Omalizumab

Active substance
Omalizumab
Domain
Chronic immune diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Allergy
Extended indication
Adjunct Therapy to Multi-Allergen OIT in Food Allergic Patients.

1. Product

Proprietary name
Xolair
Manufacturer
Novartis
Mechanism of action
Interleukin inhibitor
Route of administration
Subcutaneous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Anti-IgE

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Submission date
2021
Expected Registration
2022
Orphan drug
No
Registration phase
Clinical trials
Additional comments
Datum indiening en verwachte registratie op basis van estimated primary completion date in oktober 2020.

3. Therapeutic value

Therapeutic value
No judgement
Duration of treatment
Average 18 week / weeks
Frequency of administration
1 times every 2 weeks
Dosage per administration
75 mg of 150 mg
References
NCT03881696
Additional comments
Toediening elke 2 of 4 weken.

4. Expected patient volume per year

There is currently nothing known about the expected patient volume.

5. Expected cost per patient per year

Cost
1,700 - 3,400
References
Farmacotherapeutisch Kompas
Additional comments
Xolair, 0,5 ml injectievloeistof 150mg/ml is €189,88 en Xolair, 1 ml injectievloeistof 150mg/ml is €379,75. Uitgaande van een behandeling van 18 weken en een toediening van elke 2 weken zou dat neerkomen op: €1.700-€3.400. Het kan meerkosten met zich meebrengen als het middel niet alleen ingezet wordt bij de bijwerkingen in het begin.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.