Omalizumab had been approved by NICE to treat severe, persistent allergic asthma in adults in 2007, although it was rejected for use in children.
But now NICE has withdrawn its recommendation in updated draft guidance, saying the drug is 'not as clinically or cost-effective as was first thought'.
Charity Asthma UK called the decision 'surprising and disappointing'.
Severe persistent allergic asthma affects over 14,000 people in the UK. Omalizumab, branded as Xolair and administered by injection, is prescribed by specialists when standard treatments such as high-dose corticosteroids or long-acting beta-2 agonists have failed to control symptoms. It has been shown to cut hospital admissions by 61%.But a new analysis published today in draft form does not recommend omalizumab for use by the NHS. It again rejected its use in children.
Although treatments can still be prescribed without NICE approval, commissioners have often clamped down on this activity in the past.
Leicestershire GP and Primary Care Respiratory Society member Dr Dermot Ryan said the decision was a 'retrograde step'. 'For those people who respond, it has been absolutely life-transforming, stopping them from ending up in hospital and allowing them to go back to work,' he said.
He criticised NICE for focusing more on budgets than patient care. 'I think there's more to medicine than just the sums involved. It's very clear there are a small number of people who benefit from this medication. More expensive treatments with less defined benefits seem to be approved. This decision can only move to undermine NICE's credibility with the health profession.'
Asthma UK chief executive Neil Churchill said: 'There is no doubt that without it, more people with asthma will suffer frequent life-threatening asthma attacks and disabling daily symptoms. We find it hard to understand why NICE wants to change its previous recommendation when there is no major new evidence to suggest that it is any less effective than was previously thought.'
The drug costs around £8,000 per patient per year. Around 2,000 people are thought to be taking omalizumab, while a further 2,000 could benefit from the drug.
The treatment is available in Scotland as it was approved for restricted use by the Scottish Medicines Consortium in June 2011.
Sir Andrew Dillon, NICE chief executive, said the committee behind the guidance 'is aware that severe, persistent allergic asthma can have a detrimental effect on a person’s life' and that omalizumab is an effective treatment. '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,' he said.
NICE will now run a consultation on the guidance and make a final decision in April.