Mepolizumab for Treating Severe Refractory Eosinophilic Asthma (TA431)

Technology Appraisal Guidance No. 431

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Mepolizumab, as an add-on to optimised standard therapy, is recommended as an option for treating severe refractory eosinophilic asthma in adults, only if:

  • the blood eosinophil count is 300 cells/microlitre or more in the previous 12 months and

  • the person has agreed to and followed the optimised standard treatment plan and
    - has had 4 or more asthma 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 and

  • the company provides the drug with the discount agreed in the patient access scheme.

1.2 At 12 months of treatment:

  • stop mepolizumab if the asthma has not responded adequately or

  • continue treatment if the asthma has responded adequately and assess response each year.

An adequate response is defined as:

  • at least 50% fewer asthma exacerbations needing systemic corticosteroids in those people with 4 or more exacerbations in the previous 12 months or

  • a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control

1.3 This guidance is not intended to affect the position of patients whose treatment with mepolizumab was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email:

Mepolizumab for treating severe refractory eosinophilic asthma

Issue Date: January 2017

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