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Apixaban

Eliquis

Extended indication

Extension to the existing indication to include treatment of venous thromboembolism (VTE) and preven

Therapeutic value

Possible benefit in ease of use
Registration phase

Registered and reimbursed

Product

Active substance

Apixaban
Domain

Cardiovascular diseases
Reason of inclusion

Indication extension
Main indication

Antithrombotic medications
Extended indication

Extension to the existing indication to include treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in children, associated with the addition of new pharmaceutical forms and new strengths (0.15mg granules in capsules for opening, as well as 0.5mg, 1.5mg and 2mg coated granules in sachet)
Proprietary name

Eliquis
Manufacturer

BMS
Mechanism of action

Anticoagulant
Route of administration

Oral
Therapeutical formulation

Tablet
Budgetting framework

Extramural (GVS)

Registration

Registration route

Centralised (EMA)
Type of trajectory

Normal trajectory
ATMP

No
Submission date

August 2023
Expected Registration

July 2024
Orphan drug

No
Registration phase

Registered and reimbursed
Additional remarks 
Positieve CHMP-opinie mei 2024

Therapeutic value

Current treatment options

Subcutaan laag moleculair heparine (LMWH) of oraal vitamine K antagonist
Therapeutic value

Possible benefit in ease of use
Substantiation

Er is mogelijk een voordeel in toedieningsgemak met de nieuwe toedieningsvormen. Er zijn nog geen studieresultaten om de therapeutische waarde verder te onderbouwen.
References 
NCT02464969 (CANINES)

Expected patient volume per year

Patient volume

< 350

Market share is generally not included unless otherwise stated.
References 
Kindertrombose. Werkgroep Pediatrische Trombose en Stroke. 2024 (1).
Additional remarks 
Veneuze trombo-embolie (VTE) omvat zowel diepe veneuze trombose (DVT) als longembolie. DVT en longembolie treden jaarlijks op bij ongeveer 350 kinderen in Nederland (1).

Expected cost per patient per year

There is currently nothing known about the expected cost.

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.