from NICE 3 - Centre for Medicines Optimisation

Actions for Commissioning Teams
Management of COPD
within primary care
June 2012
Actions for Commissioning Teams
Why are we looking at this?
COPD exacerbations: 2nd most common cause of emergency
admission and one of the most costly inpatient conditions to
be treated by the NHS.1
o In the West Midlands:
• 94,000 patients diagnosed with COPD (1.6% of population)
• In last year, 31,795 emergency COPD admissions (~4% of all emergency
• 3-fold variation in emergency admission rates across West Mids CCGs
• Annual prescribing spend on respiratory drugs: £106m (11% of total spend)
Major cause of mortality:
o DH estimates 23 000 deaths per year in UK attributable to COPD1
o Premature mortality almost double that of EU average2
The missing millions?
o Thought to be significant level of underdiagnosis1
o Early diagnosis and optimising interventions in primary care may improve
outcomes and reduce costly admissions
DH ‘Outcomes Strategy for COPD & asthma’ published in 20112
o Focus on earlier, accurate diagnosis, optimising phamacotherapy, and
prolonging survival through appropriate interventions
o Optimising the management of COPD should also feature heavily in CCGs
Long-term Conditions Strategy
Actions for Commissioning Teams
What are we covering?
The following slides provide selected information on:
• Diagnosis
o Recommendations from NICE/spirometry/MRC dyspnoea scale
Smoking Cessation
Pharmacological management of stable COPD
o Recommendations from NICE on inhaled and oral therapies
o Update on safety advice for tiotropium
o Selected points regarding the evidence for inhaled therapies
Management of exacerbations
o Management in primary care and when to admit to hospital
NICE recommendations on patient review and selfmanagement
Prescribing home oxygen
Actions for Commissioning Teams
Diagnosis: key points from NICE3
Consider a diagnosis of COPD for people who are over 35, and
smokers or ex-smokers*, and have any of these symptoms:
exertional breathlessness
chronic cough
regular sputum production
frequent winter ‘bronchitis’
and do not have clinical features of asthma:
o chronic unproductive cough, variable breathlessness, night-time
Ask about presence of other features:
o Weight loss, effort intolerance, waking at night, ankle swelling,
fatigue, occupational hazard, chest pain, haemoptysis (note: the
last two are uncommon in COPD and raise the possibility of alternative
* although bear in mind a significant proportion of patients with COPD may have never
smoked (~28% in a recent population study).4
Actions for Commissioning Teams
Diagnosis: Spirometry
If COPD seems likely, NICE recommend performing spirometry:
o Post-bronchodilator spirometry recommended for COPD
• e.g. 15 mins after 400 mcg salbutamol; pMDI + spacer is suitable5
o Working definition of COPD:
• Airflow obstruction defined as FEV1/FVC ratio < 0.7
• If FEV1 ≥ 80% predicted, a diagnosis of COPD should only be made in the
presence of respiratory symptoms (breathlessness or cough)
o Post-bronchodilator spirometry also used to grade severity of
obstruction and can help guide choice of appropriate inhaled
• Stage 1 - mild: FEV1 ≥ 80% predicted (symptoms also should be present to
diagnose COPD in people with mild airflow obstruction).
• Stage 2 - moderate: FEV1 50-79%.
• Stage 3 - severe: FEV1 30-49%
• Stage 4 - very severe: FEV1 < 30% (or FEV1 < 50% but with respiratory
o To help early identification, NICE also recommend spirometry in
patients > 35 yrs, current or ex-smokers, with chronic cough.
Also, consider screening patients with chronic bronchitis.
Actions for Commissioning Teams
Some points to consider in relation to spirometry…
o Have operators received adequate training in spirometry?
o Are operators confident to coach spirometry technique to patients
and interpret readings?
o Are spirometers maintained and adequately calibrated?
o Bear in mind that the European Respiratory Society 1993
reference values recommended by NICE may lead to underdiagnosis in older people and are not applicable in black and
Asian populations.3
• BTS COPD consortium guide ‘Spirometry in Practice’ recommends
reducing predicted values by 7% for Asians and by 13% for AfroCaribbeans and also includes calculations for elderly patients6
Actions for Commissioning Teams
COPD or asthma or both?
Resolving the two conditions can be problematic, particularly
in older patients. Conditions may co-exist (~ 20% of patients7)
Findings that can help identify asthma (from NICE3):
o On reversibility testing, there is a large (>400 ml) response to
o A large (>400 ml) response to 2 weeks, 30 mg/day oral
o Serial peak flow measurements showing 20% or greater
diurnal/day-to-day variability
Clinically significant COPD is not present if FEV1 and FEV1/FVC
ration return to normal with drug treatment3
Reconsider diagnosis of COPD if a patient reports a marked
response to inhaled therapies3
Actions for Commissioning Teams
Diagnosis: other tests3
As part of initial diagnosis, NICE also recommends:
o chest X-ray to exclude other diagnoses (investigate abnormalities
using a CT scan)
o full blood count to identify anaemia or polycythaemia
o BMI calculation
Also consider screening for alpha-1 antitrypsin deficiency
o Associated with 1-2% of cases; consider screening in younger
patients, minimal smoking, or family history
Additional investigations may be needed in some
circumstances, e.g.
o Serial peak flow to help exclude asthma
o transfer factor for carbon monoxide (TLCO) or CT scan, to
investigate symptoms that seem disproportionate to the
spirometric impairment
o ECG/echocardiogram if features of cor pulmonale;
o pulse oximetry to assess need for oxygen
o sputum culture if purulence persistent
Actions for Commissioning Teams
Grading dyspnoea
NICE recommend use of MRC dyspnoea scale3,8
Can help identify patients who may benefit from pulmonary
rehabilitation (PR)
NICE recommend that PR should be made available to all
patients who consider themselves functionally disabled
(usually MRC 3 and over), including those who have had a
recent hospitalisation for an acute exacerbation.
Actions for Commissioning Teams
Smoking cessation
All COPD patients still smoking, regardless of
age, should be encouraged to stop, and offered
help to do so, at every opportunity.3
Smoking cessation has been shown to slow the deterioration in
lung function in patients with COPD
o Compared with continuation of smoking, rate of decline was
approximately halved in participants with mild-to-moderate COPD
in one major prospective RCT who quit smoking9)
Nicotine replacement, varenicline or bupropion may be offered,
unless contraindicated, combined with appropriate support3
Actions for Commissioning Teams
Management of stable COPD3
Routinely check a patient’s inhaler technique. Try to identify
reasons for non-compliance with inhaled treatments.
Actions for Commissioning Teams
Evidence: Risks/benefits of ICS
High-dose ICS with LABA widely used in COPD, but are the
benefits of the ICS component over-estimated?
o Findings from TORCH:10
• 3-year RCT (n= 6,112) comparing LABA/ICS (salmeterol/fluticasone) with
placebo, LABA (salmeterol) alone or ICS (fluticasone) alone
• No significant reduction in mortality with LABA/ICS compared with placebo
• LABA/ICS significantly reduced annual rate of exacerbations compared with
LABA alone, but not severe exacerbations requiring hospitalisation
• Pneumonia more frequent with LABA/ICS and ICS groups compared with
LABA or placebo (19% vs. 13%); NNH = 17
o Findings from 2010 Cochrane review - LABA/ICS vs LABA11
• Compared with LABA alone, LABA/ICS significantly reduced exacerbation
rate (18%); also greater improvements in QOL and FEV1.
• No significant difference in mortality or hospitalisation rates
• Pneumonia occurred more commonly with LABA/ICS: 58% increase
BOTTOM LINE: Benefits of ICS need to be viewed against
increased risk of side-effects, particularly pneumonia.
Actions for Commissioning Teams
Tiotropium or LABA(/ICS)?
For patients experiencing exacerbations or persistent
breathlessness (despite use of SABA) there is a choice:
o Either a LAMA (currently tiotropium) or a LABA (+ICS if FEV1 is
<50% predicted)
Regarding the evidence:
o NICE Guideline Development Group: concluded no strong
evidence to favour LABA over LAMA12
o 2010 Cochrane review: uncertainties in relative benefits of
LABA/ICS vs. tiotropium due to shortcomings in trials13
o POET-COPD RCT (2011):14 tiotropium reduced risk of
moderate/severe exacerbations compared with salmeterol, but
use of ICS in study complicates application in context of NICE
o 2012 systematic review: Compared with tiotropium monotherapy,
LABA/ICS associated with some improvements in FEV1, QOL and
dyspnoea, but no difference in exacerbations, and higher risk of
SAEs and pneumonia15
BOTTOM LINE: No strong recommendations to guide choice, but
consider suitability of device, tolerability, and adverse effects on ICS.
Actions for Commissioning Teams
Evidence for triple therapy
Triple therapy (LABA/ICS plus LAMA):
o A new option recommended by NICE for patents with persistent
breathlessness or persistent exacerbations irrespective of FEV1
o Strength of evidence to support approach has been questioned
o Based on most recent systematic review (2012):15
• compared with tiotropium alone, triple therapy associated with clinically
significant improvements in lung function and QOL
• but non-statistically significant reduction in exacerbations (OR 0.57; 95%
CI: 0.24 to 1.37, p = 0.21).
• authors concluded that the data “are still scarce and studies too short to
generate a strong recommendation”.
o Also, Cochrane systematic review (2011):16
• studies inadequate for authors to draw firm conclusions about benefits of
triple therapy on mortality, hospitalisation and pneumonia compared with
tiotropium or LABA/ICS alone
• Small benefits seen in terms of effects on QOL and lung function tests
BOTTOM LINE: Triple therapy is a costly treatment option if used
inappropriately, and there is uncertainty over long-term benefits
Actions for Commissioning Teams
Recent safety advice for tiotropium
MHRA (2010): discrepancies in safety findings for tiotropium
Spiriva Handihaler and Respimat devices reported:17
o Numerical excess in mortality, which was statistically significant
in patients with known cardiac disorders, found in trials of
o Excess risk not apparent with Handihaler (e.g. 4-yr UPLIFT study
tiotropium via Handihaler associated with lower mortality
compared with placebo)
BMJ meta-analysis (2011):18
o 46% excess risk of all-cause mortality with 5 mcg tiotropium via
Resipimat®▼ vs placebo (absolute difference = 0.8%; NNH = 124
(95%CI: 52 to 5682)
Current advice from MHRA:17
o Spiriva Respimat▼ should be used with caution in patients with known
cardiac rhythm disorders
o Remind patients on tiotropium not to exceed the recommended doses
o If switch to Handihaler® is being considered, provide training in inhaler
technique for the dry power formulation
Actions for Commissioning Teams
NICE guidance: oral therapies for
stable COPD3
Oral corticosteroids:
o Use as regular maintenance therapy not normally recommended.
o ..but some patients may require on-going treatment when use
cannot be withdrawn following an exacerbation, in which case…
• Keep dose as low as possible
• Monitor for osteoporosis and prescribe appropriate prophylaxis
• Patients aged over 65 should receive prophylaxis without monitoring.
Oral theophylline:
o Reserved for use after trial of bronchodilators, or if unable to use
inhaled therapy.
o May be combined with either an inhaled beta2-agonist or
antimuscarinic; narrow therapeutic window
Oral mucolytics:
o May be considered for patients with chronic productive cough
o Perform trial - continue only if symptomatic improvement.
o Do not prescribe routinely for exacerbations in stable COPD
Anti-tussive therapy and prophylactic antibiotics are not
recommended for stable COPD
Actions for Commissioning Teams
Managing exacerbations - treat at
home or admit to hospital? 3
Consider the following factors, as recommended by NICE
Actions for Commissioning Teams
Treating exacerbations in primary
Increase use of SABAs
Unless contraindicated, prescribe oral corticosteroids if
significant increase in breathlessness, which is interfering with
daily activities
o Prescribe prednisolone 30 mg daily for 7 to 14 days (no advantage
Prescribe antibiotics if more purulent sputum
o Patients without more purulent sputum do not need antibiotics
in >14 days)
Consider prophylaxis for osteoporosis in patients requiring
frequent course
unless consolidation on chest X-ray or clinical signs of pneumonia
Sputum culture not recommended in routine practice
recommended by NICE
Measure oxygen saturation – if SaO2 < 90% treat in hospital
Actions for Commissioning Teams
Patient review and self-management
Patient review
o Frequency of review:
• At least annual review in patients at Stages 1 to 3
• At least twice yearly in Stage 4 patients
o Record FEV1 and FVC, BMI and MRC score at review (SaO2 also
recommended for Stage 4 patients)
o Clinical assessment should include:
smoking status, desire to quit
treatment review, inhaler technique
need for additional assistance (e.g pulmonary rehabilitation; O2)
also nutritional state & presence of depression in Stage 4 patients
Self-management of exacerbations
o NICE advocates that patients at risk of an exacerbation should be
given a course of antibiotic and corticosteroid tablets to keep at
Actions for Commissioning Teams
COPD patients should receive annual flu vaccine3
Pneumococcal vaccination (one-off) also required for patients
with COPD:3
o Re-vaccination not recommended but individuals who have
previously received 12- or 14-valent PPV or 7-valent PCV should
be immunised with 23-valent PPV to gain protection from
additional serotypes. 20
Actions for Commissioning Teams
Supplying oxygen – when to refer
Home oxygen supply:
o significant variation seen in spend across PCTs
o Home O2 has been a focus for improvement, e.g. referral of
patients to HOS-ARs to assess the initial and on-going needs
NICE recommend to refer for O2 assessment:3
o Where airflow obstruction is very severe (FEV1 < 30% predicted)
o in patients with cyanosis, polycythaemia, peripheral oedema, or
raised jugular venous pressure
o If oxygen sats ≤ 92% breathing air
o Also, consider referring for assessment if FEV1 30-49% predicted
Advise patients that O2 should be used for 15 hours per day –
greater benefits seen for 20 hours per day
Patients on O2 should be reviewed at least once per year by
practitioners familiar with long-term O2
Actions for Commissioning Teams
Supplying oxygen - changes
Changes to the Home Oxygen Service are underway
Home Oxygen Order Form (HOOF) has been separated into
o HOOF A – designed to be completed by a healthcare
• Non specialists
• For temporary orders (static supply only)
• Can be used to discharge from hospital
• To be completed ONLY by specialist/commissioned HOS assessment and
review service
• For static and ambulatory supply
Actions for Commissioning Teams
Supplying Oxygen – commissioning
Commissioners will need to assess what services are provided
for patients currently needing oxygen and who will require
oxygen assessment.
A small poll of commissioners in the West Midlands has
o Most provide oxygen assessment and review services for patients
with COPD
o Most provide pulmonary rehabilitation services for patients with
o Few (only 1 from the sample of 9 PCTs that responded) provide
services for patients with:
Heart failure
Paediatric assessment
Palliative care
Neurological conditions
Actions for Commissioning Teams
Summary – final key points
Diagnose earlier and accurately:
o Based on clinical signs and quality-assured spirometry
In relation to management/prevention of exacerbations:
Offer smoking cessation at every opportunity
Follow NICE sequential approach to pharmacotherapy
Check inhaler technique routinely; address non-compliance
Exacerbations: treat promptly; offer self-management advice
Review patients regularly
Offer vaccinations
Refer to pulmonary rehabilitation patients with MRC 3 or higher
Long-term oxygen therapy: consider patient’s on-going
Actions for Commissioning Teams
A final point to consider…(reproduced from the NHS
Companion Document on the Outcomes Strategy for COPD1)
Actions for Commissioning Teams
An Outcomes Strategy for COPD and Asthma: NHS Companion Document. 2012. Department of
2. Outcomes Strategy for COPD and asthma. Department of Health. 2011.
3. Chronic obstructive pulmonary disease (updated). Clinical guideline CG101: June. National Institute
for Health and Clinical Excellence. 2010.
4. Lamprecht et al. COPD in never smokers: results from the population-based burden of obstructive
lung disease study. Chest 2011;139:752-63.
5. Global Strategy for Diagnosis, Management, and Prevention of COPD (2011 update). Global
Initiative for Chronic Obstructive Lung Disease. 2011.
6. Spirometry in Practice. BTS COPD Consortium.
7. Zeki et al. The Asthma-COPD Overlap Syndrome: A Common Clinical Problem in the Elderly. J.
Allergy 2011: doi: 10.1155/2011/861926
8. Fletcher CM et al. The significance of respiratory symptoms and the diagnosis of chronic bronchitis
in a working population. BMJ 1959; 2:257-66
9. Scanlon et al. Smoking cessation and lung-function in mild-to-moderate COPD. Am J Respir Crit
Care Med 2000; 161 (2):381-90
10. Calverley et al. Salmeterol and fluticasone propionate and survival in COPD. N Engl J Med 2007;
Actions for Commissioning Teams
References (continued)
11. Nannini et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus longacting beta-agonists for chronic obstructive pulmonary disease. Cochrane Database of
Systematic Reviews 2007, Issue 4. Art. No.: CD006829
12. CG101: COPD (update): full guideline. National Institute for Health and Clinical Excellence.
13. Welsh et al. Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for
COPD. Cochrane Database of Systematic Reviews 2010, Issue 5. Art. No.: CD007891
14. Vogelmeier et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N
Engl J Med 2011;364:1093–103
15. Rodrigo et al. Comparison of three combined pharmacological approaches with tiotropium
monotherapy in stable moderate to severe COPD: A systematic review. Pulmon Pharmacol
Therapeutics 2012; 25: 40-47
16. Karner et al. Combination inhaled steroid and long-acting beta2-agonist in addition to tiotropium
versus tiotropium or combination alone for chronic obstructive pulmonary disease. Cochrane
Database of Systematic Reviews 2011, Issue 3. Art. No:CD008532.
17. Drug Safety Update, November 2010. Tiotropium: safety studies of Spiriva Respimat. Medicines
and Healthcare Products Regulatory Agency. 2010
18. Celli et al. Mortality in the 4-Year trial of tiotropium (UPLIFT) in patients with COPD. Am J Respir
Crit Care Med 2009; 180: 948–55
19. Singh et al. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive
pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ
20. Immunisation against infectious disease (The Green Book) 2012 update. Department of Health.
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