betula verrucosa (Itulazax)

following a full submission:

standardised allergen extract of pollen from white birch (Betula verrucosa) (Itulazax®) is accepted for restricted use within NHSScotland.

Indication under review: in adults and children (5 years or older) for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous. It is indicated in patients with a clinical history of symptoms despite use of symptom-relieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE).

SMC restriction: for use in adults, 18 to 65 years.

Area Drug and Therapeutic Committees (ADTCs) may make formulary decisions on paediatric licence extensions for medicines that are accepted for use (or restricted use) in adults.

Evidence from a double-blind phase III study demonstrated that in combination with standard care one tree pollen season’s treatment with Itulazax® significantly improved a combined measure of rhinoconjunctivitis symptom severity and medication use (total combined score) compared with placebo plus standard care.