1. Actions for Commissioning Teams Management of COPD within primary care June 2012

2. Actions for Commissioning Teams Why are we looking at this? COPD exacerbations: 2 nd 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 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 COPD 1 o Premature mortality almost double that of EU average 2 The missing millions? o Thought to be significant level of underdiagnosis 1 o Early diagnosis and optimising interventions in primary care may improve outcomes and reduce costly admissions DH ‘Outcomes Strategy for COPD & asthma’ published in 2011 2 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 2

3. 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 Immunisations NICE recommendations on patient review and self-management Prescribing home oxygen 3

4. Actions for Commissioning Teams Diagnosis: key points from NICE 3 Consider a diagnosis of COPD for people who are over 35, and smokers or ex-smokers*, and have any of these symptoms: o exertional breathlessness o chronic cough o regular sputum production o frequent winter ‘bronchitis’ o 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 4

5. 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 suitable 5 o Working definition of COPD: Airflow obstruction defined as FEV 1 /FVC ratio < 0.7 If FEV 1 ≥ 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: FEV 1 ≥ 80% predicted (symptoms also should be present to diagnose COPD in people with mild airflow obstruction). Stage 2 - moderate: FEV 1 50-79%. Stage 3 - severe: FEV 1 30-49% Stage 4 - very severe: FEV 1 < 30% (or FEV 1 < 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. 5

6. Actions for Commissioning Teams Spirometry 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 under- diagnosis 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 Afro- Caribbeans and also includes calculations for elderly patients 6 6

7. 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 patients 7 ) Findings that can help identify asthma (from NICE 3 ): 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 Clinically significant COPD is not present if FEV 1 and FEV 1 /FVC ration return to normal with drug treatment 3 Reconsider diagnosis of COPD if a patient reports a marked response to inhaled therapies 3 7

8. Actions for Commissioning Teams Diagnosis: other tests 3 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 8

9. Actions for Commissioning Teams Grading dyspnoea NICE recommend use of MRC dyspnoea scale 3,8 9 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.

10. 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 smoking 9 ) Nicotine replacement, varenicline or bupropion may be offered, unless contraindicated, combined with appropriate support 3 10

11. Actions for Commissioning Teams Management of stable COPD 3 11 Routinely check a patient’s inhaler technique. Try to identify reasons for non-compliance with inhaled treatments.

12. 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 LABA 11 Compared with LABA alone, LABA/ICS significantly reduced exacerbation rate (18%); also greater improvements in QOL and FEV 1. 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. 12

13. 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 FEV 1 is <50% predicted) Regarding the evidence: o NICE Guideline Development Group: concluded no strong evidence to favour LABA over LAMA 12 o 2010 Cochrane review: uncertainties in relative benefits of LABA/ICS vs. tiotropium due to shortcomings in trials 13 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 FEV 1, QOL and dyspnoea, but no difference in exacerbations, and higher risk of SAEs and pneumonia 15 BOTTOM LINE: No strong recommendations to guide choice, but consider suitability of device, tolerability, and adverse effects on ICS. 13

14. 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 FEV 1 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 14

15. 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 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 15

16. Actions for Commissioning Teams NICE guidance: oral therapies for stable COPD 3 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 beta 2 -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 16

17. Actions for Commissioning Teams Managing exacerbations - treat at home or admit to hospital? 3 Consider the following factors, as recommended by NICE 17

18. Actions for Commissioning Teams Treating exacerbations in primary care 3 18 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 in >14 days) o Consider prophylaxis for osteoporosis in patients requiring frequent course Prescribe antibiotics if more purulent sputum o Patients without more purulent sputum do not need antibiotics unless consolidation on chest X-ray or clinical signs of pneumonia o Sputum culture not recommended in routine practice recommended by NICE Measure oxygen saturation – if SaO2 < 90% treat in hospital

19. 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 FEV 1 and FVC, BMI and MRC score at review (SaO 2 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; O 2 ) 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 19

20. Actions for Commissioning Teams Immunisations COPD patients should receive annual flu vaccine 3 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 20

21. Actions for Commissioning Teams Supplying oxygen – when to refer Home oxygen supply: o significant variation seen in spend across PCTs o Home O 2 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 O 2 assessment: 3 o Where airflow obstruction is very severe (FEV 1 < 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 FEV 1 30-49% predicted Advise patients that O 2 should be used for 15 hours per day – greater benefits seen for 20 hours per day Patients on O 2 should be reviewed at least once per year by practitioners familiar with long-term O 2 21

22. Actions for Commissioning Teams Supplying oxygen - changes 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 22

23. Actions for Commissioning Teams 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: Heart failure Paediatric assessment Palliative care Neurological conditions 23

24. 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: o Offer smoking cessation at every opportunity o Follow NICE sequential approach to pharmacotherapy o Check inhaler technique routinely; address non-compliance o Exacerbations: treat promptly; offer self-management advice o Review patients regularly o Offer vaccinations o Refer to pulmonary rehabilitation patients with MRC 3 or higher o Long-term oxygen therapy: consider patient’s on-going requirements 24

25. Actions for Commissioning Teams Summary A final point to consider…(reproduced from the NHS Companion Document on the Outcomes Strategy for COPD 1 ) 25

26. 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 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 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/CG101http://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 http://www.goldcopd.org/uploads/users/files/GOLD_Report_2011_Feb21.pdf 6.Spirometry in Practice. BTS COPD Consortium. www.brit- thoracic.org.uk/portals/0/.../spirometry_in_practice051.pdfwww.brit- thoracic.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: 10.1155/2011/86192610.1155/2011/861926 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 26

27. Actions for Commissioning Teams References (continued) 11.Nannini et al. Combined corticosteroid and long-acting beta-agonist in one inhaler versus long- acting 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.pdfhttp://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 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 http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalass et/dh_133118.pdf 27