Extended indication Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active p
Therapeutic value No estimate possible yet
Registration phase Registered and reimbursed

Product

Active substance Risankizumab
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Rheumatism
Extended indication Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
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 December 2021
Orphan drug No
Registration phase Registered and reimbursed
Additional comments SPS United Kingdom: "Apr 21 · AbbVie submits applications to EMA and Unites States FDA for treatment of adults with active psoriatic arthritis". Positive CHMP opinie ontvangen oktober 2021

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 Anti-IL 17 wordt ingezet na falen van anti-TNF therapie en conventionele synthetische DMARDS, daarna een JAK remmer en vervolgens ustekniumab. Risankizumab zal de concurrentie aangaan met ustekinumab en guselkumab. De twee fase 3 studies lieten een vooruitgang zien van huid- en gewrichtssymptomen en bewegingsfunctie.
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 ongeveer 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; kosten €13.136 per patiënt 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.