1. Tobacco Addiction & The CURE Project
Dr Matthew Evison
Consultant in Respiratory Medicine, Manchester University NHS Foundation Trust
Director of the Lung Pathway Board Greater Manchester Cancer
Clinical Lead for the CURE Programme, Greater Manchester

2. Overview The scale of the tragedy
Pharmacotherapy for tobacco addiction evidence base
What are the barriers to treating tobacco addiction
The CURE Project
What do I ask of you?

3. The Scale of the tragedy

4. Global Scale of the Tragedy

5. UK Scale of the Tragedy

6. Greater Manchester Scale of the Tragedy

7. Pharmacotherapy for tobacco addiction
The evidence-base

8. Nicotine Replacement Therapy
Nicotine replacement therapy is an effective treatment for tobacco addiction increasing the chance of abstinence by approximately 60% compared to placebo (RR %CI )
Cochrane Review 2012, 117 trials, Stead et al
Adding NRT to behavioural support in hospitalised smokers increases abstinence by approximately 60% (HR 1.54 95%CI )
Cochrane Review 2012, 6 trials, Rigotti et al
NRT is cost-effective even when modelling at the lowest quit rate (9%) and most expensive NRT (£763 per person). Cost per QALY £634 (NICE threshold £30,000)
2018 NICE PHG94

9. Varenicline
Varenicline is an effective treatment for tobacco addiction increasing the chance of abstinence by over 200% versus placebo (RR %CI )
Cochrane Review 2013, 27 trials, 12,625 patients, Cohill et al
Varenicline is more effective than bupropion. Smokers are approximately 40% more likely to stop with varenicline versus bupropion (RR %CI )
Cochrane Review 2013, 5 trials, 5877 patients, Cohill et al
Varenicline and behavioural support is the most effective combination to treat tobacco addiction in meta-analysis of 115 trials and 57,000 patients. Smokers are approximately 60% more likely to stop smoking with varenicline and behavioural support than with bupropion (OR %CI ) and NRT (OR %CI )
Windle et al. Am J Prev Med 2016

10. Safety – Cardiovascular events
No increase in cardiovascular events with varenicline in a systematic review of 38 trials (RR %CI )
Sterling et al. J Am Heart Assoc 2016
No increased risk of cardiovascular events with varenicline in a study of 14,350 patients with COPD
Kotz et al. Thorax 2017
NRT is safe in stable and unstable cardiovascular disease
NICE PH48
Safety – Neuropsychiatric adverse events
No increase in neuropsychiatric adverse events from pharmacotherapy for tobacco addiction in network meta-analysis
Roberts et al. Addiction 2016

11. Varenicline: provide in conjunction with counselling/support, but if such support is refused or is not available, this should not preclude treatment with varenicline (NICE)

12. What are the barriers to treating tobacco addiction

13. Stigma – lifestyle choice
Highly prevalent disease & single biggest cause of death and illness
Highly effective and cost-effective medical treatment
Comprehensive treatment services throughout the NHS
What are the barriers to comprehensive tobacco addiction services accessible to all smokers??
Stigma – lifestyle choice
Smoking is a choice and a focus on will power and behavioural change to stop
Healthcare professional training and competence
Healthcare physician behaviour and attitudes
Historic service set-up and structure
Funding streams and government policy
Ongoing concern over medication-related adverse events – mental health
Perceived costs

14. What are the barriers to treating tobacco addiction
The stigma

15. Lets look at some definitions………..
What is a disease?
What is the purpose of the NHS?
“An abnormal condition of a body part, an organ, or a system resulting from various causes, such as infection, genetic defect, or environmental stress, and characterized by an identifiable group of signs or symptoms.”
To provide equal & fair access to all patients to the most effective & evidence based treatments for their illness and disease, physical or mental

16. Tobacco addiction is a disease
Nicotine binds to nicotine receptors in the brain
Binding of nicotine triggers the release of Dopamine: feel good and calming hormone
Drop in dopamine levels lead to irritability & feelings of stress.
Craving for dopamine
Repeated nicotine exposure leads to upregulaton & hyperexcitibility of receptors
Need for more and more nicotine to alleviate increasingly intense cravings for dopamine
Tobacco Addiction
Symptoms of withdrawal:
Restlessness
Agitation
Sweating
Nausea
Headaches
Insomnia
Poor concentration
Anxiety
Anger
Irritability
Environmental stress: ‘The Trigger’
Tobacco addiction is a disease
A chronic & relapsing disease that often begins in childhood
Pathological condition:
‘Abnormal change in structure or function’
Identifiable group of symptoms

17. Nicotine is a relatively harmless drug
Highly addictive in the brain but otherwise very similar to caffeine
NICE PH45
Nicotine causes:
No increase in serious adverse events
No increase cardiovascular events
No increase in cancer
No increase in mortality
Adverse events common but not severe

19. Changing the stigma Past Future Negative message You must stop
Will power
Your fault if you fail
Choice
Nicotine is dangerous
Cant cope without it
Lifestyle choice
Positive message
Physical disease
Chemical dependence
False pleasure / desire
Nicotine is harmless
Treatments work
Never give up on giving up

20. What are the barriers to treating tobacco addiction
Service structure and funding streams

21. Public health services, which include stop smoking services, were part of the NHS and commissioned by PCTs until 2013
2012 Health and Social Care Act transferred the public health function and budget from the NHS to local authorities who became responsible for commissioning stop smoking services.
Funding was provided through a ring-fenced grant from the Department of Health, but allowed considerable scope for local authorities to decide for themselves how to use the grant.
£147 billion
Local authorities also inherited from the NHS the costs of providing stop smoking medications to people using stop smoking services & these services are now delivered independently from NHS patient services.

22. What is the purpose of the NHS?
To provide equal & fair access to all patients to the most effective & evidence based treatments for their illness and disease, physical or mental
These successive cuts to stop smoking service budgets have substantially diminished the support available to smokers in England. In 2013, when the NHS relinquished responsibility for commissioning stop smoking services, all smokers could access a local specialist stop smoking service. In 2017, this universal specialist offer was available in only 61% of local authorities.
Delivering stop smoking services to patients is no longer regarded as an NHS responsibility.
NHS is not required to commission services for NHS patients that smoke
There is currently no NHS standard tariff for providing stop smoking support to hospital patients
The majority of English NHS patients who smoke can only access treatment for tobacco dependence outside the NHS.

23. In 2013 only 5% of smokers accessed stop smoking services
In 2013, when the NHS relinquished responsibility for commissioning stop smoking services, all smokers could access a local specialist stop smoking service
In 2013 only 5% of smokers accessed stop smoking services
The number of smokers accessing services since 2012/2013 declined by over 60% in England
The data indicates that the decline in service uptake in most of the UK is not entirely attributable to funding cuts, or indeed to the separation of smoking services from the NHS
Health services throughout the UK are failing to engage the great majority of smokers in any formal quit attempt.
The current opt-in model of service provision, whereby smokers accessing NHS services are referred on to stand-alone stop smoking services is no longer an optimal model.

24. The call to arms….
Move responsibility for smoking interventions back into the NHS
Ensure treating tobacco addiction becomes a core NHS activity.

26. What are the barriers to treating tobacco addiction
Mental Health Disease

30. Largest trial of smoking cessation pharmacotherapy
Study requested and co-designed with the FDA
140 centres, 16 countries, 5 continents
Double-blind, triple dummy, placebo controlled, randomised trial
Smokers aged 18-75, at least 10 cpd
12 weeks of treatment + 12 weeks of further FU (24 week trial)
Total 15 clinic visits – 10 minutes of smoking cessation advice
8144 participants randomised

31. Neuropsychiatric safety outcomes
Psychiatric vs non psychiatric cohorts
Psychiatric illness stable for 3 months – no medication changes
Psychiatric illness stratified as mood, anxiety, psychotic, personality
Clearly defined composite outcome – 16 neuropsychiatric symptoms
‘Neuropsychiatric adverse event Interview’ – 25 questions
Healthcare professional interview if ‘Yes’ to any question
8000 patients to estimate a 75% increase in neuropsychiatric adverse event rate within +1·59% or –1·59%

32. Efficacy outcomes
Varenicline vs bupropion vs NRT (21mg patch) vs placebo
80% treatment compliance (completing ≥ 80% of course)
Chemically validated quit rate at 9-12 weeks and 9-24 weeks
Placebo tablets and placebo patch
8000 patients to detect a two fold increase in quit rate

35. The average total HADS score improved from baseline through the treatment phase by about 2 points in the non-psychiatric cohort and 3 points in the psychiatric cohort, an effect that was similar across the treatment groups

36. Neuropsychiatric Adverse Events
There is no increased risk of moderate to severe neuropsychiatric adverse events with varenicline (EAGLES study 2016, The Lancet).
The act of stopping smoking carries a small risk of moderate to severe neuropsychiatric events and this is regardless of the treatment used.
The risk is higher in those with a history of psychiatric illness (5%) versus those without (2%). Advise patients to seek help in the event of a neuropsychiatric event.
In the long term, stopping smoking improves mental health disease, e.g. stopping smoking is more effective than antidepressants in treating depression.

38. What are the barriers to treating tobacco addiction
Perceived costs

39. Secondary Care Concentrated population of smokers
Sick smokers
Teachable moment
Motivation
Effective mitigation of withdrawal
Effective long term treatments
Immediate benefits to the patient, hospital and society
Secondary Care
20,000 smokers in hospital on any given day in the UK
1 million smokers admitted to hospital at least once each yr
Smokers are 36% more likely to be admitted to hospital
Perceived vulnerability
Fear for future
Realisation of impact
Link illness to smoking
Forced abstinence
Removed from normal home and habits
Intensive motivational interviewing
Immediate feedback
Monitoring
Compliance
Education

40. Ottawa model of smoking cessation
The systematic identification and documentation of all smokers admitted to hospital
The systematic administration of pharmacotherapy & behavioural support to active smokers in hospital
The systematic attachment to long term community follow-up services after discharge
The 5As: Ask, Advise, Assess, Assist, Arrange

41. Ottawa Model for Smoking Cessation
Mortality halved by 1 year
11.4% vs 5.4%; p<0.001
Mortality reduction at 2 years
15.1% vs 7.9%; p<0.001
Increase quit rates at 6 months 35% vs 20%
Re-admission halved by 30 days
13.3% vs 7.1%; p<0.001
Re-admission reduced at 1 year
38.4% vs 26.7%; p<0.001
Effectiveness of a hospital-initiated smoking cessation programme: 2-year health and healthcare outcomes. Mullen et al Tob Control 2016;0:1–7. doi: /tobaccocontrol

42. 3273 readmissions prevented at 30 days
Applying the Ottawa Model to Greater Manchester: Key benefits and outcomes
Conservative estimation of 263,900 adult admissions to hospital across GM per
Assuming 20% were active smokers = 52,780 smokers.
3273 readmissions prevented at 30 days
6176 readmissions prevented at 1 year
3141 lives saved in 1 year
18,473 successful quitters in the first year
The 2015 Department of Health Reference Costs state an average non-elective hospital admission costs £1609. Therefore, the estimated savings from prevention of readmissions by applying the Ottawa Model to Greater Manchester is therefore £9,937,184 per year.
The average length of hospital stay in England is 5 days (NGS Digital Data The CURE project is estimated to save 30,880 bed bays per year, equivalent to 84 additional beds per day across Greater Manchester

43. The cure project

45. Mandatory training modules
Active smoker admitted to Wythenshawe Hospital
Admitting team identify smoking status and provide brief advice (C)
Automated electronic referral to the CURE team – opt-out service
Admitting team assess the level of tobacco addiction (U)
Admitting immediately commences NRT according to level of addiction and CURE protocol (R)
Mandatory training modules
Specialist assessment by the CURE team (E)
Behavioural change support & motivational interviewing (40 min consultation)
Signposting and patient information
Offer & commence varenicline (bupropion in rare circumstances)
Discharged from hospital
1 week of discharge medications
Telephone FU at 1-2 weeks
Clinic FU at 4 weeks with CO confirmed quit rate
Telephone clinic FU at 12 weeks
Discharged back to primary care

46. Click to add text

48. Communication with primary care:
Discharge summary will contain all tobacco addiction medication
CURE specialist assessment form sent to GP
Telephone and clinic forms sent to GP
Generic prescribing information concerning medications relevant to that patient
GMMMG treatment pathway – co-developed with the CURE team

50. What do I ask of you?

51. Recognise the failings of our health services to treat the most deadly disease in our local population – collective responsibility
Change the stigma
Smoking Cessation = tobacco addiction
Lifestyle choice = disease
Prevention & public health = treatment & NHS
Correct the failings of the past
Support CURE in its implementation – ongoing prescriptions
Support roll out at Stockport Hospital 2019
Drive the agenda in primary care and commissioning circles
Break the barriers – prescribe!
Bring tobacco addiction treatment back into the Greater Manchester NHS patient services
Refer patients post discharge to community services
What do we ask of you?

53. “Tobacco is the most effective agent of death ever developed and deployed on a worldwide scale”
Questions?

54. Making Smoking History in Stockport:
NICE PH19 recommends the referral of all smokers to specialist services
Approx 30,000 smokers in Stockport
Prevalence: 28.8% Routine and Manual
30% in areas of deprivation
Gap in life expectancy 10 years (Ref: Public Health Profile 2018)
Approx 1,400 smokers attempted to quit in Stockport in 2017/18

55. Initiative in a Midlands Practice – 2 Year Period:
Specialist service in-house 1 day per week
Unplanned admissions for smoking related illness halved
Home visits to that group halved
GP appointments for smokers with long term conditions halved
Prescribing budget reduced

56. Embed smoking cessation into all care pathways – opt out NOT opt in
Refer patients to the specialist service
Tel:
Fax:
Website:
Specialist services will work in partnership within Practices
Support and medication
4 times likely to quit

57. ‘If you can’t make people want to do it, make them need to do it’
Professor Robert West, UKNSCC June 2015