1. Berkshire West CCG TIPs 28th January 2015
Use COPD: Up to date management and new drugs
Catherine Thomas
Consultant Respiratory Physician
Sanjay Desai and Jillian Powell
Medicines Optimisation Team
Katy Beckford
Respiratory Team Leader

2. Objectives of the session
COPD Fact and Figures
NICE guidelines
Inhaler Update

3. COPD
COPD is an obstructive and irreversible lung disease, a combination of emphysema and chronic bronchitis in varying proportions, predominantly caused by cigarette smoking.
3rd commonest cause of death worldwide by 2020
4th commonest cause of death in UK, with ~28,000 deaths
Second commonest cause of acute hospital admission
Cost to NHS - >£ 800 million in direct healthcare cost

4. Diagnosis History Usually >10 pack yrs and >35y old Cough SOB
Sputum production
Activity level
Exacerbation frequency
Smoking status
Evidence of cor pulmonale
Weight loss – assoc. with poor outcome

5. Diagnosis FEV1/FVC Ratio FEV1 Stage
Diagnosis by spirometry (post bronchodilator)
Nice guidelines grade severity on FEV1
FEV1/FVC Ratio FEV1 Stage
< % Mild
< % Moderate
< % Severe
< <30% Very Severe

6. MRC dyspnoea score
1. Not troubled by breathlessness except on strenuous exercise
2. Short of breath when hurrying or walking up a slight hill
3. Walks slower than contemporaries on the level because of breathlessness, or has to stop for breath when walking at own pace
4. Stops for breath after about 100 m or after a few minutes on the level
5. Too breathless to leave the house, or breathless when dressing or undressing 

7. Cat score Assesses the impact of COPD on patients’ health status
Best use for monitoring patients
?3 monthly

8. Exacerbations of COPD ~10% of acute medical admissions
National Audit % mean increase in COPD admissions cf. 2008
1 in 10 die within 90 days, 1/3 readmitted in same time frame
National Audit 2014 – IP mortality ~5%
One-year mortality ranging from 22% to 43%, and a 2-year mortality of 36 to 49%

9. Treatment of COPD

10. The Facts and Figures £7,376,079.41 (13.3% of total spend)
In 2013/14 the 4 CCGs in Berkshire West spent £55,437, on prescribing.
How much of this was spent on drugs in the Respiratory chapter of the BNF?
£7,376,079.41
(13.3% of total spend)
This is £102,520 less than 2012/13
This does not include the spend on Oxygen.

11. The 5 most costly drugs to the NHS (This data is from August 2013)
In 5th Place – Novorapid Insulin - £5.8 million/month In 4th Place – Symbicort 200 Turbohaler - £7.9 million/month In 3rd Place – Seretide 500 Accuhaler - £8.0 million/month In 2nd Place – Tiotropium Handihaler - £12 million/month

12. Approximately £157.2 million/year
And in 1st Place
Seretide 250 Evohaler
£13.1 million/month
Approximately £157.2 million/year
All of the top 5 drugs prescribed nationally are inhalers

13. How do the Berkshire West CCGs compare?
Symbicort 200 Turbohaler £70,574/month
Spiriva Handihaler £66,555/month
Seretide 250 Evohaler £64,853/month
Seretide 500 Accuhaler £53,378/month
True Result Test Strips £50,834/month
(Epact data for first 6 months of 2014/15)

14. COPD Prevelance National Prevalence – 1.7%
North and West Reading CCG – 1.2%
Newbury and District CCG – 1.2%
South Reading CCG – 0.9%
Wokingham CCG – 1.0%
There are a number of possible reasons for this difference
Work place factors – No mining, low factory, high office and white collar jobs
Environment – Better weather
Social – Less deprivation
Other – Low rates of diagnosis and identification, poor registers.

15. How many COPD patients are there across the 4 Berkshire West CCGs?
List size of CCGs are not identical and demographics vary
5201 patients (based on QOF 2013 data)

16. What does NICE say?
NICE clinical guideline 101: Chronic obstructive pulmonary disease; June 2010
Offer therapy Consider therapy Exacerbations or persistent breathlessness Persistent exacerbations or *SABA as required may continue at all stages **Discontinue SAMA
SABA or SAMA as required*
FEV1≥50%
FEV1<50%
LABA
LAMA**
Offer LAMA in preference to regular SAMA qds.
LABA + ICS combo
Consider LABA+LAMA if ICS declined or not tolerated
LAMA**
Offer LAMA in preference to regular SAMA qds.
Triple therapy – LAMA, LABA and ICS reserved for the really difficult to manage patients with persistent exacerbations or breathlessness.
NICE states “Be aware of the potential risk of developing side effects (including non-fatal pneumonia) in people with COPD treated with inhaled corticosteroids and be prepared to discuss this with patients.” Ask Katy
LABA + ICS combo
Consider LABA+LAMA if ICS declined or not tolerated
LAMA + LABA +ICS

17. What does NICE say?
All people with COPD who still smoke, regardless of age, should be encouraged to stop, and offered help to do so at every opportunity.
Offer pneumococcal vaccination and an annual influenza vaccine as recommended by the Chief Medical Officer
Offer pulmonary rehabilitation to all appropriate people with COPD, including those who have had a recent hospitalisation for an exacerbation and those who consider themselves functionally disabled by COPD (usually MRC grade 3 and above)
Give people at risk of exacerbations a course of antibiotics and corticosteroid tablets to keep at home. Monitor the use of these drugs and advise people to contact a healthcare professional if their symptoms do not improve.
Patients should have a self management plan
Katy to talk about Pulmonary Rehab referral and appropriateness
Katy to talk about rescue packs (which drugs, what dose, how long?)
Jillian to ask “How often do you review the number of rescue packs patients are ordering?”

18. In the last 12 months there have been a number of new drugs, combinations of treatments and devices introduced in to the market. This makes the picture of COPD treatment more confusing and there are now treatment options without an obvious place on the previous chart e.g. LABA/LAMA combinations. NICE is not due to review the current guidance until June 2016.

19. So how are we doing?
Jillian to give a breif introduction to Primis and Chart.
Katy to explain the reason why this may be the case.

20. 56 patient in the mild and moderate group are on triple therapy, total number of patients in this group is 127. Almost half.
However 70% of all patients have an MRC score of ≤ 2.

21. Inhaler technique is not being annually assessed and therefore the question has to be are patients getting the most out of the inhalers we are prescribing?
Only 6 patients appear to be having > 2 exacerbation in 12 months which asks further questions about the number of patients on triple therapy.
Make it clear that we are not saying stop patients on triple therapy but to ensure that all options are considered and that it is being used at the appropriate time.

23. Cost Effectiveness Triple Therapy - £35,000-£187,000/QALY
Tiotropium or LABA - £5,000 to £8,000/QALY
Pulmonary Rehab –
£2,000 to £8,000/QALY
Smoking Cessation - £2,000/QALY
Flu vaccination - £1,000/QALY
NICE
Cost effectiveness is expressed as ‘£ per QALY'. (Quality Adjusted Life Year)
Each drug is considered on a case-by-case basis. Generally, however, if an individual treatment costs more than £20,000-30,000 per QALY, then it would not be considered cost effective.
For further information on value, see IMPRESS Guide to the relative value of COPD interventions.
and BMJ Editorial, 17 September, BMJ 2012; 345:e6192

24. The updated cost effectiveness pyramid

25. What do we prescribe?

27. Indacaterol – Onbrez Breezhaler®
Tiotropium – Spiriva®
Antimuscarinic Bronchodilator
Licensed for maintenance treatment of COPD
For Adults over 18 years of age
Handihaler® Dose : 1 inhalation once daily
Respimat® Dose : 2 puffs once daily
Approved by APC in November 2013
Indacaterol – Onbrez Breezhaler®
Long Acting Beta2 Agonist Bronchodilator
Black Triangle▼
Dose : 1 inhalation daily, increased to max. 2 inhalations daily
Approved by EPC in March 2011

28. Aclidinium Bromide – Eklira Genuair®
Antimuscarinic Bronchodilator
Black Triangle▼
Licensed for maintenance treatment of COPD
For Adults over 18 years of age
Dose : 1 inhalation twice a day
Glycopyrronium – Seebri Breezhaler®
Dose : 1 capsule once a day
APC 024 November 2013 – Both of these agents are only to be used second line after Tiotropium , where there are no cardiovascular contraindications. New local guidelines will be launched soon and this may change the local choices.

29. Fluticasone and Salmeterol – Seretide®
Combination of Inhaled Corticosteroid and Long Acting Beta2 Agonist
Accuhaler – Licensed for COPD and Asthma
From 5 years of age depending on strength
Dose : 1 puff twice daily
Evohaler – Licensed for Asthma only
Dose : 2 puff twice daily
Budesonide and Formoterol – Symbicort Turbohaler®
Licensed for COPD and Asthma
From 6 years of age, depending on strength and condition
Dose : See SPC or BNF.

30. Beclometasone and Formoterol – Fostair®
Combination of Inhaled Corticosteroid and Long Acting Beta2 Agonist
Licensed for COPD and Asthma
From 18 years of age
Dose for COPD: 2 puff twice daily
Dose for Asthma: 1 or 2 puff twice daily
Fluticasone and Formoterol – Flutiform®
Licensed for Asthma only
From 12 years of age depending on strength
Dose : 2 puff twice daily

31. Some of the new products to enter the market
Olodaterol – Striverdi Respimat®
Long Acting Beta2 Agonist Bronchodilator
Black Triangle▼
Licensed for maintenance treatment of COPD
For Adults over 18 years of age
Dose : 2 puffs once daily
Umeclidimium – Incruse Ellipta®
Antimuscarinic Bronchodilator
Dose : 1 inhalation daily

32. Vilanterol and Fluticasone – Relvar Ellipta®
Combination of Long Acting Beta2 Agonist and Corticosteroid
Black Triangle▼
NB. Two strengths available
Low strength inhaler (22/92) - Licensed for COPD and Asthma
High strength inhaler (22/184) - Licensed for Asthma only
From 12 years of age
Dose, regardless of strength and indication: 1 inhalation daily
APC 080 May 2014 – This agent is not currently recommended
Vilanterol and Umeclidinium – Anoro Ellipta®
Licensed for maintenance treatment of COPD
For Adults over 18 years of age
Dose : 1 inhalation daily

33. So which inhaler is the most expensive?

34. The one that never gets used or is not used correctly

35. Why not seretide? Cost Risk of pneumonia
Non-fatal pneumonia
Trials only shown this with Fluticasone
TORCH, INSPIRE (64% and 94% increased risk of pneumonia respectively). Mulitple other trials confirm
Increased risk with advancing age, lower FEV1, increasing dose of steroid
Recent large trial of severe COPD – no effect on disease off combination, decreased risk of pneumonia
Trials show no significant increase with budesonide
?Relvar – Increase of approx 50% (3 to 6%)

36. Take Home Messages Check your COPD register - Is it up to date?
Check that all COPD patients have a COPD severity
Check that rescue packs are on acute and not repeat
Check what dose and duration of prednisolone you are issuing for an exacerbation
Tiotropium remains the first line LAMA at present but watch out for the launch of the new local guidelines which will incorporate the new agents.
Fostair first line for combination inhaler.
Check compliance before assuming that a treatment is not working
Always encourage the use of a spacer device with an MDI
Ensure that inhaler technique is being reviewed at every opportunity

37. Convinced yet that we need training on how to use inhalers?

38. Health Professionals speed of inhalation when asked to inhale as if using an MDI - “Slowly and Deeply”
Speed of
inhalation
MDI
Inhaler
91 L and above
61 – 90 L/min
Total = 3271 tests conducted :
over 94% inhaled too fast
This is a slide to indicate the number of expert healthcare professionals and how many of them were unable to perform accurate inhaler technique
60 L/min or less
General Practitioners, Practice Nurses, Respiratory Nurses (Primary & Secondary Care), Pharmacists (Community, Retail and Hospital), Pharmacy Dispensers, Prescribing Advisors, Physiotherapists, Hospital Physicians (General Medicine and Thoracic),
Pharmaceutical Company Employees (Representatives, Medical Advisors, Educational Staff)
Presented at ERS Annual Scientific Meeting, Stockholm 2007 (No. 91, Primary Care Day, 15/9/07):
Jon Bell, Canday Medical Ltd. data collected between 1st June 2006 and 5th September 2007

39. Asthmatics – Speed of inhalation through Metered Dose Inhaler
MDI
Inhaler
91 L/min and above
90 L/min or less
This is the number of patients who were unable to perform accurate inhaler technique.
Total = 476 individuals tested:
over 92% inhaled too fast
Al-Showair R A M , Pearson S B, Chrystyn H. The Potential of a 2Tone Trainer To Help
Patients Use Their Metered-Dose Inhalers Chest 2007; 131:

40. But this is Nationally…. Berkshire West are better than this… aren’t we?

41. We recently put on an Inhaler Training course for BHFT Staff
39 Staff members attended (availability for 60 staff)
Consisted of
Respiratory Nurses
Respiratory Physiotherapists
Community Matrons
Practice Nurses responsible for COPD Clinics
Pharmacists

42. What did we do?
Invited Jon Bell (inventor of the In-Check device) to do 3 x 1 hour training sessions.
As well as learning about why we need to use inhalers correctly staff were assessed, using the In-Check, to see if they were able to effectively use a Metered Dose Inhaler (MDI)
The results are as follows……

43. Berkshire West Results
N = 4
N = 35
Total = 39 tests conducted :
over 90% inhaled too fast
< 40 L/Min is required for effective inhalation of an MDI

44. How can we improve this?
ALL staff need to know how to use inhalers correctly
Please do come to the respiratory team in the break to see if you are able to do this
Encourage all staff to attend inhaler training courses that are put on (50% under utilised for this event)
Refer to the Community Respiratory Team if you are struggling with any patients and wish them to be reviewed.

45. Who are the Respiratory Team and what do they do?
Team leader Katy Beckford
Respiratory Nurses Martin Weighman
Ann McKinnon
Caroline Smeeton
Respiratory Physiotherapists Cath Darby
Alexandra Christie
Maria Nogueira
Heather Yuille
Marc Bowen – Physiotherapist Assistant
Admin Lisa McCreery

46. What we can offer
Supportive discharges (all patients who have had an admission for COPD exacerbation)
2hr Rapid Response service with the aim of preventing unnecessary or unplanned admissions
Education and advice for patients and clinicians
MDT education and attend GP meetings
Pulmonary Rehabilitation
6 Month and Annual review of patients on Home Oxygen
Smoking Cessation
Telehealth

47. How do you refer to us? All referrals are taken via the Health Hub
Telephone
Fax

48. What do we need?
All we require is that a patient has a confirmed diagnosis.
With the referral we require
Patient Summary
Most recent Spirometry
Why the patient needs to be seen
How soon the patient needs to be seen

49. How can we improve in Berkshire West?
Earlier referral to the CRT
All suitable patients to have back up antibiotics and steroids
Referring to the CRT after 1 week if no improvement on treatment
All patients with an MRC 3> should have a PR referral

50. What to do next… Smoking cessation
Pulmonary rehabilitation – re-offer if done already, particularly post exacerbation/admission to aid recovery
Influenza vaccination, pneumococcal vaccination
Check inhalers - correct for spirometry, can use?
Consider dietician – Low BMI associated with inc. mortality
Rescue pack
Self management plan
Carbocisteine – 750mg tds
Theophylline
Steroid enhancing effects even at low dose

51. Discharge Checklist Faxed to practice
Activity level, sputum, discharge saturations
Inhaler technique
Smoking cessation
Pulmonary rehab
Rescue pack
Community COPD team referral (seen within 2 weeks post discharge)
Respiratory CNS call at 48h to check patient

52. When to refer Unsure of diagnosis Young patients Severe COPD
Rapid decline in FEV1
Frequent exacerbators (>2 per year)
Evidence from COPD cohorts suggest ~30% have bronchiectasis and managed as such
Evidence of complications – cor pulmonale, weight loss, haemoptysis

53. What might we do… PDE4 inhibitors - Roflulimast / Rolipram – not used
Azithromycin
Used in trials for between 8 weeks to 1 yr in frequent exacerbators
Reduces exacerbation rate and time to next hospitalization
Risks of resistance?
Assessment for LTOT
Severe COPD, Sats <92%, cor pulmonale, polycythaemia
Two ABG’s at least 3/52 apart in stable COPD
Also ambulatory oxygen
NIV
End of life care
Trials show reduction in exacerbations and slight improvement in FEV1 causes weight loss Use in severe/very severe frequent exacerbators

54. What might we do Consider surgical therapies Endobronchial valves
LVRS
endobronchial treatment (valves/coils)
Endobronchial valves
Full lung function criteria
Reasonable performance status
Heterogeneous emphysema on scans
High flow oxygen, significant PH contra-indications
Coils
Homogenous emphysema
Still only at trial stage

55. For listening!

56. Useful websites and resources
Chronic obstructive pulmonary disease (updated) (CG101)
An Outcomes Strategy for Chronic Obstructive Pulmonary Disease (COPD) and Asthma in England
Interactive Health Atlas for Lung Conditions in England
Summary of Product Characteristics for all drugs and devices
Medicines Optimisation Team generic address -