Expected patient volume per year

Patient volume

< 50

Market share is generally not included unless otherwise stated.

References NHG-Standaard Urineweginfecties, expert opinie
Additional remarks 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.

Expected cost per patient per year

Cost < 14,000.00
References Blinkhealth.com
Additional remarks $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.

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.