Extended indication Extension of indication for the treatment of active psoriatic arthritis in adults.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Risankizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Extension of indication for the treatment of active psoriatic arthritis in adults.
Proprietary name Skyrizi
Manufacturer Abbvie
Mechanism of action Interleukin inhibitor
Route of administration Subcutaneous
Therapeutical formulation Injection
Budgetting framework Intermural (MSZ)
Additional comments Interleukin-23 subunit p19 inhibitors

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date April 2021
Expected Registration November 2021
Orphan drug No
Registration phase Registration application pending
Additional comments SPS United Kingdom: "Apr 21 · AbbVie submits applications to EMA and Unites States FDA for treatment of adults with active psoriatic arthritis"

Therapeutic value

Current treatment options DMARD-therapie, adalimumab, apremilast, certolizumab pegol, etanercept, golimumab, infliximab, abatacept, ixekizumab, tofacitinib, ustekinumab en secukinumab
Therapeutic value No estimate possible yet
Substantiation Eerst wordt een anti IL-17 ingezet, daarna een JAK remmer en vervolgens een ustekniumab. Risankizumab zal de concurrentie aangaan met ustekinumab. De fase 3 resultaten moeten uitwijzen of er een verschil is in effectiviteit.
References NCT03675308

Expected patient volume per year

References IQVIA
Additional comments Naar schatting zijn er ongeveer 18.544 mensen in Nederland met psoriatrische artritis die in ziekenhuizen behandeld worden. Hiervan wordt ~26% met een biological behandeld (4.914).

Expected cost per patient per year

Cost 13,136.00
References G-standaard, Z-index mei 2020; fabrikant.
Additional comments AIP van €3.284 per pak met twee wegwerpspuiten, dus €1.642 per wegwerpspuit; €13.136 per jaar.

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.