Asthma injection for children too expensive says NIH in the U.K.
Press reports from the U.K. reflect that the drug called omalizumab, marketed as Xolair, is given as a monthly injection by a doctor and has been shown to reduce the number of times a child has a severe attack. But because it does not reduce the number of times a child visits A&E or their doctor, it was not deemed effective enough to justify its cost, the National Institute for Health and Clinical Excellence has said.
It costs more than £26,000 per patient per year which when the improvement in quality of life is taken into account means its cost effectiveness ratio is at least twice as much as Nice would normally approve. Although there are over one million children in Britain with asthma, only around 300 of those would qualify for the treatment because of the severity of their condition and that it cannot be controlled with other medications. The guidance applies to children under the age of 12 but older people are allowed to receive Xolair under other Nice guidance.
Nice will now re-examine the guidance for people over the age of 12 because it was acknowledged that it is best to have uniform guidelines. Sir Andrew Dillon, Chief Executive of Nice, said: “The evidence reviewed by our independent advisory committee showed little benefit for young children between six and eleven years old. “Omalizumab does not reduce hospitalisation rates, A&E visits, unscheduled doctor visits or total emergency visits. The only demonstrable benefit was in reducing the rate of clinically significant exacerbations for children who had had three or more exacerbations per year. “With such little extra benefit for these young patients, Nice is unable to recommend diverting NHS resources to such a high cost treatment. ”We understand that this may be a disappointing decision, especially as Nice does recommend omalizumab for some people aged twelve and over. The Appraisal Committee who developed the guidance on behalf of Nice recognised that it would be preferable to have a single piece of guidance covering recommendations for all age groups. In light of this, Nice does intend to review its guidance on omalizumab for both age groups at the earliest opportunity.”
A clinically significant exacerbation was defined as a worsening of symptoms requiring a doubling of medication for at least three days.
Children who already use the drug should be able to continue, Nice has said. Neil Churchill, Chief Executive at Asthma UK, said: “We are extremely disappointed that Nice has decided not to recommend Xolair for children under the age of 12. “This action will deny children across England with the most severe, allergic asthma, a pioneering treatment that many doctors tell us they want to prescribe and that could free these children from endless trips to hospital and huge amounts of time off school. “It is good news however, that the guidance indicates that those children who have already trialled Xolair and had their lives transformed, should not have their treatment withdrawn by their primary care trusts. “We are also urging PCTs to consider exceptional funding for the very small number of children who would derive significant benefit from Xolair.”
