NICE Recommends Betula Verrucosa for Severe Birch Tree Allergy

In a final draft guideline published July 21, 2025, the National Institute for Health and Care Excellence (NICE) recommended betula verrucosa (Itulazax 12 SQ-Bet), developed by Alk-Abelló, for allergic rhinitis or conjunctivitis triggered by birch trees.1

“This treatment will help improve people’s quality of life. Severe tree pollen allergies trap people indoors during beautiful weather and disrupt their work, education, and family life,” said Helen Knight, director of medicines evaluation at NICE, in a statement. “The daily tablet offers genuine long-term relief rather than just managing symptoms.”

Individuals with severe birch tree allergies experience more than just nasal congestion. Uncomfortable symptoms can range from debilitating fatigue and breathing difficulties to light sensitivity and vision changes. However, with betula verrucosa, a sublingual lyophilisate immunotherapy, patients may be able to get the long-term symptom relief they need. Betula verrucosa is indicated to treat moderate-to-severe allergic rhinitis or conjunctivitis induced by pollen from birch trees in adults and children aged ≥ 5 years.

Rather than simply masking symptoms, as conventional treatments do, this under-the-tongue immunotherapy trains the immune system to tolerate tree pollen over 3 years of daily use. Since betula verrucosa targets the root cause of allergic rhinitis and not the symptoms, this treatment has the potential to provide long-term versus temporary relief for individuals living with severe allergies.

A phase 3 randomized, double-blind, placebo-controlled multi-site trial evaluated betula verrucosa in 634 adults and adolescents aged 12 – 65 years with birch pollen-induced allergic rhinitis or conjunctivitis for 32 weeks.2 The primary endpoint was the average total combined score of rhinoconjunctivitis symptoms and medication use during the birch pollen season. The trial showed that patients taking the drug had 33% fewer symptoms and 47% less medication use than those taking a placebo.3

Patients in England with a confirmed birch tree pollen allergy (a positive skin prick or blood test) will be able to obtain betula verrucosa within 3 months of NICE publishing the final guideline, expected to be out on August 6, 2025.1

This treatment should be initiated outside of pollen season and continued during. Betula verrucosa has demonstrated meaningful benefit with an initiation 16 weeks before the beginning of the tree pollen season. No data exists on betula verrucosa initiation during pollen season.

Guidelines recommend a 3-year treatment period with betula verrucosa. If a patient does not experience improvement during the first year, this could be an indicator that the treatment is not working.

Betula verrucosa should be initiated under physician supervision, with at least half an hour of monitoring. The drug should be taken with dry fingers from the package and immediately placed under the tongue; the patient should avoid swallowing for about a minute and avoid food and beverages for 5 minutes.

Mild to moderate local allergic reactions may occur within the first few days of treatment, starting as early as 10 minutes, and disappear within a few months. Adverse events may only last 1 – 2 weeks. Very common adverse events included ear pruritus, throat irritation, oedema mouth, oral pruritus, paraesthesia oral, and tongue pruritus. Other common adverse events included oral allergy syndrome, dysgeusia, symptoms of allergic conjunctivitis, cough, dry throat, dysphonia, dysponea, oropharyngeal pain, pharyngeal oedema, pharyngeal paraesthesia, rhinitis, abdominal pain, diarrhea, dyspepsia, dysphagia, hypoaesthesia oral, lip oedema, lip pruritus, nausea, oral discomfort, oral mucosal blistering, stomatitis, swollen tongue, urticaria., chest discomfort, and sensation of foreign body.

Betula verrucosa should not be taken for patients with any of the following contraindications: hypersensitivity to any of the excipients, FEV1 <70% of predicted value, severe asthma exacerbation or uncontrolled asthma within 3 months before initiation, active systemic autoimmune diseases, immune defects, immunodeficiencies or immunosuppression, malignant neoplasia, and acute severe oral inflammation or oral wounds.

References

1. Thousands could benefit from first immunotherapy for severe birch tree pollen allergy. National Institute for Health and Care Excellence. July 21, 2025. https://www.nice.org.uk/news/articles/first-immunotherapy-for-severe-birch-tree-pollen-allergy-recommended-by-nice. Accessed July 21, 2025.

2. ITULAZAX 12 SQ-Bet. EMC. https://www.medicines.org.uk/emc/product/12906/smpc#gref. Accessed July 22, 2025.

3. NICE approves first immunotherapy tablet to treat tree pollen allergy. PULSE. July 21, 2025. https://www.pulsetoday.co.uk/news/clinical-areas/nice-approves-first-immunotherapy-tablet-to-treat-tree-pollen-allergy/. Accessed July 22, 2025.