The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of Novartis’ asthma injection Xolair as an add-on therapy on the NHS in England and Wales.
The final guidance means Xolair (omalizumab) is now an option for treating severe, persistent allergic asthma in adults, adolescents and children and brings together previous recommendations across different age groups.
The condition, which is characterised by breathlessness, wheezing and coughing, particularly at night, affects around 5.2 million people in the UK, more than a million of whom are children.
The key to the latest decision is a confidential patient access scheme which Novartis agreed with NICE after the watchdog said last year that it was going to stop recommending the drug in adults.
Xolair is given every two or four weeks (with a maximum dosage of 600 mg every two weeks), with dose determined by a patient’s body weight and IgE level.
It costs £256.15 for a 150-mg vial and £128.07 for a 75-mg vial before VAT, with costs per patient – again, before VAT – ranging from approximately £1,665 per year for a 75-mg dose administered every four weeks to around £26,640 per year should the maximum recommended dose be required.
NICE said Novartis’ patient access scheme “makes the treatment more cost-effective” and that the most plausible ICER is £23,200 per QALY when this is taken into account.
Sixteen weeks after the start of treatment with Xolair, doctors should assess how effective it is, and continue “only in patients whose asthma has markedly improved”, the guidance concludes.
The new guidance means Xolair can be used for severe, persistent confirmed allergic immunoglobulin E (IgE)-mediated asthma – the most common type – as an add-on to optimised standard therapy for those people who need four or more courses of oral corticosteroids.
Xolair works by blocking IgE antibodies from attaching to allergens, thus preventing the process that leads to an allergic reaction causing symptoms in the nose, lungs or throat, or on the skin.
Standard therapy also includes high-dose inhaled anti-inflammatory corticosteroids and long-acting beta-2 agonists – which relax the muscles lining the airways that carry air to the lungs, allowing them to stay open longer and making breathing easier.