UK's NICE reaffirms decision to deny use of Novartis' asthma drug Xolair for children

The UK's drug use watchdog the National Institute for Health and Clinical Excellence (NICE), in a final appraisal document issued yesterday, has again stated that Swiss drug major Novartis' asthma drug Xolair (omalizumab) should not be recommended for the treatment of severe persistent allergic asthma in children aged under six to 11 under the National Health Service. The decision is, however, open to appeal.

The NICE said that high cost of Xolair, which is injected, and is approved for use in older children, does not justify its "little extra benefit compared with existing treatments." The cost of omalizumab ranges from approximately £1,665 ($2,659) per patient per year (excluding VAT) for a 75mg dose administered every four weeks to around £26,640 per patient per year (excluding VAT) for a 600mg dose (the maximum recommended dose in the SPC) administered every two weeks. Costs may vary in different settings because of negotiated procurement discounts.

Gillian Leng, deputy Chief Executive of the NCIE, said it had considered all the research, noting that "this evidence demonstrates no proven reduction in hospitalization rates, accident and emergency visits, unscheduled doctor visits or total emergency visits for children in this age group treated with omalizumab. The Committee found that omalizumab is only useful in reducing the rate of clinically significant exacerbations for children who had had three or more exacerbations per year. We are unable to recommend that NHS funds be diverted to a treatment with such high costs which only provides very limited benefits for patients."