Cessation in Pregnancy Incentives Trial (CPIT): effectiveness & cost effectiveness

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

2. Outline • CPIT Trial • Background & context • Design • Main Results • Economic Evaluation • Within-trial analysis • Lifetime analysis • Results • Conclusions

3. Background 70%women have babies - pregnancy ideal opportunity to help > 20% of pregnant women smoke in Scotland - < 1 in 20 quit Protects from miscarriage, stillbirth, pre-term birth & low birth weight Lifelong benefits include reduced incidence asthma, ADD & adult CVD Children of smokers often smoke themselves Extra 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 success Evidence that increase engagement, retention & cessation Best evidence of efficacy for incentives in pregnancy Cochrane review - financial incentives more effective than other intervention strategies Growing evidence of ‘real world’ effectiveness from incentives schemes across UK NICE Recommendation for UK trial of incentives

5. Trial Design Assessment Allocation Intervention & control Primary O/C Cessation in late pregnancy (saliva cotinine validated )

6. Main Trial Results Primary Outcome • 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] • Results unaffected after control for nicotine dependence • Around 20% may have ‘gamed’ cotinine assay • ‘True’ quit rate perhaps more modest 18% vs 7% Secondary Outcomes • 81% intervention vs 78% control engaged with SPS • 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 group • No difference in birthweight, stillbirth, miscarriage, or premature births between groups

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

8. Voucher Spend

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

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

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

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

13. Base-case results

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 services • Financial Incentives are likely to be highly cost-effective & well below the NICE threshold of £20,000/QALY • Uncertainty 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 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 Foundation 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 colleagues Particular thanks to: NHS 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