NICE makes U-turn, recommending Novartis' Xolair for children aged six-11 years

UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has today (March 7) issued a final draft guidance in the form of a Final Appraisal Determination (FAD) which recommends Swiss drug major Novartis’ (NOVN: VX) Xolair (omalizumab) for patients with severe persistent allergic asthma, aged six years and older, who are on continuous or frequent oral corticosteroids (OCS) (defined as four or more OCS courses in the previous year).

Today’s FAD also proposes to overturn the negative Appraisal Consultation Document (ACD) published by NICE last fall, which threatened to deny all appropriate patients access to this effective medicine (The Pharma Letter November 2012). In addition, the FAD proposes to remove the requirement that asthma patients be hospitalized for asthma before being eligible for treatment. One year of treatment with omalizumab has been shown to reduce hospital admissions by 61% and overnight hospital stays by 70%.

The NICE Appraisal Committee heard from patient experts and clinical specialists, as well as through comments received during the consultation, that omalizumab has resulted in life-changing improvements in reducing the number of asthma-related clinically significant exacerbations. The Committee concluded that omalizumab is a clinically effective and innovative therapy which is a cost effective use of National Health Service resources.