Extended indication Extension of Indication for Stelara to include treatment of adult patients with moderately to severe
Therapeutic value No judgement
Total cost 7,600,000.00
Registration phase Registration application pending

Product

Active substance Ustekinumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Bowel diseases
Extended indication Extension of Indication for Stelara to include treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Proprietary name Stelara
Manufacturer Janssen
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments IL12/23 remmer.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2019
Expected Registration October 2019
Orphan drug No
Registration phase Registration application pending

Therapeutic value

Current treatment options Mesalazines (oraal/ topicaal), glucocorticoiden en budesonides (oraal/ topicaal), thiopurines (oraal), tacrolimus (oraal), anti-TNF (sc, iv), vedolizumab (iv)
Therapeutic value No judgement
Frequency of administration 1 times every 12 weeks
Dosage per administration 90-130 mg
References NCT02407236
Additional comments 130 mg IV als inductie, daarna 90 mg SC als onderhoud elke 12 weken.

Expected patient volume per year

Patient volume

400

Market share is generally not included unless otherwise stated.

References Crohn-colitis.nl; GIPdatabank
Additional comments Er zijn momenteel ruim 80.000 mensen in Nederland met een chronische darmontsteking. Dit is ongeveer 1 op de 200 mensen. Hiervan heeft iets meer dan de helft colitis. Een vergelijkbare biological die gericht is tegen integrines is vedolizumab. In 2017 werd vedolizumab voorgeschreven aan 1.658 patiënten met chronische darmontstekingen, hiervan hebben er ongeveer 800 UC. Uitgaande van 50% marktaandeel wordt geschat dat ustekinumab zal worden voorgeschreven aan 400 patiënten per jaar.

Expected cost per patient per year

Cost 19,000.00
References Medicijnkosten.nl; fabrikant
Additional comments Huidige listprijs (+BTW) voor 1 spuit 90 mg is €3254,72. 30% krijgt om de 12 weken een 90 mg spuit, 70% om de 8 weken. Dat wil zeggen gemiddeld 5,85 dosissen op jaarbasis. Dus €19.040 per patiënt per jaar.

Potential total cost per year

Total cost

7,600,000.00

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

Indication extension Yes
Indication extensions Lupus

Other information

There is currently no futher information available.