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Upadacitinib

Extended indication Upadacitinib is indicated for the treatment of moderate to severe atopic dermatitis in patients who
Therapeutic value Possible equal value
Total cost 6,250,000.00
Registration phase Clinical trials

Product

Active substance Upadacitinib
Domain Chronic immune diseases
Reason of inclusion Indication extension
Main indication Skin diseases
Extended indication Upadacitinib is indicated for the treatment of moderate to severe atopic dermatitis in patients who have failed to respond to conventional (topical) therapies.
Manufacturer Abbvie
Mechanism of action JAK tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)
Additional remarks JAK1 inhibitor. Vergelijkbaar met baricitinib en tofacitinib.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials

Therapeutic value

Current treatment options Dupilumab
Therapeutic value Possible equal value
Substantiation Plaatsbepaling JAK-remmers versus biologicals is vooralsnog onduidelijk.
Frequency of administration 1 times a day
Dosage per administration 15 mg -30 mg
References fabrikant

Expected patient volume per year

Patient volume

200 - 800

Market share is generally not included unless otherwise stated.
References Nav inschatting Dupilumab
Additional remarks Het is te verwachten dat het aantal CE patiënten die in aanmerking komen voor JAK remmers vergelijkbaar is met de inschatting voor dupilumab. Deze inschatting is gemaakt op basis van orale immunosuppressiva gebruik in Nederland (maximaal 2046 patiënten). Aangezien de drempel wat lager wordt, verwacht de werkgroep een stijgend aantal CE patiënten die behandeld gaan worden met systemische middelen. De werkgroep verwacht dat uiteindelijk enkele honderden patiënten behandeld zullen worden met upadacitinib indien effectief.

Expected cost per patient per year

Cost 10,000.00 - 15,000.00
Additional remarks Kosten inschatting op basis van andere JAK remmers.

Potential total cost per year

Total cost

6,250,000.00

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

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Phase III: Crohn's disease; Psoriatic arthritis; Ulcerative colitis
References https://adisinsight.springer.com/drugs/800037410

Other information

There is currently no futher information available.