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New HTA Decisions in England
March 2021
Drug name
NUCALA® (mepolizumab)
Company
GlaxoSmithKline
Decision date
18/12/2020
Therapeutic area
Respiratory conditions
Therapeutic sub area
Asthma
Decision
Recommended with restrictions
Indication
Mepolizumab, as an add-on therapy, is recommended as an option for treating severe refractory eosinophilic asthma.
Decision Detail
It is recommended only if: • it is used for adults who have agreed to and followed the optimised standard treatment plan and; • the blood eosinophil count has been recorded as 300 cells per microlitre or more and the person has had at least 4 exacerbations needing systemic corticosteroids in the previous 12 months, or has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months or; • the blood eosinophil count has been recorded as 400 cells per microlitre or more and the person has had at least 3 exacerbations needing systemic corticosteroids in the previous 12 months (so they are also eligible for either benralizumab or reslizumab). Mepolizumab is recommended only if the company provides it according to the commercial arrangement (there is a simple discount patient access scheme for mepolizumab). If mepolizumab, benralizumab or reslizumab are equally suitable, start treatment with the least expensive option (taking into account drug and administration costs). At 12 months: • stop mepolizumab if the asthma has not responded adequately or; • continue mepolizumab if the asthma has responded adequately and assess response each year. An adequate response is defined as: • a clinically meaningful reduction in the number of severe exacerbations needing systemic corticosteroids or; • a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control.
Summary
There is no evidence directly comparing mepolizumab with benralizumab and reslizumab, therefore an indirect treatment comparison (including 9 placebo-controlled studies) was presented. The committee concluded that there was sufficient evidence that mepolizumab has comparable efficacy to benralizumab and reslizumab for people with a blood eosinophil count of 400 cells per microlitre or more. The committee concluded that, at list price, mepolizumab was cost saving compared with benralizumab and reslizumab. It is now also recommended for people with a blood eosinophil count of 400 cells per microlitre or more and at least 3 severe exacerbations in the previous 12 months.