The U.K.’s National Institute for Health and Clinical Excellence (NICE) this weekend issued a draft guidance stating that it does not recommend omalizumab, an asthma medication marketed as Xolair by Novartis Pharmaceuticals. NICE is a U.K. health authority that publishes guidelines for the National Health Service.

Omalizumab currently has a U.K. marketing authorization as an add-on therapy for persistent allergic asthma in adults and children. It works by blocking immunoglobulin E antibodies from attaching to allergens.

NICE stated that new evidence, including new mortality data, that has be come available influenced its decision. It also took into account the dosing schedule for the drug, and the effect that had on its cost effectiveness. These factors and other “uncertainties in the evidence and analysis presented,” influenced NICE to withhold a recommendation for omalizumab. The health-related quality of life benefits of the drug are not currently considered quantifiable, and were not part of the economic modeling used by NICE.

“The Committee is aware that severe, persistent allergic asthma can have a detrimental effect on a person’s life and that omalizumab is an effective therapy for children, adolescents and adults with severe persistent allergic asthma,” said Sir Andrew Dillon, chief executive of NICE. “But new evidence that has become available since our original appraisal of omalizumab in 2007 indicates that it is not as clinically or cost-effective as was first thought. The Committee explored ways to identify a subgroup of people for whom omalizumab might provide a cost effective treatment, including using favorable assumptions in the modeling. In addition, the Committee recognized that there could be additional health-related benefits for patients and carers as a result of using omalizumab. However, there was no quantifiable data relating to these benefits. Unfortunately, the Committee was unable to continue to recommend omalizumab for use in the NHS. The next step is for the manufacturer and other consultees to respond to the Committee’s concerns.”