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Apremilast

Otezla

Extended indication Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in c
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Apremilast
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Skin diseases
Extended indication Extension of indication to include the treatment of moderate to severe chronic plaque psoriasis in children and adolescents from the age of 6 years who have a contraindication, have an inadequate response, or are intolerant to at least one other systemic therapy or phototherap
Proprietary name Otezla
Manufacturer Amgen
Mechanism of action Enzyme inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Centre of expertise ErasmusMC, AMC/VUMC/READE
Additional remarks PDE4-inhibitor

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date January 2024
Expected Registration November 2024
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie september 2024.

Therapeutic value

Current treatment options TNF remmers, IL-12/IL-23 remmers.
Therapeutic value No estimate possible yet
Substantiation Apremilast is een alternatief voor andere biologicals die al ingezet worden binnen deze indicatie. Bij volwassenen wordt wat minder effectiviteit gezien dan andere behandelopties. Bij kinderen met prikangst zal het een mooi alternatief kunnen zijn. Er zijn geen head-to-head studies met de andere biologicals.
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 20mg - 30mg
References NCT04175613
Additional remarks Voor patiënten die 50kg of meer wegen is de aanbevolen onderhoudsdosering tweemaal daags 30mg. Voor patiënten die 20kg tot minder dan 50 kg wegen is de aanbevolen onderhoudsdosering tweemaal daags 20mg.

Expected patient volume per year

Patient volume

< 100

Market share is generally not included unless otherwise stated.
Additional remarks In Nederland zijn dat er circa 165.000 patiënten met plaque psoriasis. Aangezien de indicatie voor patiënten van 6 tot 18 jaar is gesteld is de verwachting dat er niet meer dan 100 patiënten voor in aanmerking komen.

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.