1 Recommendations
1.1
Dupilumab as add-on maintenance therapy is recommended as an option for treating severe asthma with type 2 inflammation that is inadequately controlled in people 12 years and over, despite maintenance therapy with high-dose inhaled corticosteroids and another maintenance treatment, only if:
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the dosage used is 400 mg initially and then 200 mg subcutaneously every other week
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the person has agreed to and follows an optimised standard treatment plan
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the person has a blood eosinophil count of 150 cells per microlitre or more and fractional exhaled nitric oxide of 25 parts per billion or more, and has had at least 4 or more exacerbations in the previous 12 months
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the person is not eligible for mepolizumab, reslizumab or benralizumab, or has asthma that has not responded adequately to these biological therapies
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the company provides dupilumab according to the commercial arrangement.
1.2
Stop dupilumab if the rate of severe asthma exacerbations has not been reduced by at least a 50% after 12 months.
1.3
These recommendations are not intended to affect treatment with dupilumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For young people, this decision should be made jointly by them, their clinician, and their parents or carers.
Why the committee made these recommendations
Severe asthma is usually treated with inhaled corticosteroids plus another drug, such as a long-acting beta-agonist. Oral corticosteroids may also be needed to prevent exacerbations (asthma attacks), but they can cause long-term adverse effects. Also, these treatments may not work well enough for severe asthma with type 2 inflammation, which can be difficult to control.
Clinical trial results show that adding dupilumab to standard asthma treatment is more effective than placebo plus standard treatment at reducing the frequency of severe exacerbations, and the use of oral corticosteroids in people with severe asthma with type 2 inflammation.
The company proposes dupilumab 200 mg for very severe asthma with type 2 inflammation in people not eligible for mepolizumab, reslizumab or benralizumab, or whose asthma has not adequately responded to these biological treatments. This is a narrower population than that in the marketing authorisation. It represents people with the highest unmet need and people only eligible for standard care. Dupilumab could be a valuable treatment option in these people because, without it, they will need regular oral corticosteroids.
The cost-effectiveness estimates for dupilumab plus standard care are at the higher end of what NICE usually considers an acceptable use of NHS resources. But there is an unmet need for people with very severe asthma with type 2 inflammation and dupilumab represents an additional treatment option before oral corticosteroids. Also, the benefits associated with avoiding oral corticosteroids to people with this type of asthma and to the NHS may not have been fully captured in the cost-effectiveness estimates. So, dupilumab (200 mg) is recommended for treating inadequately controlled very severe asthma with type 2 inflammation.