Pharmaceutical Business review

NICE Recommends Against Novartis Xolair

Recently, Scottish Medicines Consortium (SMC) has accepted the use of Novartis’ omalizumab for children in Scotland aged 6 to 11 years with severe, persistent allergic asthma who are prescribed chronic systemic steroids.

In 2005, Omalizumab was approved as add-on therapy in the EU by the European regulator (EMEA) for patients 12 years and older with severe persistent allergic asthma. Most recently EMEA has also approved omalizumab as add-on therapy for severe persistent allergic asthma in children aged 6 to 11 years.

Novartis has said that the Omalizumab is a licensed medicine shown to stabilise severe allergic asthma in a significant proportion of patients by blocking the action of the IgE antibody, a factor in the inflammatory cascade associated with allergic asthma.

Omalizumab thereby inhibits the body’s reaction to inhaled particles such as cat dander and house-dust mite droppings that cause the symptoms associated with severe allergic asthma. By targeting IgE, omalizumab can prevent the onset of debilitating symptoms, such as shortness of breath and wheezing, in severely affected patients.

Tim Cave, medical director at Novartis UK, said: “We are disappointed by NICE’s initial decision and concerned that the small number of young children with severe asthma in whom omalizumab would be used will be denied access to this drug. If the initial decision stands, doctors will not be able to give children a treatment which could alleviate their asthma symptoms.”