Benralizumab as an add-on to standard care can be used, within its marketing authorisation, as an option to treat relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA) in adults. It can only be used if the company provides it according to the commercial arrangement.
Stop benralizumab after 52 weeks if the EGPA has not responded. Response is:
a Birmingham Vasculitis Activity Score (BVAS) score of 0, and
a reduction in oral corticosteroid use, either:
by 50% or more since starting benralizumab, or
to 7.5 mg or less per day.
This recommendation is not intended to affect treatment with benralizumab 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 healthcare professional consider it appropriate to stop.
What this means in practice
Benralizumab must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Benralizumab must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that benralizumab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Standard care for relapsing or refractory EGPA is oral corticosteroids with or without immunosuppressants.
Benralizumab plus standard care has not been directly compared in a clinical trial with standard care alone. But indirect comparisons suggest that benralizumab plus standard care increases the likelihood of remission (having fewer or no symptoms of EGPA) and reduces relapse (having worse symptoms) compared with standard care alone.
Despite uncertainties in the clinical evidence and in the economic model, the cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources.
In the economic model, people stopped having benralizumab if their condition had not responded after 52 weeks.
So, benralizumab can be used, but should be stopped after 52 weeks if the condition has not responded.