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Canakinumab

Ilaris

Extended indication Secundaire preventie van cardiovasculaire incidenten bij patiënten met een doorgemaakt myocard infar
Therapeutic value Possible added value
Registration phase Registration application pending

Product

Active substance Canakinumab
Domain Cardiovascular diseases
Main indication Other medication for cardiovascular diseases
Extended indication Secundaire preventie van cardiovasculaire incidenten bij patiënten met een doorgemaakt myocard infarct en inflammatoire atherosclerose.
Proprietary name Ilaris
Manufacturer Novartis
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Indication extension
Submission date February 2018
Expected Registration April 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options PCSK9 remmers
Therapeutic value Possible added value
Duration of treatment continuous
Frequency of administration 4 times a year
References Ridker et al. NEJM 2017.

Expected patient volume per year

References Fabrikant; www.volksgezondheidenzorg.info; Ridker. JACC 2016, vol 67, no 6, 2016, 712-23.
Additional remarks Fabrikant heeft max. patiëntvolume gebaseerd op circa 252.000 patiënten in Nederland die een myocard infarct hebben doogemaakt, waarvan 25% (63.000) een verhoogde biomarker hsCRP heeft (vereiste voor behandeling).

Expected cost per patient per year

Cost 50,000.00
References Medicijnkosten.nl
Additional remarks Zeer hoge meerkosten verwacht. €11.660,00 per injectieflacon.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.