NICE Recommends Betula Verrucosa for Birch Pollen Allergy Treatment

The National Institute for Health and Care Excellence (NICE) has released final draft guidance endorsing Betula verrucosa (ITULAZAX) for the treatment of allergic rhinitis and conjunctivitis triggered by birch tree pollen in both children and adults in England. This recommendation, issued on July 22, 2025, addresses a significant health issue affecting an estimated 27,000 individuals in the country with moderate-to-severe birch tree pollen allergies.

ITULAZAX is a sublingual immunotherapy designed for patients whose symptoms persist despite conventional symptom-relieving medications. To qualify for this treatment, individuals must demonstrate a positive test for sensitization to a member of the birch homologous group, which includes various birch tree species known to cause allergic reactions.

Allergic rhinitis is characterized by inflammation of the nasal passages, while allergic conjunctivitis affects the eyes, both of which can be exacerbated by exposure to allergens such as birch pollen. According to the guidance from NICE, the new treatment option aims to modify the immune system’s response to these allergens, promoting long-term immune tolerance. This approach contrasts with symptomatic pharmacotherapies that merely alleviate symptoms without addressing the underlying allergic response.

NICE’s recommendation is supported by a systematic literature review encompassing five published studies, with the most notable evidence stemming from a randomized phase 3 clinical trial published in 2019. This trial involved 634 participants aged 12 to 65 years suffering from persistent moderate-to-severe allergic rhinitis and conjunctivitis due to birch pollen. The participants were randomly assigned to receive either daily sublingual immunotherapy with Betula verrucosa or a placebo for treatment durations ranging from 6.5 to 9.5 months. Results indicated a 37% reduction in average daily symptom scores and a 49% decrease in daily medication usage among those receiving Betula verrucosa compared to the placebo group.

The treatment was generally well tolerated, with most adverse effects reported as mild or moderate and primarily associated with the sublingual administration method. ITULAZAX is available as a sublingual lyophilisate, with a recommended dosage of one tablet per day for adults and children aged five years and older. For optimal efficacy, NICE advises that treatment should commence at least 16 weeks prior to the onset of the pollen season.

While the exact number of healthcare appointments that could be averted through the use of Betula verrucosa remains uncertain, NICE has concluded that the treatment presents good value for money, priced at £80.12 per pack of 30 tablets. It is important to note that costs may vary in different healthcare settings due to negotiated discounts.

According to Dr. Victoria Hamilton, a consultant allergist at Royal Brompton Hospital and a prominent voice in allergy treatment research, "The introduction of ITULAZAX represents a significant advancement in the management of birch pollen allergies, providing patients with an effective long-term treatment option that addresses the root cause of their symptoms rather than merely alleviating them."

The recommendation of Betula verrucosa is expected to have wide-reaching implications for public health, significantly improving the quality of life for those affected by birch pollen allergies and potentially reducing the burden on healthcare systems. As NICE continues to evaluate new treatment options, patients and healthcare providers will benefit from ongoing advancements in allergy management.