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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.