It seems Novartis' Xolair will remain an option for the treatment of patients with asthma on the National Health Service after all, following a u-turn by cost regulators.
The National Institute for Health and Clinical Excellence said it now recommends Xolair (omalizumab) as an option for treating severe, persistent allergic asthma in adults, adolescents and children, in a complete turnaround from its earlier intention to ban it from the NHS.
In 2007, the Institute published guidelines supporting the use of Xolair on the NHS for adults whose asthma is poorly controlled, and in 2011 went on to reject its use in children aged six-11 years.
But a review of these guidelines, in which new evidence, particularly new mortality data, was considered, prompted NICE to turn down the drug's use in both children and adults in draft guidance published in November last year, on grounds that it is not as clinically and cost-effective as previously thought.
Not taking this decision lying down, however, Novartis submitted both additional analyses and a patient access scheme (PAS) to secure a cost-effectiveness tick for its drug and a change of heart from NICE.
Consequently, Xolair is now recommended as an option for treating severe, persistent confirmed allergic IgE-mediated asthma in people aged six years and older, as an add-on to optimised standard therapy for patients needing continuous or frequent treatment with oral corticosteroids, as long as the drug is offered at a discount as per the PAS.
The cost of Xolair ranges from around £1,665 per patient per year (excluding VAT) for a 75mg dose given every four weeks to approximately £26,640 per patient per year (excluding VAT) for the maximum 600mg dose administered every two weeks.
In the setting recommended, the Institute's Appraisal Committee calculated an accpetable ICER (incremental cost effectiveness ratio) for Xolair of £23,200 per QALY (quality-adjusted life year).
The Committee also acknowledged the health-related quality of life benefits (which were not quantifiable) of reducing dependence on oral corticosteroids, and was persuaded these additional benefits would be sufficient to make the drug a cost effective option for treating the condition.