Extended indication Adjunct Therapy to Multi-Allergen OIT in Food Allergic Patients.
Therapeutic value No judgement
Registration phase No registration expected

Product

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

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Orphan drug No
Registration phase No registration expected
Additional comments Momenteel vinden voor omalizumab binnen Food Allergy enkel studies plaats in de Verenigde Staten. Deze studies worden gesponsord door een onafhankelijke instantie, de NIAID (National Institute of Allergy and Infectious Diseases) en niet door Novartis. Momenteel zijn er volgens de fabrikant geen geluiden dat omalizumab voor Food Allergy in Europa op de markt zal worden gebracht.

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.

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 1,700.00 - 3,400.00
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.

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.