NICE, the drug price watchdog in the U.K., says it has changed its mind on Xolair, the severe asthma drug from Novartis ($NVS). It announced today that it no longer believes the National Health Service should prescribe it for adults or children.
In a statement, the National Institute for Health and Clinical Excellence said, "After considering new evidence that has become available since the original guidance was published--particularly new mortality data--the NICE draft guidance does not recommend omalizumab for either adults or children."
The agency said its reversal also was affected by new dosing recommendations that change the cost of the drug. The Pharma Letter says its cost ranges from £1,665 ($2,651) per patient per year to as high as £26,640 ($42,384).
In an email statement, the company said, "Novartis is disappointed and surprised by this draft decision and remains confident that Xolair is a cost-effective option for the treatment of severe persistent allergic asthma."
It pointed out that the decision was not final and "proposes no change to the existing negative recommendation for children aged 6-11 years (TA201). ... It said new evidence from clinical trials and 'real world' settings has been considered, which further supports the efficacy of Xolair. Despite this, the draft guidance proposes to reverse the existing recommendation." It said it will work with NICE to understand the decision.
In the U.S., Xolair is approved for children over 12 and adults but the FDA in 2009 rejected it for children under 6. Its concerns were tied to studies showing increased heart risks.