Expand all sections

Ixekizumab

Taltz

Extended indication Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have r
Therapeutic value Possible added value
Total cost 14,118,000.00
Registration phase Positive CHMP opinion

Product

Active substance Ixekizumab
Domain Chronic immune diseases
Reason of inclusion 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).
Proprietary name Taltz
Manufacturer Eli Lilly
Mechanism of action Immunosuppression
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional remarks Door elke reumatoloog in Nederland voor te schrijven.

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 remarks Positieve CHMP-opinie in april 2020.

Therapeutic value

Current treatment options Verschillende TNF blokkers na falen NSAID of anti-IL17A; secukinumab.
Therapeutic value Possible 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 remarks Toediening Q2W en Q4W worden getest.

Expected patient volume per year

Patient volume

< 1,000

Market share is generally not included unless otherwise stated.
Additional remarks 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.

Expected cost per patient per year

Cost 14,118.00
References G-standaard juni 2020
Additional remarks 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.

Potential total cost per year

Total cost

14,118,000.00

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.