Award Title: Tezepelumab for treating severe asthma [ID3910]
Funder: Department of Health and Social Care

Abstract: Asthma is a chronic inflammatory disease associated with variable airflow obstruction and airway hyperresponsiveness. It is characterised by exacerbations associated with symptoms such as breathlessness, chest tightness, wheezing, sputum production and cough. Asthma is classified as severe when it does not improve with standard therapy. [1]  Eosinophils are thought to play a major role in airway inflammation in asthma. Asthma can also have an allergic component, resulting in over-production of human immunoglobulin E (IgE)._x000D_
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People with severe asthma often have a severely impaired quality of life which can lead to fatigue, absence from school or work and psychological problems including stress, anxiety and depression. There were 1,484 deaths from asthma in the UK in 2017. [2] Around 4.8 million people in England and Wales currently have treatment for asthma. [2]_x000D_
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NICE guideline [NG80] on asthma: diagnosis, monitoring and chronic asthma management, and guidelines from the Global Initiative for Asthma (GINA)[3] recommend a stepwise approach for treating asthma. Control is maintained by stepping up treatment as necessary using combinations of inhaled corticosteroids (ICS), leukotriene receptor antagonists (LTRAs) and long-acting beta-2 agonists (LABAs), and stepping down when control is good. People whose asthma is inadequately controlled by medium-dose ICS plus a LABA with or without an LTRA should be stepped up to have high-dose ICS or offered a trial of an additional drug (for example, a long-acting muscarinic receptor agonist or theophylline)._x000D_
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NICE TA278 recommends omalizumab for treating severe persistent confirmed allergic IgE-mediated asthma as an add-on to optimised standard therapy in people aged 6 and older who need continuous or frequent treatment with oral corticosteroids (4 or more courses in the previous year). Optimised standard therapy is defined as a full trial of and, if tolerated, documented compliance with high-dose ICS, LABAs, LTRAs, theophyllines, oral corticosteroids, and smoking cessation if clinically appropriate._x000D_
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NICE TA479 recommends reslizumab as an add-on for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose ICS plus another drug, only if the blood eosinophil count has been recorded as 400 cells per microlitre or more with 3 or more severe asthma exacerbations needing systemic corticosteroids in the past 12 months. _x000D_
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NICE TA565 and NICE TA671 recommend benralizumab and mepolizumab in adults as add-ons for treating severe refractory eosinophilic asthma, only if:_x000D_
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• the blood eosinophil count has been recorded as 300 cells per microlitre or more with 4 or more exacerbations needing systemic corticosteroids in the previous 12 months, or the person has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months, or _x000D_
• the blood eosinophil count has been recorded as 400 cells per microlitre or more with 3 or more exacerbations needing systemic corticosteroids in the past 12 months._x000D_
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References_x000D_
1. Asthma UK. What is severe asthma? Accessed February 2021_x000D_
2. Asthma UK. Asthma facts and statistics. Accessed February 2021_x000D_
3. Global Initiative for Asthma (2019) Global strategy for asthma management and prevention. Accessed February 2021

Lay Abstract: To appraise the clinical and cost effectiveness of tezepelumab within its marketing authorisation for treating severe asthma.

Research Activity Codes: 6.1 PHARMACEUTICALS
Health Categories: RESPIRATORY