Benralizumab for treating relapsing or refractory eosinophilic granulomatosis with polyangiitis

Recommendations

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:

Eligible population for benralizumab

Prevalence, incidence and healthcare burden of eosinophilic granulomatosis with polyangiitis in the UK estimates that the prevalence of people with EGPA is 56.8 per 1 million.

A professor of clinical autoimmunity has estimated that 50% of people with EGPA have relapsing or refractory EGPA and do not take a biologic for severe asthma.

Note: The numbers in table 1 for market share include people who have had benralizumab and have discontinued and now have best supportive care.

The market share for benralizumab is based on respiratory consultant opinion. It can be amended to reflect local practice in the resource impact template.

Treatment options for the eligible population

There are no approved medicines specifically for EGPA in the UK. The main treatment is oral corticosteroids, which are associated with severe side effects including diabetes, cardiovascular disease, osteoporosis, eye problems, peptic ulcers, pneumonia and renal impairment. Immunosuppressants can be added if necessary for relapsing or refractory EGPA.

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.

Immunosuppressant use is expected to be the same for people having benralizumab plus standard care as for people having standard care alone. Oral corticosteroid (prednisolone) use is expected to reduce for people having benralizumab plus standard care compared with standard care alone. The cost of prednisolone is very low, and it is administered orally. So, the cost of standard care is not included in either treatment arm because it has minimal impact.

People who also have severe eosinophilic asthma can have benralizumab (see NICE's technology appraisal guidance on benralizumab for treating severe eosinophilic asthma) or mepolizumab (see NICE's technology appraisal guidance on mepolizumab for treating severe eosinophilic asthma).

For more information about the treatments, such as dose and average treatment duration, see the resource impact template.

Financial resource impact (cash items)

The company has a commercial arrangement (commercial access agreement). This makes benralizumab available to the NHS with a discount. The size of the discount is commercial in confidence.

Users can input the confidential price of benralizumab, and amend other variables, in the resource impact template.

The payment mechanism for the technology is determined by the responsible commissioner and depends on the technology being classified as high cost.

For further analysis or to calculate the financial impact of cash items, see the resource impact template.

Capacity impact

Treatment with benralizumab may result in fewer appointments with specialists and GPs compared with standard care. The reduction in oral corticosteroid use seen with benralizumab may result in fewer adverse events.

Benralizumab-related adverse events were not included because of the low incidence of serious adverse events observed in the MANDARA trial.

Users can input the number of GP and specialist appointments in the resource impact template to model the capacity impact.

Costs for standard care are not included in the model because they are used in both treatment arms. The use of these drugs in combination with benralizumab may reduce but the cost impact is minimal so for simplicity they have not been included.

For further analysis, or to calculate the financial capacity impact from a commissioner (national) and provider (local) perspective, see the resource impact template.

Key information

About this resource impact summary report

This resource impact summary report accompanies the NICE guidance on benralizumab for treating relapsing or refractory eosinophilic granulomatosis with polyangiitis and should be read with it.

ISBN: 978-1-4731-7207-4