1. Cessation in Pregnancy Incentives Trial (CPIT): effectiveness & cost effectiveness Linda Bauld & Kathleen Boyd Linda Bauld & Kathleen Boyd on behalf of The CPIT Research Team Jun-14

2. Outline CPIT TrialCPIT Trial –Background & context –Design –Main Results Economic EvaluationEconomic Evaluation –Within-trial analysis –Lifetime analysis –Results ConclusionsConclusions

3. Background 70% women have babies - pregnancy ideal opportunity to help70% women have babies - pregnancy ideal opportunity to help > 20% of pregnant women smoke in Scotland - 20% of pregnant women smoke in Scotland - < 1 in 20 quit Protects from miscarriage, stillbirth, pre-term birth & low birth weightProtects from miscarriage, stillbirth, pre-term birth & low birth weight Lifelong benefits include reduced incidence asthma, ADD & adult CVDLifelong benefits include reduced incidence asthma, ADD & adult CVD Children of smokers often smoke themselvesChildren of smokers often smoke themselves Extra pregnancy (£100-£700) & first year health services costs (£150 - £300) per smokerExtra pregnancy (£100-£700) & first year health services costs (£150 - £300) per smoker

4. Why Financial Incentives? Used in other areas of public health with some successUsed in other areas of public health with some success Evidence that increase engagement, retention & cessationEvidence that increase engagement, retention & cessation Best evidence of efficacy for incentives in pregnancyBest evidence of efficacy for incentives in pregnancy Cochrane review - financial incentives more effective than other intervention strategiesCochrane review - financial incentives more effective than other intervention strategies Growing evidence of ‘real world’ effectiveness from incentives schemes across UKGrowing evidence of ‘real world’ effectiveness from incentives schemes across UK NICE Recommendation for UK trial of incentivesNICE Recommendation for UK trial of incentives

5. All women in Greater Glasgow & Clyde HB area who smoked offered enrolment over 15 months 612 pregnant smokers enrolled 306 normal care Usual NHS support 9% quitters 306 incentives Up to £400 contingent on setting quit date & abstinence @ 4, 12 & 34-38 weeks PLUS normal NHS support 23% quitters Intervention & control Primary O/C Cessation in late pregnancy (saliva cotinine validated ) Allocation Assessment Trial Design

6. Main Trial Results Primary Outcome 14% absolute reduction in quit rates late pregnancy (9% vs 23%)14% absolute reduction in quit rates late pregnancy (9% vs 23%) RR smoking at end of pregnancy 0.85 [95% CI 0.79-0.91, p<0.0001]RR smoking at end of pregnancy 0.85 [95% CI 0.79-0.91, p<0.0001] Results unaffected after control for nicotine dependenceResults unaffected after control for nicotine dependence Around 20% may have ‘gamed’ cotinine assayAround 20% may have ‘gamed’ cotinine assay ‘True’ quit rate perhaps more modest 18% vs 7%‘True’ quit rate perhaps more modest 18% vs 7% Secondary Outcomes 81% intervention vs 78% control engaged with SPS81% intervention vs 78% control engaged with SPS Improved cessation rate at 4 weeks with incentives (43% vs 21%)Improved cessation rate at 4 weeks with incentives (43% vs 21%) SR abstinence postnatally (>=12 months after quit date) did not show increase in relapse rate in incentives groupSR abstinence postnatally (>=12 months after quit date) did not show increase in relapse rate in incentives group No difference in birthweight, stillbirth, miscarriage, or premature births between groupsNo difference in birthweight, stillbirth, miscarriage, or premature births between groups

7. Qualitative & Health Economic Results Qualitative analysis indicates:Qualitative analysis indicates: - accounts of trial participation positive - accounts of trial participation positive - home based monitoring visits acceptable - incentives generally acceptable to women & HCPs - incentives generally acceptable to women & HCPs - women & HCPs thought ‘gaming’ was possible - women & HCPs thought ‘gaming’ was possible Health economic analysis indicates:Health economic analysis indicates: - short term cost effectiveness £1127 per additional quitter - short term cost effectiveness £1127 per additional quitter - lifetime analysis incremental cost of £482 per QALY gained - lifetime analysis incremental cost of £482 per QALY gained - uncertainty around sustained quit rates postnatally & - uncertainty around sustained quit rates postnatally & results sensitive to this results sensitive to this

8. Voucher Spend

9. Economic Evaluation We know that smoking cessation is cost-effectiveWe know that smoking cessation is cost-effective Could Financial Incentives offer value for money compared to other cessation support?Could Financial Incentives offer value for money compared to other cessation support? Financial Incentives+ usual care V’s usual careFinancial Incentives+ usual care V’s usual care Incremental cost-effectiveness ratio (ICER)Incremental cost-effectiveness ratio (ICER) Within-trial analysis: Incremental cost per quitterWithin-trial analysis: Incremental cost per quitter Lifetime analysis: Incremental cost per QALYLifetime analysis: Incremental cost per QALY

10. Methods – Within trial Estimate Resource UseEstimate Resource Use –NRT –Cessation support Face to face, phone callsFace to face, phone calls –Financial Incentive vouchers Combine with unit costsCombine with unit costs –PSSRU, BNF –NHS Reference Costs Estimate Quit RateEstimate Quit Rate –34-38 week cotinine validated Incremental cost, Incremental quitIncremental cost, Incremental quit

11. Pregnant woman who smokes Treatment Financial incentive + usual care Quit 34-38 weeks Not quit Within trial analysis - trial duration Control Usual care outcomes £ cost Quit 34-38 weeks Not quit Decision Tree pathway

12. Lifetime analysis - Markov Model £ cost low birth weight baby Utility Model Specifics 2 Cohorts Mean age 28 yrs (CPIT trial) Time horizon 75 years Annual cycles Discount rate 3.5% Sensitivity Analysis Probabilistic analysis 6 scenario analyses Postnatal relapse Successful quit 34-38 weeks No postnatal relapse 3 months No quit 34-38 weeks 3 months postnatal relapse Risk relapse up to 8 yrs Background mortality rate Utility £ cost (scenario analysis) Smoking related mortality rate

13. Base-case results Within trial outcomes Lifetime model outcomes (discounted 3.5%) Intervention Within trial Mean Cost Prob quit 34-38 wks Lifetime Mean cost Lifetime QALY gained Control£85.380.086£1,26519.10 Incentives£242.750.227£1,28219.14 Difference£157.360.14-£17.210.036 (95% CI) (£155, £162)(0.08, 0.19)(-£93, £107)(-0.058, 0.145) ICER £1127 per quitter£482 per QALY gained

14. Cost-effectiveness plane: Incentives vs usual care 1000 incremental cost & QALY results from PSA Considerable uncertainty! Driven by uncertainty in postnatal relapse -assumed 60% Incentives, 30% Usual care

15. Conclusions Financial incentives may double the rates of abstinence from smoking at the end of pregnancy (8.6% to 22.5%) when added to existing cessation servicesFinancial incentives may double the rates of abstinence from smoking at the end of pregnancy (8.6% to 22.5%) when added to existing cessation services Financial Incentives are likely to be highly cost-effective & well below the NICE threshold of £20,000/QALYFinancial Incentives are likely to be highly cost-effective & well below the NICE threshold of £20,000/QALY Uncertainty remains regarding post-natal relapseUncertainty remains regarding post-natal relapse –When we use self-reported postnatal estimates at 3 months Financial incentives are cost saving and improve QALYs! Larger trial now required to demonstrate if this can work in other areasLarger trial now required to demonstrate if this can work in other areas

16. Acknowledgements This study was funded by the Chief Scientist’s Office of the Scottish Government, NHS Greater Glasgow and Clyde, the Glasgow Centre for Population Health and the Yorkhill Children’s FoundationThis study was funded by the Chief Scientist’s Office of the Scottish Government, NHS Greater Glasgow and Clyde, the Glasgow Centre for Population Health and the Yorkhill Children’s Foundation Research Team members included:Research Team members included: Prof David Tappin, Prof Linda Bauld, Ms Lesley Sinclair, Dr Kathleen Boyd, Prof Andy Briggs, Dr Alex McConnachie, Mr David Purves, Dr Andrew Radley, Prof Tim Coleman, Mrs Margaret McFadden, Mrs Sue Stevenson and colleaguesProf David Tappin, Prof Linda Bauld, Ms Lesley Sinclair, Dr Kathleen Boyd, Prof Andy Briggs, Dr Alex McConnachie, Mr David Purves, Dr Andrew Radley, Prof Tim Coleman, Mrs Margaret McFadden, Mrs Sue Stevenson and colleagues Particular thanks to:Particular thanks to: NHS GG&C Smokefree Pregnancy Service staff, Prof Carol Tannahill, Dr Linda de Caesteker, Mrs Brenda Friel, and Mrs Janet FergusonNHS GG&C Smokefree Pregnancy Service staff, Prof Carol Tannahill, Dr Linda de Caesteker, Mrs Brenda Friel, and Mrs Janet Ferguson

17. Thank you Linda.Bauld@stir.ac.uk Kathleen.Boyd@glasgow.ac.uk

18. Additional Info – Scenario analyses