NICE to look again at Novartis' Xolair for Asthma
This article was originally published in Scrip
NICE, the health technology appraisal body for England and Wales, will again appraise Novartis' asthma drug Xolair (omalizumab), which could lead to widened recommendations. The institute has published a draft appraisal scope for the drug.
Last year NICE rejected the drug as a treatment for severe persistent allergic asthma in children aged six to eleven years. The institute claimed that the drug did not represent value for money in the younger population (scripintelligence.com, 27 October 2010). The institute also made further recommendations for research – a randomised controlled trial to compare omalizumab as an add-on therapy to standard care with oral corticosteroids in children aged six to 11 with severe persistent allergic asthma, with oral corticosteroid use.
Back in 2007, NICE recommended Xolair for treating severe persistent allergic asthma as an add-on therapy to optimised standard therapy in patients aged 12 and over with severe unstable disease. Patients must first have had either two or more severe exacerbations of asthma requiring hospital admission within the previous year, or three or more severe exacerbations of asthma within the previous year. At least one of these exacerbations should have required admission to hospital, and a further two should have required treatment or monitoring beyond the patient's usual regimen, in an accident and emergency unit.
NICE is proposing to review both pieces of guidance (technology appraisal guidance 133 and technology appraisal guidance 201, respectively) as in a single review of the drug's clinical and cost-effectiveness within its licensed indications.
The scope proposes that standard therapy without Xolair be used as the comparator. Standard therapy for Xolair's patient population is inhaled corticosteroids of up to 2,000 micrograms per day for adult, and up to 800 micrograms per day for children aged five-12. Leukotriene receptor agonists, theophyllines or slow release beta-2 agonist tablets can also be considered at this stage. If patients fail on these options, they could then be treated with daily steroids at the lowest possible dose that provides adequate control. These approaches form steps four and five of guidelines from the British Thoracic Society and the Scottish Intercollegiate Guidelines Network.
The scope also lists the outcomes to be considered. These include: objective measuring of lung function, the incidence of clinically significant acute exacerbations; levels of corticosteroid use; and mortality, among others.
Novartis will have the opportunity to submit further evidence. However, the company did not wish to comment on the appraisal "at this early stage". The first appraisal committee meeting is scheduled for July 2012.
Xolair is the first approved humanised antibody treatment for asthma. It blocks the action of immunoglobulin E, an antibody involved in the underlying mechanism of allergic asthma.