The National Institute for Health and Care Excellence (NICE) has recommended ITULAZAX (12 SQ-Bet), a once-daily immunotherapy tablet designed to treat moderate to severe tree pollen hay fever, marking the first time a treatment targeting the underlying cause of the condition has received this kind of guidance.

Developed by ALK, the tablet is a sublingual immunotherapy (SLIT) that retrains the immune system rather than simply masking allergy symptoms. The recommendation opens access to an at-home treatment option for an estimated 26,800 adults in England living with tree pollen-induced hay fever.

Tree pollen season in the UK can be especially difficult for people with moderate to severe allergic rhinitis, often triggered by birch, alder or hazel trees. According to NICE, many patients are unable to manage their condition adequately using over-the-counter or symptomatic medications alone.

Hay fever is classified as moderate to severe when symptoms lead to disrupted sleep or interfere with daily activities such as work, leisure or education. Each year, allergy-related absences contribute to an estimated 3.2 million lost working days in the UK, while students with hay fever are 40% more likely to see a drop in grades during the pollen season.

The NICE recommendation comes as tree pollen levels in the UK continue to rise due to unseasonably warm weather. Scientists have warned that the 2025 season began early, affecting up to 15.8 million people in the UK who experience hay fever, including approximately 2.9 million with more severe forms of the condition.

Amena Warner, head of clinical services at Allergy UK, said: “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 well-being. NICE’s recommendation is so important because it 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.”

Dr Robin Gore, president of the British Society for Allergy and Clinical Immunology (BSACI), added: “This is now the second NICE recommendation for SLIT tablets, which marks a shift from simply managing symptoms to long-term disease modification. For years, patients have relied on temporary relief. We now have a second recommended immunotherapy option that targets the underlying cause of the allergy. This is a significant development for patients with disruptive allergies such as seasonal allergic rhinitis, offering a proactive way to manage their condition and improve their quality of life.”

This is the second NICE recommendation for an at-home SLIT therapy. The first, issued in March 2025, was for ACARIZAX, a tablet targeting house dust mite allergies.

Emil Stage Olsen, general manager for the UK and Republic of Ireland at ALK, said: “We welcome this positive NICE recommendation, which is another meaningful advancement for 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. We are proud to lead the way in providing accessible treatments that offer more than just temporary relief and can truly change lives.”

The treatment is expected to reduce pressure on NHS services during pollen season by offering a cost-effective alternative to repeated GP or specialist visits.