NICE gives the go ahead for the use of Xolair® (omalizumab) to treat potentially disabling skin condition
Novartis is delighted that the National Institute of Health and Care Excellence (NICE) has recommended Xolair® (omalizumab) as an option for add-on therapy for treating severe CSU for adults and young people (aged 12 and above) across England who have not responded to treatment with H1-antihistamines and leukotriene receptor antagonists (LTRAs). 1
Already approved by the European Commission, omalizumab is the first and only add-on therapy to H1-antihistamines for patients who do not respond to other treatments and is the first new type of medicine licensed for the treatment of CSU since the 1950s.4 The committee that developed NICE’s recommendation commented that the speed at which omalizumab works, and its comparative safety profile, means it can be considered ‘innovative’ in the treatment of this condition.1 Subject to appeal, clinicians and patients will have access to omalizumab by the summer.
Dr Sinisa Savic, Consultant Immunologist at St James’s University Hospital, Leeds, comments: “CSU can be an unpleasant condition which can have a huge impact on patients’ physical and psychological wellbeing. For some of my patients CSU has had a devastating effect on their lives. For many years treatment options for patients with the severe form of CSU have been quite limited and there has been a real medical need for an effective, licensed medicine to be available to patients and clinicians. The positive final appraisal determination issued today by NICE is a very welcome and important step forward for healthcare professionals and people living with CSU.”
CSU is characterised by red, swollen, itchy and painful ‘wheals’ (also known as ‘hives’) that recur daily, or almost daily for six weeks, it is an often distressing skin condition which can be disabling. 3, 5, 6The itch is often very persistent, causing sleepless nights, and is sometimes accompanied by unpleasant deep tissue swelling – angioedema – which can affect the face, neck, hands and feet in particular. CSU may affect up to half a million people in the UK. 2, 7
International experts agree that effective treatment for CSU should ultimately result in patients being symptom-free, which is not possible in up to 50% of cases with the only other licensed therapy, H1-antihistamines, given at licensed doses.2, 4
During three placebo-controlled clinical trials (ASTERIA I, ASTERIA II and GLACIAL) that involved over 1,000 patients not responding to H1-antihistamine treatment, omalizumab 300mg was shown to significantly improve itch and hives, including rapid itch relief, and in many cases completely cleared symptoms (when compared to placebo).8, 9, 10 In these studies, the incidence and severity of adverse events (AEs) was similar between omalizumab and placebo.8, 9, 10 Quality of life was also significantly improved for patients treated with omalizumab 300mg across the Phase III study programme.8, 9, 10
Maureen Jenkins, Clinical Director, Allergy UK, says: “We receive many calls about CSU to our helpline; it’s a condition which has a significant and often underestimated impact on people’s lives. People living with CSU are often at their wits’ end, longing for relief from their symptoms which can place huge limitations on their everyday lives. We’re delighted that NICE has recognised the role of omalizumab as an effective treatment for patients who’ve struggled unsuccessfully to achieve control over their symptoms using other medicines.”
NICE’s positive guidance on omalizumab, the first and only add-on therapy to H1-antihistamines to be licensed for the treatment of CSU, follows the Scottish Medicines Consortium’s decision to make the medicine available to adults and young people (aged 12 and above) living with CSU living in Scotland with an inadequate response to combination therapy with H1-antihistamines, H2-antihistamines and leukotriene receptor antagonists (LTRAs). 2, 8, 11
NICE’s recommendation makes omalizumab available to patients with a severe form of the condition and states that the severity of the patient’s condition must be assessed objectively using a recognised scale, for example the weekly urticaria activity score. 1 The detail of NICE’s recommendation can be accessed via NICE’s website (www.nice.org).Novartis is committed to working with NICE and the NHS to support the swift implementation of the advice to ensure that eligible CSU patients have access to this important medicine.
About Xolair® (omalizumab)
Omalizumab is a targeted therapy that binds to free immunoglobulin E (IgE), which is circulating in the bloodstream. IgE binds to IgE receptors on histamine-releasing cells. Omalizumab suppresses histamine-induced skin reactions, potentially through its reduction of IgE and consequent downstream effects on histamine-release activation mechanisms.
Omalizumab has been approved by the European Commission for use in the European Union (EU), including the UK, as add-on therapy for the treatment of CSU in adult and young people (aged 12 and above) patients with inadequate response H1-antihistamine treatment.
Research is ongoing to fully understand the mechanism of action of omalizumab in CSU, which could lead to deeper understanding of how the disease develops.
Omalizumab is approved for the treatment of moderate-to-severe persistent allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the UK since 2005. In the UK it is approved for the treatment of severe persistent allergic asthma in children (aged six and above), young people, and adults.
 National Institute for Health and Care Excellence. Final appraisal determination. Omalizumab for previously treated chronic spontaneous urticaria. Available www.nice.org.uk [Accessed March 2015]
 Maurer M, Weller, K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 66 (2011) 317-330
 O’Donnell BF, Lawlor F, Simpson J, Morgan M, Greaves MW. The impact of chronic urticaria on the quality of life. British Journal of Dermatology 1997;136:197-201
 Zuberbier T, Asero R, Bindslev-Jensen C, et al. The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy, 2014; DOI: 10.1111/all.12313
 Sánchez-Borges M. Asero R, Asotegui IJ, et al. Diagnosis and treatment of angioedemia: a worldwide perspective (position paper). World Allergy Organization Journal. 2012; 5:125-147
 Wheals of Despair market research amongst 103 patients, November 2013 – January 2014.
 Population Estimates for UK, England and Wales, Scotland and Northern Ireland, Mid-2011 and Mid-2012. Office of National Statistics. http://www.ons.gov.uk/ons/rel/pop-estimate/population-estimates-for-uk–england-and-wales–scotland-and-northern-ireland/mid-2011-and-mid-2012/index.html [Accessed March 2015]
 Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. Journal of Allergy and Clinical Immunology. 2013 Jul; 132(1):101-9. doi: 10.1016/j.jaci.2013.05.013
 Maurer M, Rosén K, Hsieh, HJ, et al. Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. New England Journal of Medicine. 2013;368:924-35
 Saini SS, Bindslev-Jensen C, Maurer M, et al., Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015; 135(1):67-75
 SMC Advice: Omalizumab as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. Available: http://www.scottishmedicines.org.uk/ [Accessed March 2015]