NICE has recommended biological medicine tezepelumab (Tezspire) as an add-on treatment for people with severe uncontrolled asthma.
Final draft recommendations say the monthly injectable treatment is now an option where high-dose inhaled corticosteroids plus another maintenance treatment has not worked well enough.
Adults and those over the age of 12 years in this group can be prescribed tezepelumab only if they have had three or more 3 or more exacerbations in the previous year or are having maintenance oral corticosteroids, NICE said.
The drug, which is given by injector pen every four weeks should be stopped after a year if the rate of severe asthma exacerbations, or the maintenance oral corticosteroid dose, have not been reduced by at least 50%.
AstraZeneca, who developed tezepelumab, has estimated that just 98,000 people in England and Wales could potentially be eligible to receive add on maintenance therapy with tezepelumab.
It has also been calculated that patients with severe uncontrolled asthma, who can have repeated hospitalisations and poor quality of life, account for approximately 50% of NHS asthma-related costs
The company has agreed to provide tezepelumab to the NHS at a commercially confidential discount but the list price is £1,265 per 210 mg prefilled syringe, NICE said.
In reviewing the evidence, NICE said while current biological treatments have been life-changing for some people, not everyone with severe asthma can access them because they come with specific eligibility criteria, such as blood eosinophil count and FeNO levels.
A treatment that comes without the need for biomarker assessment in patients with severe asthma would be welcome, the committee added.
Tezepelumab is effective for different asthma phenotypes whether they are eligible for existing treatments or not, the committee heard.
The decision is based on evidence from the Navigator phase 3 clinical trial which showed tezepelumab improved outcomes including significantly reducing the annualised rate of exacerbations compared with placebo.
Professor David Jackson, professor of respiratory medicine and clinical lead for Guy’s & St Thomas’ Asthma Service, said the decision by NICE was excellent news for patients.
‘Many with severe uncontrolled asthma have multiple inflammatory drivers of disease and tezepelumab’s unique mechanism of action means it has the potential to treat a broad population of patients, irrespective of inflammatory phenotype.’
Any appeal against the final draft guidance must be submitted by 11 April.
