Apremilast

Extended indication	Ziekte van Behçet
Therapeutic value	No judgement
Total cost	2,820,000.00
Registration phase	Clinical trials

Product

Active substance	Apremilast
Domain	Chronic immune diseases
Reason of inclusion	Indication extension
Main indication	Cardiovascular diseases
Extended indication	Ziekte van Behçet
Proprietary name	Otezla
Manufacturer	celgene
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
Submission date	2019
Expected Registration	May 2020
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Registratie verwacht in Q2 2020.

Therapeutic value

Current treatment options	Geen geregistreerde opties; Off-label Revlimid en anti-TNFα
Therapeutic value	No judgement
Substantiation	Doordat er relatief weinig bijwerkingen zijn is dit mogelijk een goed alternatief voor de huidige behandelopties.
Duration of treatment	continuous
Frequency of administration	2 times a day
Dosage per administration	30 mg
References	RELIEF: NCT02307513

Expected patient volume per year

Patient volume	150 - 450 Market share is generally not included unless otherwise stated.
References	Expertopinie
Additional remarks	In totaal in Nederland 450 patiënten met de ziekte van Behçet. Meest ernstige vorm hiervan betreft zo'n 150-200 patiënten. Geen geregistreerde behandelopties op dit moment, dus veel patiënten zullen in aanmerking komen voor dit geneesmiddel.

Patient volume

150 - 450

Market share is generally not included unless otherwise stated.

References

Expertopinie

Additional remarks

In totaal in Nederland 450 patiënten met de ziekte van Behçet. Meest ernstige vorm hiervan betreft zo'n 150-200 patiënten. Geen geregistreerde behandelopties op dit moment, dus veel patiënten zullen in aanmerking komen voor dit geneesmiddel.

Expected cost per patient per year

Cost	9,400.00
References	G-standaard
Additional remarks	Kosten per patiënt per jaar, o.b.v. lijstprijs 1 juli 2018

Potential total cost per year

Total cost	2,820,000.00 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.

Total cost

2,820,000.00

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

Off label use	No

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.