NICE has approved monoclonal antibody treatment dupilumab for patients with severe asthma that is not properly controlled by standard therapy.
In a final appraisal document, NICE said dupilumab should be used as an add-on therapy in patients with severe asthma with type 2 inflammation that is not controlled with high-dose inhaled corticosteroids and other maintenance treatment.
But asthma charities warned that in order for patients to access the potential game-changing treatment, clearer guidance was needed on when to refer patients to specialist services.
To qualify for treatment patients must meet several criteria including a blood eosinophil count of 150 cells per microlitre or more and fractional exhaled nitric oxide of 25 parts per billion or more as well as having at least four or more exacerbations in the previous year.
Patients must also have already tried biological therapy if they are eligible for it.
The NHS has agreed a discount with the makers of dupliumab – which has a list price of £1,264 for two prefilled syringes – under the patient access scheme. Treatment should be stopped if the rate of severe exacerbations has not reduced by at least 50% after 12 months, NICE said.
The eligibility criteria is more stringent than the marketing authorisation for the drug, NICE added, but ‘represents people with the highest unmet need’. The decision does not impact those who were already prescribed the treatment.
Asthma UK and the British Lung Foundation said dupilumab had the potential to transform the lives of people with severe asthma but only if they could access it.
It is estimated there are around 200,000 people in the UK with asthma who don’t respond to standard treatment and have regular asthma attacks which may end up with a hospital admission.
But they estimate three in four of those who are potentially eligible for biologic treatments are not yet able to access them.
They want NICE to develop new guidelines so healthcare professionals are confident on when to refer patients with to specialist services.
Scotland approved dupilumab in April 2021 but it has taken years for NICE to reach a decision, the charities added because of initial concerns over cost-effectiveness.
Dr Samantha Walker, director of research and innovation at Asthma UK and the British Lung Foundation, said: ’Today’s news could be a real game-changer for the thousands of people with severe asthma across England, Wales and Northern Ireland who live in constant fear of a life-threatening asthma attack happening at any time.
‘Asthma UK and the British Lung Foundation is calling for NICE to develop new, clear guidelines so healthcare professionals are confident about when to refer patients with possible severe asthma to get the specialist care they so desperately need.’