The National Institute for Health and Care Excellence (NICE) has approved Itulazax 12 SQ-Bet (Betula verrucosa) for NHS use in England, marking a significant breakthrough for patients suffering from severe tree pollen allergies. The under-the-tongue immunotherapy tablet, manufactured by ALK-Abello, contains birch pollen extract and represents the first treatment of its kind to receive NICE approval for long-term hayfever management.
Treatment Mechanism and Clinical Benefits
The immunotherapy works by gradually increasing the body's tolerance to tree pollen through controlled daily exposure to small amounts of pollen over a three-year treatment period. Clinical trials demonstrate that the tablet can significantly reduce severe hayfever symptoms by fundamentally changing how the body responds to allergens, rather than merely managing symptoms.
Helen Knight, director of medicines evaluation at NICE, emphasized the treatment's transformative potential: "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. The daily tablet offers genuine long-term relief rather than just managing symptoms."
Patient Population and Eligibility
NICE estimates that approximately 27,000 people in England will benefit from this recommendation. The treatment is specifically indicated for patients whose hayfever symptoms persist despite taking antihistamines or using nasal sprays. Before receiving the tablets, patients must undergo skin prick or blood tests to confirm an allergy to birch tree pollen.
According to Allergy UK, birch pollen allergy affects an estimated 25% of hayfever sufferers. Severe tree pollen allergies can cause debilitating symptoms during spring and summer months, including fatigue, breathing difficulties, inflamed sinuses, itchy and watery eyes, and vision changes.
Clinical Impact and Quality of Life
Amena Warner, head of clinical services at Allergy UK, highlighted the significant burden these allergies place on patients: "Many people don't realise how awful it is having an itchy, runny nose, sneezing episodes or itchy, irritated eyes in the pollen season. We frequently hear from people who avoid time outdoors, keep doors and windows shut, check pollen counts and try and minimise any exposure, which takes a significant toll on their physical and emotional wellbeing."
Warner added that NICE's recommendation "provides a genuine opportunity for people to manage the root cause of their pollen allergy, offering the chance to break free from this burden and enjoy a better quality of life."
Implementation Timeline
The NHS in England will provide the treatment within three months of NICE publishing its final guidance. Emil Stage Olsen, general manager UK and Republic of Ireland at ALK, welcomed the positive recommendation, stating: "This is another meaningful advancement for the UK allergy community. Our focus is now on working closely with the NHS to ensure eligible patients can benefit from this first-in-class immunotherapy."
