Omalizumab Medicine 10 June 2020 Extended indication Adjunct Therapy to Multi-Allergen OIT in Food Allergic Patients. Therapeutic value No judgement Total cost Registration phase No registration expected Product Active substance Omalizumab Domain Chronic immune diseases Reason of inclusion Indication extension IND Main indication Allergy Extended indication Adjunct Therapy to Multi-Allergen OIT in Food Allergic Patients. Current proprietary name Already available biosimilars / generics Proprietary name Xolair Manufacturer Novartis Portfolio holder Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-IgE Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase No registration expected Reimbursement Medicine sluice Additional remarks 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 Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation 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 remarks Toediening elke 2 of 4 weken. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 1,700.00 - 3,400.00 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. References Farmacotherapeutisch Kompas Additional remarks 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks