Ixekizumab

Active substance
Ixekizumab
Domain
Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Rheumatism
Extended indication
Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy and patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

1. Product

Proprietary name
Taltz
Manufacturer
Eli Lilly
Mechanism of action
Immunosuppression
Route of administration
Subcutaneous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Door elke reumatoloog in Nederland voor te schrijven.

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
September 2019
Expected Registration
June 2020
Orphan drug
No
Registration phase
Positive CHMP opinion
Additional comments
Positieve CHMP-opinie in april 2020.

3. Therapeutic value

Current treatment options
Verschillende TNF blokkers na falen NSAID of anti-IL17A; secukinumab.
Therapeutic value
Potential added value
Substantiation
Mogelijke meerwaarde ten opzichte van TNFi op effectiviteit. De meerwaarde is vooral zichtbaar bij patiënten die falen op een TNF-blokker. De werkgroep verwacht echter gelijke waarde met secukinumab voor deze indicatie. Onduidelijk wat het effect is op lange termijn.
Duration of treatment
lifetime
Frequency of administration
2 times a month
Dosage per administration
80 mg
References
NCT02757352 https://acrabstracts.org/abstract/ixekizumab-significantly-improves-signs-symptoms-and-spinal-inflammation-of-active-ankylosing-spondylitis-radiographic-axial-spondyloarthritis-16-week-results-of-a-phase-3-randomized-active-a/
Additional comments
Toediening Q2W en Q4W worden getest.

4. Expected patient volume per year

Patient volume

< 1,000

Market share is generally not included unless otherwise stated.

Additional comments
Axiale spondyloartritis komt voor bij ongeveer 1 op de 400 mensen, dit zijn in Nederland ongeveer 42.500 mensen. De inschatting is dat ongeveer 3.000-4.000 patiënten anti-TNF medicatie krijgen. Na het falen op anti-TNF komen patiënten in aanmerking voor ixekizumab, dit zijn er minder dan 1.000.

5. Expected cost per patient per year

Cost
14,118
References
G-standaard juni 2020
Additional comments
Apotheekinkoopprijs per verpakking van 80 mg: €1.086 Behandelschema (op basis van SmPC en de pivotale registratiestudies): Dosering: 80 mg (voor zowel radiografisch als non-radiografisch) Toedieningsfrequentie: De aanbevolen startdosering is 160mg (door middel van 2 subcutane injecties van 80 mg) in week 0, gevolgd door onderhoudsdosering 80 mg iedere 4 weken. Kosten ixekizumab per onderhoudsjaar = €1.086 x 13 = €14.118.

6. Potential total cost per year

Total cost

14,118,000

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.

7. Off label use

Off label use
No

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.