Transcript 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?
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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:
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• 94,000 patients diagnosed with COPD (1.6% of population)
• In last year, 31,795 emergency COPD admissions (~4% of all emergency
admissions)
• 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
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Actions for Commissioning Teams
What are we covering?
The following slides provide selected information on:
• Diagnosis
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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
Immunisations
NICE recommendations on patient review and selfmanagement
Prescribing home oxygen
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Actions for Commissioning Teams
Diagnosis: key points from NICE3
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Consider a diagnosis of COPD for people who are over 35, and
smokers or ex-smokers*, and have any of these symptoms:
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exertional breathlessness
chronic cough
regular sputum production
frequent winter ‘bronchitis’
wheeze
and do not have clinical features of asthma:
o chronic unproductive cough, variable breathlessness, night-time
wakening
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
diagnoses)
* although bear in mind a significant proportion of patients with COPD may have never
smoked (~28% in a recent population study).4
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Actions for Commissioning Teams
Diagnosis: Spirometry
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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
therapy:
• 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
failure).
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.
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Actions for Commissioning Teams
Spirometry
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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
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Actions for Commissioning Teams
COPD or asthma or both?
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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
bronchodilators
o A large (>400 ml) response to 2 weeks, 30 mg/day oral
prednisolone
o Serial peak flow measurements showing 20% or greater
diurnal/day-to-day variability
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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
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Actions for Commissioning Teams
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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
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Actions for Commissioning Teams
Grading dyspnoea
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NICE recommend use of MRC dyspnoea scale3,8
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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.
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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
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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)
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Nicotine replacement, varenicline or bupropion may be offered,
unless contraindicated, combined with appropriate support3
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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.
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Actions for Commissioning Teams
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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.
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Actions for Commissioning Teams
Tiotropium or LABA(/ICS)?
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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.
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Actions for Commissioning Teams
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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
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Actions for Commissioning Teams
Recent safety advice for tiotropium
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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
Respimat▼
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
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Actions for Commissioning Teams
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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:
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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
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Actions for Commissioning Teams
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Managing exacerbations - treat at
home or admit to hospital? 3
Consider the following factors, as recommended by NICE
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Actions for Commissioning Teams
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Treating exacerbations in primary
care3
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
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Prescribe antibiotics if more purulent sputum
o Patients without more purulent sputum do not need antibiotics
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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
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Actions for Commissioning Teams
Patient review and self-management
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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:
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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
home
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Actions for Commissioning Teams
Immunisations
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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
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Actions for Commissioning Teams
Supplying oxygen – when to refer
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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
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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
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Actions for Commissioning Teams
Supplying oxygen - changes
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Changes to the Home Oxygen Service are underway
Home Oxygen Order Form (HOOF) has been separated into
HOOF A and HOOF B
o HOOF A – designed to be completed by a healthcare
professionals:
• Non specialists
• For temporary orders (static supply only)
• Can be used to discharge from hospital
o HOOF B:
• To be completed ONLY by specialist/commissioned HOS assessment and
review service
• For static and ambulatory supply
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Actions for Commissioning Teams
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Supplying Oxygen – commissioning
issues
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
revealed:
o Most provide oxygen assessment and review services for patients
with COPD
o Most provide pulmonary rehabilitation services for patients with
COPD
o Few (only 1 from the sample of 9 PCTs that responded) provide
services for patients with:
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Heart failure
Paediatric assessment
Palliative care
Neurological conditions
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Actions for Commissioning Teams
Summary – final key points
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Diagnose earlier and accurately:
o Based on clinical signs and quality-assured spirometry
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In relation to management/prevention of exacerbations:
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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
requirements
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Actions for Commissioning Teams
Summary
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A final point to consider…(reproduced from the NHS
Companion Document on the Outcomes Strategy for COPD1)
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Actions for Commissioning Teams
References
1.
An Outcomes Strategy for COPD and Asthma: NHS Companion Document. 2012. Department of
Health.
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_
134000
2. Outcomes Strategy for COPD and asthma. Department of Health. 2011.
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_128428.
pdf
3. Chronic obstructive pulmonary disease (updated). Clinical guideline CG101: June. National Institute
for Health and Clinical Excellence. 2010. http://guidance.nice.org.uk/CG101
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.
http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21.pdf
6. Spirometry in Practice. BTS COPD Consortium. www.britthoracic.org.uk/portals/0/.../spirometry_in_practice051.pdf
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;
356:775-89
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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.
2010. http://www.nice.org.uk/nicemedia/live/13029/49425/49425.pdf
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
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON099869
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
2011;342:d3215
20. Immunisation against infectious disease (The Green Book) 2012 update. Department of Health.
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalass
et/dh_133118.pdf
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