The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending betula verrucosa (ITULAZAX 12 SQ-Bet, Alk-Abelló) for treating birch tree pollen-induced allergic rhinitis or conjunctivitis in children and adults.
The sublingual immunotherapy is indicated for people with moderate to severe symptoms that persist despite the use of symptom-relieving medicines. Eligibility also requires a positive test of sensitisation to a member of the birch homologous group.
Long-term Immune Tolerance
Allergic rhinitis is an inflammatory condition affecting the nasal passages, while allergic conjunctivitis affects the eyes. Both are triggered by allergens such as birch pollen.
NICE estimates that up to 27,000 people in England with moderate to severe birch tree pollen allergy could benefit from the treatment.
ITULAZAX contains betula verrucosa pollen extract. Unlike symptomatic pharmacotherapies, it works by modifying the immune system’s response to allergens, eventually inducing immune tolerance.
Evidence from Phase 3 Trial
NICE’s recommendation follows a systematic literature review that included five publications.
The most significant evidence came from a randomized phase 3 clinical trial published in 2019. It involved 634 patients aged 12 to 65 years with persistent, moderate to severe allergic rhinitis and conjunctivitis caused by birch pollen.
Participants were randomised 1:1 to receive either daily betula verrucosa sublingual immunotherapy or placebo. Treatment lasted between 6.5 months and 9.5 months.
Those taking betula verrucosa showed a 37% reduction in average daily symptom scores and a 49% reduction in daily medication use compared with placebo.
Well-tolerated with Mild Side Effects
The treatment was generally well-tolerated. Most adverse effects were mild or moderate local reactions linked to sublingual administration.
ITULAZAX is available as a sublingual lyophilisate. The recommended dose is one tablet per day for adults and children aged 5 years and older.
For best results, treatment should begin at least 16 weeks before the start of the pollen season.
While the exact number of healthcare appointments potentially avoided by betula verrucosa remains unclear, NICE concluded the treatment offers value for money.
The drug is priced at £80.12 per pack of 30 tablets. Costs may vary in different settings because of negotiated discounts.
Annie Lennon is a medical journalist. Her writing appears on Medscape Medical News, Medical News Today, and Psych Central, among other outlets.