Understanding Key Changes in Asthma Diagnosis and Management from NICE Guideline NG80

Dr J Alexander Consultant Respiratory Physician UHNM
Michelle Liddy Medicines Implementation consultant, London Region, NICE
Asthma: diagnosis, monitoring and chronic
asthma management
NICE guideline NG80

About you……
• Who is directly
involved in patient
care?
• Who involved in local
formulary or decision
making groups?
• Who is involved in
commissioning
services?
2
Start at the end……
• 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?

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
3
• 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

Format of the session
• NICE asthma guideline – diagnosis
• Q&A on implementing the diagnosis recommendations
• Asthma management – what’s 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

Prescribing and medicines optimisation issues
Guidance published November 2017
Asthma: diagnosis, monitoring and
chronic asthma management
NICE guideline NG80

The need for the guideline on asthma diagnosis
• 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 cost-
effective to the NHS in the long-term; NICE’s cost impact
assessment projects a saving of approximately £12 million
per year in England, before implementation costs
www.nice.org.uk/guidance/ng80/chapter/Context
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
don’t have the condition
• If a test has 90% specificity
• It correctly identifies 9 in every 10 people who don’t have the
condition
• true negatives
• It misidentifies 1 in every 10 people don’t have the condition
• false positives
9

No disease
Percent of
population
Level (arbitrary units)
Disease
100% sensitive:
no false
negatives (but
lots of false
positives)
−ve
Minimum
number of
false positives
and false
negatives
100% specific:
no false
positives (but
lots of false
negatives)
+ve
−ve +ve
−ve +ve

Contents
• Recommendations
12

The FeNO test (1)
• 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
NICE diagnostic guidance DG12 (2014)
13

The FeNO test (2)
• 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 person’s current smoking status can lower
FeNO levels both acutely and cumulatively. However, a high
level remains useful in supporting a diagnosis of asthma
NICE diagnostic guidance DG12 (2014), NICE NG80 recommendations 1.1.7, 1.3.4
14

Contents
• Recommendations
15

Overview of the NICE approach to diagnosis
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
Recommendations in sections 1.1, 1.2, 1.3
18

19
Algorithm A: initial
clinical assessment

Initial clinical assessment (1)
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
Recommendations 1.1.1–1.1.3
20

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
Recommendations 1.1.4
21

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

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

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
• 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 6–12 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)
• 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 5–16) if there is
diagnostic uncertainty: see guideline
Section 1.3
26

Objective tests recommended in the guideline (2)
• Peak expiratory flow variability
• Monitor or consider monitoring for 2–4 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
Section 1.3
27

Positive test thresholds for objective tests
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
FEV1/FVC ratio <70% (or
below lower limit of normal if
this value is available)
Bronchodilator
reversibility
(BDR) test
Adults Improvement in FEV1 of ≥12%
≥200 ml increase in volume
Children and young people 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
Table 1, section 1.4
28

No disease
Percent of
population
FeNO level
40 ppb or more =positive (adults)
35 ppb or more =positive (children and young people)
Disease
100% sensitive:
no false
negatives (but
lots of false
positives)
−ve
Minimum
number of
false positives
and false
negatives
100% specific:
no false
positives (but
lots of false
negatives)
+ve
−ve +ve
−ve +ve

Diagnosis in children and young people aged 5–16 (1)
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
6–12 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
Recommendations 1.3.14–1.3.17, Algorithm B
30

31
Algorithm
B: children
and young
people

Diagnosis in children and young people aged 5–16
(2)
• 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
person’s medical records, alongside the coded diagnostic entry
Recommendations 1.3.15, 1.3.21, 1.3.22
32

Diagnosis in adults (1)
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 2–4 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
Recommendations 1.3.18–1.3.20, Algorithm C
33

Diagnosis in adults (2)
• 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 person’s medical records, alongside the coded
diagnostic entry
Recommendations 1.3.19, 1.3.21, 1.3.22
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
• 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
• Recommendations
38

Diagnostic accuracy of FeNO
• 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
Full guideline page 148
42

Economic considerations for FeNO
• 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
Full guideline pages 148–149
43

Practical considerations for FeNO
• 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
Full guideline pages 149–151
44

Phased implementation (1)
• 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 NICE’s primary care pilot sites, which trialled
the use of FeNO
Full guideline pages 14 and 15
45

Phased implementation (2)
• 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
Full guideline pages 14 and 15
46

Diagnostic hubs
• 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
Recommendation 1.3.1
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
• 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
Recommendations 1.1.2, 1.1.3, 1.1.8, 1.3.15, 1.3.19
57

Asthma pathway
https://pathways.nice.org.uk/pathways/asthma
58

Evidence into practice
Maskrey N, 2014
Research
National guidance
Local implementation
Care of Individual
people
RNLI
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

Aim of the guideline: chronic asthma management
• 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
www.nice.org.uk/guidance/ng80/chapter/Context
64

Changes from traditional clinical practice
• 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
Sections 1.6, 1.7, 1.8
65

Contents
• Recommendations and comparison with BTS/ SIGN for
• children under 5
• children and young people aged 5–16
• adults aged 17 and over
with suspected or diagnosed asthma
66

‘Offer’ and ‘consider’
• People have the right to be involved in discussions and
make informed decisions about their care
• Take into account the person’s 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
• We use 'consider' to reflect a recommendation for which the
evidence of benefit is less certain
www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-guidelines/making-
decisions-using-nice-guidelines
67

Responsibilities (1)
• 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
www.nice.org.uk/guidance/ng80
68

Responsibilities (2)
• 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.
www.nice.org.uk/guidance/ng80
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)
• 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
• Uncontrolled asthma describes asthma that has an impact on a
person’s lifestyle or restricts their normal activities
• Symptoms such as coughing, wheezing, shortness of breath and chest
tightness can significantly decrease a person’s 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
Recommendations: terms used in this guideline
72

Reminder of SIGN/BTS guidance
definition of controlled asthma
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
SIGN 153 December 2016: quick reference guide
73

Principles of pharmacological treatment (2)
• 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
Recommendations 1.5.2 to 1.5.5
74

ICS doses (1)
• 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
Recommendations: terms used in this guideline
75

ICS doses (2)
www.nice.org.uk/guidance/ng80/resources
76

Contents
• 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
77

Algorithm D:
Asthma
management in
under 5s
78

Treatment pathway for children under 5 (1)
• 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, asthma-related symptoms 3
times a week or more, or causing waking at night) or
• Suspected asthma that is uncontrolled with a SABA alone
Recommendations 1.8.1 and 1.8.2
79

• 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

• 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
• 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
82

Algorithm E: Asthma
management in
children and young
people aged 5 to 16
83

Treatment pathway for people aged 5 to 16 (1)
• 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:
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

• 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
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

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

• 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

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
• 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
91

Treatment pathway for adults aged 17 and over (1)
• 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:
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

• 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

• 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 person’s 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

• 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)
• 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
• 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 person’s 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)
• 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)
• 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
person’s 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
• 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 non-adherence to
asthma medicines, psychosocial problems and repeated
episodes of unscheduled care for asthma
101

Monitoring asthma control (1)
• Monitor asthma control at every review. If control is
suboptimal:
• Confirm the person’s adherence to prescribed treatment (see the
NICE guideline on medicines adherence)
• Review the person’s inhaler technique
• Review if treatment needs to be changed
• Ask about occupational asthma and/or other triggers, if relevant
102

• 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

• Observe and give advice on the person’s 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
105

Contents
• Why LTRA rather than LABA?
106

ICS low dose + LTRA versus ICS low dose + LABA:
clinical evidence discussions (1)
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 pre-
determined 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
Full guideline section 7.1.1.7
113

clinical evidence discussions (2)
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

economic evidence
• 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
Full guideline sections 7.1.1.6; 7.1.1.7
115

ICS + LABA as MART vs ICS + LABA + SABA
• 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 5–16
• Economic evidence
• 3 health economic studies
Full guideline sections 7.1.2.1, 7.1.2.2
116

MART vs ICS + LABA + SABA: clinical evidence (1)
• Clinical benefit in terms of:
• Severe exacerbations
• Hospitalisations
117
• No clinical difference in
terms of:
• Mortality
• Quality of life
• Asthma control
• Reliever medication use and
total steroid dose
• FEV1
• PEF
• Respiratory infection
People over 16

MART vs ICS + LABA + SABA: clinical evidence (2)
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
• 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
• Possible implementation issues for medicines
optimisation
121

Evidence into practice
Maskrey N, 2014
Research
National guidance
Local implementation
Care of Individual
people
RNLI
122

123
• 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
Possible implementation issues for medicines
optimisation (N  L)

Possible issues for individual patient decision-
making (L  I)
124
• 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

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?
126
• 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

Understanding Key Changes in Asthma Diagnosis and Management from NICE Guideline NG80

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