Asthma: diagnosis, monitoring and chronic asthma management NICE

Asthma: diagnosis, monitoring and chronic asthma management NICE

Asthma: diagnosis, monitoring and chronic asthma management NICE guideline NG80 Dr J Alexander Consultant Respiratory Physician UHNM Michelle Liddy Medicines Implementation consultant, London Region, NICE About you Start at the end Who is directly involved in patient care? Who involved in local formulary or decision

making groups? Who is involved in commissioning services? What do I need to do following the update? Who should I discuss this with in my team? Who else in the care of patients needs to be involved? How am I going to do this? 2

Aims and Objectives Understand the key recommendations on the diagnosis of asthma changes from current practices, and the reasons why the GDG came to the recommendations Discussion on implementing the diagnosis recommendations Understand the key

recommendations on the management of asthma key changes from current practice and the reasons why the recommendations were made Have an understanding of the economic evaluation and the implications for practice 3 Format of the session NICE asthma guideline diagnosis Q&A on implementing the diagnosis recommendations

Asthma management whats new and why Q&A on the asthma management recommendations Group work on implementing the asthma guidelines Conclusion of the session Revisit relevance and actions following the session Reference to tools and resources- local and from NICE 4 Asthma: diagnosis, monitoring and chronic asthma management NICE guideline NG80 Prescribing and medicines optimisation issues

Guidance published November 2017 The need for the guideline on asthma diagnosis www.nice.org.uk/guidance/ng80/chapter/Context There is currently no gold standard test available to diagnose asthma Studies of adults diagnosed with asthma suggest that up to 30% do not have clear evidence of asthma Conversely, other studies suggest that asthma may be underdiagnosed in some cases This guideline will improve patient outcomes and is costeffective to the NHS in the long-term; NICEs cost impact assessment projects a saving of approximately 12 million per year in England, before implementation costs 6

Contents Reminder on diagnostic tests The fractional exhaled nitric oxide (FeNO) test Recommendations Rationale for recommendations Possible implementation issues for medicines optimisation Possible issues for individual patient decision-making 7 Terms used (1) Sensitivity How good the test is at correctly identifying people who have the condition

If a test has 90% sensitivity It correctly identifies 9 in every 10 people who have the condition true positives It fails to identify 1 in every 10 people who have the condition false negatives 8 Terms used (2) Specificity How good the test is at correctly identifying people who dont have the condition If a test has 90% specificity

It correctly identifies 9 in every 10 people who dont have the condition true negatives It misidentifies 1 in every 10 people dont have the condition false positives 9 100% sensitive: no false negatives (but lots of false

positives) Percent of populatio n ve +v e ve No disease

ve +v e +v e Disease Level (arbitrary units) 100% specific: no false positives (but lots of

false negatives) Minimum number of false positives and false negatives Contents Reminder on diagnostic tests The fractional exhaled nitric oxide (FeNO) test Recommendations Rationale for recommendations Possible implementation issues for medicines optimisation

Possible issues for individual patient decision-making 12 The FeNO test (1) NICE diagnostic guidance DG12 (2014) Nitric oxide is produced in the lungs and is present in exhaled breath It acts as a vasodilator, bronchodilator, neurotransmitter and inflammatory mediator in the lungs and airways Fractional exhaled nitric oxide (FeNO) is a non-invasive marker of airway inflammation in people with asthma FeNO levels are raised in people with eosinophilic asthma, which may respond to treatment with corticosteroids Neutrophilic asthma generally does not respond to

corticosteroids 13 The FeNO test (2) NICE diagnostic guidance DG12 (2014), NICE NG80 recommendations 1.1.7, 1.3.4 2 FeNO tests are available: NIOX Vero and NObreath Be aware that the results of spirometry and FeNO tests may be affected in people who have been treated empirically with inhaled corticosteroids Be aware that a persons current smoking status can lower FeNO levels both acutely and cumulatively. However, a high level remains useful in supporting a diagnosis of asthma

14 Contents Reminder on diagnostic tests The fractional exhaled nitric oxide (FeNO) test Recommendations Rationale for recommendations Possible implementation issues for medicines optimisation Possible issues for individual patient decision-making 15 Overview of the NICE approach to diagnosis Recommendations in sections 1.1, 1.2, 1.3

1. Take a structured clinical history Do not diagnose asthma on symptoms alone, or a history of atopy alone, without an objective test (but see later for children aged <5 years) 2. Examine the person and treat them if they have acute symptoms Perform objective tests if equipment is available and testing will not compromise treatment If the tests cannot be done immediately, do them when the acute symptoms have been controlled 3. Carry out objective tests (see later for children aged <5 years) 4. Do not rule out other diagnoses if symptom control continues to remain poor after treatment 18

Algorithm A: initial clinical assessment 19 Initial clinical assessment (1) Recommendations 1.1.11.1.3 Clinical history Take a structured clinical history in people with suspected asthma. Specifically, check for: Wheeze, cough or breathlessness, and any daily or seasonal variation in these symptoms Any triggers that make symptoms worse A personal or family history of atopic disorders

Do not use symptoms alone without an objective test to diagnose asthma Do not use a history of atopic disorders alone to diagnose asthma 20 Initial clinical assessment (2) Recommendations 1.1.4 Physical examination Examine people with suspected asthma to identify expiratory polyphonic wheeze and signs of other causes of respiratory symptoms, but be aware that even if examination results are normal the person may still have asthma An expiratory polyphonic wheeze has multiple pitches and

tones heard over different areas of the lung when the person breathes out 21 Initial clinical assessment (3) Recommendations 1.1.51.1.7 Initial treatment and objective tests for acute symptoms at presentation Treat people immediately if they are acutely unwell at presentation, and perform objective tests for asthma if the equipment is available and testing will not compromise treatment of the acute episode If objective tests cannot be done immediately, carry them out when acute symptoms have been controlled

advise people to contact their healthcare professional immediately if they become unwell while waiting to have objective tests Be aware that the results of spirometry and FeNO tests may be affected in people who have been treated empirically with inhaled corticosteroids 22 Initial clinical assessment (4) Recommendations 1.1.81.1.9 Testing for asthma Do not offer the following as diagnostic tests for asthma: skin prick tests to aeroallergens serum total and specific IgE

peripheral blood eosinophil count exercise challenge (to adults aged 17 and over) Use skin prick tests to aeroallergens or specific IgE tests to identify triggers after a formal diagnosis of asthma has been made 23 Initial clinical assessment (5) Recommendations 1.1.101.1.11 Occupational asthma Check for possible occupational asthma by asking employed people with suspected new-onset asthma, or established asthma that is poorly controlled: Are symptoms better on days away from work?

Are symptoms better when on holiday? Holiday here means any longer time away from work than usual breaks at weekends or between shifts Make sure all answers are recorded for later review Refer people with suspected occupational asthma to an occupational asthma specialist 24 Diagnosing asthma in children <5 years Recommendations 1.2.11.2.2 For children under 5 with suspected asthma, treat symptoms based on observation and clinical judgement, and review the child on a regular basis. If they still have symptoms when they reach 5 years, carry out objective tests

If a child is unable to perform objective tests when they are aged 5: continue to treat based on observation and clinical judgement try doing the tests again every 612 months until satisfactory results are obtained consider referral for specialist assessment if the child repeatedly cannot perform objective tests and is not responding to treatment 25 Objective tests recommended in the guideline (1) Section 1.3 Spirometry Offer to everyone aged 5 and over

Bronchodilator reversibility (BDR) Offer to adults with obstructive spirometry and consider in children and young people with obstructive spirometry Fractional exhaled nitric oxide (FeNO) Offer to adults (people aged 17 and over) Consider for children and young people (aged 516) if there is diagnostic uncertainty: see guideline 26 Objective tests recommended in the guideline (2) Section 1.3 Peak expiratory flow variability Monitor or consider monitoring for 24 weeks in adults,

children and young people if there is diagnostic uncertainty: see guideline Direct bronchial challenge test with histamine or methacholine Offer or consider in adults if there is diagnostic uncertainty: see guideline 27 Positive test thresholds for objective tests Table 1, section 1.4 Test Population

Positive result FeNO Adults 40 ppb or more Children and young people 35 ppb or more Obstructive spirometry

Adults, children and young people Bronchodilator reversibility (BDR) test Adults FEV1/FVC ratio <70% (or below lower limit of normal if this value is available) Improvement in FEV1 of 12% and 200 ml increase in volume

Improvement in FEV1 of 12% Peak flow variability Adults, children and young people Variability >20% Direct bronchial challenge test Adults

PC20 8 mg/ml Children and young people Not applicable Children and young people 28 100% sensitive: no false

negatives (but lots of false positives) Percent of populatio n ve +v e ve

No disease ve +v e +v e Disease 100% specific: no false positives

(but lots of false negatives) Minimum number of false positives and false negatives FeNO level 40 ppb or more =positive (adults) 35 ppb or more =positive (children and young people) Diagnosis in children and young people aged 516 (1) Recommendations 1.3.141.3.17, Algorithm B

Order of tests Perform spirometry in children and young people with symptoms of asthma If a child is unable to perform objective tests treat based on observation and clinical judgement and try doing the tests again every 612 months Consider a bronchodilator reversibility (BDR) test if spirometry shows an obstruction If diagnostic uncertainty remains after spirometry and BDR, consider FeNO If diagnostic uncertainty remains after FeNO, monitor peak flow variability for 2 to 4 weeks 30

Algorithm B: children and young people 31 Diagnosis in children and young people aged 516 (2) Recommendations 1.3.15, 1.3.21, 1.3.22 Do not rule out other diagnoses if symptom control continues to remain poor after treatment. Review the diagnosis after 6 weeks by repeating any abnormal tests and reviewing symptoms If a young person or child with symptoms suggestive of

asthma cannot perform a particular test, try to perform at least 2 other objective tests. Diagnose suspected asthma based on symptoms and any positive objective test results Record the basis for a diagnosis of asthma in a single entry in the persons medical records, alongside the coded diagnostic entry 32 Diagnosis in adults (1) Recommendations 1.3.181.3.20, Algorithm C Order of tests Measure FeNO first followed by spirometry Carry out a bronchodilator reversibility (BDR) test if spirometry shows an obstruction

If diagnostic uncertainty remains after FeNO, spirometry and BDR, monitor peak flow variability for 24 weeks If diagnostic uncertainty remains after measuring peak flow variability, refer for a histamine or methacholine direct bronchial challenge test If this test is unavailable suspect asthma and review diagnosis after treatment 33 Algorithm C: adults 34 Diagnosis in adults (2)

Recommendations 1.3.19, 1.3.21, 1.3.22 Do not rule out other diagnoses if symptom control continues to remain poor after treatment. Review the diagnosis after 6 to 10 weeks by repeating spirometry and objective measures of asthma control and reviewing symptoms If an adult with symptoms suggestive of asthma cannot perform a particular test, try to perform at least 2 other objective tests. Diagnose suspected asthma based on symptoms and any positive objective test results Record the basis for a diagnosis of asthma in a single entry in the persons medical records, alongside the coded diagnostic entry 35

Diagnosis: key points Objective tests help the diagnosis in people aged >5 with clinical symptoms suggestive of asthma No single test to rule in or rule out asthma Combination of symptoms suggestive of asthma plus at least 2, usually at least 3 objective tests: i.e. a Bayesian approach Do not rule out other diagnoses if symptom control continues to remain poor after treatment 36 Using objective tests to monitor asthma Recommendations 1.14.21.14.6

Consider using a validated questionnaire (for example, the Asthma Control Questionnaire or Asthma Control Test) to monitor asthma control in adults Monitor asthma control at each review in adults, young people and children aged 5 and over using either spirometry or peak flow variability testing Do not routinely use FeNO to monitor asthma control Consider FeNO measurement as an option to support asthma management in people who are symptomatic despite using inhaled corticosteroids Do not use challenge testing to monitor asthma control 37 Contents Reminder on diagnostic tests The fractional exhaled nitric oxide (FeNO) test

Recommendations Rationale for recommendations Possible implementation issues for medicines optimisation Possible issues for individual patient decision-making 38 Diagnostic accuracy of FeNO Full guideline page 148 The sensitivity and specificity of FeNO in adults was high In children and young people, FeNO had a moderate sensitivity in 1 study and high sensitivity in the other with high specificity in both

FeNO had the best diagnostic accuracy of all the tests that can be conducted in primary care. The GC agreed that FeNO should appear in every diagnostic pathway as it would be pivotal in making a diagnosis 42 Economic considerations for FeNO Full guideline pages 148149 The recommended strategy (FeNO + spirometry BDR and, when there are conflicting results, PEFv and MCT) dominated all other strategies apart from those which performed challenge tests at more points in the pathway The ICERs of adopting these further strategies were above

20,000 per QALY gained Depends on the cost of FeNO being 93 or less For the marginal cost of FeNO to rise to 93 the machine would only be used approximately 28 times in a 5 year time span The GC noted that even for small GP practices under the most conservative assumptions of the number of new diagnoses made each year, this level of use would still be attainable 43 Practical considerations for FeNO Full guideline pages 149151 A project was conducted to assess the impact and feasibility of adopting the diagnostic tests (e.g. FeNO and spirometry) recommended, into primary care

The main barrier to implementation cited was the cost of the device and consumables rather than the practicality or accuracy of the test The project cited positive feedback for the FeNO machine with very good patient compliance All sites agreed that the device was easy to use and training was not lengthy (less than for spirometry) Moreover, fewer patients were unable to complete FeNO measurement than spirometry 44 Phased implementation (1) Full guideline pages 14 and 15 NICE is recommending objective testing with spirometry and FeNO for most people with suspected asthma; a

significant enhancement to current practice, which will take the NHS some time to implement, with additional infrastructure and training needed in primary care New models of care, being developed locally, could offer the opportunity to implement these recommendations. This may involve establishing diagnostic hubs to make testing efficient and affordable. They will be able to draw on the positive experience of NICEs primary care pilot sites, which trialled the use of FeNO 45 Phased implementation (2) Full guideline pages 14 and 15 The investment and training required to implement

the new guidance will take time. In the meantime, primary care services should implement what they can of the new guidelines, using currently available approaches to diagnosis until the infrastructure for objective testing is in place 46 Diagnostic hubs Recommendation 1.3.1 Those responsible for planning diagnostic service support to primary care (for example, clinical commissioning groups) should consider establishing asthma diagnostic hubs to achieve economies of scale and improve the practicality of implementing

the recommendations in this guideline 47 NICE Adoption support for asthma diagnosis: insights from the NHS History Guideline development paused for a feasibility project Can the diagnostic recommendations be implemented in primary care? 7 GP practices across England (May 2016 October 2016) Findings presented to GDG in early 2017 Guideline progressed to publication November 2017 Key learning gained about how to:

assess the readiness of an organisation to implement the diagnostic recommendations implement the diagnostic recommendations 49 Adoption resource aims Shares learning from the sites Aligned with the phased implementation statement in the Asthma guideline Provides practical information and advice to help Assess current practice and what needs to change to implement the recommendations Overcome barriers and implement diagnostic recommendations 50

Process Published process for developing adoption resources for NICE medical technology and diagnostics guidance Interviews with sites Engaged with primary care commissioners and service managers of diagnostic hubs Internal and external review Internal sign off and publication 51 Adoption resource content readiness for change Section 1:

Introduction and overview Section 2: Understand the guideline 52 Adoption resource content readiness for change Section 3: Assess the current context (the scale of the change required) Demand on the

service Current pathway Availability of equipment Competency in objective testing 53 Adoption resource content implementation Section 4: Implementing the recommendations and learning for future service redesign Data collection New care pathways

Device procurement Training Implementation barriers 54 Adoption resource content implementation Section 5: New models of care 55 Finding the adoption resource NICE asthma guideline landing page (NG80) Tools and resource tab https ://www.nice.org.uk/guidance/ng80/resources

56 Do not do statements in the guideline Recommendations 1.1.2, 1.1.3, 1.1.8, 1.3.15, 1.3.19 Do not use symptoms alone without an objective test to diagnose asthma Do not use a history of atopic disorders alone to diagnose asthma Do not offer the following as diagnostic tests for asthma skin prick tests to aeroallergens serum total and specific IgE peripheral blood eosinophil count exercise challenge (to adults aged 17 and over) Do not rule out other diagnoses if symptom control continues

to remain poor after treatment 57 Asthma pathway https://pathways.nice.org.uk/pathways/asthma 58 Evidence into practice Maskrey N, 2014 Research RNLI

National guidance Local implementation Care of Individual people 59 Possible implementation issues for medicines optimisation (N L) Change in practice: emphasis on objective tests differs from approach in BTS/SIGN guideline How will you convince people to change?

The diagnostic algorithms might be difficult to follow Posters should be available in the next few months Cost of the devices and consumables Diagnostic hubs? How will you ensure that those doing spirometry (and FeNO) have been suitably trained? Do they have a regular opportunity to demonstrate their competence explicitly? 60 Possible issues for individual patient decision-making (L I) Skills required to explain the process to the person Need for multiple tests

Implications of a positive or negative result from objective tests Not a yes/no tool; part of a diagnostic pathway Explanation of why this is a different process from in the past 61 Asthma diagnosis; Summary At present, asthma is both over and under diagnosed This guideline is a major change in practice, from diagnosis based primarily on symptoms to a requirement for objective tests Implementing the guideline will bring challenges Processes, training, acceptance, quality assurance, costs

This guideline will improve patient outcomes and is cost-effective to the NHS in the long-term 62 Asthma: diagnosis, monitoring and chronic asthma management NICE guideline NG80 Prescribing and medicines optimisation issues Guidance published November 2017 Aim of the guideline: chronic asthma management www.nice.org.uk/guidance/ng80/chapter/Context

The guideline covers children under 5, children and young people aged 5 to 16, and adults aged 17 and over with suspected or diagnosed asthma The sections on managing chronic asthma aim to provide clear advice for healthcare professionals and people with asthma to develop a personalised action plan The plan should support self-management of asthma, and ensure that the person is receiving the best possible treatment for their current level of illness. Guideline focuses on the pharmacological management of chronic asthma, in particular the treatment pathway for people with uncontrolled asthma. It also covers adherence to treatment, risk stratification and self-management. The guideline does not cover severe, difficult-to-control asthma or the management of acute asthma attacks 64

Changes from traditional clinical practice Sections 1.6, 1.7, 1.8 The recommendations on asthma management are for people with newly suspected or confirmed asthma, or asthma symptoms that are uncontrolled on their current treatment Where the recommendations represent a change from traditional clinical practice, people whose asthma is well controlled on their current treatment should not have their treatment changed purely to follow this guidance 65

Contents Recommendations and comparison with BTS/ SIGN for children under 5 children and young people aged 516 adults aged 17 and over with suspected or diagnosed asthma Rationale for recommendations Possible implementation issues for medicines optimisation Possible issues for individual patient decision-making 66 Offer and consider

www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/niceguidelines/making-decisions-using-nice-guidelines People have the right to be involved in discussions and make informed decisions about their care Take into account the persons needs and preferences Explain the treatment and care in a way the person understands Some recommendations are made with more certainty than others. We word our recommendations to reflect this We use 'offer' (or similar words) to reflect a strong recommendation, usually where there is clear evidence of benefit 67

Responsibilities (1) www.nice.org.uk/guidance/ng80 The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian

68 Responsibilities (2) www.nice.org.uk/guidance/ng80 Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties. Commissioners and providers have a responsibility to promote an

environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. 69 Abbreviations used in these slides ICS: inhaled corticosteroid LABA: long-acting beta2 agonist LAMA: long-acting muscarinic receptor antagonist LTRA: leukotriene receptor antagonist MART: maintenance and reliever therapy A form of combined ICS and LABA treatment in which a single inhaler, containing both ICS and a fast-acting LABA, is used for both daily maintenance therapy and the relief of symptoms as required MART is available only for ICS and LABA combinations in which the

LABA has a fast-acting component (for example, formoterol) SABA: short-acting beta2 agonist 70 Principles of pharmacological treatment (1) Recommendation 1.5.1 Take into account the possible reasons for uncontrolled asthma before starting or adjusting medicines for asthma in adults, young people and children. These may include: alternative diagnoses lack of adherence suboptimal inhaler technique smoking (active or passive)

occupational exposures psychosocial factors seasonal or environmental factors 71 Uncontrolled asthma Recommendations: terms used in this guideline Uncontrolled asthma describes asthma that has an impact on a persons lifestyle or restricts their normal activities Symptoms such as coughing, wheezing, shortness of breath and chest tightness can significantly decrease a persons quality of life and may lead to a medical emergency Questionnaires are available that can be used to quantify this

This guideline uses the following pragmatic thresholds to define uncontrolled asthma: 3 or more days a week with symptoms or 3 or more days a week with required use of a SABA or 1 or more nights a week with awakening due to asthma 72 Reminder of SIGN/BTS guidance definition of controlled asthma SIGN 153 December 2016: quick reference guide Complete control of asthma is defined as: no daytime symptoms no night-time awakening due to asthma

no need for rescue medication no asthma attacks no limitations on activity including exercise normal lung function in practical terms FEV1 and/or PEF>80% predicted or best minimal side effects from medication 73 Principles of pharmacological treatment (2) Recommendations 1.5.2 to 1.5.5 After starting or adjusting medicines for asthma, review the response to treatment in 4 to 8 weeks If ICS maintenance therapy is needed, offer regular daily

ICS rather than intermittent or when required ICS therapy Adjust the dose of ICS maintenance therapy over time, aiming for the lowest dose required for effective asthma control Ensure that a person with asthma can use their inhaler device: at any asthma review, either routine or unscheduled whenever a new type of device is supplied 74 ICS doses (1) Recommendations: terms used in this guideline ICS doses and their pharmacological strengths vary across different formulations In general, people with asthma should use the

smallest doses of ICS that provide optimal control for their asthma, to reduce the risk of side effects 75 ICS doses (2) www.nice.org.uk/guidance/ng80/resources 76 Contents Recommendations and comparison with BTS/ SIGN for children under 5 It can be difficult to confirm asthma diagnosis in young children, therefore these recommendations apply to children

with suspected or confirmed asthma Asthma diagnosis should be confirmed when the child is able to undergo objective tests children and young people aged 516 adults aged 17 and over with suspected or diagnosed asthma 77 Algorithm D: Asthma management in under 5s www.nice.org.uk/guidance/ng80/resources

78 Treatment pathway for children under 5 (1) Recommendations 1.8.1 and 1.8.2 Offer a SABA as reliever therapy to children under 5 with suspected asthma Consider an 8 week trial of a paediatric moderate dose of an ICS in children under 5 with: Symptoms at presentation that clearly indicate the need for maintenance therapy (for example, asthmarelated symptoms 3 times a week or more, or causing waking at night) or Suspected asthma that is uncontrolled with a SABA alone 79

Treatment pathway for children under 5 (2) Recommendation 1.8.3 After 8 weeks, stop ICS treatment and continue to monitor the child's symptoms: if symptoms did not resolve during the trial period, review whether an alternative diagnosis is likely if symptoms resolved then reoccurred within 4 weeks of stopping ICS treatment, restart the ICS at a paediatric low dose as first-line maintenance therapy if symptoms resolved but reoccurred beyond 4 weeks after stopping ICS treatment, repeat the 8 week trial of a paediatric moderate dose of ICS 80

Treatment pathway for children under 5 (3) Recommendations 1.8.4 and 1.8.5 If suspected asthma is uncontrolled in children under 5 on a paediatric low dose of ICS as maintenance therapy, consider an LTRA in addition to the ICS Zafirlukast is not licensed in children aged under 12 years, montelukast licensed in children aged 6 months and older If suspected asthma is uncontrolled in children under 5 on a paediatric low dose of ICS and an LTRA as maintenance therapy, stop the LTRA and refer the child to a healthcare professional with expertise in asthma for further investigation and management

81 Contents Recommendations and comparison with BTS/ SIGN for children under 5 children and young people aged 516 children and young people with newly diagnosed asthma or asthma that is uncontrolled on their current treatment where the recommendations represent a change from traditional clinical practice, children and young people whose asthma is well controlled on their current treatment should not have their treatment changed purely to follow guidance adults aged 17 and over with suspected or diagnosed asthma

82 Algorithm E: Asthma management in children and young people aged 5 to 16 www.nice.org.uk/guidance/ng80/resources 83 Treatment pathway for people aged 5 to 16 (1) Recommendations 1.7.1 to 1.7.3

Offer a SABA as reliever therapy to people aged 5 to 16 with newly diagnosed asthma For people aged 5 to 16 with asthma who have infrequent, short-lived wheeze and normal lung function, consider treatment with SABA reliever therapy alone Offer a paediatric low dose of an ICS as the first-line maintenance therapy to people aged 5 to 16 with: Symptoms at presentation that clearly indicate the need for maintenance therapy (for example, asthma-related symptoms 3 times a week or more, or causing waking at night) or Asthma that is uncontrolled with a SABA alone 84 Treatment pathway for people aged 5 to 16 (2) Recommendations 1.7.4 and 1.7.5

If asthma is uncontrolled in people aged 5 to 16 on a paediatric low dose of ICS as maintenance therapy, consider an LTRA in addition to the ICS and review the response to treatment in 4 to 8 weeks Zafirlukast is not licensed in children aged under 12 years, montelukast licensed in children aged 6 months and older If asthma is uncontrolled in people aged 5 to 16 on a paediatric low dose of ICS and an LTRA as maintenance therapy, consider stopping the LTRA and starting a LABA in combination with the ICS Not all LABAs are licensed for use in people aged under 18 years 85

Treatment pathway for people aged 5 to 16 (3) Recommendation 1.7.6 If asthma is uncontrolled in people aged 5 to 16 on a paediatric low dose of ICS and a LABA as maintenance therapy, consider changing their ICS and LABA maintenance therapy to a MART regimen with a paediatric low maintenance ICS dose MART is not licensed in children aged under 12 years Ensure that the child or young person is able to understand and comply with the MART regimen 86 Treatment pathway for people aged 5 to 16 (4)

Recommendation 1.7.7 If asthma is uncontrolled in people aged 5 to 16 on a MART regimen with a paediatric low maintenance ICS dose, consider increasing the ICS to a paediatric moderate maintenance dose Either continuing on a MART regimen or changing to a fixed-dose of an ICS and a LABA, with a SABA as a reliever therapy MART is not licensed in children aged under 12 years 87 Treatment pathway for people aged 5 to 16 (5) Recommendation 1.7.8

If asthma is uncontrolled in people aged 5 to 16 on a paediatric moderate maintenance ICS dose with LABA (either as MART or a fixed-dose regimen), consider seeking advice from a healthcare professional with expertise in asthma and consider either: Increasing the ICS dose to paediatric high maintenance dose (only as part of a fixed-dose regimen, with a SABA used as a reliever therapy) or A trial of an additional drug (for example, theophylline) 88 Contents Recommendations and comparison with BTS/ SIGN for

children under 5 children and young people aged 516 adults aged 17 and over for people with newly diagnosed asthma or asthma that is uncontrolled on their current treatment where the recommendations represent a change from traditional clinical practice, people whose asthma is well controlled on their current treatment should not have their treatment changed purely to follow this guidance 90 Algorithm F: Asthma management in adults

www.nice.org.uk/guidance/ng80/resources 91 Treatment pathway for adults aged 17 and over (1) Recommendations 1.6.1 to 1.6.3 Offer a SABA as reliever therapy to adults with newly diagnosed asthma For adults with asthma who have infrequent, short-lived wheeze and normal lung function, consider treatment with SABA reliever therapy alone Offer a low dose of an ICS as the first-line maintenance therapy to adults with: Symptoms at presentation that clearly indicate the need for

maintenance therapy (for example, asthma-related symptoms 3 times a week or more, or causing waking at night) or Asthma that is uncontrolled with a SABA alone 92 Treatment pathway for adults aged 17 and over (2) Recommendations 1.6.4 and 1.6.5 If asthma is uncontrolled in adults on a low dose of ICS as maintenance therapy, offer an LTRA in addition to the ICS and review the response to treatment in 4 to 8 weeks If asthma is uncontrolled in adults on a low dose of ICS and an LTRA as maintenance therapy, offer a LABA in combination with the ICS, and review LTRA treatment as

follows: Discuss with the person whether or not to continue LTRA treatment Take into account the degree of response to LTRA treatment 93 Treatment pathway for adults aged 17 and over (3) Recommendations 1.6.6 and 1.6.7 If asthma is uncontrolled in adults on a low dose of ICS and a LABA, with or without an LTRA, as maintenance therapy, offer to change the persons ICS and LABA maintenance therapy to a MART regimen with a low maintenance ICS dose If asthma is uncontrolled in adults on a MART regimen

with a low maintenance ICS dose, with or without an LTRA, consider increasing the ICS to a moderate maintenance dose (either continuing on a MART regimen or changing to a fixed-dose of an ICS and a LABA, with a SABA as a reliever therapy) 94 Treatment pathway for adults aged 17 and over (4) Recommendation 1.6.8 If asthma is uncontrolled in adults on a moderate maintenance ICS dose with a LABA (either as MART or a fixed-dose regimen), with or without an LTRA, consider: Increasing the ICS to a high maintenance dose (this should only be offered as part of a fixed-dose regimen, with a SABA

used as a reliever therapy) or A trial of an additional drug (for example, a LAMA or theophylline) or Seeking advice from a healthcare professional with expertise in asthma 95 Self-management (1) Recommendations 1.10.1 and 1.10.2 Offer an asthma self-management programme, comprising a written personalised action plan and education, to adults, young people and children aged 5 and over with a diagnosis of asthma (and their families or carers if appropriate)

Consider an asthma self-management programme, comprising a written personalised action plan and education, for the families or carers of children under 5 with suspected or confirmed asthma 97 Self-management (2): ICS doses Recommendations 1.11.1 and 1.11.2 Within a self management plan for people who are using an ICS in a single inhaler, when asthma control deteriorates: Offer an increased dose of ICS for 7 days to adults aged 17 and over Consider an increased dose of ICS for 7 days for people aged 5 to 16)

Clearly outline in the persons asthma action plan how and when to do this, and what to do if symptoms do not improve When increasing ICS treatment: Consider quadrupling the regular ICS dose Do not exceed the maximum licensed daily dose 98 Decreasing maintenance therapy (1) Recommendations 1.12.1 and 1.12.2 Consider decreasing maintenance therapy when a person's asthma has been controlled with their current maintenance therapy for at least 3 months Discuss with the person (or their family or carer if appropriate) the potential risks and benefits of

decreasing maintenance therapy 99 Decreasing maintenance therapy (1) Recommendations 1.12.3 to 1.12.5 When reducing maintenance therapy: Stop or reduce the dose of medicines in an order that takes into account the clinical effectiveness when introduced, side effects and the persons preference Only consider stopping ICS treatment completely for people who are using low dose ICS alone as maintenance therapy and are symptom free Agree with the person (or their family or carer if appropriate) how the effects of decreasing maintenance therapy will be

monitored and reviewed, including self-monitoring and a follow up with a healthcare professional Review and update the person's asthma action plan when decreasing maintenance therapy 100 Risk stratification Recommendation 1.13.1 Consider using risk stratification to identify people with asthma who are at increased risk of poor outcomes, and use this information to optimise their care Base risk stratification on factors such as nonadherence to asthma medicines, psychosocial problems and repeated episodes of unscheduled care

for asthma 101 Monitoring asthma control (1) Recommendation 1.14.1 Monitor asthma control at every review. If control is suboptimal: Confirm the persons adherence to prescribed treatment (see the NICE guideline on medicines adherence) Review the persons inhaler technique Review if treatment needs to be changed Ask about occupational asthma and/or other triggers, if relevant

102 Monitoring asthma control (2) Recommendations 1.14.2 to 1.14.6 Consider using a validated questionnaire to monitor asthma control in adults (aged 17 and over) For example, the Asthma Control Questionnaire or Asthma Control Test Monitor asthma control at each review in adults, young people and children aged 5 and over using either spirometry or peak flow variability testing Do not routinely use FeNO to monitor asthma control Consider FeNO measurement as an option to support asthma management in people who are symptomatic despite using inhaled corticosteroids

Do not use challenge testing to monitor asthma control 103 Monitoring asthma control (3) Recommendation 1.14.7 Observe and give advice on the persons inhaler technique: At every consultation relating to an asthma attack, in all care settings When there is deterioration in asthma control When the inhaler device is changed At every annual review If the person asks for it to be checked

104 Contents Recommendations and comparison with BTS/ SIGN for children under 5 children and young people aged 516 adults aged 17 and over with suspected or diagnosed asthma Rationale for recommendations Possible implementation issues for medicines optimisation Possible issues for individual patient decision-making 105

Contents Recommendations and comparison with BTS/ SIGN for children under 5 children and young people aged 516 adults aged 17 and over with suspected or diagnosed asthma Rationale for recommendations Why LTRA rather than LABA? Possible implementation issues for medicines optimisation Possible issues for individual patient decision-making 106

ICS low dose + LTRA versus ICS low dose + LABA: clinical evidence discussions (1) Full guideline section 7.1.1.7 People over 16 Direct comparison of the two additional preventers suggested the two had roughly equivalent effects ICS + LABA appeared to be more effective than ICS + LTRA for severe exacerbations but this did not breach the predetermined minimally important difference Based on consensus and their clinical experience the committee noted that people often either benefit considerably from LTRAs or do not respond at all The committee emphasised that if people do not appear to be gaining any benefit from LTRAs, they should be stopped 113

ICS low dose + LTRA versus ICS low dose + LABA: clinical evidence discussions (2) Full guideline section 7.1.1.7 Young people and children between the ages of 5 and 16 ICS + LTRA and ICS low dose had a clinical benefit over ICS + LABA, particularly for severe exacerbations, quality of life and hospitalisations very low quality of the evidence and small sample size Due to concerns about overmedication in this age group, the committee recommended that this age group stop their LTRA prior to starting a LABA Under 5 age group There was no evidence available in the under 5 age group

114 ICS low dose + LTRA versus ICS low dose + LABA: economic evidence Full guideline sections 7.1.1.6; 7.1.1.7 ICS + LTRA is the most cost effective treatment option for individuals with asthma at this point in the treatment pathway ICER for low dose ICS + LABA compared with ICS + LTRA = 56,977 per QALY It was noted that given the size of the asthma population the movement to LTRAs at this point in the pathway could save tens of millions each year The clinical efficacy of low dose ICS + LABA was not

sufficient to justify such a large spend 115 ICS + LABA as MART vs ICS + LABA + SABA Full guideline sections 7.1.2.1, 7.1.2.2 What is the clinical and cost effectiveness of using ICS + LABA as preventer and reliever therapy compared to using ICS + LABA as preventer and a SABA as reliever therapy? Clinical evidence: 7 studies included a population over the age of 16 1 study included a population aged 516 Economic evidence

3 health economic studies 116 MART vs ICS + LABA + SABA: clinical evidence (1) Full guideline section 7.1.2.3 People over 16 Clinical benefit in terms of: No clinical difference in terms of: Severe exacerbations

Mortality Hospitalisations Quality of life Asthma control Reliever medication use and total steroid dose FEV1 PEF Respiratory infection 117 MART vs ICS + LABA + SABA: clinical evidence (2) Full guideline section 7.2.1.3

Young people and children between the ages of 5 and 16 Clinical benefit for severe exacerbations No clinical difference for Reliever medication use FEV1 PEF 118 MART vs ICS + LABA + SABA: economic discussion Full guideline section 7.1.2.4 Overall there is strong evidence to indicate that MART is a cost effective and perhaps cost-saving therapy The clinical evidence showed that MART reduced

exacerbations and hospitalisations which will have considerable health benefits to individuals with asthma Given the clear clinical benefit and economic evidence the committee decided that MART therapy would be a cost effective option for individuals whose asthma was not controlled on a ICS + LABA as maintenance and SABA as reliever regimen 119 Asthma pathway https://pathways.nice.org.uk/pathways/asthma 120

Contents Recommendations and comparison with BTS/ SIGN for children under 5 children and young people aged 516 adults aged 17 and over with suspected or diagnosed asthma Rationale for recommendations Possible implementation issues for medicines optimisation Possible issues for individual patient decisionmaking 121 Evidence into practice Maskrey N, 2014

Research RNLI National guidance Local implementation Care of Individual people 122 Possible implementation issues for

medicines optimisation (N L) Benchmark current practice against key recommendations considering: Existing local policies and prescribing Incorporation into local asthma guidelines Do local formularies need to be updated? Frameworks for reviews (4-8 weeks) Identify and address potential challenges Multidisciplinary approach Training in changes to current practice Assessment, risk stratification, treatment options 123 Possible issues for individual patient decision-making (L I)

Skills required to explain management stages to the person and their carers Frequent reviews (4-8 weeks) Possible changes in devices Inhaler technique (multiple devices) Prescription costs Ownership of self-management plans 124 Summary NICE has updated recommendations on some aspects of asthma management to reflect clinical and economic evidence Some changes to pharmacological recommendations

Individualised approach to optimising treatment More pragmatic view of asthma control Emphasis on supported self-management 125 Implementation- over to you.. What do I need to do following the update? Who should I discuss this with in my team? Who else in the care of patients needs to be involved? How am I going to do this?

Tools and resources available from NICE Local tools and resources Links to local clinical networks Links to national networks such as NICE Associates Shared learning 126

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